RecruitingNCT06184373

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

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

Sponsor

Ohio State University

Enrollment

20 participants

Start Date

Jun 6, 2025

Study Type

OBSERVATIONAL

Conditions

Hyperglycemia Gestational Diabetes

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 50 Years

Inclusion Criteria3

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 Criteria8

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

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Interventions

DEVICEContinuous glucose monitor

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

DIAGNOSTIC_TESTOral 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.

DIAGNOSTIC_TESTHemoglobin 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