Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

NCT05884775 — Not applicable, Terminated, 37 participants, NYU Langone Health

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

Registry	NCT05884775
Status	Terminated - Funding was terminated for the study.
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, health services research
Enrollment	37 (Actual)
Sponsor	NYU Langone Health (Other)
Conditions	Type 2 Diabetes
Interventions	Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool (Other)
Dates	start 2025-11-04, primary completion 2026-05-19, completion 2026-06-19, first posted 2023-06-01, last updated 2026-08-27
Locations	1 site in United States

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
iMatter2	Experimental	Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool	All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.
Usual Care (UC)	No intervention		All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.

Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool (Other), also known as iMatter2: 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.

+Outcome measures

Primary outcomes

Change in Hemoglobin A1C (HbA1c) [Baseline, Month 12]: HbA1c will be extracted from lab data available within the EHR

Secondary outcomes

Percentage of Patients Eligible for Participation in Trial who Enroll [Up to Month 14]
Percentage of PCP Practices Eligible for Participation in Trial that Enroll [Up to Month 14]
Percentage of Providers who View PRO Reports [Up to Month 14]
Percentage of Patients who Respond to PRO Text Messages [Up to Month 14]
Percentage of Patients who View PRO Interactive Dashboard [Up to Month 14]
Mean Number of EHR Reports Viewed by Providers [Up to Month 14]
Total Number of EHR Reports Viewed by Providers [Up to Month 14]
Percentage of PRO Messages Responded To by Patients [Up to Month 14]
Mean Number of PRO Messages Responded To by Patients [Up to Month 14]
Total Number of PRO Messages Responded To by Patients [Up to Month 14]
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard [Up to Month 14]
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard [Up to Month 14]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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 Criteria:

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.

+Locations (1)

Facility	City	Country	Status
NYU Langone Health	New York, New York	United States

+Investigators

Devin Mann, Principal investigator, NYU Langone Health