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Digital diet program aims to remit diabetes in 64 patients

NCT ID NCT04663061

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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 completed study tested whether a high-intensity medical weight loss program, supported by a digital platform and continuous glucose monitors, could help people with type 2 diabetes lose weight and achieve remission. 64 participants were enrolled and compared to a group receiving standard diabetes education. The goal was 15% weight loss and an A1c below 6.5% without diabetes medications.

What this could mean

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

Active substance
intensive medical weight loss program (diet, exercise, counseling) plus continuous glucose monitoring and digital support
What this could lead to
If successful, this approach could offer a scalable way to help many people with type 2 diabetes achieve remission without long-term medication.
What could go wrong
This is a small, completed trial (64 participants) with no phase designation, so results may not apply broadly. Weight loss is difficult to maintain, and remission may not be permanent.

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

64 people

The number who actually took part.

Started

Jun 2021

Finished

Nov 2024

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: * Individuals with T2DM diagnosed within the past 6 years * Body Mass Index (BMI) of 30-39.9 kg/m2. * Participants must have an HbA1c between 6.5-11.9%. * Participants should be able to participate in all aspects of the recommended interventions, including being able to participate in exercise, make recommended dietary changes, and engage in individual and group counseling. Exclusion criteria: * Poorly controlled depression * Recent hospitalization for psychosis or bipolar disorder * Poorly controlled blood pressure (\>159/99) * Prior surgical procedure for weight control or liposuction * Unable to make changes to their diet * Unable to exercise (walk for at least 6 minutes and perform simple strength and stretch exercise tests) * Use of weight loss medications in previous 3 months * Recent self-reported weight change (+/- 15lbs) * Current use of oral corticosteroids more than 5days/month * Cardiovascular disease event within the past 6 months * Severe pulmonary disease requiring supplemental oxygen * Renal failure (end stage renal disease) * History of non-skin cancer in the past 5 years * Major liver dysfunction within the last 2 years * Recently quit smoking less than 6 months prior * Inability to attend visits and adhere to study protocols * Pregnancy or currently lactating

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Obesity obesity disorder type 2 diabetes mellitus

As listed by the trial registrant

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

Obesity Type 2 diabetes

Contacts and locations

Locations

  • Wake Forest Univesity Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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