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Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

NCT05884775 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 353

Last updated 2026-04-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Antoinette Schoenthaler · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-04
Primary Completion
2028-03-31
Completion
2028-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05884775 on ClinicalTrials.gov