NCT05884775

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 353 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-11-04
• Primary completion: 2028-03-31
• Completion: 2028-05-31
• First posted: 2023-06-01
• Last updated: 2026-04-09

Locations

1 site across 1 country: United States