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

PRO00030802

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.

2021-05-04

2026-03-31

2026-10-01

Recruiting

Early phase I

416

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This will be a randomized, controlled trial of 284 women with a diagnosis of GDM. Women will be consented and randomized at the time of their diagnosis. All women with GDM will receive counseling regarding diet and exercise and instructions on self-monitoring blood glucose values. The investigators will apply cutoffs of 95 mg/dL for fasting and 120 mg/dL for 2-hour post-prandial levels. Once randomized, the first treatment arm will be assigned to a limit of 20% abnormal values before we start treatment and to titrate up dosages as needed, while using the 20% threshold of abnormal CBG values at each subsequent review of glucose log. To specify, if more than 20% of values for the week are elevated, treatment would be initiated. Once treatment is initiated, the dosage of medication will be adjusted with cutoff of 20% of abnormal values per week. The second treatment arm will utilize the same protocol, however, the limit to start medications or adjust dosages will be 40% abnormal values.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 416, 'type': 'ESTIMATED'}}

2024-01-23