Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
Recruiting · NCT05884775 · Interventional (participants receive a specific treatment) · Lead sponsor: NYU Langone Health
View the official record on ClinicalTrials.gov →Interventions studied
Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
What this trial is 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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- NYU Langone Health - New York, New York, United States