Could a simple CGM device help manage type 2 diabetes without insulin?
NCT ID NCT07422831
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at whether using an over-the-counter continuous glucose monitor (CGM) every 30 or 90 days can help people with type 2 diabetes who do not use insulin better manage their blood sugar. About 188 participants will wear the Dexcom Stelo device periodically over six months. Researchers will compare changes in A1C and time in range to usual care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dexcom Stelo continuous glucose monitor (device)
- What this could lead to
- If successful, this could show that periodic use of over-the-counter CGM helps people with type 2 diabetes manage their blood sugar without needing insulin, potentially making glucose monitoring more accessible.
- What could go wrong
- This is a relatively small, early-stage trial (188 participants) focused on feasibility and short-term outcomes. The device is not a treatment, and results may not apply to all people with type 2 diabetes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 188 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, 80045, United States
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