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
This trial does not accept healthy volunteersQualifiers
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 population
Postpartum individuals with pregnancies complicated by GDM.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dexcom Stelo real-time Continuous Glucose Monitor
DeviceThe 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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Postpartum Stelo Users1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
Postpartum Fasting Glucose
Postpartum fasting glucose as determined by a blood test
Time frame
Measured at 6 and 12 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Oregon Health and Science University
Lead sponsor
DexCom, Inc.
Collaborator
University of Pennsylvania
Collaborator
Sansum Diabetes Research Institute
Collaborator
Source ClinicalTrials.gov
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