Over-the-Counter Glucose Monitoring for Type 2 Diabetes
(T2D INSIGHT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to learn if periodic use of over-the-counter continuous glucose monitoring (CGM) can support glucose management in people with type 2 diabetes not using insulin being treated in primary care settings. The main questions it aims to answer are:
* Is periodic use of CGM every 30 or 90 days for six months associated with reduced A1C compared to usual care at baseline?
* Is periodic use of CGM every 30 or 90 days for six months associated with increased time in range and time in tight range compared to usual care at baseline?
* Is periodic use of CGM every 90 days over six months associated with non-inferior A1C reduction compared to periodic use of CGM every 30 days?
* Are clinician feasibility and acceptability of periodic, OTC CGM higher than for prescription CGM?
* How acceptable is periodic, OTC CGM to people with non-insulin-treated type 2 diabetes? Researchers will compare use of periodic CGM every 30 and 90 days to see if less frequent periodic CGM use can support glucose management as effectively as more frequent use.
Participants will:
* be assigned to one of two groups using the 15-day Dexcom Stelo® glucose biosensor every 30 or 90 days over a six-month period.
* receive Stelo devices every 30 or 90 days (as randomized)
* complete up to 9 virtual or in-person visits with the study team.
* complete 3 fingerstick A1c tests.
* wear a blinded CGM device at 3 time points outside of Dexcom Stelo® use.
* complete a survey at the end of the study.
Who Is on the Research Team?
Tamara Oser, MD
Principal Investigator
University of Colorado Denver Anschutz Medical Campus
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use the 15-day Dexcom Stelo® glucose biosensor every 30 or 90 days over a six-month period
Follow-up
Participants are monitored for changes in A1C, time in range, and other glucose metrics
What Are the Treatments Tested in This Trial?
Interventions
- Periodic, over-the-counter continuous glucose monitoring
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Use of periodic, OTC CGM every 90 days for six months.
Use of periodic, OTC CGM every 30 days for six months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
American Diabetes Association
Collaborator
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