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Can an app prevent diabetes as well as a human coach?

NCT ID NCT05056376

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 fully automated digital program could help people with prediabetes lose weight and lower their blood sugar as effectively as a program led by a human coach. About 368 adults with prediabetes and overweight took part. The goal was to see which approach works better for reducing the risk of developing 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

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

368 people

The number who actually took part.

Started

Oct 2021

Finished

Dec 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 to 75 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: * Provision of signed and dated informed consent form. * Stated willingness to comply with all study procedures and availability for the duration of the study. * Laboratory evidence of prediabetes, defined as any of the following lab results, in the past year: 1. Hemoglobin A1C 5.7% to 6.4% 2. Fasting glucose 100-125 mg/dL 3. Plasma glucose of 140-199 mg/dL measured 2 hours after a 75 gm glucose load * Body mass index (BMI) ≥25 kg/m2 (or≥23 kg/m2 for Asians). * Proficiency in reading English. * Smartphone user (Android Operating System (OS) 9.0 or iOS 13.3 or newer). * Plans to reside in recruitment area for the next 12 months (participant's zip code of residence is within \~45 miles of the study recruitment site. Exclusion Criteria: * Medical conditions that prevent adoption of moderate physical activity (per primary care clinician). * Aortic stenosis. * Unstable cardiac disease (myocardial infarction, heart failure, or stroke in previous 6 months, currently participating in cardiac rehabilitation). * Has a pacemaker, implantable cardioverter-defibrillator (ICD), or other implanted electronic device. * Use of any glucose-lowering medications, weight loss medications, or any systemic glucocorticoids within the previous 3 months. * Active malignancy of any type or diagnosed with or treated for cancer within the past 2 years. Individuals with basal and squamous cell carcinoma of the skin that has been successfully treated will be allowed to participate. * Diagnosis of diabetes mellitus. * Pregnancy or planned pregnancy in the next 12 months. * Anemia. * Receiving treatment for iron-deficiency anemia, vitamin B12 deficiency, or folate d efficiency. * Hemoglobinopathy (HbS or HbC disease). * Blood transfusion in previous 4 months. * On dialysis or active organ transplant list. * Treated with erythropoietin. * Major psychiatric disorder (schizophrenia) or use of antipsychotic medications within the past 1 year. * Dementia or Alzheimer's disease. * Diagnosed with an eating disorder (anorexia nervosa, avoidant/restrictive food intake disorder, binge eating disorder, bulimia nervosa, Pica, rumination disorder, other specified or unspecified feeding or eating disorder) * Diagnosed or self-reported alcohol or substance abuse. * Known allergy to steel. * Participation in another clinical trial related to lifestyle management or diabetes prevention. * Currently attending or attended a diabetes prevention program in the previous 2 years. * Unwilling to accept random assignments. * Had bariatric surgery within the 12 months prior randomization or is planning to undergo bariatric surgery during the study.

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Conditions

The condition(s) this trial relates to.

Body Weight glucose intolerance hyperglycemia Motor Activity Obesity obesity disorder Overweight prediabetes syndrome Risk Reduction Behavior Sedentary Behavior Weight Loss type 2 diabetes mellitus prevention target

As listed by the trial registrant

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

Contacts and locations

Locations

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Reading Hospital - Tower Health

    Reading, Pennsylvania, 19611, United States

More trials for these conditions

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