The One Step test: The better diagnostic approach for gestational diabetes mellitus

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Article
Changed
Mon, 12/16/2019 - 15:49
Author(s)
Vincenzo Berghella, MD
Gabriele Saccone, MD

Gestational diabetes mellitus (GDM) generally is defined as any degree of glucose intolerance with onset or first recognition during pregnancy.1-14 The best approach and exact criteria to use for GDM screening and diagnosis are under worldwide debate. In TABLE 1 we present just some of the many differing suggestions by varying organizations.2,7-9,11,12,15-17 The American College of Obstetricians and Gynecologists, for instance, suggests a Two Step approach to diagnosis.15 We will make the argument in this article, however, that diagnosis should be defined universally as an abnormal result with the One Step 75-g glucose testing, as adopted by the World Health Organization, International Federation of Gynecology and Obstetrics, and others. Approximately 8% of all pregnancies are complicated by GDM by the One Step test in the United States.18-22 The prevalence may range from 1% to 14% of all pregnancies, depending on the population studied and the diagnostic tests employed.1,19

Diagnostic options

Different methods for screening and diagnosis of GDM have been proposed by international societies; there is controversy regarding the diagnosis of GDM by either the One Step or the Two Step approach.6

The One Step approach includes an oral glucose tolerance test with a 75-g glucose load with measurement of plasma glucose concentration at fasting state and 1 hour and 2 hours post–glucose administration. A positive result for the One Step approach is defined as at least 1 measurement higher than 92, 180, or 153 mg/dL at fasting, 1 hour, or 2 hours, respectively.

The Two Step approach includes a nonfasting oral 50-g glucose load, with a glucose blood measurement 1 hour later. A positive screening, defined often as a blood glucose value higher than 135 mg/dL (range, 130 to 140 mg/dL), is followed by a diagnostic test with a 100-g glucose load with measurements at fasting and 1, 2, and 3 hours post–glucose administration. A positive diagnostic test is defined as 2 measurements higher than the target value.

Why we support the One Step test

There are several reasons to prefer the One Step approach for the diagnosis of GDM, compared with the Two Step approach.

Women testing negative for GDM with Two Step still experience complications pregnancy. Women who test positive for GDM with the One Step test, but negative with the Two Step test, despite having therefore a milder degree of glucose intolerance, do have a higher risk of experiencing several complications.23 For the mother, these complications include gestational hypertension, preeclampsia, and cesarean delivery. The baby also can experience problems at birth (TABLE 2).23 Therefore, women who test positive for GDM with the One Step test deserve to be diagnosed with and treated for the condition, as not only are they at risk for these complications but also treatment of the GDM decreases the incidence of these complications.18,19


There is indeed an increased GDM diagnosis rate with the One Step (about 8%) compared with the Two Step test (about 4%). Nonetheless, this increase is mild and nonsignificant in the meta-analysis of randomized controlled trials (RCTs),18,19 is less than the 18% difference in diagnosis rate previously hypothesized, is consistent with the increased diabetes/prediabetes rates in the general population, and is linked to the increasing incidence of obesity and insulin resistance.

Overall test adherence is better. Five percent to 15% of patients, depending on the study, are not adherent with taking the second part of the Two Step test. Women indeed prefer the One Step approach; the second step in the Two Step approach may be a burden.

Less costly. The One Step process is cost-effective when postpregnancy diabetes mellitus prevention is considered.

Better maternal and perinatal outcomes. Probably the most important and convincing reason the One Step test should be used is that meta-analysis of the 4 RCTs comparing the approaches (including 2 US trials) shows that diagnosing and treating mild GDM as per the One Step approach, compared with screening and treating using the Two Step approach, is associated with increased incidence of GDM (8% vs 4%) and with better maternal and perinatal outcomes.13,18,19 In fact, the One Step approach is associated with significant reductions in: large for gestational age (56%), admission to neonatal intensive care unit (51%), and neonatal hypoglycemia (48%). Tests of heterogeneity in the meta-analysis and of quality all pointed to better outcomes in the One Step test group.13,19

The need for a second step in the Two Step approach delays diagnosis and treatment. The One Step approach is associated with an increase in GDM test adherence and earlier diagnosis,13 which is another reason for better outcomes with the One Step approach. In the presence of risk factors, such as prior GDM, prior macrosomia, advanced maternal age, multiple gestations, and others, the One Step test should be done at the first prenatal visit.

Continue to: US guidelines should be reconsidered...

 

 

US guidelines should be reconsidered

The One Step, 75-g, 2-hour oral glucose tolerance test is universally used to diagnose diabetes mellitus outside of pregnancy. Given our many noted reasons (TABLE 3), we recommend universal screening of GDM by using the One Step approach. It is time, indeed, for the United States to reconsider its guidelines for screening for GDM.

References

 

  1. Kampmann U, Madsen LR, Skajaa GO, et al. Gestational diabetes: a clinical update. World J Diabetes. 2015;6:1065-1072.
  2. HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358:1991-2002.
  3. Meltzer SJ, Snyder J, Penrod JR, et al. Gestational diabetes mellitus screening and diagnosis: a prospective randomised controlled trial comparing costs of one-step and two-step methods. BJOG. 2010;117:407-415.
  4. Sevket O, Ates S, Uysal O, et al. To evaluate the prevalence and clinical outcomes using a one-step method versus a two-step method to screen gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2014;27:36-41.
  5. Scifres CM, Abebe KZ, Jones KA, et al. Gestational diabetes diagnostic methods (GD2M) pilot randomized trial. Matern Child Health J. 2015;19:1472-1480.
  6. Farrar D, Duley L, Medley N, et al. Different strategies for diagnosing gestational diabetes to improve maternal and infant health. Cochrane Database Syst Rev. 2015;1:CD007122.
  7. American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2017;40(suppl 1):S11-S24.
  8. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Diabetes and Pregnancy. Can J Diabetes. 2013;37(suppl 1):S168-S183.
  9. NICE guideline. Diabetes in pregnancy: management from preconception to the postnatal period. February 2015. https://www.nice.org.uk/guidance/ng3/. Last updated August 2015. Accessed November 18, 2019.
  10. WHO 1999. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus. From http://apps.who.int/iris/bitstream/10665/66040/1/WHO
    _NCD_NCS_99.2.pdf. Accessed November 18, 2019.
  11. World Health Organization. Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy. 2013. http://apps.who.int/iris/bitstream/10665/85975/1/WHO_
    NMH_MND_13.2_eng.pdf. Accessed November 18, 2019.
  12. Hod M, Kapur A, Sacks DA, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: a pragmatic guide for diagnosis, management, and care. Int J Gynaecol Obstet. 2015;131(suppl 3):S173-S211.
  13. Berghella V, Caissutti C, Saccone G, et al. The One Step approach for diagnosing gestational diabetes is associated with better perinatal outcomes than using the Two Step approach: evidence of randomized clinical trials. Am J Obstet Gynecol. 2019;220:562-564.
  14. Berghella V, Caissutti C, Saccone G, et al. One-Step approach to identifying gestational diabetes mellitus: association with perinatal outcomes. Obstet Gynecol. 2019;133:383.
  15. American College of Obstetricians and Gynecologists. Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 180: gestational diabetes mellitus. Obstet Gynecol. 2017;130:e17-e31.
  16. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982;144:768-773.
  17. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes. 1979;28:1039-1057.
  18. Saccone G, Khalifeh A, Al-Kouatly HB, et al. Screening for gestational diabetes mellitus: one step versus two step approach. A meta-analysis of randomized trials. J Matern Fetal Neonatal Med. 2018:1-9.
  19. Saccone G, Caissutti C, Khalifeh A, et al. One step versus two step approach for gestational diabetes screening: systematic review and meta-analysis of the randomized trials. J Matern Fetal Neonatal Med. 2019;32:1547-1555.
  20. Khalifeh A, Eckler R, Felder L, et al. One-step versus two-step diagnostic testing for gestational diabetes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018:1-6.
  21. Caissutti C, Saccone G, Khalifeh A, et al. Which criteria should be used for starting pharmacologic therapy for management of gestational diabetes in pregnancy? Evidence from randomized controlled trials. J Matern Fetal Neonatal Med. 2019;32:2905-2914.
  22. Caissutti C, Saccone G, Ciardulli A, et al. Very tight vs. tight control: which should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials. Acta Obstet Gynecol Scand. 2018;97:235-247.
  23. Caissutti C, Khalifeh A, Saccone G, et al. Are women positive for the One Step but negative for the Two Step screening tests for gestational diabetes at higher risk for adverse outcomes? Acta Obstet Gynecol Scand. 2018;97:122-134.
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Vincenzo Berghella, MD 
Professor and Director, Division of Maternal-Fetal Medicine and Fellowship Program, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania  
 
Gabriele Saccone, MD  
Resident, Department of Neuroscience, Reproductive Sciences and Dentistry School of Medicine, University of Naples Federico II, Naples, Italy 

The authors report no financial relationships relevant to this article.
 

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Vincenzo Berghella, MD 
Professor and Director, Division of Maternal-Fetal Medicine and Fellowship Program, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania  
 
Gabriele Saccone, MD  
Resident, Department of Neuroscience, Reproductive Sciences and Dentistry School of Medicine, University of Naples Federico II, Naples, Italy 

The authors report no financial relationships relevant to this article.
 

Author and Disclosure Information

Vincenzo Berghella, MD 
Professor and Director, Division of Maternal-Fetal Medicine and Fellowship Program, Department of Obstetrics and Gynecology, Sidney Kimmel Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania  
 
Gabriele Saccone, MD  
Resident, Department of Neuroscience, Reproductive Sciences and Dentistry School of Medicine, University of Naples Federico II, Naples, Italy 

The authors report no financial relationships relevant to this article.
 

Article PDF
obgm0311222_commentary_berghella.pdf
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obgm0311222_commentary_berghella.pdf

Gestational diabetes mellitus (GDM) generally is defined as any degree of glucose intolerance with onset or first recognition during pregnancy.1-14 The best approach and exact criteria to use for GDM screening and diagnosis are under worldwide debate. In TABLE 1 we present just some of the many differing suggestions by varying organizations.2,7-9,11,12,15-17 The American College of Obstetricians and Gynecologists, for instance, suggests a Two Step approach to diagnosis.15 We will make the argument in this article, however, that diagnosis should be defined universally as an abnormal result with the One Step 75-g glucose testing, as adopted by the World Health Organization, International Federation of Gynecology and Obstetrics, and others. Approximately 8% of all pregnancies are complicated by GDM by the One Step test in the United States.18-22 The prevalence may range from 1% to 14% of all pregnancies, depending on the population studied and the diagnostic tests employed.1,19

Diagnostic options

Different methods for screening and diagnosis of GDM have been proposed by international societies; there is controversy regarding the diagnosis of GDM by either the One Step or the Two Step approach.6

The One Step approach includes an oral glucose tolerance test with a 75-g glucose load with measurement of plasma glucose concentration at fasting state and 1 hour and 2 hours post–glucose administration. A positive result for the One Step approach is defined as at least 1 measurement higher than 92, 180, or 153 mg/dL at fasting, 1 hour, or 2 hours, respectively.

The Two Step approach includes a nonfasting oral 50-g glucose load, with a glucose blood measurement 1 hour later. A positive screening, defined often as a blood glucose value higher than 135 mg/dL (range, 130 to 140 mg/dL), is followed by a diagnostic test with a 100-g glucose load with measurements at fasting and 1, 2, and 3 hours post–glucose administration. A positive diagnostic test is defined as 2 measurements higher than the target value.

Why we support the One Step test

There are several reasons to prefer the One Step approach for the diagnosis of GDM, compared with the Two Step approach.

Women testing negative for GDM with Two Step still experience complications pregnancy. Women who test positive for GDM with the One Step test, but negative with the Two Step test, despite having therefore a milder degree of glucose intolerance, do have a higher risk of experiencing several complications.23 For the mother, these complications include gestational hypertension, preeclampsia, and cesarean delivery. The baby also can experience problems at birth (TABLE 2).23 Therefore, women who test positive for GDM with the One Step test deserve to be diagnosed with and treated for the condition, as not only are they at risk for these complications but also treatment of the GDM decreases the incidence of these complications.18,19


There is indeed an increased GDM diagnosis rate with the One Step (about 8%) compared with the Two Step test (about 4%). Nonetheless, this increase is mild and nonsignificant in the meta-analysis of randomized controlled trials (RCTs),18,19 is less than the 18% difference in diagnosis rate previously hypothesized, is consistent with the increased diabetes/prediabetes rates in the general population, and is linked to the increasing incidence of obesity and insulin resistance.

Overall test adherence is better. Five percent to 15% of patients, depending on the study, are not adherent with taking the second part of the Two Step test. Women indeed prefer the One Step approach; the second step in the Two Step approach may be a burden.

Less costly. The One Step process is cost-effective when postpregnancy diabetes mellitus prevention is considered.

Better maternal and perinatal outcomes. Probably the most important and convincing reason the One Step test should be used is that meta-analysis of the 4 RCTs comparing the approaches (including 2 US trials) shows that diagnosing and treating mild GDM as per the One Step approach, compared with screening and treating using the Two Step approach, is associated with increased incidence of GDM (8% vs 4%) and with better maternal and perinatal outcomes.13,18,19 In fact, the One Step approach is associated with significant reductions in: large for gestational age (56%), admission to neonatal intensive care unit (51%), and neonatal hypoglycemia (48%). Tests of heterogeneity in the meta-analysis and of quality all pointed to better outcomes in the One Step test group.13,19

The need for a second step in the Two Step approach delays diagnosis and treatment. The One Step approach is associated with an increase in GDM test adherence and earlier diagnosis,13 which is another reason for better outcomes with the One Step approach. In the presence of risk factors, such as prior GDM, prior macrosomia, advanced maternal age, multiple gestations, and others, the One Step test should be done at the first prenatal visit.

Continue to: US guidelines should be reconsidered...

 

 

US guidelines should be reconsidered

The One Step, 75-g, 2-hour oral glucose tolerance test is universally used to diagnose diabetes mellitus outside of pregnancy. Given our many noted reasons (TABLE 3), we recommend universal screening of GDM by using the One Step approach. It is time, indeed, for the United States to reconsider its guidelines for screening for GDM.

Gestational diabetes mellitus (GDM) generally is defined as any degree of glucose intolerance with onset or first recognition during pregnancy.1-14 The best approach and exact criteria to use for GDM screening and diagnosis are under worldwide debate. In TABLE 1 we present just some of the many differing suggestions by varying organizations.2,7-9,11,12,15-17 The American College of Obstetricians and Gynecologists, for instance, suggests a Two Step approach to diagnosis.15 We will make the argument in this article, however, that diagnosis should be defined universally as an abnormal result with the One Step 75-g glucose testing, as adopted by the World Health Organization, International Federation of Gynecology and Obstetrics, and others. Approximately 8% of all pregnancies are complicated by GDM by the One Step test in the United States.18-22 The prevalence may range from 1% to 14% of all pregnancies, depending on the population studied and the diagnostic tests employed.1,19

Diagnostic options

Different methods for screening and diagnosis of GDM have been proposed by international societies; there is controversy regarding the diagnosis of GDM by either the One Step or the Two Step approach.6

The One Step approach includes an oral glucose tolerance test with a 75-g glucose load with measurement of plasma glucose concentration at fasting state and 1 hour and 2 hours post–glucose administration. A positive result for the One Step approach is defined as at least 1 measurement higher than 92, 180, or 153 mg/dL at fasting, 1 hour, or 2 hours, respectively.

The Two Step approach includes a nonfasting oral 50-g glucose load, with a glucose blood measurement 1 hour later. A positive screening, defined often as a blood glucose value higher than 135 mg/dL (range, 130 to 140 mg/dL), is followed by a diagnostic test with a 100-g glucose load with measurements at fasting and 1, 2, and 3 hours post–glucose administration. A positive diagnostic test is defined as 2 measurements higher than the target value.

Why we support the One Step test

There are several reasons to prefer the One Step approach for the diagnosis of GDM, compared with the Two Step approach.

Women testing negative for GDM with Two Step still experience complications pregnancy. Women who test positive for GDM with the One Step test, but negative with the Two Step test, despite having therefore a milder degree of glucose intolerance, do have a higher risk of experiencing several complications.23 For the mother, these complications include gestational hypertension, preeclampsia, and cesarean delivery. The baby also can experience problems at birth (TABLE 2).23 Therefore, women who test positive for GDM with the One Step test deserve to be diagnosed with and treated for the condition, as not only are they at risk for these complications but also treatment of the GDM decreases the incidence of these complications.18,19


There is indeed an increased GDM diagnosis rate with the One Step (about 8%) compared with the Two Step test (about 4%). Nonetheless, this increase is mild and nonsignificant in the meta-analysis of randomized controlled trials (RCTs),18,19 is less than the 18% difference in diagnosis rate previously hypothesized, is consistent with the increased diabetes/prediabetes rates in the general population, and is linked to the increasing incidence of obesity and insulin resistance.

Overall test adherence is better. Five percent to 15% of patients, depending on the study, are not adherent with taking the second part of the Two Step test. Women indeed prefer the One Step approach; the second step in the Two Step approach may be a burden.

Less costly. The One Step process is cost-effective when postpregnancy diabetes mellitus prevention is considered.

Better maternal and perinatal outcomes. Probably the most important and convincing reason the One Step test should be used is that meta-analysis of the 4 RCTs comparing the approaches (including 2 US trials) shows that diagnosing and treating mild GDM as per the One Step approach, compared with screening and treating using the Two Step approach, is associated with increased incidence of GDM (8% vs 4%) and with better maternal and perinatal outcomes.13,18,19 In fact, the One Step approach is associated with significant reductions in: large for gestational age (56%), admission to neonatal intensive care unit (51%), and neonatal hypoglycemia (48%). Tests of heterogeneity in the meta-analysis and of quality all pointed to better outcomes in the One Step test group.13,19

The need for a second step in the Two Step approach delays diagnosis and treatment. The One Step approach is associated with an increase in GDM test adherence and earlier diagnosis,13 which is another reason for better outcomes with the One Step approach. In the presence of risk factors, such as prior GDM, prior macrosomia, advanced maternal age, multiple gestations, and others, the One Step test should be done at the first prenatal visit.

Continue to: US guidelines should be reconsidered...

 

 

US guidelines should be reconsidered

The One Step, 75-g, 2-hour oral glucose tolerance test is universally used to diagnose diabetes mellitus outside of pregnancy. Given our many noted reasons (TABLE 3), we recommend universal screening of GDM by using the One Step approach. It is time, indeed, for the United States to reconsider its guidelines for screening for GDM.

References

 

  1. Kampmann U, Madsen LR, Skajaa GO, et al. Gestational diabetes: a clinical update. World J Diabetes. 2015;6:1065-1072.
  2. HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358:1991-2002.
  3. Meltzer SJ, Snyder J, Penrod JR, et al. Gestational diabetes mellitus screening and diagnosis: a prospective randomised controlled trial comparing costs of one-step and two-step methods. BJOG. 2010;117:407-415.
  4. Sevket O, Ates S, Uysal O, et al. To evaluate the prevalence and clinical outcomes using a one-step method versus a two-step method to screen gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2014;27:36-41.
  5. Scifres CM, Abebe KZ, Jones KA, et al. Gestational diabetes diagnostic methods (GD2M) pilot randomized trial. Matern Child Health J. 2015;19:1472-1480.
  6. Farrar D, Duley L, Medley N, et al. Different strategies for diagnosing gestational diabetes to improve maternal and infant health. Cochrane Database Syst Rev. 2015;1:CD007122.
  7. American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2017;40(suppl 1):S11-S24.
  8. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Diabetes and Pregnancy. Can J Diabetes. 2013;37(suppl 1):S168-S183.
  9. NICE guideline. Diabetes in pregnancy: management from preconception to the postnatal period. February 2015. https://www.nice.org.uk/guidance/ng3/. Last updated August 2015. Accessed November 18, 2019.
  10. WHO 1999. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus. From http://apps.who.int/iris/bitstream/10665/66040/1/WHO
    _NCD_NCS_99.2.pdf. Accessed November 18, 2019.
  11. World Health Organization. Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy. 2013. http://apps.who.int/iris/bitstream/10665/85975/1/WHO_
    NMH_MND_13.2_eng.pdf. Accessed November 18, 2019.
  12. Hod M, Kapur A, Sacks DA, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: a pragmatic guide for diagnosis, management, and care. Int J Gynaecol Obstet. 2015;131(suppl 3):S173-S211.
  13. Berghella V, Caissutti C, Saccone G, et al. The One Step approach for diagnosing gestational diabetes is associated with better perinatal outcomes than using the Two Step approach: evidence of randomized clinical trials. Am J Obstet Gynecol. 2019;220:562-564.
  14. Berghella V, Caissutti C, Saccone G, et al. One-Step approach to identifying gestational diabetes mellitus: association with perinatal outcomes. Obstet Gynecol. 2019;133:383.
  15. American College of Obstetricians and Gynecologists. Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 180: gestational diabetes mellitus. Obstet Gynecol. 2017;130:e17-e31.
  16. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982;144:768-773.
  17. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes. 1979;28:1039-1057.
  18. Saccone G, Khalifeh A, Al-Kouatly HB, et al. Screening for gestational diabetes mellitus: one step versus two step approach. A meta-analysis of randomized trials. J Matern Fetal Neonatal Med. 2018:1-9.
  19. Saccone G, Caissutti C, Khalifeh A, et al. One step versus two step approach for gestational diabetes screening: systematic review and meta-analysis of the randomized trials. J Matern Fetal Neonatal Med. 2019;32:1547-1555.
  20. Khalifeh A, Eckler R, Felder L, et al. One-step versus two-step diagnostic testing for gestational diabetes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018:1-6.
  21. Caissutti C, Saccone G, Khalifeh A, et al. Which criteria should be used for starting pharmacologic therapy for management of gestational diabetes in pregnancy? Evidence from randomized controlled trials. J Matern Fetal Neonatal Med. 2019;32:2905-2914.
  22. Caissutti C, Saccone G, Ciardulli A, et al. Very tight vs. tight control: which should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials. Acta Obstet Gynecol Scand. 2018;97:235-247.
  23. Caissutti C, Khalifeh A, Saccone G, et al. Are women positive for the One Step but negative for the Two Step screening tests for gestational diabetes at higher risk for adverse outcomes? Acta Obstet Gynecol Scand. 2018;97:122-134.
References

 

  1. Kampmann U, Madsen LR, Skajaa GO, et al. Gestational diabetes: a clinical update. World J Diabetes. 2015;6:1065-1072.
  2. HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008;358:1991-2002.
  3. Meltzer SJ, Snyder J, Penrod JR, et al. Gestational diabetes mellitus screening and diagnosis: a prospective randomised controlled trial comparing costs of one-step and two-step methods. BJOG. 2010;117:407-415.
  4. Sevket O, Ates S, Uysal O, et al. To evaluate the prevalence and clinical outcomes using a one-step method versus a two-step method to screen gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2014;27:36-41.
  5. Scifres CM, Abebe KZ, Jones KA, et al. Gestational diabetes diagnostic methods (GD2M) pilot randomized trial. Matern Child Health J. 2015;19:1472-1480.
  6. Farrar D, Duley L, Medley N, et al. Different strategies for diagnosing gestational diabetes to improve maternal and infant health. Cochrane Database Syst Rev. 2015;1:CD007122.
  7. American Diabetes Association. Classification and diagnosis of diabetes. Diabetes Care. 2017;40(suppl 1):S11-S24.
  8. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. Diabetes and Pregnancy. Can J Diabetes. 2013;37(suppl 1):S168-S183.
  9. NICE guideline. Diabetes in pregnancy: management from preconception to the postnatal period. February 2015. https://www.nice.org.uk/guidance/ng3/. Last updated August 2015. Accessed November 18, 2019.
  10. WHO 1999. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus. From http://apps.who.int/iris/bitstream/10665/66040/1/WHO
    _NCD_NCS_99.2.pdf. Accessed November 18, 2019.
  11. World Health Organization. Diagnostic criteria and classification of hyperglycaemia first detected in pregnancy. 2013. http://apps.who.int/iris/bitstream/10665/85975/1/WHO_
    NMH_MND_13.2_eng.pdf. Accessed November 18, 2019.
  12. Hod M, Kapur A, Sacks DA, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on gestational diabetes mellitus: a pragmatic guide for diagnosis, management, and care. Int J Gynaecol Obstet. 2015;131(suppl 3):S173-S211.
  13. Berghella V, Caissutti C, Saccone G, et al. The One Step approach for diagnosing gestational diabetes is associated with better perinatal outcomes than using the Two Step approach: evidence of randomized clinical trials. Am J Obstet Gynecol. 2019;220:562-564.
  14. Berghella V, Caissutti C, Saccone G, et al. One-Step approach to identifying gestational diabetes mellitus: association with perinatal outcomes. Obstet Gynecol. 2019;133:383.
  15. American College of Obstetricians and Gynecologists. Committee on Practice Bulletins—Obstetrics. Practice Bulletin No. 180: gestational diabetes mellitus. Obstet Gynecol. 2017;130:e17-e31.
  16. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982;144:768-773.
  17. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes. 1979;28:1039-1057.
  18. Saccone G, Khalifeh A, Al-Kouatly HB, et al. Screening for gestational diabetes mellitus: one step versus two step approach. A meta-analysis of randomized trials. J Matern Fetal Neonatal Med. 2018:1-9.
  19. Saccone G, Caissutti C, Khalifeh A, et al. One step versus two step approach for gestational diabetes screening: systematic review and meta-analysis of the randomized trials. J Matern Fetal Neonatal Med. 2019;32:1547-1555.
  20. Khalifeh A, Eckler R, Felder L, et al. One-step versus two-step diagnostic testing for gestational diabetes: a randomized controlled trial. J Matern Fetal Neonatal Med. 2018:1-6.
  21. Caissutti C, Saccone G, Khalifeh A, et al. Which criteria should be used for starting pharmacologic therapy for management of gestational diabetes in pregnancy? Evidence from randomized controlled trials. J Matern Fetal Neonatal Med. 2019;32:2905-2914.
  22. Caissutti C, Saccone G, Ciardulli A, et al. Very tight vs. tight control: which should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials. Acta Obstet Gynecol Scand. 2018;97:235-247.
  23. Caissutti C, Khalifeh A, Saccone G, et al. Are women positive for the One Step but negative for the Two Step screening tests for gestational diabetes at higher risk for adverse outcomes? Acta Obstet Gynecol Scand. 2018;97:122-134.
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