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| ID | Type | Description | Link |
|---|---|---|---|
| 7-25-ICTSPC-408 | Other Grant/Funding Number | American Diabetes Association |
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| Name | Class |
|---|---|
| American Diabetes Association | OTHER |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 day | Experimental | Use of periodic, OTC CGM every 30 days for six months. |
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| 90 day | Experimental | Use of periodic, OTC CGM every 90 days for six months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tamara Oser, MD | University of Colorado Denver Anschutz Medical Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Denver Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
Finalizing data sharing plan for sensitive data sources.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2026 | Feb 5, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
| 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 |
| D004700 | Endocrine System Diseases |