A Pragmatic Approach to Lower Diabetes Risk After Gestational Diabetes

April 18, 2025 updated by: Tufts Medical Center

Implementation of a Pragmatic Approach to Lower Diabetes Mellitus Risk After a Diagnosis of Gestational Diabetes Mellitus

This study is testing whether daily metformin for 1 year postpartum can reduce risk of diabetes in patients who had gestational diabetes. Typical care for prediabetes after gestational diabetes is counseling on diet and lifestyle. This study is researching whether management of diabetes prevention is more effective with the drug metformin. This study will be conducted at Tufts Medical Center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women with a history of gestational diabetes mellitus (GDM) represent a unique population who may benefit from metformin as much as lifestyle intervention; when metformin is prescribed to these women remote from delivery after a diagnosis of prediabetes, it reduces their risk of developing diabetes mellitus (DM) by up to 40% over 10 years. However, in the current system in which gestational diabetes diagnosis, prediabetes testing, and metformin prescription are temporally separated by months to years, less than 20% of postpartum women undergo prediabetes testing. When prediabetes is identified in women with a history of GDM, only 7.8% are prescribed metformin.

Given the increasing public health burden of DM, there is an urgent need to remedy this problem and correct this deficiency in health care delivery that allows so many at-risk women to remain unidentified and untreated.

Compelling preliminary data, confirmed at several other sites, indicates that the postpartum glucose tolerance test to identify individuals with prediabetes can be moved from 4-12 weeks postpartum to 1-4 days postpartum, when women are still hospitalized, with test compliance of 92% and no reduction in sensitivity or specificity for prediabetes.

When individuals with a history of GDM and prediabetes are prescribed metformin, they experience a 50% reduction in DM risk and a 3 kg increase in weight loss over three years compared to placebo. If these same benefits are realized when metformin is initiated soon after delivery, then a simple change in postpartum care so that metformin is routinely prescribed at hospital discharge to women with a history of GDM and prediabetes could improve the health of thousands of women annually by decreasing the number of women who develop DM and fail to achieve postpartum weight loss.

Each year in the United States, approximately 280,000 women are diagnosed with GDM. Without intervention, up to 70% of these women will develop diabetes mellitus (DM) over their lifetime, resulting in devastating health consequences and escalating health care costs. However, implementing a postpartum glucose tolerance test and intervening with metformin for those with prediabetes may be a cost-effective change to postpartum care that would result in a profound decrease in DM incidence.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

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

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women currently pregnant with planned delivery at Tufts Medical Center
  2. Gestational diabetes mellitus diagnosed during pregnancy
  3. ≥18 years of age
  4. Opted for the 2 hour 75 gram OGTT during postpartum hospitalization
  5. Willing and able to sign the informed consent

Exclusion Criteria:

  1. Unable to commit to required study visits for any reason.

  2. Contraindications to metformin

    • Liver disease
    • Impaired renal function (Creatinine Clearance> )
    • Congestive heart failure(CHF)
    • Taking drugs that could interfere with metformin metabolism
  3. Taking metformin outside of pregnancy
  4. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids).
  5. Decided against the 2 hour 75 gram OGTT during postpartum hospitalization.
  6. Preexisting diabetes mellitus.

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metformin
Participants will be given a daily prescription of metformin for 12 months postpartum. At 12 months and again at 15 months (3 months off the drug), HbA1c and weight will be assessed.
Drug: Metformin
Metformin is used to lower blood sugar in patients with high blood sugar (diabetes).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1C
Time Frame: 12 months
These results will be shared with participants and their providers. Any participants who accepted metformin but do not have diabetes will be asked to stop all study medication and no more study medication will be dispensed.
12 months
HbA1C
Time Frame: 15 months
At 15 months postpartum, study participants with prediabetes will be seen again for their final study visit. The investigators intend to follow all participants for 3 months after metformin treatment ends for both safety reasons and efficacy reasons. If the metformin was masking diabetes, the investigators want the opportunity to identify those participants and refer them for treatment. Additionally, prior studies have not determined whether the benefits of metformin extend after the medication is discontinued (as indicated by the FDA when the investigators requested to use metformin in the first year postpartum).
15 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: 12 months
12 months
Weight
Time Frame: 15 months
15 months

Collaborators and Investigators

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

Sponsor

Tufts Medical Center

Investigators

  • Principal Investigator: Erika Werner, MD, Tufts Medical Center

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

Helpful Links

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)

June 1, 2022

Primary Completion (Actual)

March 1, 2025

Study Completion (Actual)

April 18, 2025

Study Registration Dates

First Submitted

March 3, 2022

First Submitted That Met QC Criteria

March 11, 2022

First Posted (Actual)

March 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002576

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.

Clinical Trials on Diabetes Mellitus, Type 2

Clinical Trials on Metformin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe