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
NYU Langone Health
353 participants
Nov 4, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- PCP Group:
- Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers or faculty group practices and
- Provide care to at least five patients with a diagnosis of T2D
- Patient Group:
- Have a diagnosis of T2D for ≥6 months;
- Have uncontrolled T2D defined as HbA1c >7% documented in the EHR on at least two visits in the past year;
- Fluency in English or Spanish;
- Be willing to send/receive text messages; and
- Be > 18 years of age.
Exclusion Criteria7
- Patient Group:
- Refuse or are unable to provide informed consent;
- Have acute renal failure, end stage renal disease (ESRD) or evidence of dialysis, renal transplantation, or other ESRD-related services documented in the EHR;
- Have significant psychiatric comorbidity or reports of substance abuse (as documented in the EHR);
- Are pregnant or planning to become pregnant within 12 months;
- Currently participate in another T2D study; or
- Plan to discontinue care at the clinic within the next 12 months.
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05884775