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PreDiabetesNCT05056376

Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs

A study testing Digital Diabetes Prevention Program (dDPP) and Human Coach-based Diabetes Prevention Program (hDPP) in people with PreDiabetes and Hyperglycemia, run by Johns Hopkins University at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
PreDiabetes, Hyperglycemia, Glucose, High Blood
What is being tested?
Digital Diabetes Prevention Program (dDPP) and Human Coach-based Diabetes Prevention Program (hDPP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
2 sitesUnited States
Study dates
1 Oct 2021to 16 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Reading Hospital - Tower Health

    Reading, Pennsylvania, 19611

Other trials in United States

About this study

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.

Read the detailed description

After being informed about the study and potential risk, all participants giving written informed consent will undergo screening to determine eligibility for study entry. At baseline visit (month 0). Participants who meet the eligibility requirements will be randomly assigned in 1:1 ratio to human coach-based diabetes prevention program or digital diabetes prevention program. An equal number of participants will be randomly assigned to both groups (like flipping a coin).

If participants are randomly assigned to receive the human coach-based diabetes prevention program, the participants will be referred to a local Diabetes Prevention Program close to the participants' area. The Diabetes Prevention Program consists of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.

If participants are randomly assigned to receive the digital Diabetes Prevention Program, the participants will receive the Sweetch Digital Health Kit (Sweetch Health, Ltd.) in the mail within approximately 8-12 days of the participants' first study visit. The Sweetch digital health kit consists of a smartphone app and a digital body weight scale that is connected via Bluetooth to the app. The phone app also consists of brief Centers for Disease Control and Prevention (CDC) lessons on type 2 diabetes prevention, which participants will be encouraged to complete.

There will be a total of 3 study visits (baseline, 6 months, and 12 months), each visit includes fingerstick hemoglobin A1C measurement, weight measurement, and completion of several questionnaires. Height will be measured at the first visit. Throughout the 12-month study, participants will be asked to wear a device on the participants' wrist to measure physical activity for 7 consecutive days following the first visit and once every month thereafter.

Being tested
Digital Diabetes Prevention Program (dDPP), Human Coach-based Diabetes Prevention Program (hDPP)
Keywords
Prediabetes, Diabetes Prevention Program, DPP, Obesity, Overweight, Physical Activity, Digital, Artificial Intelligence, Weight
Medical subject headings
Prediabetic State, Hyperglycemia, Overweight, Glucose Intolerance, Obesity, Weight Loss, Risk Reduction Behavior, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Diabetes Prevention Program (dDPP)Behavioural

    The Sweetch app is a hyper-personalized mobile digital coach that provides users with tailored recommendations to promote healthy lifestyle behaviors (150 minutes per week of physical activity, weight reduction, and healthy eating habits) to reduce the risk of type 2 diabetes.

    The Sweetch app uses self-tracking and multiple evidence-based persuasive eCoaching strategies. The Sweetch artificial intelligence algorithm delivers just-in-time support and/or adapt recommendations based on the user's response. For example, push notifications will be sent when the algorithm detects that the user is potentially available and able to act upon the recommendation, based on various parameters including location, previous response, calendar availability, and weather, etc.

  • Human Coach-based Diabetes Prevention Program (hDPP)Behavioural

    The Human Coach-Based Diabetes Prevention Program will consist of a CDC recognized lifestyle change program. Participants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.

Study groups in NCT05056376
Study groupRoleWhat they receive
Fully-Automated Digital Diabetes Prevention ProgramExperimentalParticipants will receive Sweetch Digital Diabetes Prevention Program consists of a smartphone app and bluetooth-enabled digital body weight scale that syncs with the app.
Receives: Behavioral: Digital Diabetes Prevention Program (dDPP)
Human Coach-Based Diabetes Prevention ProgramActive comparatorParticipants will attend a total of 16 weekly sessions during months 1 to 6 and 6 sessions during months 7 to 12. These group sessions may be delivered in-person at the local program or remotely using video conferencing. During these sessions, participants will receive information about lifestyle change behaviors focusing on weight loss, physical activity, and nutrition from a trained lifestyle coach.
Receives: Behavioral: Human Coach-based Diabetes Prevention Program (hDPP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no)

    The primary outcome was the CDC-defined diabetes risk reduction benchmark at 12 months (based on the 2021 standards), defined as at least one of the following:

    1. Weight loss of ≥5%.
    2. Weight loss of ≥4% combined with at least 150 weekly minutes of moderate-to-vigorous PA
    3. An absolute decrease of ≥0.2 points in A1C (measured in %). The A1C endpoint was applicable only to participants with baseline A1C of 5.7% to 6.4%. Maintaining an A1C <6.5% throughout the study was also a criterion for the primary outcome.

    Measured: 12 months

Secondary outcomes (10)

  1. Absolute Weight Change

    Absolute weight change (kilograms) from baseline to 12 months

    Measured: At 12 months

  2. Cost-effectiveness as Assessed by the Markov Model

    The investigators will compare the cost-effectiveness of the two interventions based on lifetime horizon by constructing a Markov model with model parameters populated from the trial results as well as other published literature. The model will estimate the incremental cost-effectiveness ratio between the two interventions.

    Measured: 12 months

  3. Change in Hemoglobin A1C

    Change in HbA1C (percentage points) from baseline to 12 months (among participants with baseline HbA1C of 5.7% - 6.4% who completed the 12-month study visit).

    Measured: At 12 months

  4. Percentage Change in Weight

    Percentage change in weight from baseline to 12 months

    Measured: At 12 months

  5. Mean Weekly Moderate-to-vigorous Physical Activity (MVPA)

    Average minutes/week of physical activity assessed using blinded Actigraphy (monthly serial consecutive 7-days wear period). If the participant did not wear their monitor for at least 5 of their 7 assigned days, they were considered noncompliant. In this case, the participant was assigned 0 minutes for physical activity for that week.To obtain the average MVPA minutes per week across the study period, the total MVPA minutes per week from all valid wear periods were summed and divided by the number of available wear periods (maximum of 11 post-baseline visits). Specifically, activity intensity was classified as MVPA if the vector magnitude of accelerometer counts per minute was equal to or greater than 3941 (Montoye's cut point).

    Measured: At 12 months

  6. Incidence of Diabetes-range A1C

    Number of individuals who had an AIC in the diabetes range (A1C ≥6.5%) at the 6-month or 12-month timepoint.

    Measured: At either 6 or 12 months

  7. Acceptability as Assessed by the 32-item Acceptability Questionnaire

    To compare the acceptability of the two interventions (satisfaction, utility, interest, motivation, user experience, etc.) using the 32-item acceptability questionnaire.

    Scoring: Sum up all responses to questions 1-31, divide by 155 and multiply by 100 to calculate percentage score out of 100%. The range of possible scores is 20% (lowest acceptability) to 100% (highest possible acceptability).

    Measured: 12 months

  8. Correlation Between Self-reported and Measured Physical Activity

    To evaluate the correlation between self-reported PA data collected using different methods:

    • Data collected and reported by hDPPs
    • Self-reported PA data collected by study team obtained at 1-month intervals
    • Objectively measured PA data (Actigraphy) obtained at 1-month intervals

    Measured: 6 months and 12 months

  9. Program Initiation Rate

    Program initiators were defined as participants who attended at least one in-person session (Human-DPP) or registered and used the Sweetch app (AI-DPP).

    Measured: At 12 months

  10. Program Completion Rate

    Program completers attended ≥8 sessions in months 1-6 and spanned ≥9 months (Human-DPP), or engaged with the app for ≥8 weeks during months 1-6 with a span of ≥9 months between initiation and last engagement (AI-DPP).

    Measured: At 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2021
  2. Study start1 Oct 2021
  3. Primary completion16 Dec 2024
  4. Study completion16 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05056376
Sponsor's protocol ID
IRB00265873
Other IDs
1R01DK125780-01
Status last verified
Dec 2025
First submitted
14 Sep 2021
Last updated
17 Dec 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The Data Coordinating Center (Johns Hopkins University) will prepare a de-identified database that is consistent with HIPAA requirements. The de-identified database will include all study research data and will be stored in a repository at Johns Hopkins University (archive.data.jhu.edu) at a time that will coincide with the online publication of the study primary endpoint paper. The repository will contain documentation designed to facilitate use of the database. The documentation prepared for the repository will include a list and timetable for secondary and exploratory papers planned by the study investigators. Access to the database will be restricted to qualified users. Qualified users will include those investigators who submit valid pre-specified hypotheses and certify that they will not use the data for commercial purposes.

Publications

  • Lalani B, Siew G, Valdez Y, Shehadeh A, Zade D, Riekert K, Mathioudakis N; AI-DPP Study Group. User Engagement and Feature Preferences in an AI-Powered mHealth Intervention for Diabetes Prevention: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2026 Sep 2;14:e92981. doi: 10.2196/92981.

    PubMed 42685343

  • Mathioudakis N, Lalani B, Abusamaan MS, Alderfer M, Alver D, Dobs A, Kane B, McGready J, Riekert K, Ringham B, Shehadeh A, Vandi F, Wanigatunga AA, Zade D, Maruthur NM; AI-DPP Study Group. An AI-Powered Lifestyle Intervention vs Human Coaching in the Diabetes Prevention Program: A Randomized Clinical Trial. JAMA. 2025 Dec 16;334(23):2079-2089. doi: 10.1001/jama.2025.19563.

    PubMed 41144242

  • Abusamaan MS, Ballreich J, Dobs A, Kane B, Maruthur N, McGready J, Riekert K, Wanigatunga AA, Alderfer M, Alver D, Lalani B, Ringham B, Vandi F, Zade D, Mathioudakis NN. Effectiveness of artificial intelligence vs. human coaching in diabetes prevention: a study protocol for a randomized controlled trial. Trials. 2024 May 16;25(1):325. doi: 10.1186/s13063-024-08177-8.

    PubMed 38755706

Questions about this trial

What is this clinical trial studying?

A study testing Digital Diabetes Prevention Program (dDPP) and Human Coach-based Diabetes Prevention Program (hDPP) in people with PreDiabetes and Hyperglycemia, run by Johns Hopkins University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of CDC's Benchmark for Type 2 Diabetes Risk Reduction as a Binary Outcome (Yes/no) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05056376, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.

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Clinical Trial NCT05056376 | AzTrials