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New approach to diabetes prevention: let patients set their own goals

NCT ID NCT05559515

Prevention Sponsor: Denver Health and Hospital Authority 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether letting people with prediabetes set their own health goals (NDPP-Flex) works better than the standard diabetes prevention program. About 200 adults from Denver Health took part. The goal was to see if this flexible approach could lower blood sugar and help more people return to normal blood sugar levels.

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 (goal-setting program)
What this could lead to
If successful, this approach could offer a more personalized way to prevent type 2 diabetes in people with prediabetes.
What could go wrong
This is a completed trial with modest expected effects (0.2% A1C improvement). Results may not apply to all populations or settings.

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

214 people

The number who actually took part.

Started

Feb 2023

Finished

Oct 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

18 to 85 years

Sex

Female participants only

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: * Established patient at Denver Health * Age ≥18 years * English- or Spanish-speaking * Prediabetes (as defined by A1C of 5.7-6.4%) * BMI ≥20 kg/m2 (≥18.5 kg/m2 if identifying as Asian) Exclusion Criteria: * Currently pregnant * Prior participation in the NDPP * Anti-hyperglycemic medication (e.g., metformin) * Diabetes (type 1 or 2) * BMI \<20 kg/m2 (\<18.5 kg/m2 if identifying as Asian)

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Conditions

The condition(s) this trial relates to.

prediabetes syndrome type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Prediabetes

Contacts and locations

Locations

  • Denver Health

    Denver, Colorado, 80204, United States

More trials for these conditions

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