Novel Digital Patient-Reported Outcomes Tool for Diabetes Management

NYU Langone Health

Status

Not yet enrolling

Conditions

Type 2 Diabetes

Treatments

Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT05884775

23-00608

Details and patient eligibility

About

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).

Enrollment

353 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.