Pregnancy and Postpartum CGM in GDM

Recruiting

• Conditions: Gestational Diabetes

• Registration Number: NCT07174245
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.

Detailed Description

Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.

Study Timeline

• Study Start: 2025-08-05
• Status Verified: 2025-09
• Study First Submitted: 2025-09-08
• Study First Submitted QC: 2025-09-08
• Last Update Submitted: 2025-09-08
• Study First Posted: 2025-09-15
• Last Update Posted: 2025-09-15
• Primary Completion: 2026-08-05
• Study Completion: 2026-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Diagnosis of gestational diabetes during current pregnancy
• age 18 or older
• prescribed Dexcom G7

Exclusion Criteria

• Pregestational diabetes
• known skin adhesive allergy which inhibits ongoing use of CGM
• chronic oral steroid use.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of postpartum TIR <96%	up to 12 weeks postpartum	Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL.; Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.

Secondary Outcome Measures

Name	Time	Method
Specificity of postpartum TIR <96%	up to 12 weeks postpartum	Specificity of postpartum TIR \<96% to predict dysglycemia on OGTT; Specificity calculated by true negatives are TIR not \<96% and normal OGTT and false positive are TIR \<96% but normal OGTT results.
Experience survey questionnaire	up to 12 weeks postpartum	6 items in non validated questionnaire to be administered remotely. first 5 questions rated on a 5 point likert scale. question 6 asks participant to choose preference between glucose sensor or oral glucose tolerance test.; Each question evaluated on its own scored 1 (Strongly disagree) to 5 (Strongly Agree). The questions are not summed.

Trial Locations

Locations (1)

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States