Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

NCT05884775 | Recruiting DMC

• 1 other identifier: 23-00608
• Study Type: interventional
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1C (HbA1c)

  HbA1c will be extracted from lab data available within the EHR

  Baseline, Month 12

Secondary Outcomes (12)

• Percentage of Patients Eligible for Participation in Trial who Enroll

  Up to Month 14

• Percentage of PCP Practices Eligible for Participation in Trial that Enroll

  Up to Month 14

• Percentage of Providers who View PRO Reports

  Up to Month 14

• Percentage of Patients who Respond to PRO Text Messages

  Up to Month 14

• Percentage of Patients who View PRO Interactive Dashboard

  Up to Month 14

Study Arms (2)

iMatter2

EXPERIMENTAL

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

Usual Care (UC)

NO INTERVENTION

All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP.

Interventions

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.

Also known as: iMatter2

iMatter2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Telemedicine; Patient Reported Outcome Measures; prolyl-proline; Equipment and Supplies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Antoinette Schoenthaler

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscilla D'antico

CONTACT

732-501-9057; Priscilla.D'antico@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: November 4, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)