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Enrolling by Invitation

NCT Number: NCT07422831

T2D Intermittent Nonprescription Sensors for Informed Glucose Health Tracking

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years at time of enrollment
  • Diagnosis of type 2 diabetes
  • Able to read and understand English (Dexcom Stelo is currently only available in English)
  • No real-time or intermittently scanned (Flash) CGM use 12 months prior to enrollment
  • Stable medication regimen (medication classes) and dose (equivalent dose if medication has been changed within the same medication class) for any glucose lowering or weight loss medications for 30 days prior to enrollment and willing to not change medications prior to randomization unless safety concerns.
  • Cell phone meeting minimum required OS compatibility with Stelo
  • Willing to use the study device and download the Stelo app
  • Willing and able to complete all study procedures per investigator discretion, including willingness to accept either experimental group (q30 or q90).
  • A1C value (from lab data or chart review) greater than or equal to 6.5 in the 6 months prior to enrollment
  • Currently receiving primary care in a participating study practice

Exclusion criteria

  • Use of insulin in the 12 months prior to screening or planning to initiate insulin during the next 12 months (short-term use of insulin in an inpatient setting is acceptable)
  • Concomitant disease or condition that in the opinion of the investigator may compromise patient safety including but not limited to severe mental illness, a diagnosed or suspected eating disorder, or any uncontrolled or chronic medical condition that would interfere with study related tasks or visits
  • Use within 30 days of screening visit of any medication that in the opinion of the investigator may exacerbate glucose dysfunction (e.g. systemic corticosteroids)
  • Current or planned use of hydroxyurea (due to interference with CGM)
  • Known presence of a hemoglobinopathy or other condition that is expected to affect the measurement of A1C in the judgment of the investigator
  • Known severe allergy to medical grade adhesive, a serious skin condition that could interfere with CGM placement, or extensive tattoos that precludes the use of CGM in an FDA approved location
  • End stage renal disease currently managed by dialysis or eGFR <30 mL/min/1.73m2
  • Current participation in another interventional study protocol that could impact participation in this study per investigator discretion
  • Pregnant or planning to become pregnant within the next 6 months.
  • Planning to switch primary care practices in the next 6 months.

Treatment and study plan

Periodic, over-the-counter continuous glucose monitoring

Device

Periodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.

Primary outcomes

  1. Change in A1C from baseline to 6 months

    Time frame: From enrollment to completion of study visits at 6 months

    Change in A1C from baseline (enrollment) to 6 months.

Secondary outcomes

  1. Change in Time in Range from baseline 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.

  2. Change in Time in Tight Range from baseline to 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.

  3. Change in mean glucose from baseline to 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.

  4. Change in TAR (>180) from baseline to 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.

  5. Change in A1C from baseline to 3 months.

    Time frame: From enrollment to 3-month study visit

    Change in A1C from baseline (enrollment) to 3 months.

  6. Change in TIR from baseline to 3 months.

    Time frame: From enrollment to 3-month study visit

    Change in TIR from baseline (enrollment) to 3 months.

  7. Change in TITR from baseline to 3 months.

    Time frame: From enrollment to 3-month study visit

    Change in TITR from baseline (enrollment) to 3 months.

  8. Change in mean glucose from baseline 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.

  9. Change in TAR (>180) from baseline to 3 months

    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.

Other outcomes

  1. Feasibility ratings of periodic, OTC CGM to primary care clinicians

    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.

  2. Acceptability ratings of periodic, OTC CGM to primary care clinicians

    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.

  3. Days of wear of periodic, OTC CGM (Patient Acceptance)

    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.

  4. Glucose monitoring satisfaction for periodic, OTC CGM (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.

  5. Willingness to pay for periodic, OTC CGM (Patient Acceptance)

    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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • American Diabetes Association

Registry information

Official study title

Improving Type 2 Diabetes Management in Primary Care Through Periodic Continuous Glucose Monitoring

Acronym: T2D INSIGHT

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 20, 2026
Registry last updated
Apr 29, 2026

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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