Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness
Oregon Health and Science University
Summary
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.
Description
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 p…
Eligibility
- Age range
- 18+ years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria: * Gestational Diabetes Mellitus (GDM) diagnosis by 1- or 2-step Oral Glucose Tolerance Test (OGTT) during pregnancy or \>= 200 mg following any glucose challenge (50g, 75g, 100g) * Has a smart phone compatible to support Dexcom Stelo app * Able to read, write, and understand English * Meet Stelo Glucose Biosensor Indications for Use (IFU) per approved commercial labeling * Willing to follow all study procedures Exclusion Criteria: * Greater than 6 weeks and 6 days postpartum at enrollment * Preexisting Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D) * End-stage renal fail…
Interventions
- DeviceDexcom Stelo real-time Continuous Glucose Monitor
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.
Locations (3)
- Sansum Diabetes Research InstituteSanta Barbara, California
- Oregon Health & Science UniversityPortland, Oregon
- University of PennsylvaniaPhiladelphia, Pennsylvania