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

University of California, Los Angeles50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Gestational Diabetes Mellitus in Pregnancy

Interventions

Continuous Glucose Monistor

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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

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

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