Actively Recruiting

Age: 18Years - 50Years
FEMALE
Healthy Volunteers
ID06184373

Early Investigation of Glucose Monitoring After Gestational Diabetes (ENGAGED): Utility and Acceptability of Continuous Glucose Monitoring in the Early Postpartum Period After Gestational Diabetes Mellitus

Led by Ohio State University · Updated on 2026-01-22

20

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

O

Ohio State University

Lead Sponsor

D

DexCom, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Gestational diabetes (GDM) affects many women during pregnancy and increases the risk of developing type 2 diabetes within three years after delivery. However, follow-up screening rates after pregnancy are low due to challenges with the recommended oral glucose tolerance test (OGTT), which requires fasting and lengthy visits. This research aims to evaluate if using continuous glucose monitors (CGM), small sensors placed under the skin, can improve postpartum diabetes screening and quality of life for women with recent GDM. In this study, 20 postpartum women with recent GDM will wear CGMs for up to 10 days at 6-8 weeks after giving birth. After wearing the CGM, participants will complete surveys about their experience and satisfaction. At 10-12 weeks postpartum, they will undergo the standard OGTT and be interviewed to compare their experiences with both screening methods. Additionally, at 11-14 months postpartum, a blood test will be done to check hemoglobin A1c for signs of insulin resistance. Participants will be involved in wearing the CGM device, completing surveys about their quality of life and glucose monitoring satisfaction, and attending follow-up visits for the OGTT and blood tests. Researchers will analyze blood glucose trends from the CGM and compare these with OGTT results to assess the accuracy and acceptability of CGM as a screening tool. The study will monitor participants for up to 15 weeks from enrollment, with a long-term follow-up blood test at about one year postpartum.

CONDITIONS

Brief Title

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

Who Can Participate

Age: 18Years - 50Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women with a viable singleton intrauterine pregnancy
  • Able to understand the study, and having understood, provide written informed consent in English
  • Recent pregnancy affected by gestational diabetes
  • Female aged 18 to 50 years
Not Eligible

You will not qualify if you...

  • Pregestational Diabetes (Type I or Type II)
  • Continued use of diabetes medications (including metformin and insulin) immediately after delivery
  • Preterm delivery (less than 37 weeks gestation)
  • Twin or higher order gestation
  • No access to a smartphone
  • Unable or unwilling to wear continuous glucose monitor or return for follow up at postpartum mother-infant dyad clinic
  • Participation in this trial in a prior pregnancy
  • History of skin allergy to adhesive products or continuous glucose monitor

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at 6-8 weeks postpartum for CGM placement and enrollment

Monitoring

Duration - Up to 10 days

Participants wear a continuous glucose monitor (CGM) for up to 10 days to assess glucose levels in the early postpartum period.

1 visit for CGM placement and approximately 1 visit for CGM removal or data collection

Diagnostic Evaluation

Duration - 1 day

Participants complete an oral glucose tolerance test (OGTT) to assess glucose metabolism at 10-12 weeks postpartum.

1 visit (in-person) for the OGTT at 10-12 weeks postpartum

Long-term Monitoring

Duration - 1 day

Participants have blood drawn to check hemoglobin A1c to evaluate for insulin resistance approximately one year after delivery.

1 visit (in-person) at 11-14 months postpartum for blood draw

Trial Site Locations

Total: 1 location

1

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

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Research Team

R

Rachel Gordon, MD, MPH

S

Seuli Brill, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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