N/A
Completed N=368
Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
Source: ClinicalTrials.gov NCT05056376 ↗Enrolled (actual)
368
Serious AEs
11.4%
Results posted
Dec 2025
Primary outcomePrimary: Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no) — 58; 59 Participants — p=<0.05
Summary
The purpose of this research study is to compare the effectiveness of a fully automated digital diabetes prevention program to standard of care human coach-based diabetes prevention programs for promoting clinically meaningful lifestyle changes to reduce the risk of type 2 diabetes in adults with prediabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no) |
58; 59 | <0.05 sig |
| SECONDARY Absolute Weight Change |
-1.00; -1.30 | — |
| SECONDARY Cost-effectiveness as Assessed by the Markov Model |
— | — |
| SECONDARY Change in Hemoglobin A1C |
0.0; -0.1 | — |
| SECONDARY Percentage Change in Weight |
-1.03; -1.43 | — |
| SECONDARY Mean Weekly Moderate-to-vigorous Physical Activity (MVPA) |
210.5; 174.4 | — |
| SECONDARY Incidence of Diabetes-range A1C |
8; 7 | — |
| SECONDARY Acceptability as Assessed by the 32-item Acceptability Questionnaire |
— | — |
| SECONDARY Correlation Between Self-reported and Measured Physical Activity |
— | — |
| SECONDARY Program Initiation Rate |
171; 153 | — |
| SECONDARY Program Completion Rate |
117; 93 | — |
Eligibility Criteria
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:
- Hemoglobin A1C 5.7% to 6.4%
- Fasting glucose 100-125 mg/dL
- 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.
Data sourced from ClinicalTrials.gov (NCT05056376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.