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Can a smart sensor stop prediabetes in its tracks?

NCT ID NCT07639593

Disease control Sponsor: Wake Forest University Health Sciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study will give 100 adults with prediabetes a continuous glucose monitor (CGM) called Stelo, which tracks blood sugar every few minutes. The goal is to see if seeing real-time sugar levels helps people make better food and activity choices, lowering their A1c and improving health. The trial is not yet recruiting and will run at two clinics.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stelo CGM (continuous glucose monitor device)
What this could lead to
If successful, this could show that using a CGM helps people with prediabetes better manage their blood sugar and adopt healthier habits, potentially preventing progression to type 2 diabetes.
What could go wrong
This is a small, early-stage trial with only 100 participants and no control group, so results may not apply broadly. The device itself is not a treatment—it only provides information, and behavior change is not guaranteed.

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

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who are meeting criteria for prediabetes listed on American Diabetes Association website, which includes A1c = or \> than 5.7% and \< or = 6.4%, who also have reliable access to a smartphone device compatible with the CGM application * Greater than or equal to 18 years old Exclusion Criteria: * Subjects who have been diagnosed with type 1 or type 2 diabetes mellitus, as defined as A1c \> or = 6.5% * Subjects who do not have reliable access to a smartphone device compatible with the CGM application * Pregnant patients

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Conditions

The condition(s) this trial relates to.

diabetes mellitus prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prediabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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