University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045, United States
NCT Number: NCT07422831
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Periodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.
Time frame: From enrollment to completion of study visits at 6 months
Change in A1C from baseline (enrollment) to 6 months.
Time frame: From enrollment to the completion of study visits at 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 (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 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 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 3-month study visit
Change in A1C from baseline (enrollment) to 3 months.
Time frame: From enrollment to 3-month study visit
Change in TIR from baseline (enrollment) to 3 months.
Time frame: From enrollment to 3-month study visit
Change in TITR from baseline (enrollment) to 3 months.
Time frame: From enrollment to 3-month study visit
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 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: Two years following practice study enrollment
Feasibility of Intervention Measure (FIM) ratings for periodic, over-the-counter continuous glucose monitoring from clinicians in participating practices. FIM items are measured on a Likert scale ranging from (1) Completely disagree to (5) Completely agree. Higher ratings indicate more favorable ratings of intervention feasibility.
Time frame: Two years following practice study enrollment
Acceptability of Intervention Measure (AIM) ratings for periodic, over-the-counter continuous glucose monitoring from clinicians in participating practices. AIM items are measured on a Likert scale ranging from (1) Completely disagree to (5) Completely agree. Higher ratings indicate more favorable ratings of intervention acceptability.
Time frame: Two years following practice study enrollment
As a proxy for patient acceptance, we will report mean days of wear for over-the-counter continuous glucose monitoring devices, measured using Dexcom Stelo device metrics. Days of wear range from 0 to 15 days per session. Higher mean values reflect greater levels of patient acceptance.
Time frame: Two years following practice study enrollment
As a proxy for patient acceptance, we will report patient ratings of satisfaction with periodic, OTC CGM use using the Glucose Monitoring Satisfaction Survey (GMSS). Ratings of GMSS items range from (1) Strongly disagree to (5) Strongly agree, with higher values indicating greater satisfaction.
Time frame: Two years following practice study enrollment
As a proxy for patient acceptance, we will report patients' willingness to pay for periodic, OTC CGM as measured by percentage of patients willing to pay up to various dollar amounts. Higher willingness-to-pay values and greater percentages of participants willing to pay at various price points reflect greater patient acceptability.
University of Colorado, Denver
Other
Improving Type 2 Diabetes Management in Primary Care Through Periodic Continuous Glucose Monitoring
Acronym: T2D INSIGHT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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