Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Location status: Recruiting
NCT Number: NCT06184373
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.
Interested in participating?
Request Info18 year–50 year
Female
Observational
Columbus, Ohio, 43210, United States
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CGMs will be worn for a maximum of 10 days at 6-8 weeks postpartum.
Other names: CGM
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.
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
Time frame: 15 weeks from enrollment
As determined by survey
Time frame: 15 weeks from enrollment
As determined by survey
Time frame: 15 weeks from enrollment
As determined by survey
Time frame: 15 weeks from enrollment
Breastfeeding practices, changes in diet and physical activity
Time frame: 15 weeks from enrollment
Number of doctor's visits (both for participant and their infant), prescribed medications
Time frame: birth outcomes only
in-hospital medical record review
Contact information is provided by the study sponsor or research team.
Rachel Gordon, MD, MPH
CONTACT
Seuli Brill, MD
CONTACT
Ohio State University
Other
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
Acronym: ENGAGED
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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