Postpartum Dysglycemia Screening With Continuous Glucose Monitoring
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Number of Participants With at Least 72 Hours of CGM Data Downloaded.
Study Overview
Brief Summary
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent & screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of Participants With at Least 72 Hours of CGM Data Downloaded.
Time Frame: Postpartum days 10-20
Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.
Secondary Outcomes
- Specificity(up to 12 weeks postpartum)
- Sensitivity(up to 12 weeks postpartum)
- Positive Predictive Value (PPV)(up to 12 weeks postpartum)
- Positive Likelihood Ratio (PLR)(up to 12 weeks postpartum)
- Negative Predictive Value (NPV)(up to 12 weeks postpartum)
- Negative Likelihood Ratio (NLR)(up to 12 weeks postpartum)
Investigators
Grenye O'Malley
Assistant Professor
Icahn School of Medicine at Mount Sinai