RecruitingNot ApplicableNCT05884775

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

Sponsor

NYU Langone Health

Enrollment

353 participants

Start Date

Nov 4, 2025

Study Type

INTERVENTIONAL

Conditions

Type 2 Diabetes

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a digital tool that allows diabetes patients to report their symptoms and health information to their doctors via text message, to see if this approach helps improve blood sugar control in people with uncontrolled type 2 diabetes. **You may be eligible if...** - You have been diagnosed with type 2 diabetes for at least 6 months - Your blood sugar (HbA1c) has been above 7% on at least two recent clinic visits - You speak English or Spanish - You are willing to send and receive text messages - You are over 18 years old **You may NOT be eligible if...** - You have acute or end-stage kidney disease, or are on dialysis - You have significant psychiatric illness that would prevent participation - You are unable to give informed consent - You are currently enrolled in another diabetes management study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERMobile 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.