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Recruiting

NCT Number: NCT05884775

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

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).

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other

Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits.

Other names: iMatter2

Primary outcomes

  1. Change in Hemoglobin A1C (HbA1c)

    Time frame: Baseline, Month 12

    HbA1c will be extracted from lab data available within the EHR

Secondary outcomes

  1. Percentage of Patients Eligible for Participation in Trial who Enroll

    Time frame: Up to Month 14

  2. Percentage of PCP Practices Eligible for Participation in Trial that Enroll

    Time frame: Up to Month 14

  3. Percentage of Providers who View PRO Reports

    Time frame: Up to Month 14

  4. Percentage of Patients who Respond to PRO Text Messages

    Time frame: Up to Month 14

  5. Percentage of Patients who View PRO Interactive Dashboard

    Time frame: Up to Month 14

  6. Mean Number of EHR Reports Viewed by Providers

    Time frame: Up to Month 14

  7. Total Number of EHR Reports Viewed by Providers

    Time frame: Up to Month 14

  8. Percentage of PRO Messages Responded To by Patients

    Time frame: Up to Month 14

  9. Mean Number of PRO Messages Responded To by Patients

    Time frame: Up to Month 14

  10. Total Number of PRO Messages Responded To by Patients

    Time frame: Up to Month 14

  11. Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard

    Time frame: Up to Month 14

  12. Total Number of Reports Viewed by Patients via PRO Interactive Dashboard

    Time frame: Up to Month 14

Study contacts

Contact information is provided by the study sponsor or research team.

Priscilla D'antico

CONTACT

Priscilla.D'[email protected]

732-501-9057

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2023
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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