NCT05884775NARecruiting
Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
NYU Langone Health
Start Date
11/4/2025
Completion Date
5/31/2028
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).
Eligibility Criteria
Age Range: 18 years to No maximum
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.
Interventions
OTHER
Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
Conditions
Type 2 Diabetes
Locations
NYU Langone Health
New York, New York 10016
United States