NCT05884775 Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
| NCT ID | NCT05884775 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 353 participants |
| Start Date | 2025-11-04 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 353 participants in total. It began in 2025-11-04 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Antoinette Schoenthaler
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT05884775 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05884775 currently recruiting?
Yes, NCT05884775 is actively recruiting participants. Contact the research team at Priscilla.D'antico@nyulangone.org for enrollment information.
Where is the NCT05884775 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05884775 clinical trial?
NCT05884775 is sponsored by NYU Langone Health. The principal investigator is Antoinette Schoenthaler at NYU Langone Health. The trial plans to enroll 353 participants.
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