Can an app prevent diabetes as well as a human coach?
NCT ID NCT05056376
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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368 people
The number who actually took part.
- Started
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Oct 2021
- Finished
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Dec 2024
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Reading Hospital - Tower Health
Reading, Pennsylvania, 19611, United States
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