Active — Not RecruitingPhase 4

Gestational Diabetes and Pharmacotherapy (GAP)

United States416 participantsStarted 2021-05-04

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Composite Neonatal Outcome

Timeframe: The data will be collected up to 6 weeks of life

Trial details

NCT IDNCT03527537

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-31

View on ClinicalTrials.gov More Gestational Diabetes trials