Gestational Diabetes and Pharmacotherapy (GAP)

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Glyburide; Insulin; Insulin, Globin Zinc; Metformin

Criteria

Inclusion Criteria:

• Viable singleton pregnancy

• Age >= 18 years old

• Diagnosed with gestational diabetes mellitus

• Able to communicate in English

Exclusion Criteria:

• Pre-gestational diabetes

• Significantly abnormal GDM testing, suggestive of the presence of pre-gestational diabetes, either with fasting values >=126 mg/dL or 2-hour post-prandial levels >=200 mg/dL

• Patients who check blood sugars on average less than 2 times per day after appropriate counseling

• Already started pharmacotherapy prior to referral to the study