T2D Intermittent Nonprescription Sensors for Informed Glucose Health Tracking
Part of paid clinical trials in Aurora, Colorado.
- Sponsor
- University of Colorado, Denver
- Study ID
- NCT07422831
- Status
- Enrolling By Invitation
Conditions
- Non Insulin Dependent Diabetes
- Type 2 Diabetes
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Periodic, over-the-counter continuous glucose monitoring — DEVICEPeriodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.
Study Details
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.
Key Dates
- Start date
- Apr 2, 2026
- Status verified
- Apr 2026
- Primary completion
- Dec 31, 2027
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 188 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: 30 dayUse of periodic, OTC CGM every 30 days for six months.
- Experimental: 90 dayUse of periodic, OTC CGM every 90 days for six months.
Primary Outcome Measure
Change in A1C from baseline to 6 months [ Time Frame: From enrollment to completion of study visits at 6 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Aurora | Colorado | 80045 | - |
Find similar trials in Aurora, CO
Related Studies
- Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness DiabetesRecruiting · University of Colorado, Denver · Aurora, Colorado
- Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up StudyEnrolling By Invitation · University of Colorado, Denver · Aurora, Colorado
- Treating Early Type 2 Diabetes by Reducing Postprandial Glucose Excursions: A Paradigm Shift in Lifestyle ModificationRecruiting · Chiara Fabris, PhD · Aurora, Colorado
- Depression in Youth Onset Type 2 DiabetesNot Yet Recruiting · University of Colorado, Denver · Aurora, Colorado