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NCT05884775NARecruiting

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

NYU Langone Health

Start Date

11/4/2025

Completion Date

5/31/2028

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

OTHER

Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool

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Conditions

Type 2 Diabetes

Locations

NYU Langone Health

New York, New York 10016

United States