Stelo Real-time Continuous Glucose Monitor Use Postpartum for Lifelong Optimal Wellness
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dexcom Stelo real-time Continuous Glucose Monitor
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
3Sansum Diabetes Research Institute93105, Santa BarbaraCalifornia, United States
Oregon Health & Science University97239, PortlandOregon, United States
University of Pennsylvania19104, PhiladelphiaPennsylvania, United States
Sponsors and collaborators
Oregon Health and Science University
Lead sponsor
DexCom, Inc.
Collaborator
University of Pennsylvania
Collaborator
Sansum Diabetes Research Institute
Collaborator
Source ClinicalTrials.gov