iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management
Sponsor: NYU Langone Health
Trial Details
| Condition | Type 2 Diabetes |
| Intervention | Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool |
| Phase | NA |
| Status | Recruiting |
| Participants | 353 |
| Est. Completion | 31 Mar 2028 |
| Last Updated | 9 Apr 2026 |
Primary Outcome
Change in Hemoglobin A1C (HbA1c)
Eligibility Criteria
Inclusion 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.
Trial Sites
Countries
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