Digital Diabetes Prevention Program (dDPP) for Prediabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prediabetes+9 MoreDigital Diabetes Prevention Program (dDPP) - Behavioral
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

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

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: Behavioral
Human Coach-Based Diabetes Prevention Program
Behavioral
ActiveComparator Group · 1 Intervention: Human Coach-based Diabetes Prevention Program (hDPP) · Intervention Types: Behavioral

Trial 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?
Pennsylvania33.3%
California33.3%
Alabama33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Johns Hopkins50.0%
Johns Hopkins Hospital50.0%
What portion of applicants met pre-screening criteria?
Met criteria66.7%
Did not meet criteria33.3%