The purpose of this prospective observational study is to gather exploratory and practical use data of the Dexcom Stelo Glucose Biosensing System (Stelo), an over-the-counter (OTC) real-time Continuous Glucose Monitoring (CGM) system among patients with Gestational Diabetes Mellitus (GDM) in their most recent pregnancy.
50 postpartum individuals with GDM during their most recent pregnancy will be enrolled in this prospective observational study. In a prior study looking at real-world use of Dexcom G7 CGM during pregnancy among people with GDM, feasibility was demonstrated as well as a willingness to continue CGM use during the postpartum period. Each enrolled subject will be asked to train and wear the Dexcom Stelo glucose biosensor system continuously for the first 6 weeks after delivery and at least 1 sensor wear every 3 months (up to 15 days at 3, 6, 9, and 12 months) for the remainder of the postpartum period up to 1 year from delivery. The first insertion will be performed under trained observation and additional supplies will be provided every 3 months. Participants will be trained and instructed to enter meals, activity, lactation, and anti-diabetic medications (if applicable) in the Dexcom Stelo App as they are willing to input. Subjects will be provided education on the importance of nutrition, physical activity, and mental health in postpartum and long-term health and tips on how to use CGM data to encourage lifestyle and behavioral modifications.
Study Type
OBSERVATIONAL
Enrollment
50
The Stelo Glucose Biosensor is an over-the-counter integrated Continuous Glucose Monitor (iCGM) intended to continuously measure, record, analyze, and display glucose values in people 18 years and older not on insulin. Participants will use Stelo for the 6 weeks following delivery and for 15 days at 3 months, 6 months, 9 months, and 1 year postpartum.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Mean Glucose
24-hour mean glucose based on Stelo Glucose Biosensor readings
Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
Glucose Percent Time in Range
Percent time-in-range (percent of the time between 70-140 mg/dL or 70-120 mg/dL) based on Stelo Glucose Biosensor readings
Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
Glucose Percent Time Above Range
Percent time-above-range (percent of the time above 140 mg/dL or 120 mg/dL) based on Stelo Glucose Biosensor readings
Time frame: Measured from birth to 6 weeks postpartum, and for 15 days at 3, 6, 9, and 12 months postpartum.
Postpartum Fasting Glucose
Postpartum fasting glucose as determined by a blood test
Time frame: Measured at 6 and 12 months postpartum
Postpartum A1C
Postpartum Hemoglobin A1C as determined by a blood test
Time frame: Measured at 6 and 12 months postpartum
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