Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

NCT ID: NCT06184373

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-06
• Study Completion Date: 2027-05-30

Brief Summary

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.

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.

Conditions

Gestational Diabetes; Hyperglycemia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Continuous glucose monitor

Intervention Type: DEVICE

CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.

Oral Glucose Tolerance Test

Intervention Type: DIAGNOSTIC_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.

Hemoglobin A1c

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Continuous glucose monitor

CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.

Intervention Type: DEVICE

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.

Intervention Type: 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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

CGM

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Rachel D'Amico

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rachel Gordon, MD, MPH

Role: CONTACT

rachel.gordon@osumc.edu

614-293-7980

Seuli Brill, MD

Role: CONTACT

seuli.brill@osumc.edu

614-293-7980

Facility Contacts

Rece Foss

Role: primary

rece.foss@osumc.edu

614-293-8000

Other Identifiers

2023H0066

Identifier Type: -

Identifier Source: org_study_id