Study Summary
This trial will compare two diabetes prevention programs to see which is more effective.
Eligible Conditions
- Prediabetes
- Lifestyle Risk Reduction
- High Blood Sugar
- Obesity
- Healthy Lifestyle
- Sedentary Lifestyle
- Weight Loss
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 11 Secondary · Reporting Duration: 6 months and 12 months
12 months
Acceptability as assessed by the 32-item acceptability questionnaire
Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)
Cost-effectiveness as assessed by the Markov model
Engagement with programs as assessed by a score out of 100%
Incidence of type 2 diabetes
Month 12
Correlation between self-reported and measured physical activity
Month 12
Absolute weight change
Change in hemoglobin A1C
Change in physical activity - average minutes/week of physical activity
Change in physical activity - average number of steps per day
Change in physical activity - hours per week of physical activity
Percentage weight change
Trial Safety
Trial Design
2 Treatment Groups
Human Coach-Based Diabetes Prevention Program
1 of 2
Fully-Automated Digital Diabetes Prevention Program
1 of 2
Active Control
Experimental Treatment
368 Total Participants · 2 Treatment Groups
Primary Treatment: Digital Diabetes Prevention Program (dDPP) · No Placebo Group · N/A
Fully-Automated Digital Diabetes Prevention Program
Behavioral
Experimental Group · 1 Intervention: Digital Diabetes Prevention Program (dDPP) · Intervention Types: BehavioralHuman Coach-Based Diabetes Prevention Program
Behavioral
ActiveComparator Group · 1 Intervention: Human Coach-based Diabetes Prevention Program (hDPP) · Intervention Types: BehavioralTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months and 12 months
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,141 Previous Clinical Trials
4,064,107 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,073 Previous Clinical Trials
31,016,857 Total Patients Enrolled
Nestoras Mathioudakis, MD MHSPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
55 Total Patients Enrolled
Eligibility Criteria
Age 18 - 75 · All Participants · 9 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are willing to comply with all study procedures and are available for the duration of the study.
You have a fasting glucose of 100-125 mg/dL.
You are using a smartphone with an Android Operating System (OS) 9.0 or iOS 13.3 or newer.
The hemoglobin A1C level is 5.7% to 6.4%.
Plasma glucose > 200 mg/dL (7.8 mmol/L) 2 hours after a 75 gm glucose load.
Who else is applying?
What state do they live in?
| Pennsylvania | 33.3% |
| California | 33.3% |
| Alabama | 33.3% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Johns Hopkins | 50.0% |
| Johns Hopkins Hospital | 50.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 66.7% |
| Did not meet criteria | 33.3% |
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments