Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test
Study Overview
Brief Summary
This is a pilot study designed to evaluate the effectiveness of continuous glucose monitoring (CGM) within hours of delivery to predict long-term risk of Type 2 Diabetes Mellitus in patients diagnosed with gestational diabetes.
Participants will be provided a CGM within 2 hours after delivery and wear the device for 24 hours. Participants will be instructed to peel off the device after 24 hours. Participants will also be asked to complete two surveys regarding their experience at 1-3 months postpartum and 12-14 months postpartum.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Prenatal care at UCLA Health
- •Planning to deliver at UCLA Ronald Reagan or UCLA Santa Monica
- •Confirmed gestational diabetes diagnosis based on 2-step approach
- •Maternal age >= 18 years
Exclusion Criteria
- •Pre-gestational diabetes (T1DM or T2DM)
- •Multifetal gestation
- •Intra-amniotic infection by clinical criteria
- •Postpartum hemorrhage
- •Maternal ICU admission
- •Known allergy to medical-grade adhesive
- •Presence of skin lesions at anticipated CGM application site
- •Scheduled postpartum non-sonographic imaging study (radiograph, magnetic resonance imaging (MRI), or computed tomography (CT) scan) during trial
- •Metformin use
- •Steroid use
- •Terbutaline use within 4 hours of delivery
- •Cystic fibrosis
- •MODY (mature onset of diabetes in the young)
Arms & Interventions
Continuous Glucose Monitor
Administration of a Continuous Glucose Monitor within 2 hours after delivery for 24-hour collection of glycemic data.
Intervention: Continuous Glucose Monistor (Device)
Outcomes
Primary Outcomes
Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test
Time Frame: 24 hours postpartum and 1-3 months postpartum
Regression analysis to assess strength and direction of the relationship between postpartum CGM data and 2 hr GTT
Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum
Time Frame: 24 hours postpartum and 1-3 months postpartum
Regression analysis to assess strength and direction of the relationship between postpartum CGM data and HbA1c
Secondary Outcomes
- Patient satisfaction with CGM use immediately postpartum to evaluate long term risk(1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test)
Investigators
Christina S. Han
Division Director, Maternal-Fetal Medicine
University of California, Los Angeles