Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool

• Registration Number: NCT05884775
• Lead Sponsor: NYU Langone Health

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Study Start: 2025-08-01
• Primary Completion: 2028-03-31
• Study Completion: 2028-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 353

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iMatter2	Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool	All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2.

Primary Outcome Measures

Name	Time	Method
Change in Hemoglobin A1C (HbA1c)	Baseline, Month 12	HbA1c will be extracted from home A1c kits.

Secondary Outcome Measures

Name	Time	Method
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 View PRO Interactive Dashboard	Up to Month 14
Total Number of EHR Reports Viewed by Providers	Up to Month 14
Percentage of Patients who Respond to PRO Text Messages	Up to Month 14
Mean Number of EHR Reports Viewed by Providers	Up to Month 14
Percentage of PRO Messages Responded To by Patients	Up to Month 14
Mean Number of PRO Messages Responded To by Patients	Up to Month 14
Total Number of PRO Messages Responded To by Patients	Up to Month 14
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard	Up to Month 14
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard	Up to Month 14

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States