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RECRUITING
NCT05884775
NA

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

Investigators will conduct a hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) to evaluate the effectiveness of iMatter2 versus usual care on reduction in HbA1c at 12-months (primary outcome) among patients with Type 2 diabetes (T2D).

Official title: iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

353

Start Date

2025-11-04

Completion Date

2028-05-31

Last Updated

2026-04-09

Healthy Volunteers

No

Conditions

Interventions

OTHER

Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool

Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits.

Locations (1)

NYU Langone Health

New York, New York, United States