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Prediabetes Research Study
N/A
Recruiting
Led By Nestoras Mathioudakis, MD MHS
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Must not have
Do you currently take diabetes medication?
Timeline
Screening 1 day
Treatment 12 months
Follow Up 6 months and 12 months
Awards & highlights
Study Summary
This trial will compare two diabetes prevention programs to see which is more effective.
Who is the study for?
Adults with prediabetes, indicated by specific lab results within the past year, who are overweight (with a BMI ≥25 kg/m2 or ≥23 kg/m2 for Asians), can read English, plan to stay local for a year, and use a recent smartphone. Excluded if they have substance abuse issues, major psychiatric disorders, diabetes medication usage, allergies to steel, other clinical trial participation in lifestyle management or diabetes prevention.Check my eligibility
What is being tested?
The study is comparing two types of diabetes prevention programs: one that's fully digital and automated (dDPP) versus another that involves human coaches (hDPP). The goal is to see which program better promotes lifestyle changes to reduce type 2 diabetes risk in adults with prediabetes.See study design
What are the potential side effects?
Since this trial focuses on lifestyle interventions rather than medications or medical procedures, traditional side effects are not applicable. Participants may experience stress or discomfort from changing their diet and exercise habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have prediabetes based on recent lab tests or my BMI.
Select...
You have a smartphone that uses Android Operating System version 9.0 or higher, or iOS version 13.3 or higher.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am currently on medication for diabetes.
Timeline
Screening ~ 1 day0 visits
Treatment ~ 12 months2 visits
Follow Up ~ 6 months and 12 months
Screening ~ 1 day
Treatment ~ 12 months
Follow Up ~6 months and 12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)
Secondary outcome measures
Absolute weight change
Acceptability as assessed by the 32-item acceptability questionnaire
Change in hemoglobin A1C
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Fully-Automated Digital Diabetes Prevention ProgramExperimental Treatment1 Intervention
Participants will receive Sweetch Digital Diabetes Prevention Program consists of a smartphone app and bluetooth-enabled digital body weight scale that syncs with the app.
Group II: Human Coach-Based Diabetes Prevention ProgramActive Control1 Intervention
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.
Find a Location
Logistics
Other reimbursement is provided
Other forms of reimbursement are provided for this trial.
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,358 Previous Clinical Trials
4,314,873 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,820,412 Total Patients Enrolled
Nestoras Mathioudakis, MD MHSPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of alcohol or drug abuse.I have not been diagnosed with schizophrenia or used antipsychotic medications in the last year.I have been diagnosed with an eating disorder.I have prediabetes based on recent lab tests or my BMI.I have been diagnosed with dementia or Alzheimer's disease.You have a device implanted in your body that helps regulate your heart's rhythm.You are allergic to steel.You cannot participate if you are already part of another study related to managing lifestyle or preventing diabetes.I am currently on medication for diabetes.I have been diagnosed with aortic stenosis.I had or plan to have weight-loss surgery within a year.You have a smartphone that uses Android Operating System version 9.0 or higher, or iOS version 13.3 or higher.
Research Study Groups:
This trial has the following groups:- Group 1: Fully-Automated Digital Diabetes Prevention Program
- Group 2: Human Coach-Based Diabetes Prevention Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 1 Weeks to process to see if you qualify in this trial.
- Treatment: You will receive the treatment for 12 Months
- Follow Ups: You may be asked to continue sharing information regarding the trial for 0 Days after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experimental protocol open to those below the age of 85?
"The upper age limit for this research trial is 75 years old, with all applicants required to be of legal age."
Answered by AI
Who can meet the requirements for enrollment in this research project?
"This clinical trial is seeking 368 adults aged 18-75 who have experienced weight loss. To be eligible, participants must agree to all study procedures and provide a signed consent form; additionally, they should demonstrate proficiency in English, operate an Android OS 9.0 or iOS 13.3 device, reside close to the recruitment site for one year (within ~25 miles), present with fasting glucose 100-125 mg/dL , BMI ≥25 kg/m2 (or≥23 kg/m2 for Asians) , HbA1C 5.7%-6.4%, and plasma glucose of 140-199 mg/dL after"
Answered by AI
Is this investigation open to new participants?
"Affirmative, according to the information available on clinicaltrials.gov this trial is actively seeking participants. Initially posted on October 1st 2021 and last updated November 23rd 2022, it requires 368 volunteers from 3 distinct medical centres."
Answered by AI
How many study participants are enrolled in this research endeavor?
"Yes, according to clinicaltrials.gov the trial remains open for recruitment, having been first posted on October 1st 2021 and most recently updated on November 23rd 2022. 368 participants must be found from 3 distinct sites."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
Pennsylvania
Other
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins
Johns Hopkins Hospital
Reading Hospital - Tower Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0
1
Why did patients apply to this trial?
Because I wanted to find a solution that works and that will help my health.
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- Reading Hospital - Tower Health: < 48 hours
Average response time
- < 2 Days
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