CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 416 target
Drug / intervention
Insulindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03527537
NCT03527537Phase 4ActiveMonitorUpdated 3mo ago · Completion was 3mo ago
Slow Enrollment

Gestational Diabetes and Pharmacotherapy (GAP) - A Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients With Gestational Diabetes

Medical College of Wisconsin·interventional·Posted May 17, 2018·Updated Mar 24, 2026

In Brief

A Phase 4 clinical trial evaluating Insulin for Gestational Diabetes. Active but no longer recruiting, targeting 416 participants across 1 site.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4Active
20192020202120222023202420252026
First PostedMay 17, 2018
Enrollment StartMay 4, 2021
Primary CompletionMar 31, 2026
Study CompletionOct 1, 2026
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 8.1 years ago

Interventions

Insulindrug

Insulin may be administered base on glucose log values. The dosing of the insulin will be determined by the provider using typical management of gestational diabetes.