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NCT03652389 · ClinicalTrials.gov registry record · NA
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
A NA study, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 246
- Enrollment target
NCT03652389: Completed NA study, sponsored by NYU Langone Health.
NCT03652389 is a NA study that has completed, run by NYU Langone Health. The registered enrollment target is 246 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03652389, a NA study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 246 participants
- Enrollment target
Study Summary
This study will integrate a technology-based patient-reported outcome (PRO) system \[herein MJS DIABETES\] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platform that utilizes text-messaging to capture patients' self-reported PROs in real-time; enhance patient engagement through data-driven feedback and motivational messages; and create dynamic visualizations of the PROs that can be shared in printed reports, and integrated into the EHR; thus making it actionable for patients and their PCPs. Using a mixed-methods design, this study will be conducted in 2 phases: 1) a formative phase, using the evidence-based user-centered design approach; and 2) a clinical-efficacy phase. For the formative phase, a qualitative research method will be used to: a) adapt MJS to the needs of PCPs and T2D patients; b) integrate MJS DIABETES into the EHR system, the primary care practice and the lives of patients with T2D; and c) evaluate the usability of MJS DIABETES in a subset of T2D patients and their PCPs in order to optimize the tool's performance and workflow integration. For the clinical efficacy phase, a randomized control trial will be used to identify the efficacy of MJS DIABETES versus Usual Care (UC) on reduction HbA1c at 12-months, among 282 patients with T2D who receive care in safety-net practices.
Primary Outcome
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
Interventions
- BEHAVIORAL MJS Diabetes
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2018-12-18 |
| Est. Completion | 2024-01-31 |
| Phase | NA |
What the finished NCT03652389 record still lists
NCT03652389 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 1 intervention - of which MJS Diabetes is the first listed.
NCT03652389 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03652389 about?
NCT03652389 is a clinical study titled "i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management". This study will integrate a technology-based patient-reported outcome (PRO) system \[herein MJS DIABETES\] that incorporates patients' perspective of their disease and functional status into the management of type 2 diabetes (T2D) in primary care practices. MJS DIABETES is an innovative mobile platf...
What is the current status of trial NCT03652389?
This trial is currently completed. It is a NA study. The enrollment target is 246 participants. The study started on 2018-12-18. Estimated completion is 2024-01-31.
What interventions are being tested in trial NCT03652389?
The interventions under investigation include: MJS Diabetes (BEHAVIORAL).
Who is sponsoring clinical trial NCT03652389?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03652389's enrollment target sits among peer trials
246 436th of 2000 higher than 1,565 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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