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New study tests smart lifestyle program to reverse prediabetes

NCT ID NCT05580978

Disease control Sponsor: University of Colorado, Denver 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether a lifestyle guide called GEM (Glycemic Excursion Minimization), combined with a continuous glucose monitor (Freestyle Libre 2) and a Fitbit activity tracker, could help people with prediabetes better manage their blood sugar. Sixty-one adults aged 25-70 with prediabetes (A1C 6.0-6.4) used the tools for 4 months. The goal was to see if this approach could reduce high blood sugar readings and improve overall glucose control.

What this could mean

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

Active substance
behavioral intervention (GEM lifestyle guide, continuous glucose monitor, and activity tracker)
What this could lead to
If it works, this approach could help people with prediabetes lower their blood sugar and reduce the risk of developing type 2 diabetes.
What could go wrong
This is a small, completed study with 61 participants, so results may not apply to everyone. Lifestyle changes can be hard to maintain long-term.

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

61 people

The number who actually took part.

Started

Nov 2022

Finished

Jan 2025

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

25 to 70 years

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: * Age 25-70 years * A1C 6.0-6.4 * Documented diagnosis of prediabetes * Have a smart phone * Able to read English, as the GEM guide is currently only available in English * Willing and able to follow the study procedures as instructed Exclusion Criteria: * Diagnosis of diabetes mellitus * Currently taking any diabetes medication * Currently taking medication that promotes insulin resistance or otherwise interferes with metabolic control (e.g., prednisone) * Has a condition that precludes a low carbohydrate diet, such as gastroparesis * Has a physical or medical condition that precludes walking 120 steps per minute for 10 minutes or longer * Has documented kidney disease that would preclude participation in study per PI discretion * Active or planned cancer treatment * Extreme visual or hearing impairment that would impair ability to use real-time CGM * Pregnant or anticipates becoming pregnant in the next 4 months * Anticipates moving within the next 4 months * Treating physician, for any reason, considers their patient inappropriate for the study (e.g., uncontrolled bipolar disease)

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Conditions

The condition(s) this trial relates to.

prediabetes syndrome

As listed by the trial registrant

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

Prediabetes

Contacts and locations

Locations

  • University of Colorado- Anschutz Medical Campus

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.