Gestational Diabetes and Pharmacotherapy (GAP) (GAP)

January 22, 2024 updated by: Anna Palatnik, MD, Medical College of Wisconsin

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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=416) 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: Determine the effect of earlier insulin initiation (20% threshold) for GDM management on adverse neonatal and maternal outcomes associated with GDM.

Hypothesis 1.1: The composite adverse neonatal outcome associated with GDM (LGA, macrosomia, birth trauma, preterm birth, neonatal hypoglycemia, and hyperbilirubinemia) will be lower in earlier insulin initiation compared with the active control group.

Hypothesis 1.2: Preeclampsia and cesarean birth frequencies will be lower in earlier insulin initiation compared with the active control group.

Hypothesis 1.3: The composite neonatal and maternal outcomes will not differ between racial and ethnic groups within each study group.

Aim 2:Assess the safety of earlier insulin initiation in pregnant patients and their neonates.

Hypothesis 2.1: The SGA rate will be higher in earlier insulin initiation compared with the active control group; however, in both groups it will be lower than the national rate of 10%. Hypothesis 2.2: Maternal hypoglycemia and perinatal death will not differ between groups.

Aim 3:Determine the effect of earlier insulin initiation on patient-reported outcomes using standardized measures and qualitative interviews.

Hypothesis 3: Anxiety, depression, perceived stress and diabetes self-efficacy will be better in patients randomized to earlier insulin initiation compared with the active control group.

Study Type

Interventional

Enrollment (Estimated)

416

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 20% cutoff group
Treatment intervention will be initiated with insulin if 20% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.
Drug: Insulin
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.
Active Comparator: 40% cutoff group
Treatment intervention will be initiated with insulin if 40% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.
Drug: Insulin
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite Neonatal Outcome
Time Frame: The data will be collected up to 6 weeks of life

Our primary outcome will be a composite adverse neonatal outcome associated with gestational diabetes:

large-for-gestational age macrosomia birth trauma preterm birth neonatal hypoglycemia hyperbilirubinemia
The data will be collected up to 6 weeks of life

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cesarean Delivery Rate
Time Frame: The data will be collected up to 6 weeks postpartum
Our secondary outcome will be to compare the rates of cesarean delivery between two thresholds for medical treatment initiation for GDM.
The data will be collected up to 6 weeks postpartum
Preeclampsia
Time Frame: The data will be collected up to 6 weeks postpartum
The data will be collected up to 6 weeks postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical College of Wisconsin

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

April 24, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 17, 2018

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO00030802

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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