Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05884775
• Other study ID #: 23-00608
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 15, 2025
• Est. completion date: October 1, 2028

Study information

• Verified date: February 2024
• Source: NYU Langone Health
• Contact: Antoinette Schoenthaler
• Phone: 6465013434
• Email: Antoinette.schoenthaler[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 353
• Est. completion date: October 1, 2028
• Est. primary completion date: February 1, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 2 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1C (HbA1c)	HbA1c will be extracted from home A1c kits.	Baseline, Month 12
Secondary	Percentage of Patients Eligible for Participation in Trial who Enroll		Up to Month 12
Secondary	Percentage of PCP Practices Eligible for Participation in Trial that Enroll		Up to Month 12
Secondary	Percentage of Providers who View PRO Reports		Up to Month 12
Secondary	Percentage of Patients who Respond to PRO Text Messages		Up to Month 12
Secondary	Percentage of Patients who View PRO Interactive Dashboard		Up to Month 12
Secondary	Mean Number of EHR Reports Viewed by Providers		Up to Month 12
Secondary	Total Number of EHR Reports Viewed by Providers		Up to Month 12
Secondary	Percentage of PRO Messages Responded To by Patients		Up to Month 12
Secondary	Mean Number of PRO Messages Responded To by Patients		Up to Month 12
Secondary	Total Number of PRO Messages Responded To by Patients		Up to Month 12
Secondary	Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard		Up to Month 12
Secondary	Total Number of Reports Viewed by Patients via PRO Interactive Dashboard		Up to Month 12