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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool

• Study Type: Interventional
• Enrollment (Estimated): 353
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antoinette Schoenthaler; Phone Number: 6465013434; Email: Antoinette.schoenthaler@nyulangone.org
• Study Contact Backup: Name: Ronaldo Patino Flores; Email: ronaldo.patinoflores@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 vi its 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iMatter2; All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.	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 home 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
No Intervention: Usual Care (UC); All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hemoglobin A1C (HbA1c)	HbA1c will be extracted from home A1c kits.	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Patients Eligible for Participation in Trial who Enroll	Up to Month 12
Percentage of PCP Practices Eligible for Participation in Trial that Enroll	Up to Month 12
Percentage of Providers who View PRO Reports	Up to Month 12
Percentage of Patients who Respond to PRO Text Messages	Up to Month 12
Percentage of Patients who View PRO Interactive Dashboard	Up to Month 12
Mean Number of EHR Reports Viewed by Providers	Up to Month 12
Total Number of EHR Reports Viewed by Providers	Up to Month 12
Percentage of PRO Messages Responded To by Patients	Up to Month 12
Mean Number of PRO Messages Responded To by Patients	Up to Month 12
Total Number of PRO Messages Responded To by Patients	Up to Month 12
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard	Up to Month 12
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard	Up to Month 12

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Antoinette Schoenthaler, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Estimated): February 15, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 23-00608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

IPD collected in this study will be available only to:

• The research team, including the Principal Investigator, study coordinators, and personnel responsible for the support or oversight of the study
• The study sponsor: The Agency for Healthcare Research and Quality

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No