Menu
Recruiting NCT05884775

Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

No phase Interventional Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool.
Who it may be relevant to
Registry conditions: Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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).

Interventions

  • Other Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
    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 async

Primary outcome measures

  • Change in Hemoglobin A1C (HbA1c) [Time frame: Baseline, Month 12]
Secondary outcome measures (12)
  • Percentage of Patients Eligible for Participation in Trial who Enroll [Time frame: Up to Month 14]
  • Percentage of PCP Practices Eligible for Participation in Trial that Enroll [Time frame: Up to Month 14]
  • Percentage of Providers who View PRO Reports [Time frame: Up to Month 14]
  • Percentage of Patients who Respond to PRO Text Messages [Time frame: Up to Month 14]
  • Percentage of Patients who View PRO Interactive Dashboard [Time frame: Up to Month 14]
  • Mean Number of EHR Reports Viewed by Providers [Time frame: Up to Month 14]
  • Total Number of EHR Reports Viewed by Providers [Time frame: Up to Month 14]
  • Percentage of PRO Messages Responded To by Patients [Time frame: Up to Month 14]
  • Mean Number of PRO Messages Responded To by Patients [Time frame: Up to Month 14]
  • Total Number of PRO Messages Responded To by Patients [Time frame: Up to Month 14]
  • Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard [Time frame: Up to Month 14]
  • Total Number of Reports Viewed by Patients via PRO Interactive Dashboard [Time frame: Up to Month 14]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT05884775 · 23-00608

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗