Digital Diabetes Prevention Program with Automated Messaging for Prediabetes

Overseen By Devin Mann, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Diabetes, Cancer, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

435 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study aims to understand the effects of automated physician directed messaging on patient engagement in the digital diabetes prevention program (dDPP). The messages are tailored to patient engagement levels based on established engagement thresholds, which are based on the patient's use of the dDPP application. The system is designed to minimize work for providers by sending automated targeted messages to patients to potentially increase engagement, prevent onset of diabetes and improve clinical outcomes. The patients in the study are automatically nudged using a combination of text messaging and MyChart messaging.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

How is the Digital Diabetes Prevention Program with Automated Messaging for Prediabetes different from other treatments for prediabetes?

This treatment is unique because it uses digital technology to deliver a diabetes prevention program, combining educational content, human health coaching, and peer support through a virtual group, making it more accessible and potentially more engaging than traditional in-person programs. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Adapted dDPP-EHR tool, Digital diabetes prevention program (dDPP)?

Research shows that digital diabetes prevention programs (dDPPs) are effective in helping people at risk for diabetes improve their health by changing their behavior. These programs have been shown to improve weight, blood sugar levels, and heart health in people with prediabetes. ^{1 6 7 8 9}

Who Is on the Research Team?

Devin Mann, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Sufficient English to be able to complete the enrollment process

Has app-capable device with data to use the dDPP application and receive text messages

Your doctor says it's okay for you to do moderate physical exercise.

Exclusion Criteria

You have a serious mental illness or dementia.

My weight changes are not due to the study's treatment but may be because of other health conditions.

You have a health condition that stops you from doing moderate exercise.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Baseline

Participants are enrolled virtually into the digital diabetes prevention program through the Noom app

0 month (at enrollment)

Virtual enrollment

Intervention

Participants receive automated targeted messaging based on their engagement levels in the digital diabetes prevention program

12 months

Continuous virtual engagement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted dDPP-EHR tool
• Digital diabetes prevention program (dDPP)

Trial Overview 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.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 2 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 group Experimental Treatment 1 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

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Published Research Related to This Trial

The digital Diabetes Prevention Program (d-DPP) significantly improved HbA1c levels and body weight among participants with prediabetes, showing a reduction in HbA1c by 0.08% and a weight loss of 5.5% compared to standard care.

Participants in the d-DPP were more likely to achieve clinically significant weight loss (43% vs 21%) and transition from prediabetes to normal HbA1c levels (58% vs 48%), indicating its effectiveness in preventing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Digital Diabetes Prevention Program: An RCT. Katula, JA., Dressler, EV., Kittel, CA., et al.[2022]

Citations

1. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of an Integrated Engagement Support System to Facilitate Patient Use of Digital Diabetes Prevention Programs: Protocol for a Randomized Controlled Trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of a Digital Diabetes Prevention Program: An RCT. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Retention and outcomes of National Diabetes Prevention Program enrollees and non-enrollees with prediabetes: The University of Michigan experience. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of a digital diabetes prevention program adapted for the Medicaid population: Study design and methods for a non-randomized, controlled trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Using a certified electronic health record technology platform to screen, test and refer patients with prediabetes. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

A 12-Month Follow-Up of the Effects of a Digital Diabetes Prevention Program (VP Transform for Prediabetes) on Weight and Physical Activity Among Adults With Prediabetes: Secondary Analysis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Digital Health-Supported Lifestyle Change Programs to Prevent Type 2 Diabetes. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Short Message Service Text Message Support for Weight Loss in Patients With Prediabetes: Pragmatic Trial. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

A National Effort to Prevent Type 2 Diabetes: Participant-Level Evaluation of CDC's National Diabetes Prevention Program. [2022]