Study Summary
This trial is comparing two different thresholds for when to start medical treatment for gestational diabetes mellitus (GDM). Pregnant women with GDM will be randomly assigned to start treatment when they reach at least 20% or 40% above the target goal for capillary blood glucose (CBG) levels. The investigators think that a lower threshold of 20% will lead to fewer obstetric and medical complications.
Eligible Conditions
- Gestational Diabetes
Treatment Effectiveness
Effectiveness Progress
This is further along than 93% of similar trials
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: The data will be collected up to 6 weeks of life
Week 6
Composite Neonatal Outcome
Week 6
Cesarean Delivery Rate
Preeclampsia
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Trial Design
2 Treatment Groups
20% cutoff group
1 of 2
40% cutoff group
1 of 2
Active Control
416 Total Participants · 2 Treatment Groups
Primary Treatment: 20% cutoff group · No Placebo Group · Phase 4
20% cutoff group
Drug
ActiveComparator Group · 1 Intervention: Insulin · Intervention Types: Drug40% cutoff group
Drug
ActiveComparator Group · 1 Intervention: Insulin · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: the data will be collected up to 6 weeks of life
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
572 Previous Clinical Trials
1,154,829 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,843 Previous Clinical Trials
2,152,388 Total Patients Enrolled
Eligibility Criteria
Age 18 - 45 · Female Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Rumbold, Alice R, and Caroline A Crowther. 2001. “Guideline Use for Gestational Diabetes Mellitus and Current Screening, Diagnostic and Management Practices in Australian Hospitals”. The Australian and New Zealand Journal of Obstetrics and Gynaecology. Wiley. doi:10.1111/j.1479-828x.2001.tb01301.x.
- American Diabetes Association. 2011. “Diagnosis and Classification of Diabetes Mellitus”. Diabetes Care. American Diabetes Association. doi:10.2337/dc12-s064.
- Boney, Charlotte M., Anila Verma, Richard Tucker, and Betty R. Vohr. 2005. “Metabolic Syndrome in Childhood: Association with Birth Weight, Maternal Obesity, and Gestational Diabetes Mellitus”. Pediatrics. American Academy of Pediatrics (AAP). doi:10.1542/peds.2004-1808.
- “Hyperglycemia and Adverse Pregnancy Outcomes”. 2008. “Hyperglycemia and Adverse Pregnancy Outcomes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0707943.
- Kim, Catherine, Katherine M. Newton, and Robert H. Knopp. 2002. “Gestational Diabetes and the Incidence of Type 2 Diabetes”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.25.10.1862.
- ATHUKORALA, Chaturica, Caroline A. CROWTHER, Kristyn WILLSON, and Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group*. 2007. “Women with Gestational Diabetes Mellitus in the ACHOIS Trial: Risk Factors for Shoulder Dystocia”. The Australian and New Zealand Journal of Obstetrics and Gynaecology. Wiley. doi:10.1111/j.1479-828x.2006.00676.x.
- Caissutti, Claudia, and Vincenzo Berghella. 2017. “Scientific Evidence for Different Options for GDM Screening and Management: Controversies and Review of the Literature”. Biomed Research International. Hindawi Limited. doi:10.1155/2017/2746471.
- Langer, Oded, Yariv Yogev, Orli Most, and Elly M.J. Xenakis. 2005. “Gestational Diabetes: The Consequences of Not Treating”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2004.11.039.
- Landon, Mark B., Catherine Y. Spong, Elizabeth Thom, Marshall W. Carpenter, Susan M. Ramin, Brian Casey, Ronald J. Wapner, et al.. 2009. “A Multicenter, Randomized Trial of Treatment for Mild Gestational Diabetes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa0902430.
- “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.
- Clausen, Tine D., Elisabeth R. Mathiesen, Torben Hansen, Oluf Pedersen, Dorte M. Jensen, Jeannet Lauenborg, Lone Schmidt, and Peter Damm. 2009. “Overweight and the Metabolic Syndrome in Adult Offspring of Women with Diet-treated Gestational Diabetes Mellitus or Type 1 Diabetes”. The Journal of Clinical Endocrinology & Metabolism. The Endocrine Society. doi:10.1210/jc.2009-0305.
- Crowther, Caroline A., Janet E. Hiller, John R. Moss, Andrew J. McPhee, William S. Jeffries, and Jeffrey S. Robinson. 2005. “Effect of Treatment of Gestational Diabetes Mellitus on Pregnancy Outcomes”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa042973.
- American Diabetes Association. 2016. “13. Management of Diabetes in Pregnancy”. Diabetes Care. American Diabetes Association. doi:10.2337/dc17-s016.
- Gilbert, W. 1999. “Associated Factors in 1611 Cases of Brachial Plexus Injury”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0029-7844(98)00484-0.
- Dabelea, Dana, Janet K. Snell-Bergeon, Cynthia L. Hartsfield, Kimberly J. Bischoff, Richard F. Hamman, and Robert S. McDuffie. 2005. “Increasing Prevalence of Gestational Diabetes Mellitus (GDM) over Time and by Birth Cohort”. Diabetes Care. American Diabetes Association. doi:10.2337/diacare.28.3.579.
- Hartling, Lisa, Donna M. Dryden, Alyssa Guthrie, Melanie Muise, Ben Vandermeer, and Lois Donovan. 2013. “Benefits and Harms of Treating Gestational Diabetes Mellitus: A Systematic Review and Meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-159-2-201307160-00661.
- “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.
- Boney CM, Verma A, Tucker R, Vohr BR. Metabolic syndrome in childhood: association with birth weight, maternal obesity, and gestational diabetes mellitus. Pediatrics. 2005 Mar;115(3):e290-6. doi: 10.1542/peds.2004-1808.
- American Diabetes Association. Diagnosis and classification of diabetes mellitus. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S64-71. doi: 10.2337/dc12-s064. No abstract available.
- Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.
- Kim C, Newton KM, Knopp RH. Gestational diabetes and the incidence of type 2 diabetes: a systematic review. Diabetes Care. 2002 Oct;25(10):1862-8. doi: 10.2337/diacare.25.10.1862.
- Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.
- Rumbold AR, Crowther CA. Guideline use for gestational diabetes mellitus and current screening, diagnostic and management practices in Australian hospitals. Aust N Z J Obstet Gynaecol. 2001 Feb;41(1):86-90. doi: 10.1111/j.1479-828x.2001.tb01301.x.
- American Diabetes Association. 13. Management of Diabetes in Pregnancy. Diabetes Care. 2017 Jan;40(Suppl 1):S114-S119. doi: 10.2337/dc17-S016. No abstract available.
- Langer O, Yogev Y, Most O, Xenakis EM. Gestational diabetes: the consequences of not treating. Am J Obstet Gynecol. 2005 Apr;192(4):989-97. doi: 10.1016/j.ajog.2004.11.039.
- Athukorala C, Crowther CA, Willson K; Austrailian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Women with gestational diabetes mellitus in the ACHOIS trial: risk factors for shoulder dystocia. Aust N Z J Obstet Gynaecol. 2007 Feb;47(1):37-41. doi: 10.1111/j.1479-828X.2006.00676.x.
- Gilbert WM, Nesbitt TS, Danielsen B. Associated factors in 1611 cases of brachial plexus injury. Obstet Gynecol. 1999 Apr;93(4):536-40. doi: 10.1016/s0029-7844(98)00484-0.
- Dabelea D, Snell-Bergeon JK, Hartsfield CL, Bischoff KJ, Hamman RF, McDuffie RS; Kaiser Permanente of Colorado GDM Screening Program. Increasing prevalence of gestational diabetes mellitus (GDM) over time and by birth cohort: Kaiser Permanente of Colorado GDM Screening Program. Diabetes Care. 2005 Mar;28(3):579-84. doi: 10.2337/diacare.28.3.579.
- Caissutti C, Berghella V. Scientific Evidence for Different Options for GDM Screening and Management: Controversies and Review of the Literature. Biomed Res Int. 2017;2017:2746471. doi: 10.1155/2017/2746471. Epub 2017 Apr 10.
- HAPO Study Cooperative Research Group; Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U, Coustan DR, Hadden DR, McCance DR, Hod M, McIntyre HD, Oats JJ, Persson B, Rogers MS, Sacks DA. Hyperglycemia and adverse pregnancy outcomes. N Engl J Med. 2008 May 8;358(19):1991-2002. doi: 10.1056/NEJMoa0707943.
- Anna Palatnik, MD 2021. "Gestational Diabetes and Pharmacotherapy (GAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03527537.
Frequently Asked Questions
Are there vacancies in this medical experiment for participants?
"Indeed, records on clinicaltrials.gov confirm that this research project is actively enrolling. It was initially posted on May 1st 2021 and has been modified most recently on August 12th 2022; it seeks 416 volunteers at a single trial site." - Anonymous Online Contributor
Unverified Answer
What research findings have been gained from the 40% cutoff group?
"Presently, there are 72 trials studying the effects of 40% cutoff group. Out of these studies, 13 have advanced to Phase 3. While many tests for this medication are based in Cincinnati, Ohio, an additional 248 locations across the globe offer access to clinical trials regarding this treatment." - Anonymous Online Contributor
Unverified Answer
How many individuals are involved in the current clinical investigation?
"Affirmative. Documentation hosted on clinicaltrials.gov verifies that recruitment for this medical trial is currently underway. It was initially posted May 1, 2021 and last modified August 12, 2022; 416 patients are being sought from a single site." - Anonymous Online Contributor
Unverified Answer
Is the current research open to participants of advanced age?
"This trial is offering participation to individuals between the ages of 18 and 45. For those under 18 or above 65, there are 196 studies available for minors and 938 trials suitable for seniors respectivelly." - Anonymous Online Contributor
Unverified Answer
Is the 40% cutoff a safe threshold for individuals?
"After a thorough review, the safety of 40% cutoff group was rated 3 on our organization's scale due to its Phase 4 status which indicates that it has been approved." - Anonymous Online Contributor
Unverified Answer
Do I satisfy the criteria to qualify for this research initiative?
"Participants aged between 18 and 45 with Gestational Diabetes Mellitus (GDM) are invited to join this study, for a total of 416 enrollees. Additionally, participants must be carrying viable singleton pregnancies in order to qualify." - Anonymous Online Contributor
Unverified Answer