Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial
Recruiting · NCT07449039 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Continuous Glucose Monistor
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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)
Where it is running
1 location listed across 1 US state.
- University of California, Los Angeles - Los Angeles, California, United States