Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sensitivity of postpartum TIR <96%
Study Overview
Brief Summary
Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.
Detailed Description
Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of gestational diabetes during current pregnancy
- •age 18 or older
- •prescribed Dexcom G7
Exclusion Criteria
- •Pregestational diabetes
- •known skin adhesive allergy which inhibits ongoing use of CGM
- •chronic oral steroid use.
Arms & Interventions
Participants with Gestational diabetes GDM
All participants who wear CGM and have their postpartum OGTT
Intervention: continuous glucose monitor (Device)
Outcomes
Primary Outcomes
Sensitivity of postpartum TIR <96%
Time Frame: up to 12 weeks postpartum
Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.
Sensitivity of postpartum TIR <96%
Time Frame: up to 12 weeks postpartum
Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.
Secondary Outcomes
- Specificity of postpartum TIR <96%(up to 12 weeks postpartum)
- Experience survey questionnaire(up to 12 weeks postpartum)
- Specificity of postpartum TIR <96%(up to 12 weeks postpartum)
- Experience survey questionnaire(up to 12 weeks postpartum)
Investigators
Grenye O'Malley
Associate Professor
Icahn School of Medicine at Mount Sinai