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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
188
Periodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States
Change in A1C from baseline to 6 months
Change in A1C from baseline (enrollment) to 6 months.
Time frame: From enrollment to completion of study visits at 6 months
Change in Time in Range from baseline to 6 months
Change in time in range (TIR) collected from patients via blinded Dexcom G7 continuous glucose monitoring from baseline (enrollment) to completion of study visits at 6 months.
Time frame: From enrollment to the completion of study visits at 6 months.
Change in Time in Tight Range from baseline to 6 months
Change in time in tight range (TITR) collected from patients via blinded Dexcom G7 continuous glucose monitoring from baseline (enrollment) to completion of study visits at 6 months.
Time frame: From enrollment to the completion of study visits at 6 months.
Change in mean glucose from baseline to 6 months
Change in mean glucose collected from patients via blinded Dexcom G7 continuous glucose monitoring from baseline (enrollment) to completion of study visits at 6 months.
Time frame: From enrollment to the completion of study visits at 6 months.
Change in TAR (>180) from baseline to 6 months
Change in time above range (\>180 mg/dL) collected from patients via blinded Dexcom G7 continuous glucose monitoring from baseline (enrollment) to completion of study visits at 6 months.
Time frame: From enrollment to the completion of study visits at 6 months.
Change in A1C from baseline to 3 months.
Change in A1C from baseline (enrollment) to 3 months.
Time frame: From enrollment to 3-month study visit
Change in TIR from baseline to 3 months.
Change in TIR from baseline (enrollment) to 3 months.
Time frame: From enrollment to 3-month study visit
Change in TITR from baseline to 3 months.
Change in TITR from baseline (enrollment) to 3 months.
Time frame: From enrollment to 3-month study visit
Change in mean glucose from baseline to 3 months
Change in mean glucose collected from patients via blinded Dexcom G7 continuous glucose monitoring from baseline (enrollment) to the 3-month study visit.
Time frame: From enrollment to 3-month study visit
Change in TAR (>180) from baseline to 3 months
Change in time above range (\>180 mg/dL) collected from patients via blinded Dexcom G7 continuous glucose monitoring from baseline (enrollment) to 3-month study visit.
Time frame: From enrollment to 3-month study visit
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