2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor for Gestational Diabetes
Phase-Based Progress Estimates
Effectiveness
Safety
Gestational Diabetes2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor - DiagnosticTest
Study Summary
This trial is looking at a new way to screen for type 2 diabetes in women who are at high risk. The goal is to improve diagnostic strategies.
Eligible Conditions
- Gestational Diabetes
Treatment Effectiveness
Effectiveness Progress
Study Objectives
0 Primary · 6 Secondary · Reporting Duration: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Month 6
Pancreatic beta cell function
Month 6
Maternal and infant body fat composition
Month 6
Maternal glucose variability
Maternal glycemia measured by CGM
Maternal hyperglycemia measured by CGM
Month 6
Maternal diabetes mellitus
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Postpartum GDM
1 of 1
Experimental Treatment
40 Total Participants · 1 Treatment Group
Primary Treatment: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor · No Placebo Group · N/A
Postpartum GDM
DiagnosticTest
Experimental Group · 1 Intervention: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor · Intervention Types: DiagnosticTestTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,435 Previous Clinical Trials
2,229,194 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,371 Previous Clinical Trials
3,930,644 Total Patients Enrolled
Eligibility Criteria
Age 18 - 45 · Female Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are 20 weeks' or less gestational age at the time of diagnosis.
You are a singleton pregnancy at 34-40 weeks gestation.
Who else is applying?
What state do they live in?
| North Carolina | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of North Carolina at Chapel Hill | 100.0% |
What portion of applicants met pre-screening criteria?
| Did not meet criteria | 100.0% |
References
- Bellamy, Leanne, Juan-Pablo Casas, Aroon D Hingorani, and David Williams. 2009. “Type 2 Diabetes Mellitus After Gestational Diabetes: A Systematic Review and Meta-analysis”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(09)60731-5.
- “ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus”. 2018. “ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002501.
- Powe, Camille E., Catherine Allard, Marie-Claude Battista, Myriam Doyon, Luigi Bouchard, Jeffrey L. Ecker, Patrice Perron, Jose C. Florez, Ravi Thadhani, and Marie-France Hivert. 2016. “Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus”. Diabetes Care. American Diabetes Association. doi:10.2337/dc15-2672.
- Moy FM, Ray A, Buckley BS, West HM. Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Jun 11;6:CD009613. doi: 10.1002/14651858.CD009613.pub3. Review. Update in: Cochrane Database Syst Rev. 2019 May 23;5:CD009613.
- Battelino, Tadej, Thomas Danne, Richard M. Bergenstal, Stephanie A. Amiel, Roy Beck, Torben Biester, Emanuele Bosi, et al.. 2019. “Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations from the International Consensus on Time in Range”. Diabetes Care. American Diabetes Association. doi:10.2337/dci19-0028.
- Benhalima, Katrien, Paul Van Crombrugge, Carolien Moyson, Johan Verhaeghe, Sofie Vandeginste, Hilde Verlaenen, Chris Vercammen, et al.. 2019. “Characteristics and Pregnancy Outcomes Across Gestational Diabetes Mellitus Subtypes Based on Insulin Resistance”. Diabetologia. Springer Science and Business Media LLC. doi:10.1007/s00125-019-4961-7.
- Immanuel, Jincy, and David Simmons. 2017. “Screening and Treatment for Early-onset Gestational Diabetes Mellitus: A Systematic Review and Meta-analysis”. Current Diabetes Reports. Springer Science and Business Media LLC. doi:10.1007/s11892-017-0943-7.
- Metzger, Boyd E, Nam H Cho, Susan M Roston, and Ruta Radvany. 1993. “Prepregnancy Weight and Antepartum Insulin Secretion Predict Glucose Tolerance Five Years After Gestational Diabetes Mellitus”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.16.12.1598.
- Yee, Lynn, and Ashley Battarbee. 2017. “Barriers to Postpartum Follow-up and Glucose Tolerance Testing in Women with Gestational Diabetes Mellitus”. American Journal of Perinatology. Georg Thieme Verlag KG. doi:10.1055/s-0037-1607284.
- Has, Phinnara, Lindsey Kanno, Adam Sullivan, Melissa Clark, and Erika Werner. 2018. “Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus”. American Journal of Perinatology. Georg Thieme Verlag KG. doi:10.1055/s-0038-1667290.
- Stumvoll, Michael, Timon Van Haeften, Andreas Fritsche, and John Gerich. 2001. “Oral Glucose Tolerance Test Indexes for Insulin Sensitivity and Secretion Based on Various Availabilities of Sampling Times”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.24.4.796.
- Pontiroli, A.E., P. Pizzocri, A. Caumo, G. Perseghin, and L. Luzi. 2004. “Evaluation of Insulin Release and Insulin Sensitivity Through Oral Glucose Tolerance Test: Differences Between NGT, IFG, IGT, and Type 2 Diabetes Mellitus. A Cross-sectional and Follow-up Study”. Acta Diabetologica. Springer Science and Business Media LLC. doi:10.1007/s00592-004-0147-x.
- Chen, R., Y. Yogev, A. Ben-Haroush, L. Jovanovic, M. Hod, and M. Phillip. 2003. “Continuous Glucose Monitoring for the Evaluation and Improved Control of Gestational Diabetes Mellitus”. The Journal of Maternal-fetal & Neonatal Medicine. Informa UK Limited. doi:10.1080/jmf.14.4.256.260.
- Yogev, Y., A. Ben-Haroush, R. Chen, B. Kaplan, M. Phillip, and M. Hod. 2003. “Continuous Glucose Monitoring for Treatment Adjustment in Diabetic Pregnancies-a Pilot Study”. Diabetic Medicine. Wiley. doi:10.1046/j.1464-5491.2003.00959.x.
- Matsuda, M, and R A DeFronzo. 1999. “Insulin Sensitivity Indices Obtained from Oral Glucose Tolerance Testing: Comparison with the Euglycemic Insulin Clamp.”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.22.9.1462.
- O'Sullivan, John B.. 1961. “Gestational Diabetes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejm196105252642104.
- O'Sullivan, John B.. 1970. “Gestational Diabetes and Its Significance”. Early Diabetes. Elsevier. doi:10.1016/b978-0-12-027361-4.50040-5.
- Danne, Thomas, Revital Nimri, Tadej Battelino, Richard M. Bergenstal, Kelly L. Close, J. Hans DeVries, Satish Garg, et al.. 2017. “International Consensus on Use of Continuous Glucose Monitoring”. Diabetes Care. American Diabetes Association. doi:10.2337/dc17-1600.
- Stumvoll, M., A. Fritsche, and H. Häring. 2001. “The OGTT as Test for Beta Cell Function?”. European Journal of Clinical Investigation. Wiley. doi:10.1046/j.1365-2362.2001.00828.x.
- Raman P, Shepherd E, Dowswell T, Middleton P, Crowther CA. Different methods and settings for glucose monitoring for gestational diabetes during pregnancy. Cochrane Database Syst Rev. 2017 Oct 29;10:CD011069. doi: 10.1002/14651858.CD011069.pub2. Review.
- “ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus”. 2018. “ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002501.
- Battelino, Tadej, Thomas Danne, Richard M. Bergenstal, Stephanie A. Amiel, Roy Beck, Torben Biester, Emanuele Bosi, et al.. 2019. “Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations from the International Consensus on Time in Range”. Diabetes Care. American Diabetes Association. doi:10.2337/dci19-0028.
- Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. doi: 10.1080/jmf.14.4.256.260.
- Stumvoll M, Van Haeften T, Fritsche A, Gerich J. Oral glucose tolerance test indexes for insulin sensitivity and secretion based on various availabilities of sampling times. Diabetes Care. 2001 Apr;24(4):796-7. doi: 10.2337/diacare.24.4.796. No abstract available.
- Pontiroli AE, Pizzocri P, Caumo A, Perseghin G, Luzi L. Evaluation of insulin release and insulin sensitivity through oral glucose tolerance test: differences between NGT, IFG, IGT, and type 2 diabetes mellitus. A cross-sectional and follow-up study. Acta Diabetol. 2004 Jun;41(2):70-6. doi: 10.1007/s00592-004-0147-x.
- Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.
- Immanuel J, Simmons D. Screening and Treatment for Early-Onset Gestational Diabetes Mellitus: a Systematic Review and Meta-analysis. Curr Diab Rep. 2017 Oct 2;17(11):115. doi: 10.1007/s11892-017-0943-7.
- Yogev Y, Ben-Haroush A, Chen R, Kaplan B, Phillip M, Hod M. Continuous glucose monitoring for treatment adjustment in diabetic pregnancies--a pilot study. Diabet Med. 2003 Jul;20(7):558-62. doi: 10.1046/j.1464-5491.2003.00959.x.
- Raman P, Shepherd E, Dowswell T, Middleton P, Crowther CA. Different methods and settings for glucose monitoring for gestational diabetes during pregnancy. Cochrane Database Syst Rev. 2017 Oct 29;10(10):CD011069. doi: 10.1002/14651858.CD011069.pub2.
- Metzger BE, Cho NH, Roston SM, Radvany R. Prepregnancy weight and antepartum insulin secretion predict glucose tolerance five years after gestational diabetes mellitus. Diabetes Care. 1993 Dec;16(12):1598-605. doi: 10.2337/diacare.16.12.1598.
- Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Norgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600.
- O'SULLIVAN JB. Gestational diabetes. Unsuspected, asymptomatic diabetes in pregnancy. N Engl J Med. 1961 May 25;264:1082-5. doi: 10.1056/NEJM196105252642104. No abstract available.
- Matsuda M, DeFronzo RA. Insulin sensitivity indices obtained from oral glucose tolerance testing: comparison with the euglycemic insulin clamp. Diabetes Care. 1999 Sep;22(9):1462-70. doi: 10.2337/diacare.22.9.1462.
- O'Sullivan JB. Gestational diabetes and its significance. Adv Metab Disord. 1970;1:Suppl 1:339+. doi: 10.1016/b978-0-12-027361-4.50040-5. No abstract available.
- Moy FM, Ray A, Buckley BS, West HM. Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009613. doi: 10.1002/14651858.CD009613.pub3.
- Stumvoll M, Fritsche A, Haring H. The OGTT as test for beta cell function? Eur J Clin Invest. 2001 May;31(5):380-1. doi: 10.1046/j.1365-2362.2001.00828.x. No abstract available.
- Ashley N. Battarbee 2021. "Postpartum Glycemia in Women at Risk For Persistent Hyperglycemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04521712.
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