Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot (ENGAGED)

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

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Gestational Diabetes
• Intervention / Treatment: Diagnostic test: Hemoglobin A1c; Diagnostic test: Oral Glucose Tolerance Test; Device: Continuous glucose monitor

Detailed Description

Gestational diabetes (GDM) is associated with a significantly increased risk of type 2 diabetes, with 1/3 of individuals with GDM developing glucose intolerance in the first 3 years postpartum. The American Diabetes Association recommends a follow up oral glucose tolerance test (OGTT) 4-12 weeks after delivery for all patients with GDM, but rates of follow up screening are as low as 19%. OGTT presents many challenges to postpartum patients, including lengthy visits and the need to fast for at least 8 hours, that likely impact these follow up rates. There is also evidence that many individuals with normal OGTT develop dysglycemia within the first year postpartum, leading to concerns about the diagnostic yield of OGTT. Continuous glucose monitors (CGM) have revolutionized the care of type 1 and 2 diabetes, but its utility in GDM is poorly studied. There are many potential benefits of CGM as a possible GDM postpartum screening, including the ability to transmit data remotely and increased glycemic data, but the impact CGMs have on quality of life postpartum and if they would be acceptable screening methods for patients after delivery has yet to be studied. Our research aims to understand the acceptability and feasibility of CGM for detection of ongoing dysglycemia in the postpartum period in GDM. A sample of 20 postpartum individuals with a history of GDM will have CGMs placed at 6-8 weeks postpartum . Participants will have surveys after the CGM period about CGM impact on quality of life as well as complete a validated glucose monitoring satisfaction survey. They will then complete the standard of care OGTT at 10-12 weeks postpartum and be asked to compare their experience with CGM versus OGTT and which screening method they found preferable. Wear times and study dropout rates will be analyzed for intervention fidelity as a marker of feasibility. The investigators will begin to characterize postpartum glycemia by mean serum glucose, time in range (TIR) and coefficient of variation (CV) as measured by CGM. Glycemic data will be compared to a 12-week OGTT to determine relative sensitivity. This study could determine if CGM may provide a novel screening method for postpartum GDM that is acceptable to patients.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Rachel Gordon, MD, MPH; Phone Number: 614-293-7980; Email: rachel.gordon@osumc.edu
• Study Contact Backup: Name: Seuli Brill, MD; Phone Number: 614-293-7980; Email: seuli.brill@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Medical Center
      • Contact: Rece Foss; Phone Number: 614-293-8000; Email: rece.foss@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

We anticipate enrolling a total of 20 participants with a recent pregnancy affected by GDM

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregestational Diabetes (Type I or Type II)
• Continued use of diabetes medications (including metformin and insulin) immediately after delivery
• Preterm delivery (< 37 weeks gestation)
• Twin or higher order gestation
• No access to a smartphone
• Unable or unwilling to wear CGM 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 CGM

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Participants; Participants will be recruited at 6-8 weeks postpartum; at that appointment, CGMs will be placed. After wearing the CGM, participants will fill out surveys regarding their experience. At 10-12 weeks postpartum, they will complete the standard of care OGTT as well as complete an interview regarding their experience. At 12 months postpartum, they will complete a blood test to check their hemoglobin A1c.

Diagnostic test: Hemoglobin A1c; At 11-14 months postpartum, participants will be asked to have their blood drawn to check their hemoglobin A1c to look for signs of developed insulin resistance; Diagnostic test: Oral Glucose Tolerance Test; At 10-12 weeks postpartum, participants will complete an oral glucose tolerance test, which involves drinking a glucose substance and having glucose levels measured a maximum of 3 times.; Device: Continuous glucose monitor; CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.; Other Names: CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of CGM	As determined by survey	15 weeks from enrollment
Comparative experience of OGTT and CGM	As determined by survey	15 weeks from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence and characteristics of dysglycemia in GDM postpartum	As determined by survey	15 weeks from enrollment
Lifestyle changes survey	Breastfeeding practices, changes in diet and physical activity	15 weeks from enrollment
Medical care	Number of doctor's visits (both for participant and their infant), prescribed medications	15 weeks from enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant outcomes	in-hospital medical record review	birth outcomes only

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: DexCom, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2025
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 30, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational; Hyperglycemia; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Glucose Tolerance Test
• Other Study ID Numbers: 2023H0066

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No