- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07449039
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
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
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)
Arms and Interventions
Participant Group / Arm |
Intervention / 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
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
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
Investigators
- Principal Investigator: Christina Han, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gestational Diabetes Mellitus in Pregnancy
-
i-Health, Inc.CompletedGestational Diabetes Mellitus in PregnancyGermany
-
The Danish Center for Strategic Research on Type...Odense University HospitalCompletedGestational Diabetes Mellitus in PregnancyDenmark
-
Services Institute of Medical Sciences, PakistanCompletedGestational Diabetes Mellitus in PregnancyPakistan
-
Danone Asia Pacific Holdings Pte, Ltd.Nutricia ResearchTerminatedGestational Diabetes Mellitus in PregnancySingapore
-
Unity Health TorontoRecruitingGestational Diabetes Mellitus in PregnancyCanada
-
Women's Hospital School Of Medicine Zhejiang UniversityActive, not recruitingGestational Diabetes Mellitus in PregnancyChina
-
Peking Union Medical College HospitalUnknownGestational Diabetes Mellitus in PregnancyChina
-
Gulsum UysalCompletedGestational Diabetes Mellitus in PregnancyTurkey
-
Washington University School of MedicineEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompletedGestational Diabetes | Gestational Diabetes Mellitus in PregnancyUnited States
-
Women's Hospital School Of Medicine Zhejiang UniversityQuzhou Maternal and Child Health Care Hospital; Hangzhou Jianhai Technology...Not yet recruitingGestational Diabetes Mellitus in PregnancyChina
Clinical Trials on Continuous Glucose Monistor
-
Charles University, Czech RepublicUnknown
-
Scripps Whittier Diabetes InstituteCompletedType 2 DiabetesUnited States
-
Kinderkrankenhaus auf der BultSenseonics, Inc.Completed
-
Senseonics, Inc.CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus | Diabetes Mellitus, Type 1United States
-
Charles University, Czech RepublicUnknownDiabetes Mellitus, Type 1Czechia
-
Vanderbilt University Medical CenterRecruitingHyperglycemia | Type 2 Diabetes Mellitus (T2DM) | Type 1 Diabetes Mellitus (T1DM)United States
-
HealthPartners InstituteThe Leona M. and Harry B. Helmsley Charitable TrustCompletedType 1 DiabetesUnited States
-
Yale UniversityMedtronicWithdrawn
-
Children's Mercy Hospital Kansas CityWithdrawnType 1 DiabetesUnited States
-
Institute for Clinical and Experimental MedicineRecruitingLiver Transplant Surgery | Intensive Care (ICU) | Solid Organ Transplantation | CGM | Major Abdominal Surgeries | Diabetes (Insulin-requiring, Type 1 or Type 2)Czechia