Gestational Diabetes Mellitus in Pregnancy
Conditions
Brief summary
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.
Interventions
DEVICEContinuous Glucose Monistor
Continuous glucose monitoring sensor that provides 24/7 detailed glycemic information. Participants will wear for 24 hours and then be instructed to peel off.
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This study will follow a within-subjects design where participants will serve as their own control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Efficacy Associated with CGM use immediately postpartum as compared to the 2 hr Glucose tolerance test | 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 |
| Clinical Efficacy Associated with CGM use immediately postpartum as compared to the HbA1c test postpartum | 24 hours postpartum and 1-3 months postpartum | Regression analysis to assess strength and direction of the relationship between postpartum CGM data and HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with CGM use immediately postpartum to evaluate long term risk | 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 * 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. |
Countries
United States
Contacts
CONTACTRujuta Sathe
CONTACTDana Levin-Lopez, MPH
PRINCIPAL_INVESTIGATORChristina Han, MD
University of California, Los Angeles
Outcome results
None listed