Clinical Trial

T2D Intermittent Nonprescription Sensors for Informed Glucose Health Tracking

Study acronym: T2D INSIGHT
Enrolling by Invitation
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Summary
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.
Protocol Amendment History 1 change
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-04-30
Trial Details
NCT Number NCT07422831
Lead Sponsor University of Colorado, Denver
Collaborators: American Diabetes Association
Conditions Type 2 Diabetes, Non Insulin Dependent Diabetes
Enrollment 188 participants
Start Date 2026-04-02
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-04-29