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Digital Diabetes Prevention Program with Automated Messaging for Prediabetes

N/A

Recruiting

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of ddpp program (average 1 year)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of ddpp program (average 1 year)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Body Mass Index (BMI) (kg/m2)

Body Weight (kilograms)

Hemoglobin A1c (HbA1c) level (mmol/mol)

Secondary outcome measures

dDPP platform coach messages sent

dDPP platform exercise log (min)

dDPP platform group social posts sent

+4 more

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,372 Previous Clinical Trials

840,620 Total Patients Enrolled

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,370 Previous Clinical Trials

4,316,131 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the requirements for enrollment in this medical research?

"This medical trial seeks 400 participants of ages 18 to 99 with impaired glucose tolerance. Furthermore, in order to be qualified for the study, applicants must meet additional criteria such as being a NYU Langone patient, possessing an app-capable device and data to use the dDPP application plus receive texts messages, safe enough to engage in moderate physical exercise (as confirmed by their PCP), and having BMI ≥ 25 kg/m2 (> 22 kg/m2 if they identify as Asian)."

Answered by AI

How many participants are taking part in this medical experiment?

"Affirmative. Clinicaltrials.gov indicates that the study, initially released on February 1st 2021, is ongoing and actively enrolling 400 participants from one site."

Answered by AI

Are there any opportunities available for subjects to join this research?

"Yes, clinicaltrials.gov data demonstrates that this research experiment, which was inaugural published on February 1st 2021, remains open for participation. 400 test subjects are needed from a single site."

Answered by AI

What are the goals of this exploration?

"Over the duration of this experiment, spanning approximately one year, investigators seek to assess patient body weight (in kilograms). Other objectives include measuring engagement with the dDPP platform via user log-ins, group social posts sent and step logs that are provided by Noom."

Answered by AI

Is the age restriction of this research protocol limited to individuals under 35?

"This medical study is open to applicants aged 18-99 years old, while there are 189 trials for minors and 977 clinical research studies targeting individuals above 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program

2021. "Evaluation of an Automated Physician-Directed Messaging on Patient Engagement in the Digital Diabetes Prevention Program". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04773834.

All > Prediabetes