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Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Recruiting
18 years and older
All
Phase N/A

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Overview

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 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.

Study details
    Type 2 Diabetes

NCT05884775

NYU Langone Health

26 February 2026

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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