Effectiveness and Cost-Effectiveness of Fully-Automated Digital vs. Human Coach-Based Diabetes Prevention Programs
2 other identifiers
interventional
368
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2021
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedStudy Start
First participant enrolled
October 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2024
CompletedResults Posted
Study results publicly available
December 17, 2025
CompletedDecember 17, 2025
December 1, 2025
3.2 years
September 14, 2021
November 6, 2025
December 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
12 months
Secondary Outcomes (10)
Absolute Weight Change
At 12 months
Cost-effectiveness as Assessed by the Markov Model
12 months
Change in Hemoglobin A1C
At 12 months
Percentage Change in Weight
At 12 months
Mean Weekly Moderate-to-vigorous Physical Activity (MVPA)
At 12 months
- +5 more secondary outcomes
Study Arms (2)
Fully-Automated Digital Diabetes Prevention Program
EXPERIMENTALParticipants will receive Sweetch Digital Diabetes Prevention Program consists of a smartphone app and bluetooth-enabled digital body weight scale that syncs with the app.
Human Coach-Based Diabetes Prevention Program
ACTIVE 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Reading Hospital - Tower Health
Reading, Pennsylvania, 19611, United States
Related Publications (2)
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.
PMID: 41144242DERIVEDAbusamaan 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.
PMID: 38755706DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study has limitations. It was unmasked, relied on surrogate outcomes, and DPP delivery may have varied by site. App updates and study visits outside standard DPP exposures may have influenced outcomes. Referrals were not from primary care, and missing data or assumptions about physical activity had minimal sensitivity impacts. COVID-19 altered DPP delivery, and results may not generalize to broader prediabetes populations due to the sample's high activity levels and education.
Results Point of Contact
- Title
- Nestoras Mathioudakis, MD MHS
- Organization
- Johns Hopkins University, School of Medicine
Study Officials
- PRINCIPAL INVESTIGATOR
Nestoras Mathioudakis, MD MHS
Johns Hopkins University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2021
First Posted
September 24, 2021
Study Start
October 1, 2021
Primary Completion
December 16, 2024
Study Completion
December 16, 2024
Last Updated
December 17, 2025
Results First Posted
December 17, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The study protocol will be submitted for publication within 1 year of the start of enrollment.
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.