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Prediabetes Research Study

N/A

Waitlist Available

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 0 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have prediabetes based on recent lab tests or my BMI.

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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:

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I am currently on medication for diabetes.

Timeline

Screening ~ 1 day0 visits

Treatment ~ 12 months2 visits

Follow Up ~ 0 days0 visits

Screening ~ 1 day

Treatment ~ 12 months

Follow Up ~0 days

This trial's timeline: 1 day for screening, 12 months for treatment, and 0 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of CDC's benchmark for type 2 diabetes risk reduction as a binary outcome (yes/no)

Secondary study objectives

Absolute weight change

Acceptability as assessed by the 32-item acceptability questionnaire

Change in hemoglobin A1C

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 5Eligibility criteria met