T2D Intermittent Nonprescription Sensors for Informed Glucose Health Tracking (T2D INSIGHT)

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

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 Overview

• Status: Enrolling by invitation
• Conditions: Type 2 Diabetes; Non Insulin Dependent Diabetes
• Intervention / Treatment: Device: Periodic, over-the-counter continuous glucose monitoring

• Study Type: Interventional
• Enrollment (Estimated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 years at time of enrollment
2. Diagnosis of type 2 diabetes
3. Able to read and understand English (Dexcom Stelo is currently only available in English)
4. No real-time or intermittently scanned (Flash) CGM use 12 months prior to enrollment
5. 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.
6. Cell phone meeting minimum required OS compatibility with Stelo
7. Willing to use the study device and download the Stelo app
8. Willing and able to complete all study procedures per investigator discretion, including willingness to accept either experimental group (q30 or q90).
9. A1C value (from lab data or chart review) greater than or equal to 6.5 in the 6 months prior to enrollment
10. Currently receiving primary care in a participating study practice

Exclusion Criteria:

1. 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)
2. 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
3. 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)
4. Current or planned use of hydroxyurea (due to interference with CGM)
5. Known presence of a hemoglobinopathy or other condition that is expected to affect the measurement of A1C in the judgment of the investigator
6. 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
7. End stage renal disease currently managed by dialysis or eGFR <30 mL/min/1.73m2
8. Current participation in another interventional study protocol that could impact participation in this study per investigator discretion
9. Pregnant or planning to become pregnant within the next 6 months.
10. Planning to switch primary care practices in the next 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 30 day; Use of periodic, OTC CGM every 30 days for six months.	Device: Periodic, over-the-counter continuous glucose monitoring; Periodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.
Experimental: 90 day; Use of periodic, OTC CGM every 90 days for six months.	Device: Periodic, over-the-counter continuous glucose monitoring; Periodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in A1C from baseline to 6 months	Change in A1C from baseline (enrollment) to 6 months.	From enrollment to completion of study visits at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	From enrollment to 3-month study visit
Change in TIR from baseline to 3 months.	Change in TIR from baseline (enrollment) to 3 months.	From enrollment to 3-month study visit
Change in TITR from baseline to 3 months.	Change in TITR from baseline (enrollment) to 3 months.	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.	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.	From enrollment to 3-month study visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility ratings of periodic, OTC CGM to primary care clinicians	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.	Two years following practice study enrollment
Acceptability ratings of periodic, OTC CGM to primary care clinicians	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.	Two years following practice study enrollment
Days of wear of periodic, OTC CGM (Patient Acceptance)	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.	Two years following practice study enrollment
Glucose monitoring satisfaction for periodic, OTC CGM (Patient Acceptance)	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.	Two years following practice study enrollment
Willingness to pay for periodic, OTC CGM (Patient Acceptance)	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.	Two years following practice study enrollment

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: American Diabetes Association
• Investigators: Principal Investigator: Tamara Oser, MD, University of Colorado Denver Anschutz Medical Campus

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Primary care; Continuous glucose monitoring; Diabetes management
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 25-1116; 7-25-ICTSPC-408 (Other Grant/Funding Number: American Diabetes Association)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Finalizing data sharing plan for sensitive data sources.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No