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NCT05884775Terminated

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

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

Source: ClinicalTrials.gov · Last updated 27 Aug 2026

Reason given: Funding was terminated for the study.

Brief summary (registry, in English)

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).

Status (registry)
Terminated
Study type
Interventional
Enrollment
37 (actual)
First submitted
23 May 2023
Start date
4 Nov 2025
Primary completion date
19 May 2026
Lead sponsor
NYU Langone Health
NCT number
NCT05884775

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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);

Other

  • Patient Group:
  • Refuse or are unable to provide informed consent;
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
NYU Langone HealthNew YorkUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.