Health TrialsbyHealthPanel

Postpartum Continuous Glucose Monitoring for Type 2 Diabetes Mellitus Risk Evaluation in Patients With Gestational Diabetes Mellitus: POSTPOD Trial

ConditionGestational Diabetes Mellitus in Pregnancy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, Los Angeles

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Pre-gestational diabetes (T1DM or T2DM)

Multifetal gestation

Intra-amniotic infection by clinical criteria

Postpartum hemorrhage

Trial design

Design model

Single group

Treatments tested in this trial

  • Continuous Glucose Monistor

    Device

    Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information. Participants will wear for 24 hours and then be instructed to peel off.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Continuous Glucose MonitorOther 1 intervention

Trial outcomes

Primary outcomes

1

Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test

Regression analysis to assess strength and direction of the relationship between postpartum CGM data and 2 hr GTT

Time frame
24 hours postpartum and 1-3 months postpartum
2

Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum

Regression analysis to assess strength and direction of the relationship between postpartum CGM data and HbA1c

Time frame
24 hours postpartum and 1-3 months postpartum

Secondary outcomes

1

Patient satisfaction with CGM use immediately postpartum to evaluate long term risk

Patient satisfaction will be measured via survey response on following statements using 5 point likert scale * Applying the CGM was painless. * Applying the CGM was easy. * Wearing the CGM for 24 hours postpartum was painless. * Wearing the CGM for 24 hours postpartum was easy. * Wearing the CGM did not interfere with my activities of daily living. * Wearing the CGM did not cause any side effects. * Removing the CGM was painless. * Removing the CGM was easy. * If given a choice between the 1-3 month postpartum OGTT and wearing the CGM for 24 hours immediately postpartum, I would choose wearing the CGM.

Time frame
1-3 months postpartum after glucose tolerance test, 12-24 months postpartum after A1C blood test

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Source ClinicalTrials.gov
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