Clinical Endocrinology News

Racial and socioeconomic disparities may be impeding access to newer diabetes medications among U.S. patients who may need them the most, according to researchers at the virtual annual scientific sessions of the American Diabetes Association.

Initiation of DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors was less likely among racial/ethnic minorities and Medicare Advantage beneficiaries in the retrospective analyses, leading the investigators to call for a better understanding of nonclinical factors that may be influencing treatment decisions.

Odds of new diabetes medication use were 55%-69% lower in patients in Medicare Advantage (MA) as compared to patients in commercial health plans, according to results of a separate study presented by Rozalina McCoy, MD, endocrinologist and researcher with Mayo Clinic, Rochester, Minn.

“The rates of use are increasing over time, but not enough in MA beneficiaries,” she said in her virtual presentation. “I think it really calls for more to be done to ensure access to and use of evidence based medications, by all people with type 2 diabetes.”

The likelihood of initiating a new diabetes drug was 29% lower among African Americans and 49% lower among Native Americans in a study of enrollees in the Look AHEAD (Action for Health in Diabetes) randomized trial, according to researcher Ahmed Elhussein, BMBCh, MPH, of the Johns Hopkins Bloomberg School of Public Health.

“This is particularly concerning, because they might have a greater need for these new diabetes medications, but reduced access,” Dr. Elhussein said in his presentation.

Disparities by race in diabetes drug use

The prevalence of type 2 diabetes in the United States is higher among racial and ethnic minorities, at about 12%-15%, versus about 7% in whites, according to Dr. Elhussein,

While the newer classes of diabetes medications have a lower risk of hyperglycemia and have cardiovascular and renal benefits, they also come at a higher cost, he added.

“This has created some concerns about access in particular for underserved groups,” he said in his presentation.

In their retrospective analysis, based on 4,892 patients enrolled in the Look AHEAD (Action for Health in Diabetes) randomized trial, Dr. Elhussein and coinvestigators identified 44% who had initiated a newer diabetes medication over a median follow-up of about 8 years.

They found black race was associated with significantly lower initiation of newer medications compared to whites, with a hazard ratio of 0.81 (95% confidence interval 0.80-0.94; P = 0.019), after adjustment for socioeconomic status.

New diabetes medication use was also significantly lower among American Indian/Alaskan Natives, with an HR of 0.51 and a confidence interval that did not include the null value of 1, according to the investigator.

No significant differences in new diabetes drug use were seen in Hispanics or those classified as other race/ethnicity, he added.

“We’d advocate for more study to try to understand what are the drivers of this disparity,” he said. “This would let us develop interventions that might help to increase access in these patient groups that might need them the most.”

Insurance type and diabetes drugs

Second-line medications, including GLP-1 receptor agonists and SGLT2 inhibitors, have “preferred” efficacy and side effect profiles, but are more costly than older, generic options such as sulfonylureas, which may affect the likelihood of their use, said Dr. McCoy, the Mayo Clinic researcher and lead author of the study on diabetes medication use by insurance type.

They analyzed 1.7 million individuals in a de-identified dataset (OptumLabs Data Warehouse) who were either privately insured or beneficiaries of Medicare Advantage, the private health plan alternative to fee-for-service Medicare.

After adjusting for race/ethnicity, baseline medications, age, gender, and other factors, odds of new medication use were significantly lower in the Medicare Advantage group, according to Dr. McCoy.

Odds ratios ranged from 0.61 (95% CI, 0.60-0.63) for DPP-4 inhibitors, to 0.45 (95% CI, 0.44-0.46) for GLP-1 receptor agonists, and to 0.31 (95% CI, 0.30-0.31) for SGLT2 inhibitors, she reported.

“This may be driven by affordability, because patients with Medicare Advantage plans are not able to access prescription savings cards (as compared to Medicare beneficiaries) and they also are more likely to have fixed incomes and not be able to afford the high costs of these drugs,” she said.

Dr. Elhussein reported no disclosures related to the research, while co-authors provided disclosures related to Abbott, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, MannKind, Medscape, Novo Nordisk, Sanofi US, and others. Dr McCoy likewise had no disclosures, while co-authors indicated disclosures related to Janssen Pharmaceuticals, the Centers for Medicare and Medicaid Services, and the U.S. Food and Drug Administration.

SOURCES: ADA 2020. Authors: McCoy R et al (38-OR), and Elhussein A, et al (37-OR).
 

Racial and socioeconomic disparities may be impeding access to newer diabetes medications among U.S. patients who may need them the most, according to researchers at the virtual annual scientific sessions of the American Diabetes Association.

Initiation of DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors was less likely among racial/ethnic minorities and Medicare Advantage beneficiaries in the retrospective analyses, leading the investigators to call for a better understanding of nonclinical factors that may be influencing treatment decisions.

Odds of new diabetes medication use were 55%-69% lower in patients in Medicare Advantage (MA) as compared to patients in commercial health plans, according to results of a separate study presented by Rozalina McCoy, MD, endocrinologist and researcher with Mayo Clinic, Rochester, Minn.

“The rates of use are increasing over time, but not enough in MA beneficiaries,” she said in her virtual presentation. “I think it really calls for more to be done to ensure access to and use of evidence based medications, by all people with type 2 diabetes.”

The likelihood of initiating a new diabetes drug was 29% lower among African Americans and 49% lower among Native Americans in a study of enrollees in the Look AHEAD (Action for Health in Diabetes) randomized trial, according to researcher Ahmed Elhussein, BMBCh, MPH, of the Johns Hopkins Bloomberg School of Public Health.

“This is particularly concerning, because they might have a greater need for these new diabetes medications, but reduced access,” Dr. Elhussein said in his presentation.

Disparities by race in diabetes drug use

The prevalence of type 2 diabetes in the United States is higher among racial and ethnic minorities, at about 12%-15%, versus about 7% in whites, according to Dr. Elhussein,

While the newer classes of diabetes medications have a lower risk of hyperglycemia and have cardiovascular and renal benefits, they also come at a higher cost, he added.

“This has created some concerns about access in particular for underserved groups,” he said in his presentation.

In their retrospective analysis, based on 4,892 patients enrolled in the Look AHEAD (Action for Health in Diabetes) randomized trial, Dr. Elhussein and coinvestigators identified 44% who had initiated a newer diabetes medication over a median follow-up of about 8 years.

They found black race was associated with significantly lower initiation of newer medications compared to whites, with a hazard ratio of 0.81 (95% confidence interval 0.80-0.94; P = 0.019), after adjustment for socioeconomic status.

New diabetes medication use was also significantly lower among American Indian/Alaskan Natives, with an HR of 0.51 and a confidence interval that did not include the null value of 1, according to the investigator.

No significant differences in new diabetes drug use were seen in Hispanics or those classified as other race/ethnicity, he added.

“We’d advocate for more study to try to understand what are the drivers of this disparity,” he said. “This would let us develop interventions that might help to increase access in these patient groups that might need them the most.”

Insurance type and diabetes drugs

Second-line medications, including GLP-1 receptor agonists and SGLT2 inhibitors, have “preferred” efficacy and side effect profiles, but are more costly than older, generic options such as sulfonylureas, which may affect the likelihood of their use, said Dr. McCoy, the Mayo Clinic researcher and lead author of the study on diabetes medication use by insurance type.

They analyzed 1.7 million individuals in a de-identified dataset (OptumLabs Data Warehouse) who were either privately insured or beneficiaries of Medicare Advantage, the private health plan alternative to fee-for-service Medicare.

After adjusting for race/ethnicity, baseline medications, age, gender, and other factors, odds of new medication use were significantly lower in the Medicare Advantage group, according to Dr. McCoy.

Odds ratios ranged from 0.61 (95% CI, 0.60-0.63) for DPP-4 inhibitors, to 0.45 (95% CI, 0.44-0.46) for GLP-1 receptor agonists, and to 0.31 (95% CI, 0.30-0.31) for SGLT2 inhibitors, she reported.

“This may be driven by affordability, because patients with Medicare Advantage plans are not able to access prescription savings cards (as compared to Medicare beneficiaries) and they also are more likely to have fixed incomes and not be able to afford the high costs of these drugs,” she said.

Dr. Elhussein reported no disclosures related to the research, while co-authors provided disclosures related to Abbott, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, MannKind, Medscape, Novo Nordisk, Sanofi US, and others. Dr McCoy likewise had no disclosures, while co-authors indicated disclosures related to Janssen Pharmaceuticals, the Centers for Medicare and Medicaid Services, and the U.S. Food and Drug Administration.

SOURCES: ADA 2020. Authors: McCoy R et al (38-OR), and Elhussein A, et al (37-OR).
 

Racial and socioeconomic disparities may be impeding access to newer diabetes medications among U.S. patients who may need them the most, according to researchers at the virtual annual scientific sessions of the American Diabetes Association.

Initiation of DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors was less likely among racial/ethnic minorities and Medicare Advantage beneficiaries in the retrospective analyses, leading the investigators to call for a better understanding of nonclinical factors that may be influencing treatment decisions.

Odds of new diabetes medication use were 55%-69% lower in patients in Medicare Advantage (MA) as compared to patients in commercial health plans, according to results of a separate study presented by Rozalina McCoy, MD, endocrinologist and researcher with Mayo Clinic, Rochester, Minn.

“The rates of use are increasing over time, but not enough in MA beneficiaries,” she said in her virtual presentation. “I think it really calls for more to be done to ensure access to and use of evidence based medications, by all people with type 2 diabetes.”

The likelihood of initiating a new diabetes drug was 29% lower among African Americans and 49% lower among Native Americans in a study of enrollees in the Look AHEAD (Action for Health in Diabetes) randomized trial, according to researcher Ahmed Elhussein, BMBCh, MPH, of the Johns Hopkins Bloomberg School of Public Health.

“This is particularly concerning, because they might have a greater need for these new diabetes medications, but reduced access,” Dr. Elhussein said in his presentation.

Disparities by race in diabetes drug use

The prevalence of type 2 diabetes in the United States is higher among racial and ethnic minorities, at about 12%-15%, versus about 7% in whites, according to Dr. Elhussein,

While the newer classes of diabetes medications have a lower risk of hyperglycemia and have cardiovascular and renal benefits, they also come at a higher cost, he added.

“This has created some concerns about access in particular for underserved groups,” he said in his presentation.

In their retrospective analysis, based on 4,892 patients enrolled in the Look AHEAD (Action for Health in Diabetes) randomized trial, Dr. Elhussein and coinvestigators identified 44% who had initiated a newer diabetes medication over a median follow-up of about 8 years.

They found black race was associated with significantly lower initiation of newer medications compared to whites, with a hazard ratio of 0.81 (95% confidence interval 0.80-0.94; P = 0.019), after adjustment for socioeconomic status.

New diabetes medication use was also significantly lower among American Indian/Alaskan Natives, with an HR of 0.51 and a confidence interval that did not include the null value of 1, according to the investigator.

No significant differences in new diabetes drug use were seen in Hispanics or those classified as other race/ethnicity, he added.

“We’d advocate for more study to try to understand what are the drivers of this disparity,” he said. “This would let us develop interventions that might help to increase access in these patient groups that might need them the most.”

Insurance type and diabetes drugs

Second-line medications, including GLP-1 receptor agonists and SGLT2 inhibitors, have “preferred” efficacy and side effect profiles, but are more costly than older, generic options such as sulfonylureas, which may affect the likelihood of their use, said Dr. McCoy, the Mayo Clinic researcher and lead author of the study on diabetes medication use by insurance type.

They analyzed 1.7 million individuals in a de-identified dataset (OptumLabs Data Warehouse) who were either privately insured or beneficiaries of Medicare Advantage, the private health plan alternative to fee-for-service Medicare.

After adjusting for race/ethnicity, baseline medications, age, gender, and other factors, odds of new medication use were significantly lower in the Medicare Advantage group, according to Dr. McCoy.

Odds ratios ranged from 0.61 (95% CI, 0.60-0.63) for DPP-4 inhibitors, to 0.45 (95% CI, 0.44-0.46) for GLP-1 receptor agonists, and to 0.31 (95% CI, 0.30-0.31) for SGLT2 inhibitors, she reported.

“This may be driven by affordability, because patients with Medicare Advantage plans are not able to access prescription savings cards (as compared to Medicare beneficiaries) and they also are more likely to have fixed incomes and not be able to afford the high costs of these drugs,” she said.

Dr. Elhussein reported no disclosures related to the research, while co-authors provided disclosures related to Abbott, Bigfoot Biomedical, Boehringer Ingelheim, Eli Lilly, MannKind, Medscape, Novo Nordisk, Sanofi US, and others. Dr McCoy likewise had no disclosures, while co-authors indicated disclosures related to Janssen Pharmaceuticals, the Centers for Medicare and Medicaid Services, and the U.S. Food and Drug Administration.

SOURCES: ADA 2020. Authors: McCoy R et al (38-OR), and Elhussein A, et al (37-OR).
 

Patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin during the landmark EMPA-REG OUTCOME trial had a solidly reduced need to either start insulin treatment or intensify existing insulin treatment, compared with those given placebo, in a post-hoc analysis of the study’s findings.

Mitchel L. Zoler/Frontline Medical News

“Empagliflozin markedly and durably delayed the need for insulin initiation, and reduced the need for large dose increases in patients already using insulin,” Muthiah Vaduganathan, MD, said at the virtual annual scientific sessions of the American Diabetes Association.

The patients in the empagliflozin (Jardiance) arm of EMPA-REG OUTCOME had a 9% rate of initiating insulin treatment after 4 years in the study, compared with a 20% rate among patients who received placebo, a statistically significant 60% relative risk reduction. All patients in the trial continued on their background oral glucose-lowering medications.

Among the 48% of study patients who entered the study already using insulin as part of their usual regimen, 18% of those receiving empagliflozin required a significant increase in their insulin dosage (an increase of at least 20% from baseline) after 4 years. But among the control patients, 35% needed this level of insulin-dosage intensification, again a statistically significant difference that computed to a 58% relative reduction in the need for boosting the insulin dosage.

For both of these endpoints, the divergence between the empagliflozin and control arms became apparent within the first 6 months on treatment, and the between-group differences steadily increased during further follow-up. The analyses pooled the patients who received empagliflozin in the trial, which studied two different dosages of the drug.

Results add to the ‘risk and benefit conversation’

“This is one of the first studies to look at this question in a more granular fashion” in patients with type 2 diabetes receiving a drug from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, said Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston. It provides “compelling” information to include when discussing oral diabetes-drug options with patients, he said in an interview.

Patients newly diagnosed with type 2 diabetes “often think about insulin” and their potential need to eventually start taking it, with the requirements it brings for training, monitoring, and drug delivery, along with the costs for insulin and glucose monitoring. “Patients are very attuned to potentially needing insulin and often ask about it. A reduced need for insulin will be an important part of the risk and benefit conversation” with patients about potential use of an SGLT2 inhibitor, he said.

Dr. Vaduganathan hypothesized that three factors could contribute to the impact of empagliflozin on insulin initiation and dosage level: a direct glycemic-control effect of the drug, the drug’s positive impact on overall well-being and function that could enhance patient movement, and the documented ability of treatment with empagliflozin and other drugs in its class to cut the rate of heart failure hospitalizations. This last feature is potentially relevant because insulin treatment often starts in patients with type 2 diabetes during a hospitalization, he noted.
 

Handelsman: Analysis shows no ‘spectacular effect’

The association of empagliflozin treatment with a reduced need for insulin seen in these data is consistent with expectations for patients with type 2 diabetes who receive an additional oral drug, commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of The Metabolic Institute of American in Tarzana, Calif. “In large part it has to do with patients on placebo having to get more insulin” because their additional oral-drug options were limited. Dr. Handelsman pointed out that during the period when the EMPA-REG OUTCOME trial ran, from 2010-2015, fewer oral drugs were available than today, and clinicians in the study were encouraged to treat patients to their goal glycemia level according to local guidelines. In addition to a modest but useful glycemic control effect from SGLT2 inhibitors that, on average, cut hemoglobin A_1c levels by about 0.5%, they may also give a small boost to insulin sensitivity that can also defer the need to add or increase insulin. The level of insulin-treatment deference reported in the new analysis was “not a spectacular effect” he said in an interview.

The EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study followed 7,020 patients at 590 sites in 42 countries for a median of 3.1 years. The study’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent MI), or nonfatal stroke, and the results showed a statistically significant 14% relative risk reduction with empagliflozin treatment (N Engl J Med. 2015 Nov 26;373[22]:2117-28 ). The results also showed that 12 weeks into the study, before patients could receive any additional drugs, HbA_1c levels averaged 0.54%-0.6% lower among the empagliflozin-treated patients than those in the placebo arm, with smaller between-group differences maintained through the balance of the study. At entry, more than half the enrolled patients were routinely treated with metformin, and close to half were receiving a sulfonyurea agent.

The EMPA-REG OUTCOME results were also notable as showing for the first time that treatment with an SGLT2 inhibitor drug produced a substantial decrease in heart failure hospitalizations, incident heart failure, and progression of renal dysfunction, effects subsequently confirmed and also found for other agents in this drug class.

EMPA-REG OUTCOME was funded in part by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin (Jardiance). Dr. Vaduganathan has been an advisor to Boehringer Ingelheim and to Amgen, AstraZeneca, Baxter, Bayer, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including Boehringer Ingelheim and Eli Lilly.

mzoler@mdedge.com

SOURCE: Vaduganathan M et al. ADA 2020, Abstract 30-OR.

Patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin during the landmark EMPA-REG OUTCOME trial had a solidly reduced need to either start insulin treatment or intensify existing insulin treatment, compared with those given placebo, in a post-hoc analysis of the study’s findings.

Mitchel L. Zoler/Frontline Medical News

“Empagliflozin markedly and durably delayed the need for insulin initiation, and reduced the need for large dose increases in patients already using insulin,” Muthiah Vaduganathan, MD, said at the virtual annual scientific sessions of the American Diabetes Association.

The patients in the empagliflozin (Jardiance) arm of EMPA-REG OUTCOME had a 9% rate of initiating insulin treatment after 4 years in the study, compared with a 20% rate among patients who received placebo, a statistically significant 60% relative risk reduction. All patients in the trial continued on their background oral glucose-lowering medications.

Among the 48% of study patients who entered the study already using insulin as part of their usual regimen, 18% of those receiving empagliflozin required a significant increase in their insulin dosage (an increase of at least 20% from baseline) after 4 years. But among the control patients, 35% needed this level of insulin-dosage intensification, again a statistically significant difference that computed to a 58% relative reduction in the need for boosting the insulin dosage.

For both of these endpoints, the divergence between the empagliflozin and control arms became apparent within the first 6 months on treatment, and the between-group differences steadily increased during further follow-up. The analyses pooled the patients who received empagliflozin in the trial, which studied two different dosages of the drug.

Results add to the ‘risk and benefit conversation’

“This is one of the first studies to look at this question in a more granular fashion” in patients with type 2 diabetes receiving a drug from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, said Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston. It provides “compelling” information to include when discussing oral diabetes-drug options with patients, he said in an interview.

Patients newly diagnosed with type 2 diabetes “often think about insulin” and their potential need to eventually start taking it, with the requirements it brings for training, monitoring, and drug delivery, along with the costs for insulin and glucose monitoring. “Patients are very attuned to potentially needing insulin and often ask about it. A reduced need for insulin will be an important part of the risk and benefit conversation” with patients about potential use of an SGLT2 inhibitor, he said.

Dr. Vaduganathan hypothesized that three factors could contribute to the impact of empagliflozin on insulin initiation and dosage level: a direct glycemic-control effect of the drug, the drug’s positive impact on overall well-being and function that could enhance patient movement, and the documented ability of treatment with empagliflozin and other drugs in its class to cut the rate of heart failure hospitalizations. This last feature is potentially relevant because insulin treatment often starts in patients with type 2 diabetes during a hospitalization, he noted.
 

Handelsman: Analysis shows no ‘spectacular effect’

The association of empagliflozin treatment with a reduced need for insulin seen in these data is consistent with expectations for patients with type 2 diabetes who receive an additional oral drug, commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of The Metabolic Institute of American in Tarzana, Calif. “In large part it has to do with patients on placebo having to get more insulin” because their additional oral-drug options were limited. Dr. Handelsman pointed out that during the period when the EMPA-REG OUTCOME trial ran, from 2010-2015, fewer oral drugs were available than today, and clinicians in the study were encouraged to treat patients to their goal glycemia level according to local guidelines. In addition to a modest but useful glycemic control effect from SGLT2 inhibitors that, on average, cut hemoglobin A_1c levels by about 0.5%, they may also give a small boost to insulin sensitivity that can also defer the need to add or increase insulin. The level of insulin-treatment deference reported in the new analysis was “not a spectacular effect” he said in an interview.

The EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study followed 7,020 patients at 590 sites in 42 countries for a median of 3.1 years. The study’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent MI), or nonfatal stroke, and the results showed a statistically significant 14% relative risk reduction with empagliflozin treatment (N Engl J Med. 2015 Nov 26;373[22]:2117-28 ). The results also showed that 12 weeks into the study, before patients could receive any additional drugs, HbA_1c levels averaged 0.54%-0.6% lower among the empagliflozin-treated patients than those in the placebo arm, with smaller between-group differences maintained through the balance of the study. At entry, more than half the enrolled patients were routinely treated with metformin, and close to half were receiving a sulfonyurea agent.

The EMPA-REG OUTCOME results were also notable as showing for the first time that treatment with an SGLT2 inhibitor drug produced a substantial decrease in heart failure hospitalizations, incident heart failure, and progression of renal dysfunction, effects subsequently confirmed and also found for other agents in this drug class.

EMPA-REG OUTCOME was funded in part by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin (Jardiance). Dr. Vaduganathan has been an advisor to Boehringer Ingelheim and to Amgen, AstraZeneca, Baxter, Bayer, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including Boehringer Ingelheim and Eli Lilly.

mzoler@mdedge.com

SOURCE: Vaduganathan M et al. ADA 2020, Abstract 30-OR.

Patients with type 2 diabetes treated with the SGLT2 inhibitor empagliflozin during the landmark EMPA-REG OUTCOME trial had a solidly reduced need to either start insulin treatment or intensify existing insulin treatment, compared with those given placebo, in a post-hoc analysis of the study’s findings.

Mitchel L. Zoler/Frontline Medical News

“Empagliflozin markedly and durably delayed the need for insulin initiation, and reduced the need for large dose increases in patients already using insulin,” Muthiah Vaduganathan, MD, said at the virtual annual scientific sessions of the American Diabetes Association.

The patients in the empagliflozin (Jardiance) arm of EMPA-REG OUTCOME had a 9% rate of initiating insulin treatment after 4 years in the study, compared with a 20% rate among patients who received placebo, a statistically significant 60% relative risk reduction. All patients in the trial continued on their background oral glucose-lowering medications.

Among the 48% of study patients who entered the study already using insulin as part of their usual regimen, 18% of those receiving empagliflozin required a significant increase in their insulin dosage (an increase of at least 20% from baseline) after 4 years. But among the control patients, 35% needed this level of insulin-dosage intensification, again a statistically significant difference that computed to a 58% relative reduction in the need for boosting the insulin dosage.

For both of these endpoints, the divergence between the empagliflozin and control arms became apparent within the first 6 months on treatment, and the between-group differences steadily increased during further follow-up. The analyses pooled the patients who received empagliflozin in the trial, which studied two different dosages of the drug.

Results add to the ‘risk and benefit conversation’

“This is one of the first studies to look at this question in a more granular fashion” in patients with type 2 diabetes receiving a drug from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class, said Dr. Vaduganathan, a cardiologist at Brigham and Women’s Hospital in Boston. It provides “compelling” information to include when discussing oral diabetes-drug options with patients, he said in an interview.

Patients newly diagnosed with type 2 diabetes “often think about insulin” and their potential need to eventually start taking it, with the requirements it brings for training, monitoring, and drug delivery, along with the costs for insulin and glucose monitoring. “Patients are very attuned to potentially needing insulin and often ask about it. A reduced need for insulin will be an important part of the risk and benefit conversation” with patients about potential use of an SGLT2 inhibitor, he said.

Dr. Vaduganathan hypothesized that three factors could contribute to the impact of empagliflozin on insulin initiation and dosage level: a direct glycemic-control effect of the drug, the drug’s positive impact on overall well-being and function that could enhance patient movement, and the documented ability of treatment with empagliflozin and other drugs in its class to cut the rate of heart failure hospitalizations. This last feature is potentially relevant because insulin treatment often starts in patients with type 2 diabetes during a hospitalization, he noted.
 

Handelsman: Analysis shows no ‘spectacular effect’

The association of empagliflozin treatment with a reduced need for insulin seen in these data is consistent with expectations for patients with type 2 diabetes who receive an additional oral drug, commented Yehuda Handelsman, MD, an endocrinologist and diabetes specialist who is medical director of The Metabolic Institute of American in Tarzana, Calif. “In large part it has to do with patients on placebo having to get more insulin” because their additional oral-drug options were limited. Dr. Handelsman pointed out that during the period when the EMPA-REG OUTCOME trial ran, from 2010-2015, fewer oral drugs were available than today, and clinicians in the study were encouraged to treat patients to their goal glycemia level according to local guidelines. In addition to a modest but useful glycemic control effect from SGLT2 inhibitors that, on average, cut hemoglobin A_1c levels by about 0.5%, they may also give a small boost to insulin sensitivity that can also defer the need to add or increase insulin. The level of insulin-treatment deference reported in the new analysis was “not a spectacular effect” he said in an interview.

The EMPA-REG OUTCOME (Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) study followed 7,020 patients at 590 sites in 42 countries for a median of 3.1 years. The study’s primary endpoint was a composite of death from cardiovascular causes, nonfatal myocardial infarction (excluding silent MI), or nonfatal stroke, and the results showed a statistically significant 14% relative risk reduction with empagliflozin treatment (N Engl J Med. 2015 Nov 26;373[22]:2117-28 ). The results also showed that 12 weeks into the study, before patients could receive any additional drugs, HbA_1c levels averaged 0.54%-0.6% lower among the empagliflozin-treated patients than those in the placebo arm, with smaller between-group differences maintained through the balance of the study. At entry, more than half the enrolled patients were routinely treated with metformin, and close to half were receiving a sulfonyurea agent.

The EMPA-REG OUTCOME results were also notable as showing for the first time that treatment with an SGLT2 inhibitor drug produced a substantial decrease in heart failure hospitalizations, incident heart failure, and progression of renal dysfunction, effects subsequently confirmed and also found for other agents in this drug class.

EMPA-REG OUTCOME was funded in part by Boehringer Ingelheim and Eli Lilly, the companies that market empagliflozin (Jardiance). Dr. Vaduganathan has been an advisor to Boehringer Ingelheim and to Amgen, AstraZeneca, Baxter, Bayer, Cytokinetics, and Relypsa. Dr. Handelsman has been a consultant to several drug companies including Boehringer Ingelheim and Eli Lilly.

mzoler@mdedge.com

SOURCE: Vaduganathan M et al. ADA 2020, Abstract 30-OR.

In its first media briefing on coronavirus in more than 3 months, the Centers for Disease Control and Prevention (CDC) warned that the COVID-19 pandemic is not over, and large gatherings pose a high risk for COVID-19 transmission.

Robert Redfield, MD, Director, CDC, and Jay C. Butler, MD, Deputy Director of Infectious Diseases and COVID-19 Response Incident Manager, CDC, discussed two new sets of CDC guidance on deciding to go out and attending group gatherings.

“We recognize that we’re all getting tired of staying at home; people long for the life that they had back in December, and as we head into the summer months, we know that Americans will be looking forward to reconnecting with family and friends and being able to attend events, and we want that to occur as safely as possible,” Butler said.

“Our recommendations evolved based on new information that becomes available, but it continues to be extremely important that we embrace the recommendations of social distancing, handwashing, and wearing a face covering when we’re in public as some of the key defenses that we have against this virus,” Redfield explained.

“The pandemic is not over and it’s important to recognize that. While COVID-19 is still making headlines everywhere, we know the pandemic hasn’t affected everyone everywhere in the same way,” Butler said.

He noted that it is important to prepare for next fall and winter, when we can expect influenza season to complicate matters. “If anything, we must be overly-prepared for what we might face later this year,” he continued, adding that it is important to get vaccinated against influenza. “[F]lu and COVID-19 could be circulating together as we move into the fall and winter months,” he concluded.

Americans Mostly Following Guidelines

The agency also presented data from an article published online June 12 in Morbidity and Mortality Weekly Report that “underscores the fact that American people have taken mitigation efforts seriously…and it demonstrates our collective spirit in responding to the pandemic,” Butler said.

In it, the researchers describe representative panel surveys conducted among 4042 adults aged 18 years or older in New York City and Los Angeles — the two most populous cities in the United States — and “broadly across the United States” during May 5 to May 12, 2020.

Most respondents supported stay-at-home orders and nonessential business closures (United States, 79.5%; New York City, 86.7%; Los Angeles, 81.5%) and always or often wore cloth face coverings in public (United States, 74.1%; New York City, 89.6%; Los Angeles, 89.8%). Respondents also agreed that nonessential workers should remain at home (United States, 67.3%; New York City, 76.6%; Los Angeles, 69.1%), report Mark É. Czeisler, from Monash University and Austin Health, both in Melbourne, Australia, and colleagues.

There was wide support with public health guidelines: more than 87% of individuals in each area agreed that individuals should keep six feet of distance between themselves and others, and more than 82% in each area said that people should limit gatherings to fewer than 10 individuals.

At the time the survey was conducted, most were against indoor dining at restaurants (United States, 66.6%; New York City, 81.5%; Los Angeles, 71.8%).

Adherence “Widespread,” Survey Finds

Most respondents said they were adhering to COVID-19 mitigation guidance, including self-isolating (United States, 77.3%; New York City, 84.6%; Los Angeles, 83.0%) and “always or often” kept at least six feet between themselves and others (New York City, 85.7%; Los Angeles, 82.6%).

More than 85% of respondents in each of the three cohorts said they always or often avoided groups of 10 or more individuals.

About 90% of respondents said they had been in a public area during the last week, with 74.1% of those saying they always or often covered their face in public; respondents in New York City (89.6%) and Los Angeles (89.8%) had higher percentages of this behavior compared with respondents from the United States overall.

Most respondents felt that restrictions in their state were balanced or too lax (United States, 84.3%; New York City, 89.7%; Los Angeles, 79.7%) and said they would feel unsafe if restrictions were eased nationwide at that time (United States, 74.3%; New York City, 81.5%; Los Angeles, 73.4%). However, some individuals who said they would feel unsafe still wanted community mitigation strategies eased and were willing to accept risks resulting from lifting restrictions (United States, 17.1%; New York City, 12.6%; Los Angeles, 12.7%).

“Reported prevalence of self-isolation and feeling safe if community mitigation strategies were lifted differed significantly by age, employment status, and essential worker status among adults in the U.S. survey cohort,” the authors write.

Reports of self-isolation were highest among persons aged 18 to 24 years (92.3%) and lowest among those aged 45 to 54 years (71.5%). Yet, young adults aged 18 to 24 years (43.1%) were more than twice as likely to say they would feel safe if community mitigation strategies were eased, compared with adults aged 65 years or older (19.2%).

Almost half (47.2%) of employed respondents in the US cohort were essential workers; essential workers were “significantly less likely” to report self-isolating when compared with nonessential workers (63.1% vs 80.6%). Some 37.7% of essential workers said they would feel safe if community mitigation strategies were eased, compared with 23.7% of nonessential workers.

“Respondents who were male, employed, or essential workers were significantly more likely to report having been in public areas in the past week. Among respondents who had been in public areas during the preceding week, significantly higher percentages of women, adults aged ≥ 65 years, retired persons, and those living in urban areas reported wearing cloth face coverings,” the authors explain.

The findings are subject to several limitations, including self-reporting and the fact that some respondents may have known someone who tested positive for COVID-19 or died from it, the authors note. Respondents were not representative of the US population and the findings may not be generalizable.


This article first appeared on Medscape.com.

In its first media briefing on coronavirus in more than 3 months, the Centers for Disease Control and Prevention (CDC) warned that the COVID-19 pandemic is not over, and large gatherings pose a high risk for COVID-19 transmission.

Robert Redfield, MD, Director, CDC, and Jay C. Butler, MD, Deputy Director of Infectious Diseases and COVID-19 Response Incident Manager, CDC, discussed two new sets of CDC guidance on deciding to go out and attending group gatherings.

“We recognize that we’re all getting tired of staying at home; people long for the life that they had back in December, and as we head into the summer months, we know that Americans will be looking forward to reconnecting with family and friends and being able to attend events, and we want that to occur as safely as possible,” Butler said.

“Our recommendations evolved based on new information that becomes available, but it continues to be extremely important that we embrace the recommendations of social distancing, handwashing, and wearing a face covering when we’re in public as some of the key defenses that we have against this virus,” Redfield explained.

“The pandemic is not over and it’s important to recognize that. While COVID-19 is still making headlines everywhere, we know the pandemic hasn’t affected everyone everywhere in the same way,” Butler said.

He noted that it is important to prepare for next fall and winter, when we can expect influenza season to complicate matters. “If anything, we must be overly-prepared for what we might face later this year,” he continued, adding that it is important to get vaccinated against influenza. “[F]lu and COVID-19 could be circulating together as we move into the fall and winter months,” he concluded.

Americans Mostly Following Guidelines

The agency also presented data from an article published online June 12 in Morbidity and Mortality Weekly Report that “underscores the fact that American people have taken mitigation efforts seriously…and it demonstrates our collective spirit in responding to the pandemic,” Butler said.

In it, the researchers describe representative panel surveys conducted among 4042 adults aged 18 years or older in New York City and Los Angeles — the two most populous cities in the United States — and “broadly across the United States” during May 5 to May 12, 2020.

Most respondents supported stay-at-home orders and nonessential business closures (United States, 79.5%; New York City, 86.7%; Los Angeles, 81.5%) and always or often wore cloth face coverings in public (United States, 74.1%; New York City, 89.6%; Los Angeles, 89.8%). Respondents also agreed that nonessential workers should remain at home (United States, 67.3%; New York City, 76.6%; Los Angeles, 69.1%), report Mark É. Czeisler, from Monash University and Austin Health, both in Melbourne, Australia, and colleagues.

There was wide support with public health guidelines: more than 87% of individuals in each area agreed that individuals should keep six feet of distance between themselves and others, and more than 82% in each area said that people should limit gatherings to fewer than 10 individuals.

At the time the survey was conducted, most were against indoor dining at restaurants (United States, 66.6%; New York City, 81.5%; Los Angeles, 71.8%).

Adherence “Widespread,” Survey Finds

Most respondents said they were adhering to COVID-19 mitigation guidance, including self-isolating (United States, 77.3%; New York City, 84.6%; Los Angeles, 83.0%) and “always or often” kept at least six feet between themselves and others (New York City, 85.7%; Los Angeles, 82.6%).

More than 85% of respondents in each of the three cohorts said they always or often avoided groups of 10 or more individuals.

About 90% of respondents said they had been in a public area during the last week, with 74.1% of those saying they always or often covered their face in public; respondents in New York City (89.6%) and Los Angeles (89.8%) had higher percentages of this behavior compared with respondents from the United States overall.

Most respondents felt that restrictions in their state were balanced or too lax (United States, 84.3%; New York City, 89.7%; Los Angeles, 79.7%) and said they would feel unsafe if restrictions were eased nationwide at that time (United States, 74.3%; New York City, 81.5%; Los Angeles, 73.4%). However, some individuals who said they would feel unsafe still wanted community mitigation strategies eased and were willing to accept risks resulting from lifting restrictions (United States, 17.1%; New York City, 12.6%; Los Angeles, 12.7%).

“Reported prevalence of self-isolation and feeling safe if community mitigation strategies were lifted differed significantly by age, employment status, and essential worker status among adults in the U.S. survey cohort,” the authors write.

Reports of self-isolation were highest among persons aged 18 to 24 years (92.3%) and lowest among those aged 45 to 54 years (71.5%). Yet, young adults aged 18 to 24 years (43.1%) were more than twice as likely to say they would feel safe if community mitigation strategies were eased, compared with adults aged 65 years or older (19.2%).

Almost half (47.2%) of employed respondents in the US cohort were essential workers; essential workers were “significantly less likely” to report self-isolating when compared with nonessential workers (63.1% vs 80.6%). Some 37.7% of essential workers said they would feel safe if community mitigation strategies were eased, compared with 23.7% of nonessential workers.

“Respondents who were male, employed, or essential workers were significantly more likely to report having been in public areas in the past week. Among respondents who had been in public areas during the preceding week, significantly higher percentages of women, adults aged ≥ 65 years, retired persons, and those living in urban areas reported wearing cloth face coverings,” the authors explain.

The findings are subject to several limitations, including self-reporting and the fact that some respondents may have known someone who tested positive for COVID-19 or died from it, the authors note. Respondents were not representative of the US population and the findings may not be generalizable.


This article first appeared on Medscape.com.

In its first media briefing on coronavirus in more than 3 months, the Centers for Disease Control and Prevention (CDC) warned that the COVID-19 pandemic is not over, and large gatherings pose a high risk for COVID-19 transmission.

Robert Redfield, MD, Director, CDC, and Jay C. Butler, MD, Deputy Director of Infectious Diseases and COVID-19 Response Incident Manager, CDC, discussed two new sets of CDC guidance on deciding to go out and attending group gatherings.

“We recognize that we’re all getting tired of staying at home; people long for the life that they had back in December, and as we head into the summer months, we know that Americans will be looking forward to reconnecting with family and friends and being able to attend events, and we want that to occur as safely as possible,” Butler said.

“Our recommendations evolved based on new information that becomes available, but it continues to be extremely important that we embrace the recommendations of social distancing, handwashing, and wearing a face covering when we’re in public as some of the key defenses that we have against this virus,” Redfield explained.

“The pandemic is not over and it’s important to recognize that. While COVID-19 is still making headlines everywhere, we know the pandemic hasn’t affected everyone everywhere in the same way,” Butler said.

He noted that it is important to prepare for next fall and winter, when we can expect influenza season to complicate matters. “If anything, we must be overly-prepared for what we might face later this year,” he continued, adding that it is important to get vaccinated against influenza. “[F]lu and COVID-19 could be circulating together as we move into the fall and winter months,” he concluded.

Americans Mostly Following Guidelines

The agency also presented data from an article published online June 12 in Morbidity and Mortality Weekly Report that “underscores the fact that American people have taken mitigation efforts seriously…and it demonstrates our collective spirit in responding to the pandemic,” Butler said.

In it, the researchers describe representative panel surveys conducted among 4042 adults aged 18 years or older in New York City and Los Angeles — the two most populous cities in the United States — and “broadly across the United States” during May 5 to May 12, 2020.

Most respondents supported stay-at-home orders and nonessential business closures (United States, 79.5%; New York City, 86.7%; Los Angeles, 81.5%) and always or often wore cloth face coverings in public (United States, 74.1%; New York City, 89.6%; Los Angeles, 89.8%). Respondents also agreed that nonessential workers should remain at home (United States, 67.3%; New York City, 76.6%; Los Angeles, 69.1%), report Mark É. Czeisler, from Monash University and Austin Health, both in Melbourne, Australia, and colleagues.

There was wide support with public health guidelines: more than 87% of individuals in each area agreed that individuals should keep six feet of distance between themselves and others, and more than 82% in each area said that people should limit gatherings to fewer than 10 individuals.

At the time the survey was conducted, most were against indoor dining at restaurants (United States, 66.6%; New York City, 81.5%; Los Angeles, 71.8%).

Adherence “Widespread,” Survey Finds

Most respondents said they were adhering to COVID-19 mitigation guidance, including self-isolating (United States, 77.3%; New York City, 84.6%; Los Angeles, 83.0%) and “always or often” kept at least six feet between themselves and others (New York City, 85.7%; Los Angeles, 82.6%).

More than 85% of respondents in each of the three cohorts said they always or often avoided groups of 10 or more individuals.

About 90% of respondents said they had been in a public area during the last week, with 74.1% of those saying they always or often covered their face in public; respondents in New York City (89.6%) and Los Angeles (89.8%) had higher percentages of this behavior compared with respondents from the United States overall.

Most respondents felt that restrictions in their state were balanced or too lax (United States, 84.3%; New York City, 89.7%; Los Angeles, 79.7%) and said they would feel unsafe if restrictions were eased nationwide at that time (United States, 74.3%; New York City, 81.5%; Los Angeles, 73.4%). However, some individuals who said they would feel unsafe still wanted community mitigation strategies eased and were willing to accept risks resulting from lifting restrictions (United States, 17.1%; New York City, 12.6%; Los Angeles, 12.7%).

“Reported prevalence of self-isolation and feeling safe if community mitigation strategies were lifted differed significantly by age, employment status, and essential worker status among adults in the U.S. survey cohort,” the authors write.

Reports of self-isolation were highest among persons aged 18 to 24 years (92.3%) and lowest among those aged 45 to 54 years (71.5%). Yet, young adults aged 18 to 24 years (43.1%) were more than twice as likely to say they would feel safe if community mitigation strategies were eased, compared with adults aged 65 years or older (19.2%).

Almost half (47.2%) of employed respondents in the US cohort were essential workers; essential workers were “significantly less likely” to report self-isolating when compared with nonessential workers (63.1% vs 80.6%). Some 37.7% of essential workers said they would feel safe if community mitigation strategies were eased, compared with 23.7% of nonessential workers.

“Respondents who were male, employed, or essential workers were significantly more likely to report having been in public areas in the past week. Among respondents who had been in public areas during the preceding week, significantly higher percentages of women, adults aged ≥ 65 years, retired persons, and those living in urban areas reported wearing cloth face coverings,” the authors explain.

The findings are subject to several limitations, including self-reporting and the fact that some respondents may have known someone who tested positive for COVID-19 or died from it, the authors note. Respondents were not representative of the US population and the findings may not be generalizable.


This article first appeared on Medscape.com.

Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available 670G hybrid closed-loop, particularly in young people with type 1 diabetes, new data suggest.

Automated insulin delivery systems are comprised of an insulin pump, continuous glucose monitor (CGM), and an automated insulin dosing algorithm.

Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented June 12 during the virtual American Diabetes Association (ADA) 80th Scientific Sessions. The AHCL is the algorithm used in Medtronic’s new MiniMed 780G system, which received a CE Mark on June 11 for the treatment of type 1 diabetes in people aged 7 to 80 years.

One trial, presented by Bruce W. Bode, MD, of Atlanta Diabetes Associates, Georgia, was the US pivotal safety study that will be submitted to the US Food and Drug Administration for approval of the Medtronic 780G.

Another trial, presented by Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, was a separate comparison of the AHCL with the 670G. (The AHCL-based system used in the three trials was identical to the 780G except it didn’t include Bluetooth, which will be a feature of the final product.)

A third trial, presented by Martin de Bock, PhD, of the University of Otago, New Zealand, included the CE Mark dataset for the 780G.

In contrast to the 670G, the 780G adds automated correction boluses for high blood glucose levels (rather than simply adjusting the basal infusion) and allows for adjustment of target glucose levels down to 100 mg/dL rather than a minimum of 120 mg/dL.

Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction. And specifically compared to the 670G, the AHCL-based system reverts to open-loop far less often because it only exits closed-loop mode when the sensor stops working or during sensor changes, but not during hyperglycemia even above 300 mg/dL.

Asked to comment, session moderator Timothy S. Bailey, MD, president and CEO of the AMCR Institute, Escondido, California, told Medscape Medical News: “Automated insulin delivery systems are getting better and better.”

“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They all take people from where they are now to better time-in-range, less time with hypoglycemia, and most important, they might make the quality of their lives better. That’s really underappreciated.”

One factor that has allowed for the improvements, Bailey said, is the recognition by regulatory bodies that the hybrid closed-loop devices are generally safer than current open-loop type 1 diabetes management so that fewer “safety” device features that interfere with tight glycemic control are necessary.

With first-generation closed-loop systems, “If a wide variety of conditions occur, users get kicked off [hybrid closed-loop mode]. Originally it was perceived by the regulatory agencies as a safety feature because they perceived the standard of care as safe. The new system was allowed to have fewer rules.”
 

Pivotal trial: Time-in-range improved, 96% say system easy to use

The goal of the AHCL system is to maximize the time-in-range of blood glucose between 70-180 mg/dL. Automated basal delivery of insulin is programmed to a set-point of 100 or 120 mg/dL, with dosing every 5 minutes.

The US pivotal trial was a single-arm, 16-center, in-home trial of 157 people with type 1 diabetes, including 39 adolescents aged 14-21 years and 118 adults aged 22-75 years. All had type 1 diabetes for at least 2 years, A_1c levels below 10%, and had been using insulin pumps for at least 6 months, with or without CGMs.

After a 14-day run-in, they wore the systems with a 100 or 120 mg/dL set-point for 45 days, then switched to the other setpoint for another 45 days. Average A1c dropped from 7.5% to 7.0%, with the proportions having an A1c ≤ 7.0% increasing from 34% to 61%.

Overall time-in-range was 75% compared to 69% at baseline, with time below range (< 70 mg/dL) of 1.8%. Overnight time-in-range was 82%, with 1.5% below range. Time-in-range increased from 62% to 73% in the adolescents and from 71% to 75% in the adults.

There were no incidences of severe hypoglycemia or diabetic ketoacidosis, and no device-related serious adverse events.

Participants reported being in hybrid closed-loop, or auto-mode, 95% of the time, compared with 33% for those who had been previously using the 670G.

The number of AHCL exits was 1.3 per week, significantly less than with the 670G. Of those, 29% were user-initiated while the rest were implemented by the device, most often when the sensor wasn’t working.

In a study questionnaire, 96% reported that the system was easy to use.
 

AHCL vs 670G: Major improvements seen

Bergenstal presented data from the Fuzzy Logic Automated Insulin Regulation (FLAIR) study, funded by the National Institute of Diabetes and Digestive and Kidney Disease, comparing Medtronic’s AHCL-based system with the currently marketed 670G hybrid closed-loop, in 113 individuals with type 1 diabetes aged 14-29 years.

“This age group has traditionally been the most difficult group in which to optimize glucose management,” Bergenstal said.

FLAIR is believed to be the first-ever study comparing an investigational automated insulin delivery system with a commercially approved system, he noted. All participants used each automated insulin delivery system for 3 months in the randomized crossover trial.

The primary outcome, time spent above 180 mg/dL during the day combined with time below 54 mg/dL over 24 hours at baseline with the 670G and AHCL went from 42% to 37% to 34%, respectively, for the former and from 0.46% to 0.50% to 0.45%, respectively, for the latter.

The percentage time-in-range over 24 hours went from 57% at baseline to 67% with the AHCL versus 63% with the 670G. A1c levels dropped from 7.9% at baseline to 7.6% with the 670G and 7.4% with AHCL.

“Remember, these are the adolescents who are the toughest of the tough, yet there was a 10% increase in time-in-range ... this is very clinically significant,” Bergenstal said.

Even among 14 patients who had been using multiple daily injections without CGM prior to the study, a group often excluded from closed-loop studies, time-in-range improved from 45% at baseline to 63% with the 670G to 65% with AHCL.

“I’m making a plea not to exclude people just because they haven’t previously used technology,” Bergenstal said.

One patient who had dosed with extra insulin manually had a severe hypoglycemia event with AHCL. No patient had diabetic ketoacidosis.

The proportion of insulin given as auto-correction boluses was 36%, which is important as it means that the system was compensating for missed meal doses, a common phenomenon among teenagers, Bergenstal noted.

“There is still room for further improvement in glycemic control in this population of patients with type 1 diabetes, but AHCL represents a significant step forward,” he concluded.
 

New Zealand study: More data in youth show AHCL benefits

Unlike the US study populations of just teens aged 14 and older, and adults, the study data used for approval in the EU — from New Zealand — included a total of 60 patients with 20 children aged 7-15 years. It, too, was a 10-week randomized crossover clinical trial comparing the AHCL to a sensor-augmented pump system with an algorithm only for predictive low-glucose management (PLGM) and no adjustments for high blood glucose.

Time-in-range was 59% at baseline and 58% with PLGM, compared to 70.4% with AHCL, and most of the time-in-range improvement occurred at night. Time below 70 mg/dL dropped from 3.1% to 2.5% to 2.1%, respectively.

Similar to the US studies, participants spent 96% of the time in closed-loop mode with only 1.2 exits per week. On a questionnaire, 95% of patients agreed that the system was easy to use and 85% that the system improved their quality of life.

De Bock showed a slide with some quotes, including one from a parent saying, “We didn’t have to be fearful at night or have that thought when we opened her bedroom door in the morning that she might not be conscious,” and from a patient, “I forgot I had diabetes today.”

Bailey commented: “Of course these devices are not free. So, the challenge is how do we make them available, less expensive, and easy to use? We have our work cut out for us, but this is heartening data. Everything has gotten better but we’re not out of a job yet.”

Bailey has reported receiving research support from Abbott, Capillary Biomedical, Dexcom, Diasome, Eli Lilly, Kowa, Lexicon, Medtronic, Medtrum, Novo Nordisk, REMD, Sanofi, Senseonics, ViaCyte, vTv Therapeutics, Zealand Pharma, and consulting or speaking honoraria from Abbott, LifeScan, Novo Nordisk, Sanofi, and Medtronic. Bode has reported receiving consulting and speaker fees from Medtronic. Bergenstal has reported participating in clinical research, being an advisory board member, and/or serving as a consultant for Abbott Diabetes Care, Ascensia, CeQure, Dexcom, Eli Lilly, Hygieia, Senseonics, and United Healthcare. De Bock has reported receiving honoraria or expenses from Novo Nordisk, Sanofi, Pfizer, Medtronic, and Lilly, and research funds from Novo Nordisk and Medtronic.



This article first appeared on Medscape.com.




 

Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available 670G hybrid closed-loop, particularly in young people with type 1 diabetes, new data suggest.

Automated insulin delivery systems are comprised of an insulin pump, continuous glucose monitor (CGM), and an automated insulin dosing algorithm.

Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented June 12 during the virtual American Diabetes Association (ADA) 80th Scientific Sessions. The AHCL is the algorithm used in Medtronic’s new MiniMed 780G system, which received a CE Mark on June 11 for the treatment of type 1 diabetes in people aged 7 to 80 years.

One trial, presented by Bruce W. Bode, MD, of Atlanta Diabetes Associates, Georgia, was the US pivotal safety study that will be submitted to the US Food and Drug Administration for approval of the Medtronic 780G.

Another trial, presented by Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, was a separate comparison of the AHCL with the 670G. (The AHCL-based system used in the three trials was identical to the 780G except it didn’t include Bluetooth, which will be a feature of the final product.)

A third trial, presented by Martin de Bock, PhD, of the University of Otago, New Zealand, included the CE Mark dataset for the 780G.

In contrast to the 670G, the 780G adds automated correction boluses for high blood glucose levels (rather than simply adjusting the basal infusion) and allows for adjustment of target glucose levels down to 100 mg/dL rather than a minimum of 120 mg/dL.

Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction. And specifically compared to the 670G, the AHCL-based system reverts to open-loop far less often because it only exits closed-loop mode when the sensor stops working or during sensor changes, but not during hyperglycemia even above 300 mg/dL.

Asked to comment, session moderator Timothy S. Bailey, MD, president and CEO of the AMCR Institute, Escondido, California, told Medscape Medical News: “Automated insulin delivery systems are getting better and better.”

“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They all take people from where they are now to better time-in-range, less time with hypoglycemia, and most important, they might make the quality of their lives better. That’s really underappreciated.”

One factor that has allowed for the improvements, Bailey said, is the recognition by regulatory bodies that the hybrid closed-loop devices are generally safer than current open-loop type 1 diabetes management so that fewer “safety” device features that interfere with tight glycemic control are necessary.

With first-generation closed-loop systems, “If a wide variety of conditions occur, users get kicked off [hybrid closed-loop mode]. Originally it was perceived by the regulatory agencies as a safety feature because they perceived the standard of care as safe. The new system was allowed to have fewer rules.”
 

Pivotal trial: Time-in-range improved, 96% say system easy to use

The goal of the AHCL system is to maximize the time-in-range of blood glucose between 70-180 mg/dL. Automated basal delivery of insulin is programmed to a set-point of 100 or 120 mg/dL, with dosing every 5 minutes.

The US pivotal trial was a single-arm, 16-center, in-home trial of 157 people with type 1 diabetes, including 39 adolescents aged 14-21 years and 118 adults aged 22-75 years. All had type 1 diabetes for at least 2 years, A_1c levels below 10%, and had been using insulin pumps for at least 6 months, with or without CGMs.

After a 14-day run-in, they wore the systems with a 100 or 120 mg/dL set-point for 45 days, then switched to the other setpoint for another 45 days. Average A1c dropped from 7.5% to 7.0%, with the proportions having an A1c ≤ 7.0% increasing from 34% to 61%.

Overall time-in-range was 75% compared to 69% at baseline, with time below range (< 70 mg/dL) of 1.8%. Overnight time-in-range was 82%, with 1.5% below range. Time-in-range increased from 62% to 73% in the adolescents and from 71% to 75% in the adults.

There were no incidences of severe hypoglycemia or diabetic ketoacidosis, and no device-related serious adverse events.

Participants reported being in hybrid closed-loop, or auto-mode, 95% of the time, compared with 33% for those who had been previously using the 670G.

The number of AHCL exits was 1.3 per week, significantly less than with the 670G. Of those, 29% were user-initiated while the rest were implemented by the device, most often when the sensor wasn’t working.

In a study questionnaire, 96% reported that the system was easy to use.
 

AHCL vs 670G: Major improvements seen

Bergenstal presented data from the Fuzzy Logic Automated Insulin Regulation (FLAIR) study, funded by the National Institute of Diabetes and Digestive and Kidney Disease, comparing Medtronic’s AHCL-based system with the currently marketed 670G hybrid closed-loop, in 113 individuals with type 1 diabetes aged 14-29 years.

“This age group has traditionally been the most difficult group in which to optimize glucose management,” Bergenstal said.

FLAIR is believed to be the first-ever study comparing an investigational automated insulin delivery system with a commercially approved system, he noted. All participants used each automated insulin delivery system for 3 months in the randomized crossover trial.

The primary outcome, time spent above 180 mg/dL during the day combined with time below 54 mg/dL over 24 hours at baseline with the 670G and AHCL went from 42% to 37% to 34%, respectively, for the former and from 0.46% to 0.50% to 0.45%, respectively, for the latter.

The percentage time-in-range over 24 hours went from 57% at baseline to 67% with the AHCL versus 63% with the 670G. A1c levels dropped from 7.9% at baseline to 7.6% with the 670G and 7.4% with AHCL.

“Remember, these are the adolescents who are the toughest of the tough, yet there was a 10% increase in time-in-range ... this is very clinically significant,” Bergenstal said.

Even among 14 patients who had been using multiple daily injections without CGM prior to the study, a group often excluded from closed-loop studies, time-in-range improved from 45% at baseline to 63% with the 670G to 65% with AHCL.

“I’m making a plea not to exclude people just because they haven’t previously used technology,” Bergenstal said.

One patient who had dosed with extra insulin manually had a severe hypoglycemia event with AHCL. No patient had diabetic ketoacidosis.

The proportion of insulin given as auto-correction boluses was 36%, which is important as it means that the system was compensating for missed meal doses, a common phenomenon among teenagers, Bergenstal noted.

“There is still room for further improvement in glycemic control in this population of patients with type 1 diabetes, but AHCL represents a significant step forward,” he concluded.
 

New Zealand study: More data in youth show AHCL benefits

Unlike the US study populations of just teens aged 14 and older, and adults, the study data used for approval in the EU — from New Zealand — included a total of 60 patients with 20 children aged 7-15 years. It, too, was a 10-week randomized crossover clinical trial comparing the AHCL to a sensor-augmented pump system with an algorithm only for predictive low-glucose management (PLGM) and no adjustments for high blood glucose.

Time-in-range was 59% at baseline and 58% with PLGM, compared to 70.4% with AHCL, and most of the time-in-range improvement occurred at night. Time below 70 mg/dL dropped from 3.1% to 2.5% to 2.1%, respectively.

Similar to the US studies, participants spent 96% of the time in closed-loop mode with only 1.2 exits per week. On a questionnaire, 95% of patients agreed that the system was easy to use and 85% that the system improved their quality of life.

De Bock showed a slide with some quotes, including one from a parent saying, “We didn’t have to be fearful at night or have that thought when we opened her bedroom door in the morning that she might not be conscious,” and from a patient, “I forgot I had diabetes today.”

Bailey commented: “Of course these devices are not free. So, the challenge is how do we make them available, less expensive, and easy to use? We have our work cut out for us, but this is heartening data. Everything has gotten better but we’re not out of a job yet.”

Bailey has reported receiving research support from Abbott, Capillary Biomedical, Dexcom, Diasome, Eli Lilly, Kowa, Lexicon, Medtronic, Medtrum, Novo Nordisk, REMD, Sanofi, Senseonics, ViaCyte, vTv Therapeutics, Zealand Pharma, and consulting or speaking honoraria from Abbott, LifeScan, Novo Nordisk, Sanofi, and Medtronic. Bode has reported receiving consulting and speaker fees from Medtronic. Bergenstal has reported participating in clinical research, being an advisory board member, and/or serving as a consultant for Abbott Diabetes Care, Ascensia, CeQure, Dexcom, Eli Lilly, Hygieia, Senseonics, and United Healthcare. De Bock has reported receiving honoraria or expenses from Novo Nordisk, Sanofi, Pfizer, Medtronic, and Lilly, and research funds from Novo Nordisk and Medtronic.



This article first appeared on Medscape.com.




 

Medtronic’s next-generation automated insulin delivery system offers significant improvements over the currently available 670G hybrid closed-loop, particularly in young people with type 1 diabetes, new data suggest.

Automated insulin delivery systems are comprised of an insulin pump, continuous glucose monitor (CGM), and an automated insulin dosing algorithm.

Data from three trials of such systems using Medtronic’s advanced hybrid closed-loop (AHCL) algorithm (trade name SmartGuard) were presented June 12 during the virtual American Diabetes Association (ADA) 80th Scientific Sessions. The AHCL is the algorithm used in Medtronic’s new MiniMed 780G system, which received a CE Mark on June 11 for the treatment of type 1 diabetes in people aged 7 to 80 years.

One trial, presented by Bruce W. Bode, MD, of Atlanta Diabetes Associates, Georgia, was the US pivotal safety study that will be submitted to the US Food and Drug Administration for approval of the Medtronic 780G.

Another trial, presented by Richard M. Bergenstal, MD, executive director of the International Diabetes Center at Park Nicollet, Minneapolis, Minnesota, was a separate comparison of the AHCL with the 670G. (The AHCL-based system used in the three trials was identical to the 780G except it didn’t include Bluetooth, which will be a feature of the final product.)

A third trial, presented by Martin de Bock, PhD, of the University of Otago, New Zealand, included the CE Mark dataset for the 780G.

In contrast to the 670G, the 780G adds automated correction boluses for high blood glucose levels (rather than simply adjusting the basal infusion) and allows for adjustment of target glucose levels down to 100 mg/dL rather than a minimum of 120 mg/dL.

Taken together, the data from the three trials showed that the AHCL-based system improved glycemic time-in-range with no increased risk for hypoglycemia, including in children and teenagers, with high patient-reported satisfaction. And specifically compared to the 670G, the AHCL-based system reverts to open-loop far less often because it only exits closed-loop mode when the sensor stops working or during sensor changes, but not during hyperglycemia even above 300 mg/dL.

Asked to comment, session moderator Timothy S. Bailey, MD, president and CEO of the AMCR Institute, Escondido, California, told Medscape Medical News: “Automated insulin delivery systems are getting better and better.”

“None of these devices is perfect, but they are a substantial improvement over what we’ve had ... They all take people from where they are now to better time-in-range, less time with hypoglycemia, and most important, they might make the quality of their lives better. That’s really underappreciated.”

One factor that has allowed for the improvements, Bailey said, is the recognition by regulatory bodies that the hybrid closed-loop devices are generally safer than current open-loop type 1 diabetes management so that fewer “safety” device features that interfere with tight glycemic control are necessary.

With first-generation closed-loop systems, “If a wide variety of conditions occur, users get kicked off [hybrid closed-loop mode]. Originally it was perceived by the regulatory agencies as a safety feature because they perceived the standard of care as safe. The new system was allowed to have fewer rules.”
 

Pivotal trial: Time-in-range improved, 96% say system easy to use

The goal of the AHCL system is to maximize the time-in-range of blood glucose between 70-180 mg/dL. Automated basal delivery of insulin is programmed to a set-point of 100 or 120 mg/dL, with dosing every 5 minutes.

The US pivotal trial was a single-arm, 16-center, in-home trial of 157 people with type 1 diabetes, including 39 adolescents aged 14-21 years and 118 adults aged 22-75 years. All had type 1 diabetes for at least 2 years, A_1c levels below 10%, and had been using insulin pumps for at least 6 months, with or without CGMs.

After a 14-day run-in, they wore the systems with a 100 or 120 mg/dL set-point for 45 days, then switched to the other setpoint for another 45 days. Average A1c dropped from 7.5% to 7.0%, with the proportions having an A1c ≤ 7.0% increasing from 34% to 61%.

Overall time-in-range was 75% compared to 69% at baseline, with time below range (< 70 mg/dL) of 1.8%. Overnight time-in-range was 82%, with 1.5% below range. Time-in-range increased from 62% to 73% in the adolescents and from 71% to 75% in the adults.

There were no incidences of severe hypoglycemia or diabetic ketoacidosis, and no device-related serious adverse events.

Participants reported being in hybrid closed-loop, or auto-mode, 95% of the time, compared with 33% for those who had been previously using the 670G.

The number of AHCL exits was 1.3 per week, significantly less than with the 670G. Of those, 29% were user-initiated while the rest were implemented by the device, most often when the sensor wasn’t working.

In a study questionnaire, 96% reported that the system was easy to use.
 

AHCL vs 670G: Major improvements seen

Bergenstal presented data from the Fuzzy Logic Automated Insulin Regulation (FLAIR) study, funded by the National Institute of Diabetes and Digestive and Kidney Disease, comparing Medtronic’s AHCL-based system with the currently marketed 670G hybrid closed-loop, in 113 individuals with type 1 diabetes aged 14-29 years.

“This age group has traditionally been the most difficult group in which to optimize glucose management,” Bergenstal said.

FLAIR is believed to be the first-ever study comparing an investigational automated insulin delivery system with a commercially approved system, he noted. All participants used each automated insulin delivery system for 3 months in the randomized crossover trial.

The primary outcome, time spent above 180 mg/dL during the day combined with time below 54 mg/dL over 24 hours at baseline with the 670G and AHCL went from 42% to 37% to 34%, respectively, for the former and from 0.46% to 0.50% to 0.45%, respectively, for the latter.

The percentage time-in-range over 24 hours went from 57% at baseline to 67% with the AHCL versus 63% with the 670G. A1c levels dropped from 7.9% at baseline to 7.6% with the 670G and 7.4% with AHCL.

“Remember, these are the adolescents who are the toughest of the tough, yet there was a 10% increase in time-in-range ... this is very clinically significant,” Bergenstal said.

Even among 14 patients who had been using multiple daily injections without CGM prior to the study, a group often excluded from closed-loop studies, time-in-range improved from 45% at baseline to 63% with the 670G to 65% with AHCL.

“I’m making a plea not to exclude people just because they haven’t previously used technology,” Bergenstal said.

One patient who had dosed with extra insulin manually had a severe hypoglycemia event with AHCL. No patient had diabetic ketoacidosis.

The proportion of insulin given as auto-correction boluses was 36%, which is important as it means that the system was compensating for missed meal doses, a common phenomenon among teenagers, Bergenstal noted.

“There is still room for further improvement in glycemic control in this population of patients with type 1 diabetes, but AHCL represents a significant step forward,” he concluded.
 

New Zealand study: More data in youth show AHCL benefits

Unlike the US study populations of just teens aged 14 and older, and adults, the study data used for approval in the EU — from New Zealand — included a total of 60 patients with 20 children aged 7-15 years. It, too, was a 10-week randomized crossover clinical trial comparing the AHCL to a sensor-augmented pump system with an algorithm only for predictive low-glucose management (PLGM) and no adjustments for high blood glucose.

Time-in-range was 59% at baseline and 58% with PLGM, compared to 70.4% with AHCL, and most of the time-in-range improvement occurred at night. Time below 70 mg/dL dropped from 3.1% to 2.5% to 2.1%, respectively.

Similar to the US studies, participants spent 96% of the time in closed-loop mode with only 1.2 exits per week. On a questionnaire, 95% of patients agreed that the system was easy to use and 85% that the system improved their quality of life.

De Bock showed a slide with some quotes, including one from a parent saying, “We didn’t have to be fearful at night or have that thought when we opened her bedroom door in the morning that she might not be conscious,” and from a patient, “I forgot I had diabetes today.”

Bailey commented: “Of course these devices are not free. So, the challenge is how do we make them available, less expensive, and easy to use? We have our work cut out for us, but this is heartening data. Everything has gotten better but we’re not out of a job yet.”

Bailey has reported receiving research support from Abbott, Capillary Biomedical, Dexcom, Diasome, Eli Lilly, Kowa, Lexicon, Medtronic, Medtrum, Novo Nordisk, REMD, Sanofi, Senseonics, ViaCyte, vTv Therapeutics, Zealand Pharma, and consulting or speaking honoraria from Abbott, LifeScan, Novo Nordisk, Sanofi, and Medtronic. Bode has reported receiving consulting and speaker fees from Medtronic. Bergenstal has reported participating in clinical research, being an advisory board member, and/or serving as a consultant for Abbott Diabetes Care, Ascensia, CeQure, Dexcom, Eli Lilly, Hygieia, Senseonics, and United Healthcare. De Bock has reported receiving honoraria or expenses from Novo Nordisk, Sanofi, Pfizer, Medtronic, and Lilly, and research funds from Novo Nordisk and Medtronic.



This article first appeared on Medscape.com.




 

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

Even without GI symptoms, many patients with COVID-19 shed viral RNA in feces, suggesting that stool testing and prevention of fecal-oral transmission may be needed to combat the ongoing pandemic, according to investigators.

A meta-analysis of 29 studies showed that 12% of patients with COVID-19 developed nausea, diarrhea, or vomiting, while 41% shed viral RNA in feces, reported lead author Sravanthi Parasa, MD, of Swedish Medical Center, Seattle.Writing in JAMA Network Open, Dr. Parasa and colleagues emphasized that respiratory symptoms remain the predominant form of disease; however, GI symptoms can occur.

“In fact, the first reported patient with COVID-19 in the U.S. reported GI symptoms of loose bowel movements and abdominal discomfort,” the investigators wrote, noting that the patient went on to test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in both respiratory and stool specimens.

“This raises the question of inadvertent human-to-human transmission via the fecal route despite public health emphasis on droplet transmission and precautions for contact with respiratory secretions,” the investigators wrote.

To address this question, the investigators conducted a systematic review and meta-analysis involving 23 published and 6 preprint studies involving a total of 4,805 patients, all of whom tested positive for SARS-CoV-2 based on PCR results from nasopharyngeal swabs. Dr. Parasa and colleagues noted that most of the studies “scored between 8 and 10 on the MINORS quality assessment,” suggesting moderate quality.

Pooled data from these studies showed that 4.6% of patients reported nausea or vomiting, while 7.4% reported diarrhea. Such symptoms may serve as an early warning flag for clinicians, the investigators noted.

“[T]he presence of GI symptoms may portend a worse outcome for patients infected with SARS-CoV-2,” they wrote, citing a study by Pan and colleagues, which found that GI symptoms were associated with lower rates of recovery and hospital discharge.

Regardless of GI symptoms, 40.5% of patients in the meta-analysis tested positive for viral RNA in feces (95% confidence interval, 27.4%-55.1%). Duration of viral shedding in feces lasted up to 11 days after symptom onset, or in a single-patient case study, 18 days after hospitalization.

The investigators called these duration figures “particularly concerning,” especially in light of a study published by Xiao and colleagues, which showed that 23.3% of patients with negative respiratory tests were still shedding live virus in feces.

“[T]he fecal-oral route of transmission could be an additional potential source of infection spread,” wrote Dr. Parasa and colleagues. “Our results also suggest that testing of the virus in feces ... could be helpful in disease monitoring and surveillance.”

David A. Johnson, MD, professor of medicine and chief of gastroenterology at Eastern Virginia Medical School in Norfolk, said that the findings confirm what has been suspected for some time: GI disease is relatively common with COVID-19.

“The evidence is clear now that a sizable percentage of patients have GI symptoms,” Dr. Johnson said in an interview.

GI issues may precede respiratory signs, he added, so clinicians should be aware that nausea, vomiting, or diarrhea could be early indicators of COVID-19, and possibly, a worse outcome.

“The other highlight of this study is that stool shedding may be extended beyond respiratory shedding,” Dr. Johnson said.

He suggested that this finding could influence current CDC criteria, which define absence of infectious risk by two consecutive, negative nasopharyngeal swabs. Instead, fecal testing may be needed, he said, along with measures to prevent fecal-oral transmission.

Dr. Johnson expressed particular concern for risk of infection via toilet plume, in which toilet flushing aerosolizes viral particles.

“As much as people try to social distance by 6 feet – you can do that when you walk into a store, or a building, but you can’t necessarily do that when you walk into a public toilet, where the plume may have been expansive for a period of time,” he said. “That toilet may never really get cleaned to a high level of disinfection, and those droplets set up potential for fecal-oral spread.”

Dr. Sharma disclosed relationships with Medtronic, Fujifilm, Boston Scientific, and others. Dr. Johnson disclosed no relevant conflicts of interest.

SOURCE: Parasa S et al. JAMA Network Open. 2020 Jun 11. doi: 10.1001/jamanetworkopen.2020.11335.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

New preliminary data from the T1D Exchange suggest that, although hyperglycemia and diabetic ketoacidosis (DKA) are common in people with type 1 diabetes who develop COVID-19, many are still able to manage the illness at home and overall mortality is relatively low.

The new findings – the first US data on individuals with type 1 diabetes and COVID-19 – were published online June 5 in Diabetes Care by Osagie A. Ebekozien, MD, vice president, quality improvement and population health at the T1D Exchange, and colleagues.

Two UK studies are the only prior ones to previously examine the topic.

The newly published study includes data as of May 5 on 64 individuals from a total of 64 US sites, including 15 T1D Exchange member clinics and an additional 49 endocrinology clinics from around the country. Since the paper was submitted, there are now 220 patients from 68 sites. Another publication with a more detailed analysis of risk factors and adjustment for confounders is planned for later this year.

Some of the findings from the preliminary data have shifted, but many aspects remain consistent, Ebekozien told Medscape Medical News.

“One thing still very true, even with the unpublished findings, is the influence of A1c and glycemic management. ...With higher A1c levels, we’re seeing more COVID-19 hospitalizations and worse outcomes,” he said.

And as has been generally reported for COVID-19, high body mass index was a major risk factor in the preliminary dataset – and remains so.

There were two deaths in the preliminary report, both individuals with comorbidities in addition to type 1 diabetes, Ebekozien said. There have been a few more deaths in the larger dataset, but the mortality rate remains relatively low.

Interestingly, females predominate in both cohorts. That may be a reporting phenomenon, another factor that is being analyzed.

Hyperglycemia Remains a Major Risk Factor

The study is specifically being conducted by the T1D Exchange’s Quality Improvement Collaborative, which Ebekozien heads.

Data were obtained for 33 patients with type 1 diabetes who tested positive for COVID-19, and another 31 who were classified as “COVID-19–like” because they had symptoms consistent with COVID-19, as identified by the Centers for Disease Control and Prevention, but hadn’t been tested for the virus.

For all 64 patients, the mean age was 20.9 years and two thirds (65.6%) were aged 18 or younger. A higher proportion of the COVID-19–like patients were pediatric than the confirmed cases. The larger dataset includes more adult patients, Ebekozien told Medscape Medical News.

Overall, 60.9% of patients were female. Nearly half were white, a quarter Hispanic, and 18.8% black. More confirmed COVID-19 cases were black compared with suspected cases (30.3% vs 6.5%).

Median A1c for the overall group (including suspected COVID-19 cases) was 8.0%, but it was 8.5% among confirmed cases. Overall, six patients (9.8%) presented with new-onset type 1 diabetes after they developed COVID-19.

Hyperglycemia was present in half (32) of patients overall. DKA occurred in 19 people (30.2%): 15 of the confirmed COVID-19 cases (45.5%) versus just 4 (13.3%) of the COVID-19–like cases. Nausea was reported in 30.2% of patients overall.

Other symptoms were typical of COVID-19, including fever (41.3%), dry cough (38.1%), and shortness of breath (27.0%). Loss of taste and smell was less common, at just 9.5% overall.

Obesity was present in 39.7% of patients overall, with similar proportions in the confirmed and suspected COVID-19 groups. Hypertension and/or cardiovascular disease were present in 14.3% of patients overall, and the rate was similar between the two subgroups.

One of the two patients who died was a 79-year-old man who had hypertension and a prior stroke in addition to type 1 diabetes. The other was a 19-year-old woman with a history of asthma who developed a pulmonary embolism during the onset of COVID-19. Neither had DKA.

Even in Type 1 Diabetes, COVID-19 Can Be Managed at Home

Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so.

At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.

Including the small proportion of patients sent home after being seen in emergency or urgent care, overall roughly half were not admitted to hospital.

“Interestingly, even in this preliminary study, half were managed at home via telemedicine with an endocrinologist and infectious disease specialist. ... I think it continues to be a case-by-case clinical decision between the patient and their provider,” Ebekozien said.

“But, we’re seeing a good number of patients who are managed at home and the symptoms resolve in a week or two, and the illness runs its course, and they don’t have to even be seen,” he added.

The research team is also collecting data on barriers to remote care, including challenges with telemedicine and how frontline providers are navigating them.

“Those are all things that our future paper will be able to shed more light on,” he explained.

Endocrinologists around the country are invited to report cases of COVID-19 in patients with type 1 diabetes to the T1D Exchange by emailing QI@T1Dexchange.org.

And in fact, Ebekozien also requested that clinicians with a large type 1 diabetes population also report if they’ve had no COVID-19 cases.

“Even if they haven’t had a case, that’s very useful information for us to know. One of the things we want to calculate down the line is the incidence ratio. Not all participating sites have had a case.”

Endocrinologists from all the participating sites have formed a dedicated community that meets regularly via webinars to share information, he noted. “It’s been a very selfless effort to work collaboratively as a community to quickly answer critical questions.”

The Helmsley Charitable Trust funds the T1D Exchange Quality Improvement Collaborative. The T1D Exchange received financial support for this study from Abbott Diabetes, Dexcom, JDRF, Insulet Corporation, Lilly, Medtronic, and Tandem Diabetes Care. No other relevant financial relationships were reported.
 

This article first appeared on Medscape.com.

Amid clouds of choking tear gas, booming flash-bang grenades and other “riot control agents,” volunteer medics plunged into street protests over the past weeks to help the injured – sometimes rushing to the front lines as soon as their hospital shifts ended.

Known as “street medics,” these unorthodox teams of nursing students, veterinarians, doctors, trauma surgeons, security guards, ski patrollers, nurses, wilderness EMTs, and off-the-clock ambulance workers poured water – not milk – into the eyes of tear-gassed protesters. They stanched bleeding wounds and plucked disoriented teenagers from clouds of gas, entering dangerous corners where on-duty emergency health responders may fear to go.

Many are medical professionals who see parallels between the front lines of COVID-19, where they confront stark racial imbalances among those stricken by the coronavirus, and what they see as racialized police brutality.

So donning cloth masks to protect against the virus – plus helmets, makeshift shields and other gear to guard against rubber bullets, projectiles and tear gas – the volunteer medics organized themselves into a web of first responders to care for people on the streets. They showed up early, set up first-aid stations, established transportation networks and covered their arms, helmets and backpacks with crosses made of red duct tape, to signify that they were medics. Some stayed late into the night past curfews until every protester had left.

Iris Butler, a 21-year-old certified nursing assistant who works in a nursing home, decided to offer her skills after seeing a man injured by a rubber bullet on her first night at the Denver protests. She showed up as a medic every night thereafter. She didn’t see it as a choice.

“I am working full time and basically being at the protest after getting straight off of work,” said Butler, who is black. That’s tiring, she added, but so is being a black woman in America.

After going out as a medic on her own, she soon met other volunteers. Together they used text-message chains to organize their efforts. One night, she responded to a man who had been shot with a rubber bullet in the chest; she said his torso had turned blue and purple from the impact. She also provided aid after a shooting near the protest left someone in critical condition.

“It’s hard, but bills need to be paid and justice needs to be served,” she said.

The street medic movement traces its roots, in part, to the 1960s protests, as well as the American Indian Movement and the Black Panther Party. Denver Action Medic Network offers a 20-hour training course that prepares them to treat patients in conflicts with police and large crowds; a four-hour session is offered to medical professionals as “bridge” training.

Since the coronavirus pandemic began, the Denver Action Medic Network has added new training guidelines: Don’t go to protests if sick or in contact with those who are infected; wear a mask; give people lots of space and use hand sanitizer. Jordan Garcia, a 39-year-old medic for over 20 years who works with the network of veteran street medics, said they also warn medics about the increased risk of transmission because of protesters coughing from tear gas, and urge them to get tested for the virus after the protests.

The number of volunteer medics swelled after George Floyd’s May 25 killing in Minneapolis. In Denver alone, at least 40 people reached out to the Denver Action Medic Network for training.

On June 3, Dr. Rupa Marya, an associate professor of medicine at the University of California,San Francisco, and the co-founder of the Do No Harm Coalition, which runs street medic training in the Bay Area, hosted a national webinar attended by over 3,000 medical professionals to provide the bridge training to be a street medic. In her online bio, Marya describes the coalition as “an organization of over 450 health workers committed to structural change” in addressing health problems.

“When we see suffering, that’s where we go,” Marya said. “And right now that suffering is happening on the streets.”

In the recent Denver protests, street medics responded to major head, face and eye injuries among protesters from what are sometimes described as “kinetic impact projectiles” or “less-than-lethal” bullets shot at protesters, along with tear-gas and flash-bang stun grenade canisters that either hit them or exploded in their faces.

Garcia, who by day works for an immigrant rights nonprofit, said that these weapons are not designed to be shot directly at people.

“We’re seeing police use these less-lethal weapons in lethal ways, and that is pretty upsetting,” Garcia said about the recent protests.

Denver police Chief Paul Pazen promised to make changes, including banning chokeholds and requiring SWAT teams to turn on their body cameras. Last week, a federal judge also issued a temporary injunction to stop Denver police from using tear gas and other less-than-lethal weapons in response to a class action lawsuit, in which a medic stated he was shot multiple times by police with pepper balls while treating patients. (Last week in North Carolina police were recorded destroying medic stations.)

Denver street medic Kevin Connell, a 30-year-old emergency room nurse, said he was hit with pepper balls in the back of his medic vest – which was clearly marked by red crosses – while treating a patient. He showed up to the Denver protests every night he did not have to work, he said, wearing a Kevlar medic vest, protective goggles and a homemade gas mask fashioned from a water bottle. As a member of the Denver Action Medic Network, Connell also served at the Standing Rock protests in North Dakota in a dispute over the building of the Dakota Access Pipeline.

“I mean, as bad as it sounds, it was only tear gas, pepper balls and rubber bullets that were being fired on us,” Connell said of his recent experience in Denver. “When I was at Standing Rock, they were using high-powered water hoses even when it was, like, freezing cold. … So I think the police here had a little bit more restraint.”

Still, first-time street medic Aj Mossman, a 31-year-old Denver emergency medical technician studying for nursing school, was shocked to be tear-gassed and struck in the back of the leg with a flash grenade while treating a protester on May 30. Mossman still has a large leg bruise.

The following night, Mossman, who uses the pronoun they, brought more protective gear, but said they are still having difficulty processing what felt like a war zone.

“I thought I understood what my black friends went through. I thought I understood what the black community went through,” said Mossman, who is white. “But I had absolutely no idea how violent the police were and how little they cared about who they hurt.”

For Butler, serving as a medic with others from various walks of life was inspiring. “They’re also out there to protect black and brown bodies. And that’s amazing,” she said. “That’s just a beautiful sight.”

This article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Amid clouds of choking tear gas, booming flash-bang grenades and other “riot control agents,” volunteer medics plunged into street protests over the past weeks to help the injured – sometimes rushing to the front lines as soon as their hospital shifts ended.

Known as “street medics,” these unorthodox teams of nursing students, veterinarians, doctors, trauma surgeons, security guards, ski patrollers, nurses, wilderness EMTs, and off-the-clock ambulance workers poured water – not milk – into the eyes of tear-gassed protesters. They stanched bleeding wounds and plucked disoriented teenagers from clouds of gas, entering dangerous corners where on-duty emergency health responders may fear to go.

Many are medical professionals who see parallels between the front lines of COVID-19, where they confront stark racial imbalances among those stricken by the coronavirus, and what they see as racialized police brutality.

So donning cloth masks to protect against the virus – plus helmets, makeshift shields and other gear to guard against rubber bullets, projectiles and tear gas – the volunteer medics organized themselves into a web of first responders to care for people on the streets. They showed up early, set up first-aid stations, established transportation networks and covered their arms, helmets and backpacks with crosses made of red duct tape, to signify that they were medics. Some stayed late into the night past curfews until every protester had left.

Iris Butler, a 21-year-old certified nursing assistant who works in a nursing home, decided to offer her skills after seeing a man injured by a rubber bullet on her first night at the Denver protests. She showed up as a medic every night thereafter. She didn’t see it as a choice.

“I am working full time and basically being at the protest after getting straight off of work,” said Butler, who is black. That’s tiring, she added, but so is being a black woman in America.

After going out as a medic on her own, she soon met other volunteers. Together they used text-message chains to organize their efforts. One night, she responded to a man who had been shot with a rubber bullet in the chest; she said his torso had turned blue and purple from the impact. She also provided aid after a shooting near the protest left someone in critical condition.

“It’s hard, but bills need to be paid and justice needs to be served,” she said.

The street medic movement traces its roots, in part, to the 1960s protests, as well as the American Indian Movement and the Black Panther Party. Denver Action Medic Network offers a 20-hour training course that prepares them to treat patients in conflicts with police and large crowds; a four-hour session is offered to medical professionals as “bridge” training.

Since the coronavirus pandemic began, the Denver Action Medic Network has added new training guidelines: Don’t go to protests if sick or in contact with those who are infected; wear a mask; give people lots of space and use hand sanitizer. Jordan Garcia, a 39-year-old medic for over 20 years who works with the network of veteran street medics, said they also warn medics about the increased risk of transmission because of protesters coughing from tear gas, and urge them to get tested for the virus after the protests.

The number of volunteer medics swelled after George Floyd’s May 25 killing in Minneapolis. In Denver alone, at least 40 people reached out to the Denver Action Medic Network for training.

On June 3, Dr. Rupa Marya, an associate professor of medicine at the University of California,San Francisco, and the co-founder of the Do No Harm Coalition, which runs street medic training in the Bay Area, hosted a national webinar attended by over 3,000 medical professionals to provide the bridge training to be a street medic. In her online bio, Marya describes the coalition as “an organization of over 450 health workers committed to structural change” in addressing health problems.

“When we see suffering, that’s where we go,” Marya said. “And right now that suffering is happening on the streets.”

In the recent Denver protests, street medics responded to major head, face and eye injuries among protesters from what are sometimes described as “kinetic impact projectiles” or “less-than-lethal” bullets shot at protesters, along with tear-gas and flash-bang stun grenade canisters that either hit them or exploded in their faces.

Garcia, who by day works for an immigrant rights nonprofit, said that these weapons are not designed to be shot directly at people.

“We’re seeing police use these less-lethal weapons in lethal ways, and that is pretty upsetting,” Garcia said about the recent protests.

Denver police Chief Paul Pazen promised to make changes, including banning chokeholds and requiring SWAT teams to turn on their body cameras. Last week, a federal judge also issued a temporary injunction to stop Denver police from using tear gas and other less-than-lethal weapons in response to a class action lawsuit, in which a medic stated he was shot multiple times by police with pepper balls while treating patients. (Last week in North Carolina police were recorded destroying medic stations.)

Denver street medic Kevin Connell, a 30-year-old emergency room nurse, said he was hit with pepper balls in the back of his medic vest – which was clearly marked by red crosses – while treating a patient. He showed up to the Denver protests every night he did not have to work, he said, wearing a Kevlar medic vest, protective goggles and a homemade gas mask fashioned from a water bottle. As a member of the Denver Action Medic Network, Connell also served at the Standing Rock protests in North Dakota in a dispute over the building of the Dakota Access Pipeline.

“I mean, as bad as it sounds, it was only tear gas, pepper balls and rubber bullets that were being fired on us,” Connell said of his recent experience in Denver. “When I was at Standing Rock, they were using high-powered water hoses even when it was, like, freezing cold. … So I think the police here had a little bit more restraint.”

Still, first-time street medic Aj Mossman, a 31-year-old Denver emergency medical technician studying for nursing school, was shocked to be tear-gassed and struck in the back of the leg with a flash grenade while treating a protester on May 30. Mossman still has a large leg bruise.

The following night, Mossman, who uses the pronoun they, brought more protective gear, but said they are still having difficulty processing what felt like a war zone.

“I thought I understood what my black friends went through. I thought I understood what the black community went through,” said Mossman, who is white. “But I had absolutely no idea how violent the police were and how little they cared about who they hurt.”

For Butler, serving as a medic with others from various walks of life was inspiring. “They’re also out there to protect black and brown bodies. And that’s amazing,” she said. “That’s just a beautiful sight.”

This article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Amid clouds of choking tear gas, booming flash-bang grenades and other “riot control agents,” volunteer medics plunged into street protests over the past weeks to help the injured – sometimes rushing to the front lines as soon as their hospital shifts ended.

Known as “street medics,” these unorthodox teams of nursing students, veterinarians, doctors, trauma surgeons, security guards, ski patrollers, nurses, wilderness EMTs, and off-the-clock ambulance workers poured water – not milk – into the eyes of tear-gassed protesters. They stanched bleeding wounds and plucked disoriented teenagers from clouds of gas, entering dangerous corners where on-duty emergency health responders may fear to go.

Many are medical professionals who see parallels between the front lines of COVID-19, where they confront stark racial imbalances among those stricken by the coronavirus, and what they see as racialized police brutality.

So donning cloth masks to protect against the virus – plus helmets, makeshift shields and other gear to guard against rubber bullets, projectiles and tear gas – the volunteer medics organized themselves into a web of first responders to care for people on the streets. They showed up early, set up first-aid stations, established transportation networks and covered their arms, helmets and backpacks with crosses made of red duct tape, to signify that they were medics. Some stayed late into the night past curfews until every protester had left.

Iris Butler, a 21-year-old certified nursing assistant who works in a nursing home, decided to offer her skills after seeing a man injured by a rubber bullet on her first night at the Denver protests. She showed up as a medic every night thereafter. She didn’t see it as a choice.

“I am working full time and basically being at the protest after getting straight off of work,” said Butler, who is black. That’s tiring, she added, but so is being a black woman in America.

After going out as a medic on her own, she soon met other volunteers. Together they used text-message chains to organize their efforts. One night, she responded to a man who had been shot with a rubber bullet in the chest; she said his torso had turned blue and purple from the impact. She also provided aid after a shooting near the protest left someone in critical condition.

“It’s hard, but bills need to be paid and justice needs to be served,” she said.

The street medic movement traces its roots, in part, to the 1960s protests, as well as the American Indian Movement and the Black Panther Party. Denver Action Medic Network offers a 20-hour training course that prepares them to treat patients in conflicts with police and large crowds; a four-hour session is offered to medical professionals as “bridge” training.

Since the coronavirus pandemic began, the Denver Action Medic Network has added new training guidelines: Don’t go to protests if sick or in contact with those who are infected; wear a mask; give people lots of space and use hand sanitizer. Jordan Garcia, a 39-year-old medic for over 20 years who works with the network of veteran street medics, said they also warn medics about the increased risk of transmission because of protesters coughing from tear gas, and urge them to get tested for the virus after the protests.

The number of volunteer medics swelled after George Floyd’s May 25 killing in Minneapolis. In Denver alone, at least 40 people reached out to the Denver Action Medic Network for training.

On June 3, Dr. Rupa Marya, an associate professor of medicine at the University of California,San Francisco, and the co-founder of the Do No Harm Coalition, which runs street medic training in the Bay Area, hosted a national webinar attended by over 3,000 medical professionals to provide the bridge training to be a street medic. In her online bio, Marya describes the coalition as “an organization of over 450 health workers committed to structural change” in addressing health problems.

“When we see suffering, that’s where we go,” Marya said. “And right now that suffering is happening on the streets.”

In the recent Denver protests, street medics responded to major head, face and eye injuries among protesters from what are sometimes described as “kinetic impact projectiles” or “less-than-lethal” bullets shot at protesters, along with tear-gas and flash-bang stun grenade canisters that either hit them or exploded in their faces.

Garcia, who by day works for an immigrant rights nonprofit, said that these weapons are not designed to be shot directly at people.

“We’re seeing police use these less-lethal weapons in lethal ways, and that is pretty upsetting,” Garcia said about the recent protests.

Denver police Chief Paul Pazen promised to make changes, including banning chokeholds and requiring SWAT teams to turn on their body cameras. Last week, a federal judge also issued a temporary injunction to stop Denver police from using tear gas and other less-than-lethal weapons in response to a class action lawsuit, in which a medic stated he was shot multiple times by police with pepper balls while treating patients. (Last week in North Carolina police were recorded destroying medic stations.)

Denver street medic Kevin Connell, a 30-year-old emergency room nurse, said he was hit with pepper balls in the back of his medic vest – which was clearly marked by red crosses – while treating a patient. He showed up to the Denver protests every night he did not have to work, he said, wearing a Kevlar medic vest, protective goggles and a homemade gas mask fashioned from a water bottle. As a member of the Denver Action Medic Network, Connell also served at the Standing Rock protests in North Dakota in a dispute over the building of the Dakota Access Pipeline.

“I mean, as bad as it sounds, it was only tear gas, pepper balls and rubber bullets that were being fired on us,” Connell said of his recent experience in Denver. “When I was at Standing Rock, they were using high-powered water hoses even when it was, like, freezing cold. … So I think the police here had a little bit more restraint.”

Still, first-time street medic Aj Mossman, a 31-year-old Denver emergency medical technician studying for nursing school, was shocked to be tear-gassed and struck in the back of the leg with a flash grenade while treating a protester on May 30. Mossman still has a large leg bruise.

The following night, Mossman, who uses the pronoun they, brought more protective gear, but said they are still having difficulty processing what felt like a war zone.

“I thought I understood what my black friends went through. I thought I understood what the black community went through,” said Mossman, who is white. “But I had absolutely no idea how violent the police were and how little they cared about who they hurt.”

For Butler, serving as a medic with others from various walks of life was inspiring. “They’re also out there to protect black and brown bodies. And that’s amazing,” she said. “That’s just a beautiful sight.”

This article originally appeared on Kaiser Health News, which is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

• Symptoms reported within a 14-day period should be on a downward trajectory.
• Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
• Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

• Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
• Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
• Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
• Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
• Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
• Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

• Symptoms reported within a 14-day period should be on a downward trajectory.
• Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
• Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

• Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
• Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
• Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
• Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
• Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
• Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

On April 16, the White House released federal guidelines for reopening American businesses – followed 3 days later by specific recommendations from the Centers for Medicare and Medicaid Services for health care practices in areas with a low incidence of COVID-19. Since then, a slew of resources and guidelines have emerged to help you safely reopen your medical practice.

Depending on where you live, you may have already reopened (or even never closed), or you may be awaiting the relaxation of restrictions in your state. (As I write this on June 10, the stay-at-home order in my state, New Jersey, is being rescinded.)

The big question, of course, is whether patients can be convinced that it is safe to leave their homes and come to your office. The answer may depend on how well you time your reopening and adhere to the appropriate federal, state, and independent guidelines.

The federal guidelines have three sections: criteria, which outline conditions each region or state should satisfy before reopening; preparedness, which lists how states should prepare for reopening; and phase guidelines, which detail responsibilities of individuals and employers during distinct reopening phases.

You should pay the most attention to the “criteria” section. The key question to ask: “Has my state or region satisfied the basic criteria for reopening?”

Those criteria are as follows:

• Symptoms reported within a 14-day period should be on a downward trajectory.
• Cases documented (or positive tests as a percentage of total tests) within a 14-day period should also be on a downward trajectory.
• Hospitals should be treating all patients without crisis care. They should also have a robust testing program in place for at-risk health care workers.

If your area meets these criteria, you can proceed to the CMS recommendations. They cover general advice related to personal protective equipment (PPE), workforce availability, facility considerations, sanitation protocols, supplies, and testing capacity.

The key takeaway: As long as your area has the resources to quickly respond to a surge of COVID-19 cases, you can start offering care to non-COVID patients. Keep seeing patients via telehealth as often as possible, and prioritize surgical/procedural care and high-complexity chronic disease management before moving on to preventive and cosmetic services.

The American Medical Association has issued its own checklist of criteria for reopening your practice to supplement the federal guidelines. Highlights include the following:

• Sit down with a calendar and pick an expected reopening day. Ideally, this should include a “soft reopening.” Make a plan to stock necessary PPE and write down plans for cleaning and staffing if an employee or patient is diagnosed with COVID-19 after visiting your office.
• Take a stepwise approach so you can identify challenges early and address them. It’s important to figure out which visits can continue via telehealth, and begin with just a few in-person visits each day. Plan out a schedule and clearly communicate it to patients, clinicians, and staff.
• Patient safety is your top concern. Encourage patients to visit without companions whenever possible, and of course, all individuals who visit the office should wear a cloth face covering.
• Screen employees for fevers and other symptoms of COVID-19; remember that those records are subject to HIPAA rules and must be kept confidential. Minimize contact between employees as much as possible.
• Do your best to screen patients before in-person visits, to verify they don’t have symptoms of COVID-19. Consider creating a script that office staff can use to contact patients 24 hours before they come in. Use this as a chance to ask about symptoms, and explain any reopening logistics they should know about.
• Contact your malpractice insurance carrier to discuss whether you need to make any changes to your coverage.

This would also be a great time to review your confidentiality, privacy, and data security protocols. COVID-19 presents new challenges for data privacy – for example, if you must inform coworkers or patients that they have come into contact with someone who tested positive. Make a plan that follows HIPAA guidelines during COVID-19. Also, make sure you have a plan for handling issues like paid sick leave or reporting COVID-19 cases to your local health department.

Another useful resource is the Medical Group Management Association’s COVID-19 Medical Practice Reopening Checklist. You can use it to confirm that you are addressing all the important items, and that you haven’t missed anything.

As for me, I am advising patients who are reluctant to seek treatment that many medical problems pose more risk than COVID-19, faster treatment means better outcomes, and because we maintain strict disinfection protocols, they are far less likely to be infected with COVID-19 in my office than, say, at a grocery store.
 

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.

Semglee, a long-acting human insulin analogue, has been approved for glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes, the Food and Drug Administration announced June 11.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus,” Patrick Archdeacon, MD, acting associate director for therapeutics in the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, said in a written statement via email.

Semglee will be marketed by Mylan Pharmaceuticals and will be available in a multidose 10-mL vial or a single-patient-use 3-mL prefilled pen.

The approval was based primarily on two randomized, confirmatory clinical trials called INSTRIDE1 and INSTRIDE 2, according to a release by Mylan and Biocon Biologic. They compared Semglee (MYL-1501D) to branded insulin glargine (Lantus) in adults and children for 1 year and found no treatment difference.

The FDA noted that, for patients with type 1 diabetes, Semglee must be used along with a short-acting insulin. The recommended starting dose is approximately one-third of the total daily insulin requirement. For those with type 2 diabetes, the starting dose is 0.2 units/kg or up to 10 units once daily, according to the prescribing information.

Semglee is not recommended for treating diabetic ketoacidosis and is contraindicated during episodes of hypoglycemia.

“Today’s approval provides patients with an additional safe and effective treatment option and also expands the number of products that are available to serve as a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product now that the biosimilar pathway is available for insulin products following the statutory transition earlier this year,” Dr. Archdeacon said.

rfranki@mdedge.com

Semglee, a long-acting human insulin analogue, has been approved for glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes, the Food and Drug Administration announced June 11.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus,” Patrick Archdeacon, MD, acting associate director for therapeutics in the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, said in a written statement via email.

Semglee will be marketed by Mylan Pharmaceuticals and will be available in a multidose 10-mL vial or a single-patient-use 3-mL prefilled pen.

The approval was based primarily on two randomized, confirmatory clinical trials called INSTRIDE1 and INSTRIDE 2, according to a release by Mylan and Biocon Biologic. They compared Semglee (MYL-1501D) to branded insulin glargine (Lantus) in adults and children for 1 year and found no treatment difference.

The FDA noted that, for patients with type 1 diabetes, Semglee must be used along with a short-acting insulin. The recommended starting dose is approximately one-third of the total daily insulin requirement. For those with type 2 diabetes, the starting dose is 0.2 units/kg or up to 10 units once daily, according to the prescribing information.

Semglee is not recommended for treating diabetic ketoacidosis and is contraindicated during episodes of hypoglycemia.

“Today’s approval provides patients with an additional safe and effective treatment option and also expands the number of products that are available to serve as a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product now that the biosimilar pathway is available for insulin products following the statutory transition earlier this year,” Dr. Archdeacon said.

rfranki@mdedge.com

Semglee, a long-acting human insulin analogue, has been approved for glycemic control in adults and children with type 1 diabetes and adults with type 2 diabetes, the Food and Drug Administration announced June 11.

“Long-acting insulin products like insulin glargine play an important role in the treatment of types 1 and 2 diabetes mellitus,” Patrick Archdeacon, MD, acting associate director for therapeutics in the FDA’s Division of Diabetes, Lipid Disorders, and Obesity, said in a written statement via email.

Semglee will be marketed by Mylan Pharmaceuticals and will be available in a multidose 10-mL vial or a single-patient-use 3-mL prefilled pen.

The approval was based primarily on two randomized, confirmatory clinical trials called INSTRIDE1 and INSTRIDE 2, according to a release by Mylan and Biocon Biologic. They compared Semglee (MYL-1501D) to branded insulin glargine (Lantus) in adults and children for 1 year and found no treatment difference.

The FDA noted that, for patients with type 1 diabetes, Semglee must be used along with a short-acting insulin. The recommended starting dose is approximately one-third of the total daily insulin requirement. For those with type 2 diabetes, the starting dose is 0.2 units/kg or up to 10 units once daily, according to the prescribing information.

Semglee is not recommended for treating diabetic ketoacidosis and is contraindicated during episodes of hypoglycemia.

“Today’s approval provides patients with an additional safe and effective treatment option and also expands the number of products that are available to serve as a reference product for a proposed insulin glargine biosimilar or interchangeable biosimilar product now that the biosimilar pathway is available for insulin products following the statutory transition earlier this year,” Dr. Archdeacon said.

rfranki@mdedge.com

Here are the stories our MDedge editors across specialties think you need to know about today:

FDA seeks COVID-19 info through CURE ID

Federal health officials are asking clinicians to use the free CURE ID mobile app and web platform as a tool to collect information on the treatment of patients with COVID-19. CURE ID is an Internet-based data repository first developed in 2013 as a collaboration between the Food and Drug Administration and the National Center for Advancing Translational Sciences, part of the National Institutes of Health. It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. “By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” said Heather A. Stone, MPH, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.” Read more.
 

Hospitalists take on new roles in COVID era

Whether it’s working shifts in the ICU, caring for ventilator patients, or reporting to postanesthesia care units and post-acute or step-down units, hospitalists are stepping into a variety of new roles as part of their frontline response to the COVID-19 pandemic. Valerie Vaughn, MD, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.” Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care professionals, who volunteered to manage COVID-19 patients in the ICU and other hospital units. Read more.

COVID-19 recommendations for rheumatic disease treatment

The European League Against Rheumatism (EULAR) issued provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Contrary to earlier expectations, there is no indication that patients with rheumatic and musculoskeletal diseases have a higher risk of contracting the virus or have a worse course if they do, according to the task force that worked on the recommendations. The task force also pointed out that rheumatology drugs are being used to treat COVID-19 patients who don’t have rheumatic diseases, raising the possibility of a shortage of disease-modifying antirheumatic drugs. Read more.

Mental health visits are 19% of ED costs

Mental and substance use disorders represented 19% of all emergency department visits in 2017 and cost $14.6 billion, according to figures from the Agency for Healthcare Research and Quality. The most costly mental and substance use disorder diagnosis was anxiety and fear-related disorders, accounting for $5.6 billion worth of visits, following by depressive disorders and alcohol-related disorders. Read more.

Food deserts linked to health issues in pregnancy

Living in a neighborhood lacking adequate access to affordable, high-quality food is associated with a somewhat greater risk of developing pregnancy morbidity, according to an observational study. Researchers found that women who lived in a food desert had a 1.6 times greater odds of pregnancy comorbidity than if they did not. “An additional, albeit less obvious factor that may be unique to patients suffering disproportionately from obstetric morbidity is exposure to toxic elements,” the researchers reported in Obstetrics & Gynecology. “It has been shown in a previous study that low-income, predominantly black communities of pregnant women may suffer disproportionately from lead or arsenic exposure.” Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

FDA seeks COVID-19 info through CURE ID

Federal health officials are asking clinicians to use the free CURE ID mobile app and web platform as a tool to collect information on the treatment of patients with COVID-19. CURE ID is an Internet-based data repository first developed in 2013 as a collaboration between the Food and Drug Administration and the National Center for Advancing Translational Sciences, part of the National Institutes of Health. It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. “By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” said Heather A. Stone, MPH, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.” Read more.
 

Hospitalists take on new roles in COVID era

Whether it’s working shifts in the ICU, caring for ventilator patients, or reporting to postanesthesia care units and post-acute or step-down units, hospitalists are stepping into a variety of new roles as part of their frontline response to the COVID-19 pandemic. Valerie Vaughn, MD, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.” Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care professionals, who volunteered to manage COVID-19 patients in the ICU and other hospital units. Read more.

COVID-19 recommendations for rheumatic disease treatment

The European League Against Rheumatism (EULAR) issued provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Contrary to earlier expectations, there is no indication that patients with rheumatic and musculoskeletal diseases have a higher risk of contracting the virus or have a worse course if they do, according to the task force that worked on the recommendations. The task force also pointed out that rheumatology drugs are being used to treat COVID-19 patients who don’t have rheumatic diseases, raising the possibility of a shortage of disease-modifying antirheumatic drugs. Read more.

Mental health visits are 19% of ED costs

Mental and substance use disorders represented 19% of all emergency department visits in 2017 and cost $14.6 billion, according to figures from the Agency for Healthcare Research and Quality. The most costly mental and substance use disorder diagnosis was anxiety and fear-related disorders, accounting for $5.6 billion worth of visits, following by depressive disorders and alcohol-related disorders. Read more.

Food deserts linked to health issues in pregnancy

Living in a neighborhood lacking adequate access to affordable, high-quality food is associated with a somewhat greater risk of developing pregnancy morbidity, according to an observational study. Researchers found that women who lived in a food desert had a 1.6 times greater odds of pregnancy comorbidity than if they did not. “An additional, albeit less obvious factor that may be unique to patients suffering disproportionately from obstetric morbidity is exposure to toxic elements,” the researchers reported in Obstetrics & Gynecology. “It has been shown in a previous study that low-income, predominantly black communities of pregnant women may suffer disproportionately from lead or arsenic exposure.” Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.

Here are the stories our MDedge editors across specialties think you need to know about today:

FDA seeks COVID-19 info through CURE ID

Federal health officials are asking clinicians to use the free CURE ID mobile app and web platform as a tool to collect information on the treatment of patients with COVID-19. CURE ID is an Internet-based data repository first developed in 2013 as a collaboration between the Food and Drug Administration and the National Center for Advancing Translational Sciences, part of the National Institutes of Health. It provides licensed clinicians worldwide with an opportunity to report novel uses of existing drugs for patients with difficult-to-treat infectious diseases, including COVID-19, through a website, a smartphone, or other mobile device. “By utilizing the CURE ID platform now for COVID-19 case collection – in conjunction with data gathered from other registries, EHR systems, and clinical trials – data collected during an outbreak can be improved and coordinated,” said Heather A. Stone, MPH, a health science policy analyst in the office of medical policy at the FDA’s Center for Drug Evaluation and Research. “This may allow us to find possible treatments to help ease this pandemic, and prepare us better to fight the next one.” Read more.
 

Hospitalists take on new roles in COVID era

Whether it’s working shifts in the ICU, caring for ventilator patients, or reporting to postanesthesia care units and post-acute or step-down units, hospitalists are stepping into a variety of new roles as part of their frontline response to the COVID-19 pandemic. Valerie Vaughn, MD, a hospitalist with Michigan Medicine and assistant professor of medicine at the University of Michigan in Ann Arbor, was doing research on how to reduce overuse of antibiotics in hospitals when the COVID-19 crisis hit and dramatically redefined her job. “We were afraid that we might have 3,000 to 5,000 hospitalized COVID patients by now, based on predictive modeling done while the pandemic was still growing exponentially,” she explained. Although Michigan continues to have high COVID-19 infection rates, centered on nearby Detroit, “things are a lot better today than they were 4 weeks ago.” Dr. Vaughn helped to mobilize a team of 25 hospitalists, along with other health care professionals, who volunteered to manage COVID-19 patients in the ICU and other hospital units. Read more.

COVID-19 recommendations for rheumatic disease treatment

The European League Against Rheumatism (EULAR) issued provisional recommendations for the management of rheumatic and musculoskeletal diseases in the context of SARS-CoV-2. Contrary to earlier expectations, there is no indication that patients with rheumatic and musculoskeletal diseases have a higher risk of contracting the virus or have a worse course if they do, according to the task force that worked on the recommendations. The task force also pointed out that rheumatology drugs are being used to treat COVID-19 patients who don’t have rheumatic diseases, raising the possibility of a shortage of disease-modifying antirheumatic drugs. Read more.

Mental health visits are 19% of ED costs

Mental and substance use disorders represented 19% of all emergency department visits in 2017 and cost $14.6 billion, according to figures from the Agency for Healthcare Research and Quality. The most costly mental and substance use disorder diagnosis was anxiety and fear-related disorders, accounting for $5.6 billion worth of visits, following by depressive disorders and alcohol-related disorders. Read more.

Food deserts linked to health issues in pregnancy

Living in a neighborhood lacking adequate access to affordable, high-quality food is associated with a somewhat greater risk of developing pregnancy morbidity, according to an observational study. Researchers found that women who lived in a food desert had a 1.6 times greater odds of pregnancy comorbidity than if they did not. “An additional, albeit less obvious factor that may be unique to patients suffering disproportionately from obstetric morbidity is exposure to toxic elements,” the researchers reported in Obstetrics & Gynecology. “It has been shown in a previous study that low-income, predominantly black communities of pregnant women may suffer disproportionately from lead or arsenic exposure.” Read more.
 

For more on COVID-19, visit our Resource Center. All of our latest news is available on MDedge.com.