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First Non-Prescription Continuous Glucose Monitor Launches
Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.
As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.
“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.
Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.
He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”
The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.
Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.”
Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”
However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”
Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”
Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.
A version of this article first appeared on Medscape.com.
Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.
As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.
“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.
Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.
He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”
The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.
Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.”
Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”
However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”
Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”
Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.
A version of this article first appeared on Medscape.com.
Dexcom’s Stelo is designed specifically for people with type 2 diabetes who don’t use insulin or who have prediabetes but is now available over the counter for anyone for $99 a month or $89 per month with a subscription. It won’t be covered by insurance and there are no financial assistance programs as of now, but people can use healthcare spending accounts to pay for the devices.
As with current CGMs used by people with diabetes who take insulin, the waterproof device is worn on the back of the upper arm and sends real-time glucose values to a smartphone. No finger sticks are required. Each sensor lasts 15 days. Unlike current CGMs, Stelo does not issue low blood sugar alarms.
“We’re excited to empower people to have access to their glucose readings, which we know studies have been done time and time again that giving people continuous glucose monitors helps improve their time in range, their A1c, and their sense of well-being living with diabetes. ... We expect the same improvements with this product that we’ve had with the G series products,” Thomas Grace, MD, Dexcom’s head of Clinical Advocacy and Outcomes, said in an interview at a product launch event held on August 21, 2024.
Dr. Grace is a family physician and medical director of the Diabetes Center, Blanchard Valley Health System, in Findlay, Ohio, where he uses technology extensively in managing patients with diabetes, prediabetes, and obesity. For example, he always starts patients on a CGM before prescribing a glucagon-like peptide 1 (GLP-1) receptor agonist to help them see the effects of both type and quantity of the food they’re eating. “On the back end of that, people are more successful getting off of medications when they have data to support their behaviors and decisions,” he said.
He anticipates the availability of Stelo will help make inroads in bringing CGM technology to primary care. “My hope is that for the places where it hasn’t taken off yet, that patients that now have access to this are the cornerstone for clinicians to see how well people can do when they have the access to that data and that will lead to some impetus for change. In the United States, roughly less than 10% of people with diabetes have CGMs right now.”
The Stelo will soon have competition, as Abbott Diabetes Care will be launching two new over-the-counter CGMs in the coming months. “Since there isn’t a one-size-fits-all approach to glucose monitoring, Abbott has designed two different products. Lingo is designed for general consumers looking to enhance their overall health and wellness, while Libre Rio is designed for people with type 2 diabetes who do not use insulin and typically manage their condition through lifestyle changes,” an Abbott spokesperson said in an interview.
Aaron Neinstein, MD, chief medical officer of Notable, a company that applies artificial intelligence to healthcare, sees a “diminishing debate” regarding the value of CGMs for people beyond those who use insulin. “Metabolic health exists on a wide spectrum, from people who are completely healthy to those at high risk for diabetes due to family history or other medical conditions, to those with insulin resistance, those with prediabetes, those with diabetes not on insulin, and those with diabetes on insulin. So when we talk and think about CGM, we need to consider this wide range of people. The question is in which specific population do the benefits of CGM outweigh costs and any potential harms? Clearly, the farther you go into poor metabolic health, the stronger is the case for CGM.”
Dr. Neinstein added that “thankfully,” there is no more debate about the value of CGM use for people who use insulin and are therefore at a risk for hypoglycemia. But there is less debate now about even those who don’t take insulin, with emerging evidence that a “CGM provides biofeedback and helps them as a tool to support behavior changes and learning. I hope we will see insurance coverage broaden over time to cover CGM for more of these people who can benefit and who can improve their metabolic health through the use of CGM.”
However, Dr. Neinstein cautioned, “If you go to people who have no medical problems, no insulin resistance, no family history of diabetes, at that point, we do not have evidence that CGM is of health benefit.”
Moreover, he said, “ultimately if you have to choose whether a healthcare dollar goes to CGM or a GLP-1, the GLP-1 is a more impactful choice. In an ideal world, we would be able to support patients in having both, but with the profound benefits from GLP-1s on weight loss, cardiovascular outcomes, and [hemoglobin] A1c reduction and more, they are more potent than using a CGM.”
Dr. Grace is a Dexcom employee. Dr. Neinstein is a full-time employee at Notable, with no current further disclosures.
A version of this article first appeared on Medscape.com.
Research Could Bring ‘New Era’ in Insulin
The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon.
“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation.
All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”
Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that.
“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.
Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development.
It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”
Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said.
The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement.
And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted.
Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”
Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.
A version of this article first appeared on Medscape.com.
The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon.
“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation.
All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”
Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that.
“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.
Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development.
It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”
Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said.
The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement.
And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted.
Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”
Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.
A version of this article first appeared on Medscape.com.
The Type 1 Diabetes Grand Challenge comprises Diabetes UK, JDRF (now called “Breakthrough T1D” in the United States), and the Steve Morgan Foundation. It will provide a total of £50 million (about $64 million in US dollars) for type 1 diabetes research, including £15 million (~$19 million) for six separate projects on novel insulins to be conducted at universities in the United States, Australia, and China. Four will aim to develop glucose-responsive “smart” insulins, another one ultrafast-acting insulin, and the sixth a product combining insulin and glucagon.
“Even with the currently available modern insulins, people living with type 1 diabetes put lots of effort into managing their diabetes every day to find a good balance between acceptable glycemic control on the one hand and avoiding hypoglycemia on the other. The funded six new research projects address major shortcomings in insulin therapy,” Tim Heise, MD, vice-chair of the project’s Novel Insulins Scientific Advisory Panel, said in a statement from the Steve Morgan Foundation.
All six projects are currently in the preclinical stage, Dr. Heise said, noting that “the idea behind the funding program is to help the most promising research initiatives to reach the clinical stage.”
Glucose-responsive, or so-called “smart,” insulins are considered the holy grail because they would become active only to prevent hyperglycemia and remain dormant otherwise, thereby not causing hypoglycemia as current insulin analogs can. The idea isn’t new. In 2010, there was excitement in the type 1 diabetes community when the pharmaceutical company Merck acquired a smaller company called SmartCells that had been working on a “smart insulin” for several years. But nothing came of that.
“The challenges then and today are pretty similar. In particular, it is quite difficult to find a glucose-sensing moiety that is safe, reacts sufficiently to relatively small changes in the human body in both falling and increasing glucose, and can be produced in large quantities,” Dr. Heise, lead scientist and co-founder of the diabetes contract research organization Profil, based in Neuss, Germany, told this news organization.
Several papers since have reported proof-of-concept in rodents, but there are no published data thus far in humans. However, in recent years the major insulin manufacturers Novo Nordisk and Eli Lilly have acquired smaller companies with the aim of smart insulin development.
It will still take some time, Dr. Heise said. “The challenges are well understood, although difficult to overcome. There has been quite some progress in the development of glucose-sensing moieties including, but not limited to, nanotechnological approaches.”
Applications for the newly funded projects “were thoroughly reviewed by a large panel of scientists with different areas of expertise. At the end, there was agreement in the review panel that these projects deserved further investigation, although considering their early stage, there still is a substantial risk of failure for all these projects,” he said.
The development path might be a bit more straightforward for the other two projects. Ultra–fast-acting insulin is needed because the action of the current ones, Novo Nordisk’s Fiasp and Eli Lilly and Company’s Lyumjev, is still delayed, potentially leading to postmeal hyperglycemia if administered after or immediately prior to eating. “A truly rapid short-acting insulin might make it finally possible to progress from hybrid to fully closed loop systems, allowing a technological ‘cure’ for people with diabetes,” Dr. Heise said in the statement.
And a protein combining insulin with glucagon could help minimize the risk for hypoglycemia, which still exists for current insulin analogs and remains “one of the major concerns associated with insulin therapy today,” he noted.
Dr. Heise told this news organization that compared with “smart” insulin, development of the other two products “might be a bit faster if they succeed. But none of these approaches will make it to market in the next 5 years, and if one entered clinic within the next 2 years, that would be a huge success.” Nonetheless, “these research projects, if successful, might do no less than heralding a new era in insulin therapy.”
Dr. Heise is an employee of Profil, which has worked with a large number of the major diabetes industry manufacturers.
A version of this article first appeared on Medscape.com.
What Every Provider Should Know About Type 1 Diabetes
In July 2024, a 33-year-old woman with type 1 diabetes was boating on a hot day when her insulin delivery device slipped off. By the time she was able to exit the river, she was clearly ill, and an ambulance was called. The hospital was at capacity. Lying in the hallway, she was treated with fluids but not insulin, despite her boyfriend repeatedly telling the staff she had diabetes. She was released while still vomiting. The next morning, her boyfriend found her dead.
This story was shared by a friend of the woman in a Facebook group for people with type 1 diabetes and later confirmed by the boyfriend in a separate heartbreaking post. While it may be an extreme case,
In my 50+ years of living with the condition, I’ve lost track of the number of times I’ve had to speak up for myself, correct errors, raise issues that haven’t been considered, and educate nonspecialist healthcare professionals about even some of the basics.
Type 1 diabetes is an autoimmune condition in which the insulin-producing cells in the pancreas are destroyed, necessitating lifelong insulin treatment. Type 2, in contrast, arises from a combination of insulin resistance and decreased insulin production. Type 1 accounts for just 5% of all people with diabetes, but at a prevalence of about 1 in 200, it’s not rare. And that’s not even counting the adults who have been misdiagnosed as having type 2 but who actually have type 1.
As a general rule, people with type 1 diabetes are more insulin sensitive than those with type 2 and more prone to both hyper- and hypoglycemia. Blood sugar levels tend to be more labile and less predictable, even under normal circumstances. Recent advances in hybrid closed-loop technology have been extremely helpful in reducing the swings, but the systems aren’t foolproof yet. They still require user input (ie, guesswork), so there’s still room for error.
Managing type 1 diabetes is challenging even for endocrinologists. But here are some very important basics that every healthcare provider should know.
We Need Insulin 24/7
Never, ever withhold insulin from a person with type 1 diabetes, for any reason. Even when not eating — or when vomiting — we still need basal (background) insulin, either via long-acting analog or a pump infusion. The dose may need to be lowered to avoid hypoglycemia, but if insulin is stopped, diabetic ketoacidosis will result. And if that continues, death will follow.
This should be basic knowledge, but I’ve read and heard far too many stories of insulin being withheld from people with type 1 in various settings, including emergency departments, psychiatric facilities, and jails. On Facebook, people with type 1 diabetes often report being told not to take their insulin the morning before a procedure, while more than one has described “sneaking” their own insulin while hospitalized because they weren’t receiving any or not receiving enough.
On the flip side, although insulin needs are very individual, the amount needed for someone with type 1 is typically considerably less than for a person with type 2. Too much can result in severe hypoglycemia. There are lots of stories from people with type 1 diabetes who had to battle with hospital staff who tried to give them much higher doses than they knew they needed.
The American Diabetes Association recommends that people with type 1 diabetes who are hospitalized be allowed to wear their devices and self-manage to the degree possible. And please, listen to us when we tell you what we know about our own condition.
Fasting Is Fraught
I cringe every time I’m told to fast for a test or procedure. Fasting poses a risk for hypoglycemia in people with type 1 diabetes, even when using state-of-the-art technology. Fasting should not be required unless absolutely necessary, especially for routine lab tests.
Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University, East Lansing, Michigan, has published several papers on a phenomenon he calls “Fasting-Evoked En Route Hypoglycemia in Diabetes,” in which patients who fast overnight and skip breakfast experience hypoglycemia on the way to the lab.
“Patients continue taking their diabetes medication but don’t eat anything, resulting in low blood sugar levels that cause them to have a hypoglycemic event while driving to or from the lab, putting themselves and others at risk,” Dr. Aldasouqi explained, adding that fasting often isn’t necessary for routine lipid panels.
If fasting is necessary, as for a surgical procedure that involves anesthesia, the need for insulin adjustment — NOT withholding — should be discussed with the patient to determine whether they can do it themselves or whether their diabetes provider should be consulted.
But again, this is tricky even for endocrinologists. True story: When I had my second carpal tunnel surgery in July 2019, my hand surgeon wisely scheduled me for his first procedure in the morning to minimize the length of time I’d have to fast. (He has type 1 diabetes himself, which helped.) My endocrinologist had advised me, per guidelines, to cut back my basal insulin infusion on my pump by 20% before going to bed.
But at bedtime, my continuous glucose monitor (CGM) showed that I was in the 170 mg/dL’s and rising, not entirely surprising since I’d cut back on my predinner insulin dose knowing I wouldn’t be able to eat if I dropped low later. I didn’t cut back the basal.
When I woke up, my glucose level was over 300 mg/dL. This time, stress was the likely cause. (That’s happened before.) Despite giving myself several small insulin boluses that morning without eating, my blood sugar was still about 345 mg/dL when I arrived at the hospital. The nurse told me that if it had been over 375 mg/dL, they would have had to cancel the surgery, but it wasn’t, so they went ahead. I have no idea how they came up with that cutoff.
Anyway, thankfully, everything went fine; I brought my blood sugar back in target range afterward and healed normally. Point being, type 1 diabetes management is a crazy balancing act, and guidelines only go so far.
We Don’t React Well to Steroids
If it’s absolutely necessary to give steroids to a person with type 1 diabetes for any reason, plans must be made in advance for the inevitable glucose spike. If the person doesn’t know how to adjust their insulin for it, please have them consult their diabetes provider. In my experience with locally injected corticosteroids, the spike is always higher and longer than I expected. Thankfully, I haven’t had to deal with systemic steroids, but my guess is they’re probably worse.
Procedures Can Be Pesky
People who wear insulin pumps and/or CGMs must remove them for MRI and certain other imaging procedures. In some cases — as with CGMs and the Omnipod insulin delivery device that can’t be put back on after removal — this necessitates advance planning to bring along replacement equipment for immediately after the procedure.
Diabetes devices can stay in place for other imaging studies, such as x-rays, most CT scans, ECGs, and ultrasounds. For heaven’s sake, don’t ask us to remove our devices if it isn’t totally necessary.
In general, surprises that affect blood sugar are a bad idea. I recently underwent a gastric emptying study. I knew the test would involve eating radioactive eggs, but I didn’t find out there’s also a jelly sandwich with two slices of white bread until the technician handed it to me and told me to eat it. I had to quickly give myself insulin, and of course my blood sugar spiked later. Had I been forewarned, I could have at least “pre-bolused” 15-20 minutes in advance to give the insulin more time to start working.
Another anecdote: Prior to a dental appointment that involved numbing my gums for an in-depth cleaning, my longtime dental hygienist told me “be sure to eat before you come.” I do appreciate her thinking of my diabetes. However, while that advice would have made sense long ago when treatment involved two daily insulin injections without dose adjustments, now it’s more complicated.
Today, when we eat foods containing carbohydrates, we typically take short-acting insulin, which can lead to hypoglycemia if the dose given exceeds the amount needed for the carbs, regardless of how much is eaten. Better to not eat at all (assuming the basal insulin dose is correct) or just eat protein. And for the provider, best to just tell the patient about the eating limitations and make sure they know how to handle them.
Duh, We Already Have Diabetes
I’ve heard of at least four instances in which pregnant women with type 1 diabetes have been ordered to undergo an oral glucose tolerance test to screen for gestational diabetes. In two cases, it was a “can you believe it?!” post on Facebook, with the women rightly refusing to take the test.
But in May 2024, a pregnant woman reported she actually drank the liquid, her blood sugar skyrocketed, she was vomiting, and she was in the midst of trying to bring her glucose level down with insulin on her own at home. She hadn’t objected to taking the test because “my ob.gyn. knows I have diabetes,” so she figured it was appropriate.
I don’t work in a healthcare setting, but here’s my guess: The ob.gyn. hadn’t actually ordered the test but had neglected to UN-order a routine test for a pregnant patient who already had diabetes and obviously should NOT be forced to drink a high-sugar liquid for no reason. If this is happening in pregnancies with type 1 diabetes, it most certainly could be as well for those with pre-existing type 2 diabetes. Clearly, something should be done to prevent this unnecessary and potentially harmful scenario.
In summary, I think I speak for everyone living with type 1 diabetes in saying that we would like to have confidence that healthcare providers in all settings can provide care for whatever brought us to them without adding to the daily burden we already carry. Let’s work together.
Reviewed by Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University. A version of this article first appeared on Medscape.com.
In July 2024, a 33-year-old woman with type 1 diabetes was boating on a hot day when her insulin delivery device slipped off. By the time she was able to exit the river, she was clearly ill, and an ambulance was called. The hospital was at capacity. Lying in the hallway, she was treated with fluids but not insulin, despite her boyfriend repeatedly telling the staff she had diabetes. She was released while still vomiting. The next morning, her boyfriend found her dead.
This story was shared by a friend of the woman in a Facebook group for people with type 1 diabetes and later confirmed by the boyfriend in a separate heartbreaking post. While it may be an extreme case,
In my 50+ years of living with the condition, I’ve lost track of the number of times I’ve had to speak up for myself, correct errors, raise issues that haven’t been considered, and educate nonspecialist healthcare professionals about even some of the basics.
Type 1 diabetes is an autoimmune condition in which the insulin-producing cells in the pancreas are destroyed, necessitating lifelong insulin treatment. Type 2, in contrast, arises from a combination of insulin resistance and decreased insulin production. Type 1 accounts for just 5% of all people with diabetes, but at a prevalence of about 1 in 200, it’s not rare. And that’s not even counting the adults who have been misdiagnosed as having type 2 but who actually have type 1.
As a general rule, people with type 1 diabetes are more insulin sensitive than those with type 2 and more prone to both hyper- and hypoglycemia. Blood sugar levels tend to be more labile and less predictable, even under normal circumstances. Recent advances in hybrid closed-loop technology have been extremely helpful in reducing the swings, but the systems aren’t foolproof yet. They still require user input (ie, guesswork), so there’s still room for error.
Managing type 1 diabetes is challenging even for endocrinologists. But here are some very important basics that every healthcare provider should know.
We Need Insulin 24/7
Never, ever withhold insulin from a person with type 1 diabetes, for any reason. Even when not eating — or when vomiting — we still need basal (background) insulin, either via long-acting analog or a pump infusion. The dose may need to be lowered to avoid hypoglycemia, but if insulin is stopped, diabetic ketoacidosis will result. And if that continues, death will follow.
This should be basic knowledge, but I’ve read and heard far too many stories of insulin being withheld from people with type 1 in various settings, including emergency departments, psychiatric facilities, and jails. On Facebook, people with type 1 diabetes often report being told not to take their insulin the morning before a procedure, while more than one has described “sneaking” their own insulin while hospitalized because they weren’t receiving any or not receiving enough.
On the flip side, although insulin needs are very individual, the amount needed for someone with type 1 is typically considerably less than for a person with type 2. Too much can result in severe hypoglycemia. There are lots of stories from people with type 1 diabetes who had to battle with hospital staff who tried to give them much higher doses than they knew they needed.
The American Diabetes Association recommends that people with type 1 diabetes who are hospitalized be allowed to wear their devices and self-manage to the degree possible. And please, listen to us when we tell you what we know about our own condition.
Fasting Is Fraught
I cringe every time I’m told to fast for a test or procedure. Fasting poses a risk for hypoglycemia in people with type 1 diabetes, even when using state-of-the-art technology. Fasting should not be required unless absolutely necessary, especially for routine lab tests.
Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University, East Lansing, Michigan, has published several papers on a phenomenon he calls “Fasting-Evoked En Route Hypoglycemia in Diabetes,” in which patients who fast overnight and skip breakfast experience hypoglycemia on the way to the lab.
“Patients continue taking their diabetes medication but don’t eat anything, resulting in low blood sugar levels that cause them to have a hypoglycemic event while driving to or from the lab, putting themselves and others at risk,” Dr. Aldasouqi explained, adding that fasting often isn’t necessary for routine lipid panels.
If fasting is necessary, as for a surgical procedure that involves anesthesia, the need for insulin adjustment — NOT withholding — should be discussed with the patient to determine whether they can do it themselves or whether their diabetes provider should be consulted.
But again, this is tricky even for endocrinologists. True story: When I had my second carpal tunnel surgery in July 2019, my hand surgeon wisely scheduled me for his first procedure in the morning to minimize the length of time I’d have to fast. (He has type 1 diabetes himself, which helped.) My endocrinologist had advised me, per guidelines, to cut back my basal insulin infusion on my pump by 20% before going to bed.
But at bedtime, my continuous glucose monitor (CGM) showed that I was in the 170 mg/dL’s and rising, not entirely surprising since I’d cut back on my predinner insulin dose knowing I wouldn’t be able to eat if I dropped low later. I didn’t cut back the basal.
When I woke up, my glucose level was over 300 mg/dL. This time, stress was the likely cause. (That’s happened before.) Despite giving myself several small insulin boluses that morning without eating, my blood sugar was still about 345 mg/dL when I arrived at the hospital. The nurse told me that if it had been over 375 mg/dL, they would have had to cancel the surgery, but it wasn’t, so they went ahead. I have no idea how they came up with that cutoff.
Anyway, thankfully, everything went fine; I brought my blood sugar back in target range afterward and healed normally. Point being, type 1 diabetes management is a crazy balancing act, and guidelines only go so far.
We Don’t React Well to Steroids
If it’s absolutely necessary to give steroids to a person with type 1 diabetes for any reason, plans must be made in advance for the inevitable glucose spike. If the person doesn’t know how to adjust their insulin for it, please have them consult their diabetes provider. In my experience with locally injected corticosteroids, the spike is always higher and longer than I expected. Thankfully, I haven’t had to deal with systemic steroids, but my guess is they’re probably worse.
Procedures Can Be Pesky
People who wear insulin pumps and/or CGMs must remove them for MRI and certain other imaging procedures. In some cases — as with CGMs and the Omnipod insulin delivery device that can’t be put back on after removal — this necessitates advance planning to bring along replacement equipment for immediately after the procedure.
Diabetes devices can stay in place for other imaging studies, such as x-rays, most CT scans, ECGs, and ultrasounds. For heaven’s sake, don’t ask us to remove our devices if it isn’t totally necessary.
In general, surprises that affect blood sugar are a bad idea. I recently underwent a gastric emptying study. I knew the test would involve eating radioactive eggs, but I didn’t find out there’s also a jelly sandwich with two slices of white bread until the technician handed it to me and told me to eat it. I had to quickly give myself insulin, and of course my blood sugar spiked later. Had I been forewarned, I could have at least “pre-bolused” 15-20 minutes in advance to give the insulin more time to start working.
Another anecdote: Prior to a dental appointment that involved numbing my gums for an in-depth cleaning, my longtime dental hygienist told me “be sure to eat before you come.” I do appreciate her thinking of my diabetes. However, while that advice would have made sense long ago when treatment involved two daily insulin injections without dose adjustments, now it’s more complicated.
Today, when we eat foods containing carbohydrates, we typically take short-acting insulin, which can lead to hypoglycemia if the dose given exceeds the amount needed for the carbs, regardless of how much is eaten. Better to not eat at all (assuming the basal insulin dose is correct) or just eat protein. And for the provider, best to just tell the patient about the eating limitations and make sure they know how to handle them.
Duh, We Already Have Diabetes
I’ve heard of at least four instances in which pregnant women with type 1 diabetes have been ordered to undergo an oral glucose tolerance test to screen for gestational diabetes. In two cases, it was a “can you believe it?!” post on Facebook, with the women rightly refusing to take the test.
But in May 2024, a pregnant woman reported she actually drank the liquid, her blood sugar skyrocketed, she was vomiting, and she was in the midst of trying to bring her glucose level down with insulin on her own at home. She hadn’t objected to taking the test because “my ob.gyn. knows I have diabetes,” so she figured it was appropriate.
I don’t work in a healthcare setting, but here’s my guess: The ob.gyn. hadn’t actually ordered the test but had neglected to UN-order a routine test for a pregnant patient who already had diabetes and obviously should NOT be forced to drink a high-sugar liquid for no reason. If this is happening in pregnancies with type 1 diabetes, it most certainly could be as well for those with pre-existing type 2 diabetes. Clearly, something should be done to prevent this unnecessary and potentially harmful scenario.
In summary, I think I speak for everyone living with type 1 diabetes in saying that we would like to have confidence that healthcare providers in all settings can provide care for whatever brought us to them without adding to the daily burden we already carry. Let’s work together.
Reviewed by Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University. A version of this article first appeared on Medscape.com.
In July 2024, a 33-year-old woman with type 1 diabetes was boating on a hot day when her insulin delivery device slipped off. By the time she was able to exit the river, she was clearly ill, and an ambulance was called. The hospital was at capacity. Lying in the hallway, she was treated with fluids but not insulin, despite her boyfriend repeatedly telling the staff she had diabetes. She was released while still vomiting. The next morning, her boyfriend found her dead.
This story was shared by a friend of the woman in a Facebook group for people with type 1 diabetes and later confirmed by the boyfriend in a separate heartbreaking post. While it may be an extreme case,
In my 50+ years of living with the condition, I’ve lost track of the number of times I’ve had to speak up for myself, correct errors, raise issues that haven’t been considered, and educate nonspecialist healthcare professionals about even some of the basics.
Type 1 diabetes is an autoimmune condition in which the insulin-producing cells in the pancreas are destroyed, necessitating lifelong insulin treatment. Type 2, in contrast, arises from a combination of insulin resistance and decreased insulin production. Type 1 accounts for just 5% of all people with diabetes, but at a prevalence of about 1 in 200, it’s not rare. And that’s not even counting the adults who have been misdiagnosed as having type 2 but who actually have type 1.
As a general rule, people with type 1 diabetes are more insulin sensitive than those with type 2 and more prone to both hyper- and hypoglycemia. Blood sugar levels tend to be more labile and less predictable, even under normal circumstances. Recent advances in hybrid closed-loop technology have been extremely helpful in reducing the swings, but the systems aren’t foolproof yet. They still require user input (ie, guesswork), so there’s still room for error.
Managing type 1 diabetes is challenging even for endocrinologists. But here are some very important basics that every healthcare provider should know.
We Need Insulin 24/7
Never, ever withhold insulin from a person with type 1 diabetes, for any reason. Even when not eating — or when vomiting — we still need basal (background) insulin, either via long-acting analog or a pump infusion. The dose may need to be lowered to avoid hypoglycemia, but if insulin is stopped, diabetic ketoacidosis will result. And if that continues, death will follow.
This should be basic knowledge, but I’ve read and heard far too many stories of insulin being withheld from people with type 1 in various settings, including emergency departments, psychiatric facilities, and jails. On Facebook, people with type 1 diabetes often report being told not to take their insulin the morning before a procedure, while more than one has described “sneaking” their own insulin while hospitalized because they weren’t receiving any or not receiving enough.
On the flip side, although insulin needs are very individual, the amount needed for someone with type 1 is typically considerably less than for a person with type 2. Too much can result in severe hypoglycemia. There are lots of stories from people with type 1 diabetes who had to battle with hospital staff who tried to give them much higher doses than they knew they needed.
The American Diabetes Association recommends that people with type 1 diabetes who are hospitalized be allowed to wear their devices and self-manage to the degree possible. And please, listen to us when we tell you what we know about our own condition.
Fasting Is Fraught
I cringe every time I’m told to fast for a test or procedure. Fasting poses a risk for hypoglycemia in people with type 1 diabetes, even when using state-of-the-art technology. Fasting should not be required unless absolutely necessary, especially for routine lab tests.
Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University, East Lansing, Michigan, has published several papers on a phenomenon he calls “Fasting-Evoked En Route Hypoglycemia in Diabetes,” in which patients who fast overnight and skip breakfast experience hypoglycemia on the way to the lab.
“Patients continue taking their diabetes medication but don’t eat anything, resulting in low blood sugar levels that cause them to have a hypoglycemic event while driving to or from the lab, putting themselves and others at risk,” Dr. Aldasouqi explained, adding that fasting often isn’t necessary for routine lipid panels.
If fasting is necessary, as for a surgical procedure that involves anesthesia, the need for insulin adjustment — NOT withholding — should be discussed with the patient to determine whether they can do it themselves or whether their diabetes provider should be consulted.
But again, this is tricky even for endocrinologists. True story: When I had my second carpal tunnel surgery in July 2019, my hand surgeon wisely scheduled me for his first procedure in the morning to minimize the length of time I’d have to fast. (He has type 1 diabetes himself, which helped.) My endocrinologist had advised me, per guidelines, to cut back my basal insulin infusion on my pump by 20% before going to bed.
But at bedtime, my continuous glucose monitor (CGM) showed that I was in the 170 mg/dL’s and rising, not entirely surprising since I’d cut back on my predinner insulin dose knowing I wouldn’t be able to eat if I dropped low later. I didn’t cut back the basal.
When I woke up, my glucose level was over 300 mg/dL. This time, stress was the likely cause. (That’s happened before.) Despite giving myself several small insulin boluses that morning without eating, my blood sugar was still about 345 mg/dL when I arrived at the hospital. The nurse told me that if it had been over 375 mg/dL, they would have had to cancel the surgery, but it wasn’t, so they went ahead. I have no idea how they came up with that cutoff.
Anyway, thankfully, everything went fine; I brought my blood sugar back in target range afterward and healed normally. Point being, type 1 diabetes management is a crazy balancing act, and guidelines only go so far.
We Don’t React Well to Steroids
If it’s absolutely necessary to give steroids to a person with type 1 diabetes for any reason, plans must be made in advance for the inevitable glucose spike. If the person doesn’t know how to adjust their insulin for it, please have them consult their diabetes provider. In my experience with locally injected corticosteroids, the spike is always higher and longer than I expected. Thankfully, I haven’t had to deal with systemic steroids, but my guess is they’re probably worse.
Procedures Can Be Pesky
People who wear insulin pumps and/or CGMs must remove them for MRI and certain other imaging procedures. In some cases — as with CGMs and the Omnipod insulin delivery device that can’t be put back on after removal — this necessitates advance planning to bring along replacement equipment for immediately after the procedure.
Diabetes devices can stay in place for other imaging studies, such as x-rays, most CT scans, ECGs, and ultrasounds. For heaven’s sake, don’t ask us to remove our devices if it isn’t totally necessary.
In general, surprises that affect blood sugar are a bad idea. I recently underwent a gastric emptying study. I knew the test would involve eating radioactive eggs, but I didn’t find out there’s also a jelly sandwich with two slices of white bread until the technician handed it to me and told me to eat it. I had to quickly give myself insulin, and of course my blood sugar spiked later. Had I been forewarned, I could have at least “pre-bolused” 15-20 minutes in advance to give the insulin more time to start working.
Another anecdote: Prior to a dental appointment that involved numbing my gums for an in-depth cleaning, my longtime dental hygienist told me “be sure to eat before you come.” I do appreciate her thinking of my diabetes. However, while that advice would have made sense long ago when treatment involved two daily insulin injections without dose adjustments, now it’s more complicated.
Today, when we eat foods containing carbohydrates, we typically take short-acting insulin, which can lead to hypoglycemia if the dose given exceeds the amount needed for the carbs, regardless of how much is eaten. Better to not eat at all (assuming the basal insulin dose is correct) or just eat protein. And for the provider, best to just tell the patient about the eating limitations and make sure they know how to handle them.
Duh, We Already Have Diabetes
I’ve heard of at least four instances in which pregnant women with type 1 diabetes have been ordered to undergo an oral glucose tolerance test to screen for gestational diabetes. In two cases, it was a “can you believe it?!” post on Facebook, with the women rightly refusing to take the test.
But in May 2024, a pregnant woman reported she actually drank the liquid, her blood sugar skyrocketed, she was vomiting, and she was in the midst of trying to bring her glucose level down with insulin on her own at home. She hadn’t objected to taking the test because “my ob.gyn. knows I have diabetes,” so she figured it was appropriate.
I don’t work in a healthcare setting, but here’s my guess: The ob.gyn. hadn’t actually ordered the test but had neglected to UN-order a routine test for a pregnant patient who already had diabetes and obviously should NOT be forced to drink a high-sugar liquid for no reason. If this is happening in pregnancies with type 1 diabetes, it most certainly could be as well for those with pre-existing type 2 diabetes. Clearly, something should be done to prevent this unnecessary and potentially harmful scenario.
In summary, I think I speak for everyone living with type 1 diabetes in saying that we would like to have confidence that healthcare providers in all settings can provide care for whatever brought us to them without adding to the daily burden we already carry. Let’s work together.
Reviewed by Saleh Aldasouqi, MD, chief of endocrinology at Michigan State University. A version of this article first appeared on Medscape.com.
As CGM Benefit Data Accrue, Primary Care Use Expands
ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.
Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.
Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)
This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.
“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.
But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
Informing Food Choice, Treatment Intensification
At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.
At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).
“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.
And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
Diabetes Care and Education Specialists (DCESs) Assist CGM Use
Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.
“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.
Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).
The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.
Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.
Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.
“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.
Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”
Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.
“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
What Predicts Primary Care CGM Prescribing?
Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”
Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.
Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.
More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.
Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.
No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.
For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.
These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.
At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.
In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”
The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.
“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”
Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.
The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.
Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
A version of this article first appeared on Medscape.com.
ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.
Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.
Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)
This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.
“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.
But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
Informing Food Choice, Treatment Intensification
At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.
At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).
“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.
And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
Diabetes Care and Education Specialists (DCESs) Assist CGM Use
Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.
“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.
Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).
The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.
Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.
Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.
“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.
Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”
Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.
“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
What Predicts Primary Care CGM Prescribing?
Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”
Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.
Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.
More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.
Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.
No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.
For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.
These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.
At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.
In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”
The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.
“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”
Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.
The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.
Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
A version of this article first appeared on Medscape.com.
ORLANDO, FLORIDA — As increasing data show benefit for continuous glucose monitoring (CGM) devices beyond just insulin-treated diabetes, efforts are being made to optimize the use of CGM in primary care settings.
Currently, Medicare and most private insurers cover CGM for people with diabetes who use insulin, regardless of the type of diabetes or the type of insulin, and for those with a history of severe hypoglycemia. Data are increasingly showing benefit for people who don’t use insulin. As of now, with the exception of some state Medicaid beneficiaries, the majority must pay out of pocket.
Such use is expected to grow with the upcoming availability of two new over-the-counter CGMs, Dexcom’s Stelo and Abbott’s Libre Rio, both made for people with diabetes who don’t use insulin. (Abbott will also launch the Lingo, a wellness CGM for people without diabetes.)
This means that CGM will become increasingly prevalent in primary care, where there is currently a great deal of variability in the capacity to manage and use the data generated by the devices to improve diabetes management, experts said during an oral abstract session at the recent American Diabetes Association (ADA) 84th Scientific Sessions and in interviews with this news organization.
“It’s picking up steam, and there’s a lot more visibility of CGM in primary care and a lot more people prescribing it,” Thomas W. Martens, MD, medical director of the International Diabetes Center at HealthPartners Institute, Minneapolis, told this news organization. He noted that the recent switch in many cases of CGM from billing as durable medical equipment to pharmacy has made prescribing easier, while television advertising has increased demand.
But still unclear, he noted, is how the CGM data are being used. “The question is, are prescriptions just being sent out and people using it like a finger-stick blood glucose monitor, or is primary care really using the data to move diabetes forward? I think that’s where a lot of the work on dissemination and implementation is going. How do we really make this a useful tool for optimizing diabetes care?”
Informing Food Choice, Treatment Intensification
At the ADA meeting, Dr. Martens presented topline data from a randomized multicenter controlled trial funded by Abbott, examining the effect of CGM use on guiding food choices and other behaviors in 72 adults with type 2 diabetes who were not using insulin but who were using other glucose-lowering medications.
At 3 months, with no medication changes, there was a significant overall 26% reduction in time spent above 180 mg/dL (P < .0001), which didn›t differ significantly between those randomized to CGM alone or in conjunction with a food logging app. Both groups also experienced a significant 1.1% reduction in A1c (P < .0001) and about a 4-lb weight loss (P = .014 for CGM alone, P = .0032 for CGM + app).
“The win for people not on insulin is you can see the impact of food choices really quickly with a CGM ... and then perhaps modify that to improve postprandial hyperglycemia,” Dr. Martens said.
And for the clinician, “not everybody with type 2 diabetes not on insulin can get where they need to be just by changing their diets. The CGM is a pretty good tool for knowing when you need to advance therapy.”
Diabetes Care and Education Specialists (DCESs) Assist CGM Use
Another speaker at the ADA meeting, Sean M. Oser, MD, director of the Practice Innovation Program and associated director of the Primary Care Diabetes Lab at the University of Colorado Anschutz Medical Campus, Aurora, Colorado, noted that 90% of adults with type 2 diabetes and 50% with type 1 diabetes receive their diabetes care in primary care settings.
“CGM is increasingly becoming standard of care in diabetes ... But [primary care providers] remain relatively untrained about CGM ... What I’m concerned about is the disparity disparities in who has access and who does not. We really need to bring our primary care colleagues along,” he said.
Dr. Oser described tools he and his wife, Tamara K. Oser, MD, professor in the Department of Family Medicine at the same institution, developed in conjunction with the American Academy of Family Physicians (AAFP), including the Transformation in Practice series (TIPS).
The PREPARE 4 CGM study examined the use of three different strategies for incorporating CGM into primary care settings: Either use of AAFP TIPS alone, TIPS plus practice facilitation services by coaches who assist the practice in implementing new workflows, or referral to a virtual CGM initiation service (virCIS) with a virtual CGM workshop that Dr. Oser and Dr. Oser also developed.
Of the 76 Colorado primary care practices participating (out of 60 planned), the 46 who chose AAFP TIPS were randomized to either the AAFP TIPS alone or to TIPS + practice facilitation. The other 30 chose virCIS with the onetime CGM basics webinar. The fact that more practices than anticipated were recruited for the study suggests that “primary care interest in CGM is very high. They want to learn,” Dr. Oser noted.
Of the 51 practice characteristics investigated, only one, the presence of a DCES, in the practice, was significantly associated with the choice of CGM implementation strategy. Of the 16 practices with access to a DCES, all of them chose self-initiation with CGM using TIPS. But of the 60 practices without a DCES, half chose the virCIS.
“We know that 36% of primary care practices have access to a DCES within the clinic, part-time or full-time, and that’s not enough, I would argue,” Dr. Oser said.
Indeed, Dr. Martens told this news organization that those professionals, formerly called “diabetes educators,” often aren’t available in primary care settings, especially in rural areas. “Unfortunately, they are not well reimbursed. A lot of care systems don’t employ as many as they ideally should because it tends not to be a moneymaker ... Something’s got to change with reimbursement for the cognitive aspects of diabetes management.”
Dr. Oser said his team’s next steps include completion of the virCIS operations, analysis of the effectiveness of the three implantation strategies in practice- and patient-level outcomes, a cost analysis of the three strategies, and further development of toolkits to assist in these efforts.
“One of our goals is to keep people at their primary care home, where they want to be ... Diabetes knows no borders. People should have access wherever they are,” Dr. Oser concluded in his ADA talk.
What Predicts Primary Care CGM Prescribing?
Further clues about effective strategies to improve CGM prescribing in primary care were provided in a study presented by Jovan Milosavljevic, MD, a second-year endocrinology fellow at the Fleischer Institute for Diabetes and Metabolism, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, New York.
He began by noting that there are currently 61.5 million diabetes visits annually in primary care compared with 32.0 million in specialty care and that there is a shortage of endocrinologists in the face of the rising number of people diagnosed with diabetes. “Primary care will continue to be the only point of care for most people with diabetes. So, standard-of-care treatment such as CGM must enter routine primary care practice to impact population-level health outcomes.”
Electronic health record data were examined for 39,710 patients with type 2 diabetes seen at 13 primary care sites affiliated with Montefiore Medical Center, a large safety net hospital in New York, where CGM is widely covered by public insurance. Between July 31, 2020, and July 31, 2023, a total of 3503, or just 8.8%, were prescribed CGM by a primary care provider.
Those with CGM prescribed were younger than those without (59.7 vs 62.7 years), about 40% of both groups were Hispanic or Black, and a majority were English-speaking: 84.5% of those prescribed CGM spoke English, while only 13.1% spoke Spanish. Over half (59.1%) of those prescribed CGM had commercial insurance, while only 11.2% had Medicaid and 29.7% had Medicare.
More patients with CGM prescribed had providers with more than 10 years in practice: 72.5% vs 64.5% with no CGM.
Not surprisingly, those with CGM prescribed were more likely on insulin — 21% using just basal and 35% on multiple daily injections. Those prescribed CGM had higher A1c levels before CGM prescription: 9.2% vs 7.2% for those not prescribed CGM.
No racial or ethnic bias was found in the relationships between CGM use and insulin use, provider experience, engagement with care, and A1c. However, there were differences by age, sex, and spoken language.
For example, the Hispanic group aged 65 years and older was less likely than those younger to be prescribed CGM, but this wasn’t seen in other ethnic groups. In fact, older White people were slightly more likely to have CGM prescribed. Spanish-speaking patients were about 43% less likely to have CGM prescribed than were English-speaking patients.
These findings suggest a dual approach might work best for improving CGM prescribing in primary care. “We can leverage the knowledge that some of these factors are independent of bias and promote clinical and evidence-based guidelines for CGM. Additionally, we should focus on physicians in training,” Dr. Milosavljevic said.
At the same time, “we need to tackle systemic inequity in prescription processes,” with measures such as improving prescription workflows, supporting prior authorization, and using patient hands-on support for older adults and Spanish-speaking individuals, he said.
In a message to this news organization, Tamara K. Oser, MD, wrote, “Disparities in CGM and other diabetes technology are prevalent and multifactorial. In addition to insurance barriers, implicit bias also plays a large role. Shared decision-making should always be used when deciding to prescribe diabetes technologies.”
The PREPARE 4 CGM study is evaluating willingness to pay for CGM, she noted.
“Even patients without insurance might want to purchase one sensor every few months to empower them to learn more about how food and exercise affect their glucose or to help assess the need for [adjusting] diabetes medications. It is an exciting time for people living with diabetes. Primary care, endocrinology, device manufacturers, and insurers should all do their part to assure increased access to these evidence-based technologies.”
Dr. Martens’ employer has received funds on his behalf for research and speaking support from Dexcom, Abbott Diabetes Care, Medtronic, Insulet, Tandem, Sanofi, Eli Lilly and Company, and Novo Nordisk, and for consulting from Sanofi and Eli Lilly and Company. He is employed by the nonprofit HealthPartners Institute dba International Diabetes Center and received no personal income from these activities.
The Osers have received advisory board consulting fees (through the University of Colorado) from Dexcom, Medscape Medical News, Ascensia, and Blue Circle Health and research grants (through the University of Colorado) from National Institute of Nursing Research, National Institute of Diabetes and Digestive and Kidney Diseases, the Helmsley Charitable Trust, Abbott Diabetes, Dexcom, and Insulet. They do not own stocks in any device or pharmaceutical company.
Dr. Milosavljevic’s work was supported by the National Institutes of Health/National Center for Advancing Translational Science and Einstein-Montefiore Clinical and Translational Science Awards. He had no further disclosures.
A version of this article first appeared on Medscape.com.
FROM ADA 2024
Non-Prescription Semaglutide Purchased Online Poses Risks
Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found.
Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Of the three delivered, one was potentially contaminated, and all three contained higher concentrations of semaglutide than indicated on the label, potentially resulting in an overdose.
“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” wrote Amir Reza Ashraf, PharmD, of the University of Pécs, Hungary, and colleagues in their paper, published online on August 2, 2024, in JAMA Network Open.
The study was conducted in July 2023, but its publication comes a week after the US Food and Drug Administration (FDA) issued an alert about dosing errors in compounded semaglutide, which typically does require a prescription.
Study coauthor Tim K. Mackey, PhD, told this news organization, “Compounding pharmacies are another element of this risk that has become more prominent now but arguably have more controls if prescribed appropriately, while the traditional ‘no-prescription’ online market still exists and will continue to evolve.”
Overall, said Dr. Mackey, professor of global health at the University of California San Diego and director of the Global Health Policy and Data Institute,
He advises clinicians to actively discuss with their patients the risks associated with semaglutide and, specifically, the dangers of buying it online. “Clinicians can act as a primary information source for patient safety information by letting their patients know about these risks ... and also asking where patients get their medications in case they are concerned about reports of adverse events or other patient safety issues.”
Buyer Beware: Online Semaglutide Purchases Not as They Seem
The investigators began by searching online for websites advertising semaglutide without a prescription. They ordered products from six online vendors that showed up prominently in the searches. Of those, three offered prefilled 0.25 mg/dose semaglutide injection pens, while the other three sold vials of lyophilized semaglutide powder to be reconstituted to solution for injection. Prices for the smallest dose and quantity ranged from $113 to $360.
Only three of the ordered products — all vials — actually showed up. The advertised prefilled pens were all nondelivery scams, with requests for an extra payment of $650-$1200 purportedly to clear customs. This was confirmed as fraudulent by customs agencies, the authors noted.
The three vial products were received and assessed physically, of both the packaging and the actual product, by liquid chromatography-mass spectrometry to determine purity and peptide concentration, and microbiologically, to examine sterility.
Using a checklist from the International Pharmaceutical Federation, Dr. Ashraf and colleagues found “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.”
Quality testing showed that one sample had an elevated presence of endotoxin suggesting possible contamination. While all three actually did contain semaglutide, the measured content exceeded the labeled amount by 29%-39%, posing a risk that users could receive up to 39% more than intended per injection, “particularly concerning if a consumer has to reconstitute and self-inject,” Dr. Mackey noted.
At least one of these sites in this study, “semaspace.com,” was subsequently sent a warning letter by the FDA for unauthorized semaglutide sale, Mackey noted.
Unfortunately, he told this news organization, these dangers are likely to persist. “There is a strong market opportunity to introduce counterfeit and unauthorized versions of semaglutide. Counterfeiters will continue to innovate with where they sell products, what products they offer, and how they mislead consumers about the safety and legality of what they are offering online. We are likely just at the beginning of counterfeiting of semaglutide, and it is likely that these false products will become endemic in our supply chain.”
The research was supported by the Hungarian Scientific Research Fund. The authors had no further disclosures.
A version of this article appeared on Medscape.com.
Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found.
Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Of the three delivered, one was potentially contaminated, and all three contained higher concentrations of semaglutide than indicated on the label, potentially resulting in an overdose.
“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” wrote Amir Reza Ashraf, PharmD, of the University of Pécs, Hungary, and colleagues in their paper, published online on August 2, 2024, in JAMA Network Open.
The study was conducted in July 2023, but its publication comes a week after the US Food and Drug Administration (FDA) issued an alert about dosing errors in compounded semaglutide, which typically does require a prescription.
Study coauthor Tim K. Mackey, PhD, told this news organization, “Compounding pharmacies are another element of this risk that has become more prominent now but arguably have more controls if prescribed appropriately, while the traditional ‘no-prescription’ online market still exists and will continue to evolve.”
Overall, said Dr. Mackey, professor of global health at the University of California San Diego and director of the Global Health Policy and Data Institute,
He advises clinicians to actively discuss with their patients the risks associated with semaglutide and, specifically, the dangers of buying it online. “Clinicians can act as a primary information source for patient safety information by letting their patients know about these risks ... and also asking where patients get their medications in case they are concerned about reports of adverse events or other patient safety issues.”
Buyer Beware: Online Semaglutide Purchases Not as They Seem
The investigators began by searching online for websites advertising semaglutide without a prescription. They ordered products from six online vendors that showed up prominently in the searches. Of those, three offered prefilled 0.25 mg/dose semaglutide injection pens, while the other three sold vials of lyophilized semaglutide powder to be reconstituted to solution for injection. Prices for the smallest dose and quantity ranged from $113 to $360.
Only three of the ordered products — all vials — actually showed up. The advertised prefilled pens were all nondelivery scams, with requests for an extra payment of $650-$1200 purportedly to clear customs. This was confirmed as fraudulent by customs agencies, the authors noted.
The three vial products were received and assessed physically, of both the packaging and the actual product, by liquid chromatography-mass spectrometry to determine purity and peptide concentration, and microbiologically, to examine sterility.
Using a checklist from the International Pharmaceutical Federation, Dr. Ashraf and colleagues found “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.”
Quality testing showed that one sample had an elevated presence of endotoxin suggesting possible contamination. While all three actually did contain semaglutide, the measured content exceeded the labeled amount by 29%-39%, posing a risk that users could receive up to 39% more than intended per injection, “particularly concerning if a consumer has to reconstitute and self-inject,” Dr. Mackey noted.
At least one of these sites in this study, “semaspace.com,” was subsequently sent a warning letter by the FDA for unauthorized semaglutide sale, Mackey noted.
Unfortunately, he told this news organization, these dangers are likely to persist. “There is a strong market opportunity to introduce counterfeit and unauthorized versions of semaglutide. Counterfeiters will continue to innovate with where they sell products, what products they offer, and how they mislead consumers about the safety and legality of what they are offering online. We are likely just at the beginning of counterfeiting of semaglutide, and it is likely that these false products will become endemic in our supply chain.”
The research was supported by the Hungarian Scientific Research Fund. The authors had no further disclosures.
A version of this article appeared on Medscape.com.
Semaglutide products sold online without a prescription may pose multiple risks to consumers, new research found.
Of six test purchases of semaglutide products offered online without a prescription, only three were actually received. The other three vendors demanded additional payment. Of the three delivered, one was potentially contaminated, and all three contained higher concentrations of semaglutide than indicated on the label, potentially resulting in an overdose.
“Semaglutide products are actively being sold without prescription by illegal online pharmacies, with vendors shipping unregistered and falsified products,” wrote Amir Reza Ashraf, PharmD, of the University of Pécs, Hungary, and colleagues in their paper, published online on August 2, 2024, in JAMA Network Open.
The study was conducted in July 2023, but its publication comes a week after the US Food and Drug Administration (FDA) issued an alert about dosing errors in compounded semaglutide, which typically does require a prescription.
Study coauthor Tim K. Mackey, PhD, told this news organization, “Compounding pharmacies are another element of this risk that has become more prominent now but arguably have more controls if prescribed appropriately, while the traditional ‘no-prescription’ online market still exists and will continue to evolve.”
Overall, said Dr. Mackey, professor of global health at the University of California San Diego and director of the Global Health Policy and Data Institute,
He advises clinicians to actively discuss with their patients the risks associated with semaglutide and, specifically, the dangers of buying it online. “Clinicians can act as a primary information source for patient safety information by letting their patients know about these risks ... and also asking where patients get their medications in case they are concerned about reports of adverse events or other patient safety issues.”
Buyer Beware: Online Semaglutide Purchases Not as They Seem
The investigators began by searching online for websites advertising semaglutide without a prescription. They ordered products from six online vendors that showed up prominently in the searches. Of those, three offered prefilled 0.25 mg/dose semaglutide injection pens, while the other three sold vials of lyophilized semaglutide powder to be reconstituted to solution for injection. Prices for the smallest dose and quantity ranged from $113 to $360.
Only three of the ordered products — all vials — actually showed up. The advertised prefilled pens were all nondelivery scams, with requests for an extra payment of $650-$1200 purportedly to clear customs. This was confirmed as fraudulent by customs agencies, the authors noted.
The three vial products were received and assessed physically, of both the packaging and the actual product, by liquid chromatography-mass spectrometry to determine purity and peptide concentration, and microbiologically, to examine sterility.
Using a checklist from the International Pharmaceutical Federation, Dr. Ashraf and colleagues found “clear discrepancies in regulatory registration information, accurate labeling, and evidence products were likely unregistered or unlicensed.”
Quality testing showed that one sample had an elevated presence of endotoxin suggesting possible contamination. While all three actually did contain semaglutide, the measured content exceeded the labeled amount by 29%-39%, posing a risk that users could receive up to 39% more than intended per injection, “particularly concerning if a consumer has to reconstitute and self-inject,” Dr. Mackey noted.
At least one of these sites in this study, “semaspace.com,” was subsequently sent a warning letter by the FDA for unauthorized semaglutide sale, Mackey noted.
Unfortunately, he told this news organization, these dangers are likely to persist. “There is a strong market opportunity to introduce counterfeit and unauthorized versions of semaglutide. Counterfeiters will continue to innovate with where they sell products, what products they offer, and how they mislead consumers about the safety and legality of what they are offering online. We are likely just at the beginning of counterfeiting of semaglutide, and it is likely that these false products will become endemic in our supply chain.”
The research was supported by the Hungarian Scientific Research Fund. The authors had no further disclosures.
A version of this article appeared on Medscape.com.
Experts Debate How to Best Define Obesity
in three new opinion papers.
The three statements were published on July 22, 2024, in Annals of Internal Medicine. In one, the authors expressed caution about the recent movement away from using BMI alone to define obesity, noting that the measure remains a useful population-level and clinical tool for addressing adiposity, particularly within racial and ethnic groups. But the authors of a second paper pointed out that the use of lower BMI cutoffs to define obesity in Asian populations, in place since 2004, is inadequate in part because it doesn’t account for heterogeneity among different Asian groups.
And in the third paper, an editorial, an Annals editor cautioned that the recent framing of obesity exclusively as a “disease” rather than a “broader, more inclusive construct” may inadvertently reinforce the bias it was meant to combat.
Asked to comment on the issues raised in the papers, Professor Gijs Goossens of Maastricht University Medical Center, Maastricht, the Netherlands, said, “It is important to emphasize that the management and treatment of obesity have wider objectives than weight loss alone and include the prevention, resolution, or improvement of obesity-related complications; achieving better quality of life and mental well-being; and improvement of physical and social functioning.”
Added Dr. Goossens, who was an author of a recent European Association for the Study of Obesity (EASO) framework calling for moving beyond BMI in defining obesity, “Personalized therapeutic goals should be set at the beginning of the treatment, according to the stage of obesity, taking into account available therapeutic options, possible side effects or risks, and patient preferences. The drivers of obesity and possible barriers to treatment should also be discussed with the patient.” Dr. Goossens emphasized that he was providing his personal views and not speaking for the EASO or his coauthors.
BMI: ‘Not a Perfect Measure of Adiposity but Remains Useful’
In their “Ideas and Opinions” paper, Adolfo G. Cuevas, PhD, of New York University School of Global Public Health, New York City, and Walter C. Willett, MD, DrPH, of Harvard T.H. Chan School of Public Health, Boston, argued that “BMI, although not a perfect measure of adiposity, remains a useful population-level and clinical tool for addressing adiposity, including within groups defined by race and ethnicity.”
They added that despite the criticism that BMI doesn’t distinguish between fat and lean body mass, the measure still strongly correlates with fat mass as well as cardiovascular risk and mortality, and it does so similarly across racial and ethnic groups.
Clinically, Dr. Cuevas and Dr. Willett pointed out that BMI correlates fat mass as assessed with the gold standard measure dual x-ray absorptiometry but is far simpler and less expensive. Measuring waist circumference can provide additional information about visceral fat and disease risk but is “more difficult to standardize and suffers from the same limitations as BMI when cut points are used.”
They suggest the addition of change in weight since early adulthood and over time as a “simple and sensitive variable” for assessing adiposity.
Luca Busetto, MD, associate professor of medicine at the University of Padua, Italy, and the first author of the EASO framework, said, “The paper from Cuevas and Willett sounds like a strong defense of BMI, and I can substantially agree with this defense ... We remain anchored on BMI, but we tried to move beyond it adding an estimate of high risk abdominal fat — waist to height ratio — and coupling the anthropometric assessment with a complete clinical evaluation and staging.”
Dr. Goossens said, “I agree with the authors that despite the limitations of BMI as a measure of body fatness, it remains a useful clinical screening tool. Yet the diagnosis of obesity should not be based solely on BMI” due to the stronger association of abdominal fat with cardiometabolic complications.
That link, he noted, “also applies to individuals with a BMI level below the current cutoff values for obesity, who may already have medical, functional, or psychological impairments. We should be aware of the risk of undertreatment in this particular group of patients.”
Does Calling Obesity a ‘Disease’ Have Unintended Consequences?
In her editorial, Christina C. Wee, MD, senior deputy editor, Annals of Internal Medicine, wrote, “Beyond diagnostic challenges, framing obesity exclusively as a disease rather than a broader, more inclusive construct may have unintended consequences — including reinforcing the weight bias this framing was in part intended to combat.”
Focusing solely on biological causes of obesity while ignoring psychosocial, cultural, environmental, and behavioral contexts could undermine public health and policy efforts to address those factors, Dr. Wee argued.
Moreover, she wrote, “Ironically, framing obesity as a disease to justify coverage for treatment reinforces weight bias. It conflates the need to label a condition a disease with healthcare reimbursement and raises the stakes for developing accurate diagnostic criteria ... By exclusively linking obesity as a disease to reimbursement, it sends the message that only those who manifest disease from excess adiposity warrant treatment — and, by inference, those on the continuum who have not yet manifested disease do not warrant treatment.”
Likening obesity to other risk factors such as hypertension or dyslipidemia for which treatment is typically reimbursed, Dr. Wee pointed out that Medicare still prohibits coverage of medications for obesity.
Regarding the high costs of newer obesity medications and the need for payers and clinicians to ration their use, Dr. Wee argued, “Rather than focusing on whether one’s adiposity conforms to an expert panel’s definition of ‘disease,’ we should address how to best stage obesity risk with sufficient accuracy and fairness and reach a consensus on how to prioritize and match treatments to individual patients.”
Dr. Busetto said that EASO stands by its definition of obesity as a disease, adding “we can adhere to the suggestion of a holistic approach deciding treatment modalities according to the risk and the presence of mental, functional, and medical complications of impairments. Of course, we cannot agree on any proposal that is oriented at leaving patients with obesity still in the asymptomatic phase of the disease without treatment. This would be like treating diabetes only after the occurrence of nephropathy or managing hypertension only after a stroke. Prevention of the symptomatic stage is a part of obesity management, even beyond weight loss.”
Dr. Goossens said, “indeed, it is of utmost importance to develop accurate risk stratification tools for adequately clinical staging of obesity, according to the severity of its medical, psychological and functional impairments.”
Do the Current Lower BMI Cutoffs for Defining Obesity in Asian People Make Sense?
Simar S. Bajaj, AB, of Harvard University, Cambridge, Massachusetts, and colleagues, all of Harvard Medical School, Boston, raised several concerns regarding the 2004 World Health Organization’s suggestion to use lower BMI categories for defining overweight and obesity in Asian populations, that is, 23-27.5 kg/m2 and 27.5 kg/m2 or higher for obesity, respectively, as opposed to 25-29.9 and ≥ 30, respectively, for other populations.
Different Asian countries have created their own obesity BMI cutoffs, ranging from 25 kg/m2 in India to 28 kg/m2 in China. But “Asian Americans continue to be treated as a monolith without official disaggregated cutoffs,” Mr. Bajaj and colleagues noted.
The heterogeneity translates to different risk levels across Asian subgroups. For example, in one study, age- and sex-adjusted BMI cutoffs for increased risk of developing type 2 diabetes were 23.9 kg/m2 in South Asian populations, 26.6 kg/m2 in Arab populations, 26.9 kg/m2 in Chinese populations, and 28.1 kg/m2 in Black populations.
These findings raise important questions, the researchers said. “Does it make sense for people of Chinese descent to use the same BMI threshold as the South Asian group when their ‘equivalent risk cutoff’ is closer to that of Arab and Black groups who share the standard BMI threshold?” Most data in this area are cross-sectional rather than the longitudinal data needed to answer those questions, they noted.
They suggest that professional diabetes and obesity organizations consider BMI thresholds to be “placeholders” until more sensitive and specific thresholds can be defined for Asian American populations.
Mr. Bajaj and colleagues also noted the need for disaggregated data is not unique to Asian groups but that they focused on Asian Americans for two main reasons. “First, success would create a precedent for complete disaggregation and help ensure that other groups do not stall at an intermediary level. Second, substantial research into Asian ethnic groups — and the WHO’s precedent 20 years ago — creates a solid foundation to build upon.”
Ultimately, they said, “advancing equity will require funding research that engages diverse Asian communities and developing tailored interventions for all ethnicities.”
Dr. Cuevas, Dr. Willett, Mr. Bajaj, and Dr. Wee had no disclosures. Dr. Goossens received research funding from the European Foundation for the Study of Diabetes, the Dutch Diabetes Research Foundation, and the Dutch Research Council. Dr. Busetto received personal funding from Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Bruno Farmaceutici as a member of advisory boards and from Rhythm Pharmaceuticals and Pronokal as a speaker.
A version of this article first appeared on Medscape.com.
in three new opinion papers.
The three statements were published on July 22, 2024, in Annals of Internal Medicine. In one, the authors expressed caution about the recent movement away from using BMI alone to define obesity, noting that the measure remains a useful population-level and clinical tool for addressing adiposity, particularly within racial and ethnic groups. But the authors of a second paper pointed out that the use of lower BMI cutoffs to define obesity in Asian populations, in place since 2004, is inadequate in part because it doesn’t account for heterogeneity among different Asian groups.
And in the third paper, an editorial, an Annals editor cautioned that the recent framing of obesity exclusively as a “disease” rather than a “broader, more inclusive construct” may inadvertently reinforce the bias it was meant to combat.
Asked to comment on the issues raised in the papers, Professor Gijs Goossens of Maastricht University Medical Center, Maastricht, the Netherlands, said, “It is important to emphasize that the management and treatment of obesity have wider objectives than weight loss alone and include the prevention, resolution, or improvement of obesity-related complications; achieving better quality of life and mental well-being; and improvement of physical and social functioning.”
Added Dr. Goossens, who was an author of a recent European Association for the Study of Obesity (EASO) framework calling for moving beyond BMI in defining obesity, “Personalized therapeutic goals should be set at the beginning of the treatment, according to the stage of obesity, taking into account available therapeutic options, possible side effects or risks, and patient preferences. The drivers of obesity and possible barriers to treatment should also be discussed with the patient.” Dr. Goossens emphasized that he was providing his personal views and not speaking for the EASO or his coauthors.
BMI: ‘Not a Perfect Measure of Adiposity but Remains Useful’
In their “Ideas and Opinions” paper, Adolfo G. Cuevas, PhD, of New York University School of Global Public Health, New York City, and Walter C. Willett, MD, DrPH, of Harvard T.H. Chan School of Public Health, Boston, argued that “BMI, although not a perfect measure of adiposity, remains a useful population-level and clinical tool for addressing adiposity, including within groups defined by race and ethnicity.”
They added that despite the criticism that BMI doesn’t distinguish between fat and lean body mass, the measure still strongly correlates with fat mass as well as cardiovascular risk and mortality, and it does so similarly across racial and ethnic groups.
Clinically, Dr. Cuevas and Dr. Willett pointed out that BMI correlates fat mass as assessed with the gold standard measure dual x-ray absorptiometry but is far simpler and less expensive. Measuring waist circumference can provide additional information about visceral fat and disease risk but is “more difficult to standardize and suffers from the same limitations as BMI when cut points are used.”
They suggest the addition of change in weight since early adulthood and over time as a “simple and sensitive variable” for assessing adiposity.
Luca Busetto, MD, associate professor of medicine at the University of Padua, Italy, and the first author of the EASO framework, said, “The paper from Cuevas and Willett sounds like a strong defense of BMI, and I can substantially agree with this defense ... We remain anchored on BMI, but we tried to move beyond it adding an estimate of high risk abdominal fat — waist to height ratio — and coupling the anthropometric assessment with a complete clinical evaluation and staging.”
Dr. Goossens said, “I agree with the authors that despite the limitations of BMI as a measure of body fatness, it remains a useful clinical screening tool. Yet the diagnosis of obesity should not be based solely on BMI” due to the stronger association of abdominal fat with cardiometabolic complications.
That link, he noted, “also applies to individuals with a BMI level below the current cutoff values for obesity, who may already have medical, functional, or psychological impairments. We should be aware of the risk of undertreatment in this particular group of patients.”
Does Calling Obesity a ‘Disease’ Have Unintended Consequences?
In her editorial, Christina C. Wee, MD, senior deputy editor, Annals of Internal Medicine, wrote, “Beyond diagnostic challenges, framing obesity exclusively as a disease rather than a broader, more inclusive construct may have unintended consequences — including reinforcing the weight bias this framing was in part intended to combat.”
Focusing solely on biological causes of obesity while ignoring psychosocial, cultural, environmental, and behavioral contexts could undermine public health and policy efforts to address those factors, Dr. Wee argued.
Moreover, she wrote, “Ironically, framing obesity as a disease to justify coverage for treatment reinforces weight bias. It conflates the need to label a condition a disease with healthcare reimbursement and raises the stakes for developing accurate diagnostic criteria ... By exclusively linking obesity as a disease to reimbursement, it sends the message that only those who manifest disease from excess adiposity warrant treatment — and, by inference, those on the continuum who have not yet manifested disease do not warrant treatment.”
Likening obesity to other risk factors such as hypertension or dyslipidemia for which treatment is typically reimbursed, Dr. Wee pointed out that Medicare still prohibits coverage of medications for obesity.
Regarding the high costs of newer obesity medications and the need for payers and clinicians to ration their use, Dr. Wee argued, “Rather than focusing on whether one’s adiposity conforms to an expert panel’s definition of ‘disease,’ we should address how to best stage obesity risk with sufficient accuracy and fairness and reach a consensus on how to prioritize and match treatments to individual patients.”
Dr. Busetto said that EASO stands by its definition of obesity as a disease, adding “we can adhere to the suggestion of a holistic approach deciding treatment modalities according to the risk and the presence of mental, functional, and medical complications of impairments. Of course, we cannot agree on any proposal that is oriented at leaving patients with obesity still in the asymptomatic phase of the disease without treatment. This would be like treating diabetes only after the occurrence of nephropathy or managing hypertension only after a stroke. Prevention of the symptomatic stage is a part of obesity management, even beyond weight loss.”
Dr. Goossens said, “indeed, it is of utmost importance to develop accurate risk stratification tools for adequately clinical staging of obesity, according to the severity of its medical, psychological and functional impairments.”
Do the Current Lower BMI Cutoffs for Defining Obesity in Asian People Make Sense?
Simar S. Bajaj, AB, of Harvard University, Cambridge, Massachusetts, and colleagues, all of Harvard Medical School, Boston, raised several concerns regarding the 2004 World Health Organization’s suggestion to use lower BMI categories for defining overweight and obesity in Asian populations, that is, 23-27.5 kg/m2 and 27.5 kg/m2 or higher for obesity, respectively, as opposed to 25-29.9 and ≥ 30, respectively, for other populations.
Different Asian countries have created their own obesity BMI cutoffs, ranging from 25 kg/m2 in India to 28 kg/m2 in China. But “Asian Americans continue to be treated as a monolith without official disaggregated cutoffs,” Mr. Bajaj and colleagues noted.
The heterogeneity translates to different risk levels across Asian subgroups. For example, in one study, age- and sex-adjusted BMI cutoffs for increased risk of developing type 2 diabetes were 23.9 kg/m2 in South Asian populations, 26.6 kg/m2 in Arab populations, 26.9 kg/m2 in Chinese populations, and 28.1 kg/m2 in Black populations.
These findings raise important questions, the researchers said. “Does it make sense for people of Chinese descent to use the same BMI threshold as the South Asian group when their ‘equivalent risk cutoff’ is closer to that of Arab and Black groups who share the standard BMI threshold?” Most data in this area are cross-sectional rather than the longitudinal data needed to answer those questions, they noted.
They suggest that professional diabetes and obesity organizations consider BMI thresholds to be “placeholders” until more sensitive and specific thresholds can be defined for Asian American populations.
Mr. Bajaj and colleagues also noted the need for disaggregated data is not unique to Asian groups but that they focused on Asian Americans for two main reasons. “First, success would create a precedent for complete disaggregation and help ensure that other groups do not stall at an intermediary level. Second, substantial research into Asian ethnic groups — and the WHO’s precedent 20 years ago — creates a solid foundation to build upon.”
Ultimately, they said, “advancing equity will require funding research that engages diverse Asian communities and developing tailored interventions for all ethnicities.”
Dr. Cuevas, Dr. Willett, Mr. Bajaj, and Dr. Wee had no disclosures. Dr. Goossens received research funding from the European Foundation for the Study of Diabetes, the Dutch Diabetes Research Foundation, and the Dutch Research Council. Dr. Busetto received personal funding from Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Bruno Farmaceutici as a member of advisory boards and from Rhythm Pharmaceuticals and Pronokal as a speaker.
A version of this article first appeared on Medscape.com.
in three new opinion papers.
The three statements were published on July 22, 2024, in Annals of Internal Medicine. In one, the authors expressed caution about the recent movement away from using BMI alone to define obesity, noting that the measure remains a useful population-level and clinical tool for addressing adiposity, particularly within racial and ethnic groups. But the authors of a second paper pointed out that the use of lower BMI cutoffs to define obesity in Asian populations, in place since 2004, is inadequate in part because it doesn’t account for heterogeneity among different Asian groups.
And in the third paper, an editorial, an Annals editor cautioned that the recent framing of obesity exclusively as a “disease” rather than a “broader, more inclusive construct” may inadvertently reinforce the bias it was meant to combat.
Asked to comment on the issues raised in the papers, Professor Gijs Goossens of Maastricht University Medical Center, Maastricht, the Netherlands, said, “It is important to emphasize that the management and treatment of obesity have wider objectives than weight loss alone and include the prevention, resolution, or improvement of obesity-related complications; achieving better quality of life and mental well-being; and improvement of physical and social functioning.”
Added Dr. Goossens, who was an author of a recent European Association for the Study of Obesity (EASO) framework calling for moving beyond BMI in defining obesity, “Personalized therapeutic goals should be set at the beginning of the treatment, according to the stage of obesity, taking into account available therapeutic options, possible side effects or risks, and patient preferences. The drivers of obesity and possible barriers to treatment should also be discussed with the patient.” Dr. Goossens emphasized that he was providing his personal views and not speaking for the EASO or his coauthors.
BMI: ‘Not a Perfect Measure of Adiposity but Remains Useful’
In their “Ideas and Opinions” paper, Adolfo G. Cuevas, PhD, of New York University School of Global Public Health, New York City, and Walter C. Willett, MD, DrPH, of Harvard T.H. Chan School of Public Health, Boston, argued that “BMI, although not a perfect measure of adiposity, remains a useful population-level and clinical tool for addressing adiposity, including within groups defined by race and ethnicity.”
They added that despite the criticism that BMI doesn’t distinguish between fat and lean body mass, the measure still strongly correlates with fat mass as well as cardiovascular risk and mortality, and it does so similarly across racial and ethnic groups.
Clinically, Dr. Cuevas and Dr. Willett pointed out that BMI correlates fat mass as assessed with the gold standard measure dual x-ray absorptiometry but is far simpler and less expensive. Measuring waist circumference can provide additional information about visceral fat and disease risk but is “more difficult to standardize and suffers from the same limitations as BMI when cut points are used.”
They suggest the addition of change in weight since early adulthood and over time as a “simple and sensitive variable” for assessing adiposity.
Luca Busetto, MD, associate professor of medicine at the University of Padua, Italy, and the first author of the EASO framework, said, “The paper from Cuevas and Willett sounds like a strong defense of BMI, and I can substantially agree with this defense ... We remain anchored on BMI, but we tried to move beyond it adding an estimate of high risk abdominal fat — waist to height ratio — and coupling the anthropometric assessment with a complete clinical evaluation and staging.”
Dr. Goossens said, “I agree with the authors that despite the limitations of BMI as a measure of body fatness, it remains a useful clinical screening tool. Yet the diagnosis of obesity should not be based solely on BMI” due to the stronger association of abdominal fat with cardiometabolic complications.
That link, he noted, “also applies to individuals with a BMI level below the current cutoff values for obesity, who may already have medical, functional, or psychological impairments. We should be aware of the risk of undertreatment in this particular group of patients.”
Does Calling Obesity a ‘Disease’ Have Unintended Consequences?
In her editorial, Christina C. Wee, MD, senior deputy editor, Annals of Internal Medicine, wrote, “Beyond diagnostic challenges, framing obesity exclusively as a disease rather than a broader, more inclusive construct may have unintended consequences — including reinforcing the weight bias this framing was in part intended to combat.”
Focusing solely on biological causes of obesity while ignoring psychosocial, cultural, environmental, and behavioral contexts could undermine public health and policy efforts to address those factors, Dr. Wee argued.
Moreover, she wrote, “Ironically, framing obesity as a disease to justify coverage for treatment reinforces weight bias. It conflates the need to label a condition a disease with healthcare reimbursement and raises the stakes for developing accurate diagnostic criteria ... By exclusively linking obesity as a disease to reimbursement, it sends the message that only those who manifest disease from excess adiposity warrant treatment — and, by inference, those on the continuum who have not yet manifested disease do not warrant treatment.”
Likening obesity to other risk factors such as hypertension or dyslipidemia for which treatment is typically reimbursed, Dr. Wee pointed out that Medicare still prohibits coverage of medications for obesity.
Regarding the high costs of newer obesity medications and the need for payers and clinicians to ration their use, Dr. Wee argued, “Rather than focusing on whether one’s adiposity conforms to an expert panel’s definition of ‘disease,’ we should address how to best stage obesity risk with sufficient accuracy and fairness and reach a consensus on how to prioritize and match treatments to individual patients.”
Dr. Busetto said that EASO stands by its definition of obesity as a disease, adding “we can adhere to the suggestion of a holistic approach deciding treatment modalities according to the risk and the presence of mental, functional, and medical complications of impairments. Of course, we cannot agree on any proposal that is oriented at leaving patients with obesity still in the asymptomatic phase of the disease without treatment. This would be like treating diabetes only after the occurrence of nephropathy or managing hypertension only after a stroke. Prevention of the symptomatic stage is a part of obesity management, even beyond weight loss.”
Dr. Goossens said, “indeed, it is of utmost importance to develop accurate risk stratification tools for adequately clinical staging of obesity, according to the severity of its medical, psychological and functional impairments.”
Do the Current Lower BMI Cutoffs for Defining Obesity in Asian People Make Sense?
Simar S. Bajaj, AB, of Harvard University, Cambridge, Massachusetts, and colleagues, all of Harvard Medical School, Boston, raised several concerns regarding the 2004 World Health Organization’s suggestion to use lower BMI categories for defining overweight and obesity in Asian populations, that is, 23-27.5 kg/m2 and 27.5 kg/m2 or higher for obesity, respectively, as opposed to 25-29.9 and ≥ 30, respectively, for other populations.
Different Asian countries have created their own obesity BMI cutoffs, ranging from 25 kg/m2 in India to 28 kg/m2 in China. But “Asian Americans continue to be treated as a monolith without official disaggregated cutoffs,” Mr. Bajaj and colleagues noted.
The heterogeneity translates to different risk levels across Asian subgroups. For example, in one study, age- and sex-adjusted BMI cutoffs for increased risk of developing type 2 diabetes were 23.9 kg/m2 in South Asian populations, 26.6 kg/m2 in Arab populations, 26.9 kg/m2 in Chinese populations, and 28.1 kg/m2 in Black populations.
These findings raise important questions, the researchers said. “Does it make sense for people of Chinese descent to use the same BMI threshold as the South Asian group when their ‘equivalent risk cutoff’ is closer to that of Arab and Black groups who share the standard BMI threshold?” Most data in this area are cross-sectional rather than the longitudinal data needed to answer those questions, they noted.
They suggest that professional diabetes and obesity organizations consider BMI thresholds to be “placeholders” until more sensitive and specific thresholds can be defined for Asian American populations.
Mr. Bajaj and colleagues also noted the need for disaggregated data is not unique to Asian groups but that they focused on Asian Americans for two main reasons. “First, success would create a precedent for complete disaggregation and help ensure that other groups do not stall at an intermediary level. Second, substantial research into Asian ethnic groups — and the WHO’s precedent 20 years ago — creates a solid foundation to build upon.”
Ultimately, they said, “advancing equity will require funding research that engages diverse Asian communities and developing tailored interventions for all ethnicities.”
Dr. Cuevas, Dr. Willett, Mr. Bajaj, and Dr. Wee had no disclosures. Dr. Goossens received research funding from the European Foundation for the Study of Diabetes, the Dutch Diabetes Research Foundation, and the Dutch Research Council. Dr. Busetto received personal funding from Novo Nordisk, Boehringer Ingelheim, Eli Lilly, Pfizer, and Bruno Farmaceutici as a member of advisory boards and from Rhythm Pharmaceuticals and Pronokal as a speaker.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Diabetes-Related Outcomes and Costs Have Mostly Improved
TOPLINE:
Over the past 20 years in Denmark, the incidence of type 2 diabetes–related outcomes and many treatment-related harms have both decreased without increased medication expenses despite an aging and more comorbid population; however, challenges remain.
METHODOLOGY:
- Analysis of data from 461,805 individuals in the Danish population with type 2 diabetes between 2002 and 2020.
- Multivariate analyses adjusted for potential confounders, including age, sex, and socioeconomic status.
TAKEAWAY:
- The population grew 2.7-fold from 2002 to 2020 (n = 113,105 to 306,962), the median age increased from 66 to 68 years, and the mean number of diseases per person increased from 5.2 to 8.8, with an increase in Charlson Comorbidity Index from 1.78 to 1.93.
- After adjustments, mortality per 1000 person-years decreased by 28% from 2002 to 2020, with the largest risk reduction, 63%, in acute myocardial infarction.
- The mean number of annually redeemed medications per person increased from 8.1 to 9.0, with statin and antihypertensive use increasing to 65% and 69%, respectively.
- Antiplatelet medication (aspirin and clopidogrel) use peaked at 48% in 2009 and dropped to 31% in 2020.
- Anticoagulant (warfarin and direct-acting oral anticoagulants) use gradually increased from 5% in 2002 to 14% in 2020.
- For glucose-lowering treatment, there was a shift away from using sulfonylureas to metformin and other medications.
- Diagnoses of hypoglycemia, falls, and gastric bleeding decreased over the study period, but incidences of volume depletion, ketoacidosis, infections, and electrolyte imbalances requiring hospitalization increased.
- Cumulative expenses for the population increased from €132,000,000 to €327,000,000 (approximately $144,406,680 to $357,734,730), corresponding to a 148% increase over the study period.
- However, the average medication cost per individual was 8% less in 2020 compared with 2002 despite increasing medication use, mainly driven by reduced costs of antiplatelets, antihypertensives, and statins, among others.
- In contrast, expenses for glucose-lowering medications have gradually increased, with the average more than doubling (138% increase) from €220 ($240) in 2002 to €524 ($573) in 2020.
IN PRACTICE:
“Although these trends suggest improvements in rational pharmacotherapy, they cannot be solely attributed to improved pharmacotherapy and appear to be multifactorial,” the authors wrote.
“Advancements in diabetes management have improved the balance between medication benefits, harms, and costs ... Remaining challenges, such as an increased risk of ketoacidosis and electrolyte imbalances as well as rising costs for glucose-lowering medications, highlight the importance of individualized treatment and continuous risk-benefits evaluations,” they added.
SOURCE:
This study was conducted by Karl Sebastian Johansson, of the Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark, and colleagues and was published online in Diabetes Care.
LIMITATIONS:
Analysis was confined to events diagnosed in hospital-based inpatient and outpatient settings, not primary healthcare. Only predefined adverse events were analyzed.
DISCLOSURES:
The study was funded by the Capital Region of Denmark. The authors reported no potential conflicts of interest relevant to this article.
A version of this article first appeared on Medscape.com.
TOPLINE:
Over the past 20 years in Denmark, the incidence of type 2 diabetes–related outcomes and many treatment-related harms have both decreased without increased medication expenses despite an aging and more comorbid population; however, challenges remain.
METHODOLOGY:
- Analysis of data from 461,805 individuals in the Danish population with type 2 diabetes between 2002 and 2020.
- Multivariate analyses adjusted for potential confounders, including age, sex, and socioeconomic status.
TAKEAWAY:
- The population grew 2.7-fold from 2002 to 2020 (n = 113,105 to 306,962), the median age increased from 66 to 68 years, and the mean number of diseases per person increased from 5.2 to 8.8, with an increase in Charlson Comorbidity Index from 1.78 to 1.93.
- After adjustments, mortality per 1000 person-years decreased by 28% from 2002 to 2020, with the largest risk reduction, 63%, in acute myocardial infarction.
- The mean number of annually redeemed medications per person increased from 8.1 to 9.0, with statin and antihypertensive use increasing to 65% and 69%, respectively.
- Antiplatelet medication (aspirin and clopidogrel) use peaked at 48% in 2009 and dropped to 31% in 2020.
- Anticoagulant (warfarin and direct-acting oral anticoagulants) use gradually increased from 5% in 2002 to 14% in 2020.
- For glucose-lowering treatment, there was a shift away from using sulfonylureas to metformin and other medications.
- Diagnoses of hypoglycemia, falls, and gastric bleeding decreased over the study period, but incidences of volume depletion, ketoacidosis, infections, and electrolyte imbalances requiring hospitalization increased.
- Cumulative expenses for the population increased from €132,000,000 to €327,000,000 (approximately $144,406,680 to $357,734,730), corresponding to a 148% increase over the study period.
- However, the average medication cost per individual was 8% less in 2020 compared with 2002 despite increasing medication use, mainly driven by reduced costs of antiplatelets, antihypertensives, and statins, among others.
- In contrast, expenses for glucose-lowering medications have gradually increased, with the average more than doubling (138% increase) from €220 ($240) in 2002 to €524 ($573) in 2020.
IN PRACTICE:
“Although these trends suggest improvements in rational pharmacotherapy, they cannot be solely attributed to improved pharmacotherapy and appear to be multifactorial,” the authors wrote.
“Advancements in diabetes management have improved the balance between medication benefits, harms, and costs ... Remaining challenges, such as an increased risk of ketoacidosis and electrolyte imbalances as well as rising costs for glucose-lowering medications, highlight the importance of individualized treatment and continuous risk-benefits evaluations,” they added.
SOURCE:
This study was conducted by Karl Sebastian Johansson, of the Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark, and colleagues and was published online in Diabetes Care.
LIMITATIONS:
Analysis was confined to events diagnosed in hospital-based inpatient and outpatient settings, not primary healthcare. Only predefined adverse events were analyzed.
DISCLOSURES:
The study was funded by the Capital Region of Denmark. The authors reported no potential conflicts of interest relevant to this article.
A version of this article first appeared on Medscape.com.
TOPLINE:
Over the past 20 years in Denmark, the incidence of type 2 diabetes–related outcomes and many treatment-related harms have both decreased without increased medication expenses despite an aging and more comorbid population; however, challenges remain.
METHODOLOGY:
- Analysis of data from 461,805 individuals in the Danish population with type 2 diabetes between 2002 and 2020.
- Multivariate analyses adjusted for potential confounders, including age, sex, and socioeconomic status.
TAKEAWAY:
- The population grew 2.7-fold from 2002 to 2020 (n = 113,105 to 306,962), the median age increased from 66 to 68 years, and the mean number of diseases per person increased from 5.2 to 8.8, with an increase in Charlson Comorbidity Index from 1.78 to 1.93.
- After adjustments, mortality per 1000 person-years decreased by 28% from 2002 to 2020, with the largest risk reduction, 63%, in acute myocardial infarction.
- The mean number of annually redeemed medications per person increased from 8.1 to 9.0, with statin and antihypertensive use increasing to 65% and 69%, respectively.
- Antiplatelet medication (aspirin and clopidogrel) use peaked at 48% in 2009 and dropped to 31% in 2020.
- Anticoagulant (warfarin and direct-acting oral anticoagulants) use gradually increased from 5% in 2002 to 14% in 2020.
- For glucose-lowering treatment, there was a shift away from using sulfonylureas to metformin and other medications.
- Diagnoses of hypoglycemia, falls, and gastric bleeding decreased over the study period, but incidences of volume depletion, ketoacidosis, infections, and electrolyte imbalances requiring hospitalization increased.
- Cumulative expenses for the population increased from €132,000,000 to €327,000,000 (approximately $144,406,680 to $357,734,730), corresponding to a 148% increase over the study period.
- However, the average medication cost per individual was 8% less in 2020 compared with 2002 despite increasing medication use, mainly driven by reduced costs of antiplatelets, antihypertensives, and statins, among others.
- In contrast, expenses for glucose-lowering medications have gradually increased, with the average more than doubling (138% increase) from €220 ($240) in 2002 to €524 ($573) in 2020.
IN PRACTICE:
“Although these trends suggest improvements in rational pharmacotherapy, they cannot be solely attributed to improved pharmacotherapy and appear to be multifactorial,” the authors wrote.
“Advancements in diabetes management have improved the balance between medication benefits, harms, and costs ... Remaining challenges, such as an increased risk of ketoacidosis and electrolyte imbalances as well as rising costs for glucose-lowering medications, highlight the importance of individualized treatment and continuous risk-benefits evaluations,” they added.
SOURCE:
This study was conducted by Karl Sebastian Johansson, of the Department of Clinical Pharmacology, Copenhagen University Hospital, Copenhagen, Denmark, and colleagues and was published online in Diabetes Care.
LIMITATIONS:
Analysis was confined to events diagnosed in hospital-based inpatient and outpatient settings, not primary healthcare. Only predefined adverse events were analyzed.
DISCLOSURES:
The study was funded by the Capital Region of Denmark. The authors reported no potential conflicts of interest relevant to this article.
A version of this article first appeared on Medscape.com.
More and More Are Living With Type 1 Diabetes Into Old Age
TOPLINE:
Mortality and disability-adjusted life years (DALYs) among people with type 1 diabetes (T1D) aged ≥ 65 years dropped significantly from 1990 to 2019. Both were lower among women and those living in higher sociodemographic areas.
METHODOLOGY:
- A population-based study of adults aged ≥ 65 years from 21 regions and 204 countries and territories, 1990-2019, was conducted.
TAKEAWAY:
- Globally, the prevalence of T1D among people aged ≥ 65 years increased by 180% between 1990 and 2019, from 1.3 million to 3.7 million.
- The proportion of older people with T1D has consistently trended upward, from 12% of all people with T1D in 1990 to 17% in 2019.
- Age-standardized mortality from T1D among this age group significantly decreased by 25%, from 4.7/100,000 population in 1990 to 3.5/100,000 in 2019.
- Age-standardized increases in T1D prevalence have occurred in both men and women worldwide, while the increase was more rapid among men (average annual percent change, 1.00% vs 0.74%).
- Globally, T1D prevalence at least tripled in every age subgroup of those aged ≥ 65 years, and even fivefold to sixfold for those ≥ 90-95 years (0.02-0.11 million for ages 90-94 years; 0.005-0.03 million for ages ≥ 95 years).
- No decreases occurred in T1D prevalence among those aged ≥ 65 years in any of the 21 global regions.
- Three primary risk factors associated with DALYs for T1D among people aged ≥ 65 years were high fasting plasma glucose levels, low temperature, and high temperature, accounting for 103 DALYs per 100,000 people, 3/100,000 people, and 1/100,000 people, respectively, in 2019.
IN PRACTICE:
“The results suggest that T1DM is no longer a contributory factor in decreased life expectancy owing to improvements in medical care over the three decades,” the authors wrote. “Management of high fasting plasma glucose levels remains a major challenge for older people with T1D, and targeted clinical guidelines are needed.”
SOURCE:
The study was conducted by Kaijie Yang, the Department of Endocrinology and Metabolism, the Institute of Endocrinology, NHC Key Laboratory of Diagnosis and Treatment of Thyroid Diseases, First Hospital of China Medical University, Shenyang, China, and colleagues. The study was published online in the BMJ.
LIMITATIONS:
Data were extrapolated from countries that have epidemiologic data. Health information systems and reporting mechanisms vary across countries and regions. Disease burden data include a time lag. Diagnosing T1D in older people can be challenging.
DISCLOSURES:
The study was supported by the National Natural Science Foundation of China and the China Postdoctoral Science Foundation. The authors reported no additional financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
Mortality and disability-adjusted life years (DALYs) among people with type 1 diabetes (T1D) aged ≥ 65 years dropped significantly from 1990 to 2019. Both were lower among women and those living in higher sociodemographic areas.
METHODOLOGY:
- A population-based study of adults aged ≥ 65 years from 21 regions and 204 countries and territories, 1990-2019, was conducted.
TAKEAWAY:
- Globally, the prevalence of T1D among people aged ≥ 65 years increased by 180% between 1990 and 2019, from 1.3 million to 3.7 million.
- The proportion of older people with T1D has consistently trended upward, from 12% of all people with T1D in 1990 to 17% in 2019.
- Age-standardized mortality from T1D among this age group significantly decreased by 25%, from 4.7/100,000 population in 1990 to 3.5/100,000 in 2019.
- Age-standardized increases in T1D prevalence have occurred in both men and women worldwide, while the increase was more rapid among men (average annual percent change, 1.00% vs 0.74%).
- Globally, T1D prevalence at least tripled in every age subgroup of those aged ≥ 65 years, and even fivefold to sixfold for those ≥ 90-95 years (0.02-0.11 million for ages 90-94 years; 0.005-0.03 million for ages ≥ 95 years).
- No decreases occurred in T1D prevalence among those aged ≥ 65 years in any of the 21 global regions.
- Three primary risk factors associated with DALYs for T1D among people aged ≥ 65 years were high fasting plasma glucose levels, low temperature, and high temperature, accounting for 103 DALYs per 100,000 people, 3/100,000 people, and 1/100,000 people, respectively, in 2019.
IN PRACTICE:
“The results suggest that T1DM is no longer a contributory factor in decreased life expectancy owing to improvements in medical care over the three decades,” the authors wrote. “Management of high fasting plasma glucose levels remains a major challenge for older people with T1D, and targeted clinical guidelines are needed.”
SOURCE:
The study was conducted by Kaijie Yang, the Department of Endocrinology and Metabolism, the Institute of Endocrinology, NHC Key Laboratory of Diagnosis and Treatment of Thyroid Diseases, First Hospital of China Medical University, Shenyang, China, and colleagues. The study was published online in the BMJ.
LIMITATIONS:
Data were extrapolated from countries that have epidemiologic data. Health information systems and reporting mechanisms vary across countries and regions. Disease burden data include a time lag. Diagnosing T1D in older people can be challenging.
DISCLOSURES:
The study was supported by the National Natural Science Foundation of China and the China Postdoctoral Science Foundation. The authors reported no additional financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE:
Mortality and disability-adjusted life years (DALYs) among people with type 1 diabetes (T1D) aged ≥ 65 years dropped significantly from 1990 to 2019. Both were lower among women and those living in higher sociodemographic areas.
METHODOLOGY:
- A population-based study of adults aged ≥ 65 years from 21 regions and 204 countries and territories, 1990-2019, was conducted.
TAKEAWAY:
- Globally, the prevalence of T1D among people aged ≥ 65 years increased by 180% between 1990 and 2019, from 1.3 million to 3.7 million.
- The proportion of older people with T1D has consistently trended upward, from 12% of all people with T1D in 1990 to 17% in 2019.
- Age-standardized mortality from T1D among this age group significantly decreased by 25%, from 4.7/100,000 population in 1990 to 3.5/100,000 in 2019.
- Age-standardized increases in T1D prevalence have occurred in both men and women worldwide, while the increase was more rapid among men (average annual percent change, 1.00% vs 0.74%).
- Globally, T1D prevalence at least tripled in every age subgroup of those aged ≥ 65 years, and even fivefold to sixfold for those ≥ 90-95 years (0.02-0.11 million for ages 90-94 years; 0.005-0.03 million for ages ≥ 95 years).
- No decreases occurred in T1D prevalence among those aged ≥ 65 years in any of the 21 global regions.
- Three primary risk factors associated with DALYs for T1D among people aged ≥ 65 years were high fasting plasma glucose levels, low temperature, and high temperature, accounting for 103 DALYs per 100,000 people, 3/100,000 people, and 1/100,000 people, respectively, in 2019.
IN PRACTICE:
“The results suggest that T1DM is no longer a contributory factor in decreased life expectancy owing to improvements in medical care over the three decades,” the authors wrote. “Management of high fasting plasma glucose levels remains a major challenge for older people with T1D, and targeted clinical guidelines are needed.”
SOURCE:
The study was conducted by Kaijie Yang, the Department of Endocrinology and Metabolism, the Institute of Endocrinology, NHC Key Laboratory of Diagnosis and Treatment of Thyroid Diseases, First Hospital of China Medical University, Shenyang, China, and colleagues. The study was published online in the BMJ.
LIMITATIONS:
Data were extrapolated from countries that have epidemiologic data. Health information systems and reporting mechanisms vary across countries and regions. Disease burden data include a time lag. Diagnosing T1D in older people can be challenging.
DISCLOSURES:
The study was supported by the National Natural Science Foundation of China and the China Postdoctoral Science Foundation. The authors reported no additional financial relationships.
A version of this article first appeared on Medscape.com.
Quitting Anabolic Steroids Can Still Impair Men Afterward
BOSTON — Men who stop using performance-enhancing anabolic-androgenic steroids (AAS) experience significant depression, anxiety, and diminished sexual function within the first year after quitting, new research found.
The data suggest that monitoring these men and, pending clinical trial evidence, intervening to minimize these effects could help prevent recidivism, Bonnie Grant, MBBS, a clinical research fellow at Imperial College London, London, England, told this news organization.
“Nothing has actually been studied in proper randomized controlled trials … but I think there’s going to be a role for medicine alongside psychological treatment … Clinicians often see men who have stopped [taking steroids] who report feeling low in mood … a lot of these men will just restart taking them again,” she said.
Anabolic steroids taken exogenously suppress the hypothalamic-pituitary-gonadal system, thereby suppressing endogenous testosterone secretion. While AAS do enhance muscle-building, they can also lead to enlarged hearts, hypertension, and infertility. Most of these are reversible if the man stops taking the AAS.
However, after stopping, the testosterone levels can take up to a year to return to normal. During that time, the man can experience symptoms including low libido, erectile dysfunction, low mood, and fatigue. This leads to a dependence syndrome in about 30%. About 65% of men who stop taking anabolic steroids will restart taking them within the first year, Dr. Grant said in presenting her findings at the annual meeting of the Endocrine Society.
Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “One question is, if you intervene with an antidepressant, will that prevent the people from relapsing and going back to using? I think that’s certainly something that would need to be explored and tested.”
Dr. Hayes also noted that fertility problems may lead some men to decide to stop using the steroids. “That can be a strong motivator. If you have a motivated patient, then you add in an antidepressant or anxiolytic or link the patients with mental health services. I think that would definitely be beneficial and definitely something we need to address and see if it is worthwhile doing.”
Dr. Grant presented data from her group’s cross-sectional, observational study. Of a total 245 men, 116 were current AAS users, 84 were previous AAS users who had quit within the past year, and 45 had never used them. All completed extensive questionnaires about their substance use, mood, sexual function, and anxiety. They had morning blood tests, and urine samples were taken for toxicology testing.
The three groups didn’t differ by age (most were in their mid-30s) or ethnicity (most were White). However, the proportion who self-reported psychiatric diagnoses (mostly depression or anxiety) was significantly higher among both the current (29%) and past (25%) AAS users than among the never users (6.6%), with P = .0094.
Dr. Hayes commented, “One of the drawbacks of this study was they didn’t have baseline data. But it would make sense, I think, that the incidence of depression and anxiety was higher in the people who went on to use anabolic steroids.”
Use of other illicit drugs — mostly cocaine and cannabis — was also higher among the past (40.5%) and current (47.4%) AAS users than among the nonusers (17.7%), P = .0025.
Not surprisingly, total testosterone levels were much higher in current AAS users (62.8 nmol/L) than in past users (20.1 nmol/L) and nonusers (20.0 nmol/L), P < .001. Levels of luteinizing hormone (LH), follicle-stimulating hormone, and sex hormone-binding globulin were significantly lower in the current AAS users than in the other two groups, while estradiol levels were significantly higher (all P < .001).
There were no differences in total testosterone between the never users and previous users. However, about 25% of the men who stopped continued to have lower-than-normal testosterone levels, Dr. Grant noted.
Depression scores, as assessed by the Beck Depression Inventory-II, were highest in men who stopped using AAS, and lowest in the never users. Moderate to severe depression was present in 20% of the men who stopped using AAS, 6% of current users, and none of the nonusers.
In multivariable analysis, having a prior psychiatric diagnosis increased the risk for current depression on the Beck inventory by twofold in the current AAS users (P = .001) and threefold in the past users (P < .001). “Interestingly, testosterone levels were not associated with depression,” she noted.
Sexual function, as measured by the International Index of Erectile Function (IIEF) 15, was significantly worse among those who had stopped using AAS compared with current users and nonusers (P = .023). At the same time, total testosterone levels were only weakly correlated with IIEF scores.
In multivariate analysis, higher LH levels were associated with worse sexual function (P = .01).
Anxiety, as measured by the General Anxiety Disorder-7 assessment, was higher in previous users than in never users. Overall, 12% of the previous users had moderate or severe anxiety vs just 2% of nonusers.
The next step in the research will be to examine the urine toxicology for AAS and other illicit substances, Dr. Grant said.
“We’re hoping this information will allow for future studies to be developed to design treatments, which will help millions of men worldwide to stop and stay off anabolic steroids,” she concluded.
Dr. Grant and Dr. Hayes had no disclosures.
A version of this article first appeared on Medscape.com.
BOSTON — Men who stop using performance-enhancing anabolic-androgenic steroids (AAS) experience significant depression, anxiety, and diminished sexual function within the first year after quitting, new research found.
The data suggest that monitoring these men and, pending clinical trial evidence, intervening to minimize these effects could help prevent recidivism, Bonnie Grant, MBBS, a clinical research fellow at Imperial College London, London, England, told this news organization.
“Nothing has actually been studied in proper randomized controlled trials … but I think there’s going to be a role for medicine alongside psychological treatment … Clinicians often see men who have stopped [taking steroids] who report feeling low in mood … a lot of these men will just restart taking them again,” she said.
Anabolic steroids taken exogenously suppress the hypothalamic-pituitary-gonadal system, thereby suppressing endogenous testosterone secretion. While AAS do enhance muscle-building, they can also lead to enlarged hearts, hypertension, and infertility. Most of these are reversible if the man stops taking the AAS.
However, after stopping, the testosterone levels can take up to a year to return to normal. During that time, the man can experience symptoms including low libido, erectile dysfunction, low mood, and fatigue. This leads to a dependence syndrome in about 30%. About 65% of men who stop taking anabolic steroids will restart taking them within the first year, Dr. Grant said in presenting her findings at the annual meeting of the Endocrine Society.
Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “One question is, if you intervene with an antidepressant, will that prevent the people from relapsing and going back to using? I think that’s certainly something that would need to be explored and tested.”
Dr. Hayes also noted that fertility problems may lead some men to decide to stop using the steroids. “That can be a strong motivator. If you have a motivated patient, then you add in an antidepressant or anxiolytic or link the patients with mental health services. I think that would definitely be beneficial and definitely something we need to address and see if it is worthwhile doing.”
Dr. Grant presented data from her group’s cross-sectional, observational study. Of a total 245 men, 116 were current AAS users, 84 were previous AAS users who had quit within the past year, and 45 had never used them. All completed extensive questionnaires about their substance use, mood, sexual function, and anxiety. They had morning blood tests, and urine samples were taken for toxicology testing.
The three groups didn’t differ by age (most were in their mid-30s) or ethnicity (most were White). However, the proportion who self-reported psychiatric diagnoses (mostly depression or anxiety) was significantly higher among both the current (29%) and past (25%) AAS users than among the never users (6.6%), with P = .0094.
Dr. Hayes commented, “One of the drawbacks of this study was they didn’t have baseline data. But it would make sense, I think, that the incidence of depression and anxiety was higher in the people who went on to use anabolic steroids.”
Use of other illicit drugs — mostly cocaine and cannabis — was also higher among the past (40.5%) and current (47.4%) AAS users than among the nonusers (17.7%), P = .0025.
Not surprisingly, total testosterone levels were much higher in current AAS users (62.8 nmol/L) than in past users (20.1 nmol/L) and nonusers (20.0 nmol/L), P < .001. Levels of luteinizing hormone (LH), follicle-stimulating hormone, and sex hormone-binding globulin were significantly lower in the current AAS users than in the other two groups, while estradiol levels were significantly higher (all P < .001).
There were no differences in total testosterone between the never users and previous users. However, about 25% of the men who stopped continued to have lower-than-normal testosterone levels, Dr. Grant noted.
Depression scores, as assessed by the Beck Depression Inventory-II, were highest in men who stopped using AAS, and lowest in the never users. Moderate to severe depression was present in 20% of the men who stopped using AAS, 6% of current users, and none of the nonusers.
In multivariable analysis, having a prior psychiatric diagnosis increased the risk for current depression on the Beck inventory by twofold in the current AAS users (P = .001) and threefold in the past users (P < .001). “Interestingly, testosterone levels were not associated with depression,” she noted.
Sexual function, as measured by the International Index of Erectile Function (IIEF) 15, was significantly worse among those who had stopped using AAS compared with current users and nonusers (P = .023). At the same time, total testosterone levels were only weakly correlated with IIEF scores.
In multivariate analysis, higher LH levels were associated with worse sexual function (P = .01).
Anxiety, as measured by the General Anxiety Disorder-7 assessment, was higher in previous users than in never users. Overall, 12% of the previous users had moderate or severe anxiety vs just 2% of nonusers.
The next step in the research will be to examine the urine toxicology for AAS and other illicit substances, Dr. Grant said.
“We’re hoping this information will allow for future studies to be developed to design treatments, which will help millions of men worldwide to stop and stay off anabolic steroids,” she concluded.
Dr. Grant and Dr. Hayes had no disclosures.
A version of this article first appeared on Medscape.com.
BOSTON — Men who stop using performance-enhancing anabolic-androgenic steroids (AAS) experience significant depression, anxiety, and diminished sexual function within the first year after quitting, new research found.
The data suggest that monitoring these men and, pending clinical trial evidence, intervening to minimize these effects could help prevent recidivism, Bonnie Grant, MBBS, a clinical research fellow at Imperial College London, London, England, told this news organization.
“Nothing has actually been studied in proper randomized controlled trials … but I think there’s going to be a role for medicine alongside psychological treatment … Clinicians often see men who have stopped [taking steroids] who report feeling low in mood … a lot of these men will just restart taking them again,” she said.
Anabolic steroids taken exogenously suppress the hypothalamic-pituitary-gonadal system, thereby suppressing endogenous testosterone secretion. While AAS do enhance muscle-building, they can also lead to enlarged hearts, hypertension, and infertility. Most of these are reversible if the man stops taking the AAS.
However, after stopping, the testosterone levels can take up to a year to return to normal. During that time, the man can experience symptoms including low libido, erectile dysfunction, low mood, and fatigue. This leads to a dependence syndrome in about 30%. About 65% of men who stop taking anabolic steroids will restart taking them within the first year, Dr. Grant said in presenting her findings at the annual meeting of the Endocrine Society.
Asked to comment, session moderator Frances Hayes, MBBCh, associate clinical chief of the Division of Reproductive Endocrinology at Massachusetts General Hospital, Boston, said, “One question is, if you intervene with an antidepressant, will that prevent the people from relapsing and going back to using? I think that’s certainly something that would need to be explored and tested.”
Dr. Hayes also noted that fertility problems may lead some men to decide to stop using the steroids. “That can be a strong motivator. If you have a motivated patient, then you add in an antidepressant or anxiolytic or link the patients with mental health services. I think that would definitely be beneficial and definitely something we need to address and see if it is worthwhile doing.”
Dr. Grant presented data from her group’s cross-sectional, observational study. Of a total 245 men, 116 were current AAS users, 84 were previous AAS users who had quit within the past year, and 45 had never used them. All completed extensive questionnaires about their substance use, mood, sexual function, and anxiety. They had morning blood tests, and urine samples were taken for toxicology testing.
The three groups didn’t differ by age (most were in their mid-30s) or ethnicity (most were White). However, the proportion who self-reported psychiatric diagnoses (mostly depression or anxiety) was significantly higher among both the current (29%) and past (25%) AAS users than among the never users (6.6%), with P = .0094.
Dr. Hayes commented, “One of the drawbacks of this study was they didn’t have baseline data. But it would make sense, I think, that the incidence of depression and anxiety was higher in the people who went on to use anabolic steroids.”
Use of other illicit drugs — mostly cocaine and cannabis — was also higher among the past (40.5%) and current (47.4%) AAS users than among the nonusers (17.7%), P = .0025.
Not surprisingly, total testosterone levels were much higher in current AAS users (62.8 nmol/L) than in past users (20.1 nmol/L) and nonusers (20.0 nmol/L), P < .001. Levels of luteinizing hormone (LH), follicle-stimulating hormone, and sex hormone-binding globulin were significantly lower in the current AAS users than in the other two groups, while estradiol levels were significantly higher (all P < .001).
There were no differences in total testosterone between the never users and previous users. However, about 25% of the men who stopped continued to have lower-than-normal testosterone levels, Dr. Grant noted.
Depression scores, as assessed by the Beck Depression Inventory-II, were highest in men who stopped using AAS, and lowest in the never users. Moderate to severe depression was present in 20% of the men who stopped using AAS, 6% of current users, and none of the nonusers.
In multivariable analysis, having a prior psychiatric diagnosis increased the risk for current depression on the Beck inventory by twofold in the current AAS users (P = .001) and threefold in the past users (P < .001). “Interestingly, testosterone levels were not associated with depression,” she noted.
Sexual function, as measured by the International Index of Erectile Function (IIEF) 15, was significantly worse among those who had stopped using AAS compared with current users and nonusers (P = .023). At the same time, total testosterone levels were only weakly correlated with IIEF scores.
In multivariate analysis, higher LH levels were associated with worse sexual function (P = .01).
Anxiety, as measured by the General Anxiety Disorder-7 assessment, was higher in previous users than in never users. Overall, 12% of the previous users had moderate or severe anxiety vs just 2% of nonusers.
The next step in the research will be to examine the urine toxicology for AAS and other illicit substances, Dr. Grant said.
“We’re hoping this information will allow for future studies to be developed to design treatments, which will help millions of men worldwide to stop and stay off anabolic steroids,” she concluded.
Dr. Grant and Dr. Hayes had no disclosures.
A version of this article first appeared on Medscape.com.
National Academies Issue New Broad Definition of Long COVID
A new broadly inclusive definition of long COVID from the National Academies of Sciences, Engineering, and Medicine (NASEM) has been developed with the aim of improving consistency, documentation, and treatment for both adults and children.
According to the 2024 NASEM definition of long COVID issued on June 11, 2024, “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”
People with long COVID may present with one or more of a long list of symptoms, such as shortness of breath, rapid heartbeat, extreme fatigue, post-exertional malaise, or sleep disturbance and with single or multiple diagnosable conditions, including interstitial lung disease, arrhythmias, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), diabetes, or autoimmune disorders. The condition can exacerbate preexisting health conditions or present as new ones.
The definition does not require laboratory confirmation or other proof of initial infection. Long COVID can follow SARS-CoV-2 infection of any severity, including asymptomatic infections, whether or not they were initially recognized.
Several working definitions and terms for long COVID had previously been proposed, including those from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, but no common definition or terminology had been established.
The new definition was developed at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). It was written by a multi-stakeholder panel convened by NASEM, which recommended that the new definition be universally adopted by the federal government, clinical societies and associations, public health practitioners, clinicians, payers, the drug industry, and others using the term long COVID.
Recent surveys suggest that approximately 7% of Americans have experienced or are experiencing long COVID. “It’s millions of people,” panel chair Harvey V. Fineberg, MD, president of the Gordon and Betty Moore Foundation, told this news organization.
The new definition “does not erase the problem of clinical judgment ... But we think this definition has the real advantage of elevating to the clinician’s mind the real likelihood in the current environment of prevalence of this virus that a presenting patient’s strange symptoms are both real and maybe related as an expression of long COVID,” Dr. Fineberg noted.
One way this new definition differs from previous ones such as WHO’s, he said, is “they talk about a diagnosis of exclusion. One of the important points in our definition is that other diagnosable conditions like ME/CFS or POTS can be part of the picture of long COVID. They are not alternative. They are, in fact, an expression of long COVID.”
Indeed, the NASEM report also introduces the term infection-associated chronic condition (IACC). This was important, Dr. Fineberg said, “because it’s the larger family of conditions of which long COVID is a part. It emphasizes a relatedness of long COVID to other conditions that can follow from a variety of infections. We also adopted the term ‘disease state’ to convey the seriousness and reality of this condition in the lives of patients.”
Comments on New Definition
In a statement provided to this news organization, Lucinda Bateman, MD, and Brayden Yellman, MD, co-medical directors of the Bateman-Horne Center in Salt Lake City, said that “describing long COVID as an IACC ... not only meets the NASEM goal of allowing clinicians, researchers, and public health officials to meaningfully identify and serve all persons who suffer illness or disability in the wake of a SARS-CoV-2 infection, but also draws direct comparison to other known IACC’s (such as ME/CFS, post-treatment Lyme, POTS) that have been plaguing many for decades.”
Dr. Fineberg noted another important aspect of the NASEM report: “Our definition includes an explicit statement on equity, explaining that long COVID can affect anyone, young and old, different races, different ages, different sexes, different genders, different orientations, different socioeconomic conditions ... This does not mean that every single person is at equal risk. There are risk factors, but the important point is the universal nature of this as a condition.”
Two clinical directors of long COVID programs who were contacted by this news organization praised the new definition. Zijian Chen, MD, director of Mount Sinai’s Center for Post-COVID Care, New York, said that it’s “very similar to the definition that we have used for our clinical practice since 2020. It is very important that the broad definition helps to be inclusive of all patients that may be affected. The inclusion of children as a consideration is important as well, since there is routinely less focus on children because they tend to have less disease frequency ... The creation of a unified definition helps both with clinical practice and research.”
Nisha Viswanathan, MD, director of the long COVID program at the University of California, Los Angeles, said: “I think they left it intentionally broad for the medical practitioner to not necessarily use the definition to rule out individuals, but to perhaps use more of a clinical gestalt to help rule in this diagnosis ... I think this definition is providing clarity to health care providers on what exactly would be falling under the long-COVID diagnosis header.”
Dr. Viswanathan also said that she anticipates this definition to help patients make their case in filing disability claims. “Because long COVID has not previously had a good fleshed-out definition, it was very easy for disability providers to reject claims for patients who continue to have symptoms ... I actually think this might help our patients ultimately in their attempt to be able to have the ability to care for themselves when they’re disabled enough to not be able to work.”
Written into the report is the expectation that the definition “will evolve as new evidence emerges and the understanding of long COVID matures.” The writing committee calls for reexamination in “no more than 3 years.” Factors that would prompt a reevaluation could include improved testing methods, discovery of medical factors and/or biomarkers that distinguish long COVID from other conditions, and new treatments.
Meanwhile, Dr. Fineberg told this news organization, “If this definition adds to the readiness, awareness, openness, and response to the patient with long COVID, it will have done its job.”
Dr. Fineberg, Dr. Bateman, Dr. Yellman, Dr. Viswanathan, and Dr. Chen have no relevant disclosures.
A version of this article appeared on Medscape.com.
A new broadly inclusive definition of long COVID from the National Academies of Sciences, Engineering, and Medicine (NASEM) has been developed with the aim of improving consistency, documentation, and treatment for both adults and children.
According to the 2024 NASEM definition of long COVID issued on June 11, 2024, “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”
People with long COVID may present with one or more of a long list of symptoms, such as shortness of breath, rapid heartbeat, extreme fatigue, post-exertional malaise, or sleep disturbance and with single or multiple diagnosable conditions, including interstitial lung disease, arrhythmias, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), diabetes, or autoimmune disorders. The condition can exacerbate preexisting health conditions or present as new ones.
The definition does not require laboratory confirmation or other proof of initial infection. Long COVID can follow SARS-CoV-2 infection of any severity, including asymptomatic infections, whether or not they were initially recognized.
Several working definitions and terms for long COVID had previously been proposed, including those from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, but no common definition or terminology had been established.
The new definition was developed at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). It was written by a multi-stakeholder panel convened by NASEM, which recommended that the new definition be universally adopted by the federal government, clinical societies and associations, public health practitioners, clinicians, payers, the drug industry, and others using the term long COVID.
Recent surveys suggest that approximately 7% of Americans have experienced or are experiencing long COVID. “It’s millions of people,” panel chair Harvey V. Fineberg, MD, president of the Gordon and Betty Moore Foundation, told this news organization.
The new definition “does not erase the problem of clinical judgment ... But we think this definition has the real advantage of elevating to the clinician’s mind the real likelihood in the current environment of prevalence of this virus that a presenting patient’s strange symptoms are both real and maybe related as an expression of long COVID,” Dr. Fineberg noted.
One way this new definition differs from previous ones such as WHO’s, he said, is “they talk about a diagnosis of exclusion. One of the important points in our definition is that other diagnosable conditions like ME/CFS or POTS can be part of the picture of long COVID. They are not alternative. They are, in fact, an expression of long COVID.”
Indeed, the NASEM report also introduces the term infection-associated chronic condition (IACC). This was important, Dr. Fineberg said, “because it’s the larger family of conditions of which long COVID is a part. It emphasizes a relatedness of long COVID to other conditions that can follow from a variety of infections. We also adopted the term ‘disease state’ to convey the seriousness and reality of this condition in the lives of patients.”
Comments on New Definition
In a statement provided to this news organization, Lucinda Bateman, MD, and Brayden Yellman, MD, co-medical directors of the Bateman-Horne Center in Salt Lake City, said that “describing long COVID as an IACC ... not only meets the NASEM goal of allowing clinicians, researchers, and public health officials to meaningfully identify and serve all persons who suffer illness or disability in the wake of a SARS-CoV-2 infection, but also draws direct comparison to other known IACC’s (such as ME/CFS, post-treatment Lyme, POTS) that have been plaguing many for decades.”
Dr. Fineberg noted another important aspect of the NASEM report: “Our definition includes an explicit statement on equity, explaining that long COVID can affect anyone, young and old, different races, different ages, different sexes, different genders, different orientations, different socioeconomic conditions ... This does not mean that every single person is at equal risk. There are risk factors, but the important point is the universal nature of this as a condition.”
Two clinical directors of long COVID programs who were contacted by this news organization praised the new definition. Zijian Chen, MD, director of Mount Sinai’s Center for Post-COVID Care, New York, said that it’s “very similar to the definition that we have used for our clinical practice since 2020. It is very important that the broad definition helps to be inclusive of all patients that may be affected. The inclusion of children as a consideration is important as well, since there is routinely less focus on children because they tend to have less disease frequency ... The creation of a unified definition helps both with clinical practice and research.”
Nisha Viswanathan, MD, director of the long COVID program at the University of California, Los Angeles, said: “I think they left it intentionally broad for the medical practitioner to not necessarily use the definition to rule out individuals, but to perhaps use more of a clinical gestalt to help rule in this diagnosis ... I think this definition is providing clarity to health care providers on what exactly would be falling under the long-COVID diagnosis header.”
Dr. Viswanathan also said that she anticipates this definition to help patients make their case in filing disability claims. “Because long COVID has not previously had a good fleshed-out definition, it was very easy for disability providers to reject claims for patients who continue to have symptoms ... I actually think this might help our patients ultimately in their attempt to be able to have the ability to care for themselves when they’re disabled enough to not be able to work.”
Written into the report is the expectation that the definition “will evolve as new evidence emerges and the understanding of long COVID matures.” The writing committee calls for reexamination in “no more than 3 years.” Factors that would prompt a reevaluation could include improved testing methods, discovery of medical factors and/or biomarkers that distinguish long COVID from other conditions, and new treatments.
Meanwhile, Dr. Fineberg told this news organization, “If this definition adds to the readiness, awareness, openness, and response to the patient with long COVID, it will have done its job.”
Dr. Fineberg, Dr. Bateman, Dr. Yellman, Dr. Viswanathan, and Dr. Chen have no relevant disclosures.
A version of this article appeared on Medscape.com.
A new broadly inclusive definition of long COVID from the National Academies of Sciences, Engineering, and Medicine (NASEM) has been developed with the aim of improving consistency, documentation, and treatment for both adults and children.
According to the 2024 NASEM definition of long COVID issued on June 11, 2024, “Long COVID is an infection-associated chronic condition that occurs after SARS-CoV-2 infection and is present for at least 3 months as a continuous, relapsing and remitting, or progressive disease state that affects one or more organ systems.”
People with long COVID may present with one or more of a long list of symptoms, such as shortness of breath, rapid heartbeat, extreme fatigue, post-exertional malaise, or sleep disturbance and with single or multiple diagnosable conditions, including interstitial lung disease, arrhythmias, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), diabetes, or autoimmune disorders. The condition can exacerbate preexisting health conditions or present as new ones.
The definition does not require laboratory confirmation or other proof of initial infection. Long COVID can follow SARS-CoV-2 infection of any severity, including asymptomatic infections, whether or not they were initially recognized.
Several working definitions and terms for long COVID had previously been proposed, including those from the World Health Organization (WHO) and the US Centers for Disease Control and Prevention, but no common definition or terminology had been established.
The new definition was developed at the request of the Administration for Strategic Preparedness and Response and the Office of the Assistant Secretary for Health (OASH). It was written by a multi-stakeholder panel convened by NASEM, which recommended that the new definition be universally adopted by the federal government, clinical societies and associations, public health practitioners, clinicians, payers, the drug industry, and others using the term long COVID.
Recent surveys suggest that approximately 7% of Americans have experienced or are experiencing long COVID. “It’s millions of people,” panel chair Harvey V. Fineberg, MD, president of the Gordon and Betty Moore Foundation, told this news organization.
The new definition “does not erase the problem of clinical judgment ... But we think this definition has the real advantage of elevating to the clinician’s mind the real likelihood in the current environment of prevalence of this virus that a presenting patient’s strange symptoms are both real and maybe related as an expression of long COVID,” Dr. Fineberg noted.
One way this new definition differs from previous ones such as WHO’s, he said, is “they talk about a diagnosis of exclusion. One of the important points in our definition is that other diagnosable conditions like ME/CFS or POTS can be part of the picture of long COVID. They are not alternative. They are, in fact, an expression of long COVID.”
Indeed, the NASEM report also introduces the term infection-associated chronic condition (IACC). This was important, Dr. Fineberg said, “because it’s the larger family of conditions of which long COVID is a part. It emphasizes a relatedness of long COVID to other conditions that can follow from a variety of infections. We also adopted the term ‘disease state’ to convey the seriousness and reality of this condition in the lives of patients.”
Comments on New Definition
In a statement provided to this news organization, Lucinda Bateman, MD, and Brayden Yellman, MD, co-medical directors of the Bateman-Horne Center in Salt Lake City, said that “describing long COVID as an IACC ... not only meets the NASEM goal of allowing clinicians, researchers, and public health officials to meaningfully identify and serve all persons who suffer illness or disability in the wake of a SARS-CoV-2 infection, but also draws direct comparison to other known IACC’s (such as ME/CFS, post-treatment Lyme, POTS) that have been plaguing many for decades.”
Dr. Fineberg noted another important aspect of the NASEM report: “Our definition includes an explicit statement on equity, explaining that long COVID can affect anyone, young and old, different races, different ages, different sexes, different genders, different orientations, different socioeconomic conditions ... This does not mean that every single person is at equal risk. There are risk factors, but the important point is the universal nature of this as a condition.”
Two clinical directors of long COVID programs who were contacted by this news organization praised the new definition. Zijian Chen, MD, director of Mount Sinai’s Center for Post-COVID Care, New York, said that it’s “very similar to the definition that we have used for our clinical practice since 2020. It is very important that the broad definition helps to be inclusive of all patients that may be affected. The inclusion of children as a consideration is important as well, since there is routinely less focus on children because they tend to have less disease frequency ... The creation of a unified definition helps both with clinical practice and research.”
Nisha Viswanathan, MD, director of the long COVID program at the University of California, Los Angeles, said: “I think they left it intentionally broad for the medical practitioner to not necessarily use the definition to rule out individuals, but to perhaps use more of a clinical gestalt to help rule in this diagnosis ... I think this definition is providing clarity to health care providers on what exactly would be falling under the long-COVID diagnosis header.”
Dr. Viswanathan also said that she anticipates this definition to help patients make their case in filing disability claims. “Because long COVID has not previously had a good fleshed-out definition, it was very easy for disability providers to reject claims for patients who continue to have symptoms ... I actually think this might help our patients ultimately in their attempt to be able to have the ability to care for themselves when they’re disabled enough to not be able to work.”
Written into the report is the expectation that the definition “will evolve as new evidence emerges and the understanding of long COVID matures.” The writing committee calls for reexamination in “no more than 3 years.” Factors that would prompt a reevaluation could include improved testing methods, discovery of medical factors and/or biomarkers that distinguish long COVID from other conditions, and new treatments.
Meanwhile, Dr. Fineberg told this news organization, “If this definition adds to the readiness, awareness, openness, and response to the patient with long COVID, it will have done its job.”
Dr. Fineberg, Dr. Bateman, Dr. Yellman, Dr. Viswanathan, and Dr. Chen have no relevant disclosures.
A version of this article appeared on Medscape.com.