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Digital Diabetes Prevention Program with Automated Messaging for Prediabetes

N/A
Waitlist Available
Led By Devin Mann, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A diagnosis of prediabetes (either diagnosis of prediabetes or an HbA1C level of 5.7%-6.4% in past 12 months) or diabetes risk factors (BMI ≥ 25 kg/m2 or > 22 kg/m2 if self-identified as Asian
18 years or older, BMI ≥ 25 kg/m2 (> 22 kg/m2 if self-identified as Asian)
Must not have
Diagnosed with diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of ddpp program (average 1 year)
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether sending automated, tailored messages to patients enrolled in a digital diabetes prevention program can help increase engagement and prevent the onset of diabetes.

Who is the study for?
This trial is for NYU Langone patients over 18 with a BMI ≥ 25 (or > 22 if Asian), who can safely exercise, speak English well enough to enroll, have an app-capable device, and are diagnosed with prediabetes or at risk of diabetes. It excludes those already diagnosed with diabetes, unable to exercise moderately due to health conditions, significant weight fluctuation issues unrelated to the intervention, or severe psychiatric disease/dementia.
What is being tested?
The study tests whether automated messages from doctors can increase patient involvement in a digital diabetes prevention program. The messages vary based on how much patients use the dDPP app and aim to prevent diabetes onset and improve outcomes by encouraging more engagement through texts and MyChart messages.
What are the potential side effects?
Since this trial involves digital messaging rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience increased screen time which could lead to eye strain or disrupted sleep patterns if using devices before bedtime.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have prediabetes or am at risk for diabetes due to my weight.
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I am over 18 and have a BMI of 25 or higher (22 if I'm Asian).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of ddpp program (average 1 year)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of ddpp program (average 1 year) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Body Mass Index (BMI) (kg/m2)
Body Weight (kilograms)
Hemoglobin A1c (HbA1c) level (mmol/mol)
Secondary study objectives
dDPP platform coach messages sent
dDPP platform exercise log (min)
dDPP platform group social posts sent
+4 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
Group I: Experimental groupExperimental Treatment2 Interventions
Participants will be enrolled virtually into a digital diabetes prevention program through the Noom app and willing to receive text messages based on their engagement levels in Noom from the study team, as well as complete text-based surveys.
Group II: Control groupExperimental Treatment1 Intervention
Participants will be enrolled virtually into the digital diabetes prevention program through the Noom app and willing to receive general text messages from the study team

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,350 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,439 Previous Clinical Trials
4,324,389 Total Patients Enrolled
Devin Mann, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

Digital diabetes prevention program (dDPP) Clinical Trial Eligibility Overview. Trial Name: NCT04773834 — N/A
Prediabetes Research Study Groups: Experimental group, Control group
Prediabetes Clinical Trial 2023: Digital diabetes prevention program (dDPP) Highlights & Side Effects. Trial Name: NCT04773834 — N/A
Digital diabetes prevention program (dDPP) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04773834 — N/A
~0 spots leftby Dec 2024