Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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).

Key Dates

Start date

Nov 4, 2025

Status verified

Apr 2026

Primary completion

Mar 31, 2028

Completion

May 31, 2028

Study Design

Enrollment

353 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

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

Primary Outcome Measure

Change in Hemoglobin A1C (HbA1c) [ Time Frame: Baseline, Month 12 ]

Central Contacts

• Priscilla D'antico
  732-501-9057
  Priscilla.D'[email protected]

Locations (1)

Find similar trials in New York, NY

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