N/A
Completed N=237
i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
Type2 Diabetes
Source: ClinicalTrials.gov NCT03652389 ↗
Enrolled (actual)
237
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcomePrimary: HbA1c Level at Baseline — 8.37; 8.29 Percentage of total hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HbA1c Level at Baseline |
8.37; 8.29 | — |
| PRIMARY HbA1c Level at Month 12 |
8.02; 8.15 | — |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score |
4.48; 4.29 | — |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score |
3.62; 3.26 | — |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score |
4.43; 3.98 | — |
| SECONDARY Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score |
4.39; 4 | — |
| SECONDARY Michigan Diabetes Knowledge Scale Score |
0.71; 0.66 | — |
| SECONDARY Diabetes Self-Efficacy Scale Score |
8.16; 7.8 | — |
| SECONDARY Interpersonal Processes of Care Score Communication Subscale Score |
4.36; 4.45 | — |
| SECONDARY Interpersonal Processes of Care: Decision Making Subscale Score |
3.93; 4.09 | — |
| SECONDARY Interpersonal Processes of Care: Inter-personal Style Subscale Score |
4.47; 4.6 | — |
Eligibility Criteria
Inclusion Criteria
Primary Care Provider Inclusion Criteria:
- Fulltime primary care provider (MD/DO, NP) practicing at the participating family health centers (FHCs) and,
- Provide care to at least five patients with a diagnosis of T2D.
Patient Inclusion Criteria:
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03652389). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.