Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial (POSTPOD)
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 Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Dana Levin-Lopez, MPH
- Phone Number: 310-794-8893
- Email: dlevinlopez@mednet.ucla.edu
Study Contact Backup
- Name: Rujuta Sathe
- Phone Number: 310-794-8893
- Email: RSathe@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- University of California, Los Angeles
-
Contact:
- Dana Levin-Lopez, MPH
- Phone Number: 310-794-8893
- Email: dlevinlopez@mednet.ucla.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Other: Continuous Glucose Monitor
Administration of a Continuous Glucose Monitor within 2 hours after delivery for 24-hour collection of glycemic data.
|
Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information.
Participants will wear for 24 hours and then be instructed to peel off.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
24 hours postpartum and 1-3 months postpartum
|
|
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
|
24 hours postpartum and 1-3 months postpartum
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction with CGM use immediately postpartum to evaluate long term risk
Time Frame: 1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test
|
Patient satisfaction will be measured via survey response on following statements using 5 point likert scale
|
1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Christina Han, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
Other Study ID Numbers
- 25-0020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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