Type 2 DiabetesT2D INSIGHTNCT07422831
T2D Intermittent Nonprescription Sensors for Informed Glucose Health Tracking
A study testing Periodic, over-the-counter continuous glucose monitoring in people with Type 2 Diabetes and Non Insulin Dependent Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Non Insulin Dependent Diabetes
- What is being tested?
- Periodic, over-the-counter continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Apr 2026to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read more
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.
- Conditions
- Type 2 Diabetes, Non Insulin Dependent Diabetes
- Being tested
- Periodic, over-the-counter continuous glucose monitoring
- Keywords
- Continuous glucose monitoring, Primary care, Diabetes management
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodic, over-the-counter continuous glucose monitoringDevice
Periodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings.
| Study group | Role | What they receive |
|---|---|---|
| 30 day | Experimental | Use of periodic, OTC CGM every 30 days for six months. Receives: Device: Periodic, over-the-counter continuous glucose monitoring |
| 90 day | Experimental | Use of periodic, OTC CGM every 90 days for six months. Receives: Device: Periodic, over-the-counter continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in A1C from baseline to 6 months
Change in A1C from baseline (enrollment) to 6 months.
Measured: From enrollment to completion of study visits at 6 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to 3-month study visit
Change in TIR from baseline to 3 months.
Change in TIR from baseline (enrollment) to 3 months.
Measured: From enrollment to 3-month study visit
Change in TITR from baseline to 3 months.
Change in TITR from baseline (enrollment) to 3 months.
Measured: 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.
Measured: 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.
Measured: From enrollment to 3-month study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start2 Apr 2026
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Tamara Oser, MD, Principal investigator, University of Colorado Denver Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422831
- Sponsor's protocol ID
- 25-1116
- Other IDs
- 7-25-ICTSPC-408
- Acronym
- T2D INSIGHT
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Finalizing data sharing plan for sensitive data sources.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Type 2 Diabetes Management in Primary Care Through Periodic Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT07422831
- Acronym / sponsor ID
- T2D INSIGHT / 25-1116
- Conditions
- Type 2 Diabetes, Non Insulin Dependent Diabetes
- Keywords
- Continuous glucose monitoring, Primary care, Diabetes management
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- 2 Apr 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 day | Experimental | Device: Periodic, over-the-counter continuous glucose monitoringUse of periodic, OTC CGM every 30 days for six months. |
| 90 day | Experimental | Device: Periodic, over-the-counter continuous glucose monitoringUse of periodic, OTC CGM every 90 days for six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Periodic, over-the-counter continuous glucose monitoringPeriodic, over-the-counter continuous glucose monitoring for people with non-insulin-treated type 2 diabetes treated in primary care settings. | Device | 30 day, 90 day |
Primary outcome
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.
9 secondary outcomes
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 Tight Range from baseline to 6 months
Time frame: From enrollment to the completion of study visits at 6 months.
Change in mean glucose from baseline to 6 months
Time frame: From enrollment to the completion of study visits at 6 months.
Change in TAR (>180) from baseline to 6 months
Time frame: From enrollment to the completion of study visits at 6 months.
Change in A1C from baseline to 3 months.
Time frame: From enrollment to 3-month study visit
Change in TIR from baseline to 3 months.
Time frame: From enrollment to 3-month study visit
Change in TITR from baseline to 3 months.
Time frame: From enrollment to 3-month study visit
Change in mean glucose from baseline to 3 months
Time frame: From enrollment to 3-month study visit
Change in TAR (>180) from baseline to 3 months
Time frame: From enrollment to 3-month study visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided. Finalizing data sharing plan for sensitive data sources.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tamara Oser, MD principal investigator
University of Colorado Denver Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodic, over-the-counter continuous glucose monitoring in people with Type 2 Diabetes and Non Insulin Dependent Diabetes, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in A1C from baseline to 6 months (time frame: From enrollment to completion of study visits at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.