Digital patient-reported outcomes tool to help manage Type 2 diabetes

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

This study will test whether iMatter2, a mobile patient-reported outcomes tool, helps adults with Type 2 diabetes lower their HbA1c over 12 months compared with usual care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 353 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: NYU Langone Health (Academic / other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT05884775 on ClinicalTrials.gov

What this trial studies

This is a hybrid type 1 effectiveness-implementation randomized controlled trial comparing the iMatter2 mobile patient-reported outcome (PRO) tool plus usual care versus usual care alone for adults with uncontrolled Type 2 diabetes. Participants are randomized and followed for 12 months with the primary outcome being change in HbA1c at 12 months. The trial collects both clinical effectiveness data and implementation measures to understand uptake, fidelity, and real-world use of the mHealth PRO tool in primary care. Enrollment is limited to English- or Spanish-speaking adults receiving care at participating NYU Langone primary care clinics who can send and receive text messages.

Who should consider this trial

Good fit: Ideal candidates are adults (over 18) with Type 2 diabetes for at least six months, uncontrolled disease (HbA1c >7% on two visits in the past year), fluent in English or Spanish, willing to send/receive text messages, and receiving care at participating NYU Langone primary care sites.

Not a fit: Patients with acute renal failure or end-stage renal disease, significant psychiatric comorbidity or substance abuse, pregnancy or plans to become pregnant, inability to consent, current participation in another T2D study, or those planning to leave care at the site are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the iMatter2 tool could improve glucose control by prompting symptom reporting, tailoring care, and enabling earlier treatment adjustments.

How similar studies have performed: Prior mHealth and PRO-based interventions for Type 2 diabetes have shown modest improvements in self-management and small reductions in HbA1c, but results are mixed and rigorous hybrid randomized trials of implementation in primary care remain limited.

Eligibility criteria

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.

Where this trial is running

New York, New York

• NYU Langone Health — New York, New York, United States (Recruiting)

Study contacts

• Principal investigator: Antoinette Schoenthaler — NYU Langone Health
• Study coordinator: Priscilla D'antico

Conditions Type 2 Diabetes