Gestational Diabetes and Pharmacotherapy (GAP)

Last updated on July 2021

Recruitment

Recruitment Status: Recruiting
Estimated Enrollment: Same as current

Summary

Conditions: Gestational Diabetes
Type: Interventional
Phase: Phase 4
Design: Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age: Between 18 years and 45 years
Gender: Only males

Description

Gestational diabetes mellitus (GDM) affects 5-8% of pregnant women, many of whom will require treatment beyond diet and exercise. Despite this high prevalence, there is no consensus regarding the glycemic threshold for conversion from diet to medical treatment for GDM. No randomized studies have been performed on how to define failure with diet and exercise and currently, the need to start insulin or oral hypoglycemic agents is at the provider's discretion. It is important to establish criterion of pharmacotherapy initiation for GDM in pregnancy as GDM under-treatment leads to increased rates of adverse obstetric outcomes associated with poor glycemic control including macrosomia, pre-eclampsia, cesarean delivery, shoulder dystocia, birth trauma, neonatal hypoglycemia and hyperbilirubinemia, childhood obesity and metabolic syndrome in the offspring. In contrast, overtreatment for women comes at increased cost due to overutilization of resources, increased expense, and adverse effects of the medications themselves. The goal of this study is to compare two different thresholds for initiation of medical treatment for GDM. Pregnant women diagnosed with GDM (N=284) 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. Aim 1: To compare the rate of a composite outcome between two thresholds for medical treatment initiation for GDM. Women who receive the diagnosis of GDM and meet eligibility criteria will be randomized to start insulin or an oral hypoglycemic agent when the number of CBG values above target reaches 20% or 40%. The primary outcome will be a composite of neonatal macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, preterm delivery, neonatal intensive care unit (NICU) admission, and stillbirth or neonatal death. The investigators hypothesize that women who receive treatment with stricter limits of abnormal blood glucose levels will have lower rates of these poor outcomes. Aim 2: To compare the rates of cesarean delivery between two thresholds for medical treatment initiation for GDM. The investigators hypothesize that women who receive treatment with stricter limits of abnormal blood glucose levels will have lower rates of cesarean delivery.

Tracking Information

NCT #: NCT03527537
Collaborators: Not Provided
Investigators: Not Provided