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
Ohio State University
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.
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…
Eligibility
- Age range
- 18–50 years
- Sex
- Female
- Healthy volunteers
- Yes
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 *…
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
Location
- Ohio State University Medical CenterColumbus, Ohio