Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness
Sponsored by Oregon Health and Science University
About this study
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 t…
Where this study is enrolling (3)
- I'm interested
Sansum Diabetes Research Institute
Santa Barbara, California
- I'm interested
Oregon Health & Science University
Portland, Oregon
- I'm interested
University of Pennsylvania
Philadelphia, Pennsylvania
Who can participate
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 failure (on dialysis)
- ✕Heart failure
- ✕Other uncontrolled high-risk condition as determined exclusionary by site investigators
- ✕Extensive skin changes/diseases that preclude wearing the required system on normal skin (e.g. extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the proposed wear sites
- ✕Known severe allergy to medical-grade adhesives
- ✕Any condition that, in the opinion of the investigator, would interfere with their participation in the trial
- ✕Obesity surgery
- ✕Insulin use prior to discharge home from the delivery admission
- ✕Current participation in another postpartum Continuous Glucose Monitoring (CGM) or lifestyle intervention trial
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.