NCT03652389

i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management

Completed NA Results posted Last updated 19 February 2025

What this trial tests

NA trial testing MJS Diabetes in Type2 Diabetes in 246 participants. Completed in 31 January 2024.

Timeline

18 December 2018

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	health services research
Enrollment	246
Start date	18 December 2018
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	1 location across United States

Drugs / interventions tested

• MJS Diabetes

Conditions studied

• Type2 Diabetes — all drugs for Type2 Diabetes →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 90, any sex, with Type2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

HbA1c Level at Baseline Primary · Baseline

Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

Group	Value	95% CI
MJS DIABETES	8.37	8.06 – 8.68
Usual Care	8.29	7.98 – 8.60

HbA1c Level at Month 12 Primary · Month 12

Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

Group	Value	95% CI
MJS DIABETES	8.02	7.69 – 8.35
Usual Care	8.15	7.82 – 8.48

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score Secondary · Baseline

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Group	Value	95% CI
MJS DIABETES	3.87	± 1.68
Usual Care	3.42	± 1.88

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score Secondary · Month 3

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Group	Value	95% CI
MJS DIABETES	4.31	± 1.64
Usual Care	4	± 1.84

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score Secondary · Month 6

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Group	Value	95% CI
MJS DIABETES	4.21	± 1.53
Usual Care	4.13	± 1.65

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score Secondary · Month 9

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Group	Value	95% CI
MJS DIABETES	4.47	± 1.48
Usual Care	4.18	± 1.67

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score Secondary · Month 12

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing, and foot care. For each item on the diet subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate healthier diet.

Group	Value	95% CI
MJS DIABETES	4.48	± 1.54
Usual Care	4.29	± 1.66

Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score Secondary · Baseline

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Group	Value	95% CI
MJS DIABETES	2.93	± 2.02
Usual Care	2.59	± 2.07

Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score Secondary · Month 3

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Group	Value	95% CI
MJS DIABETES	3.56	± 2.22
Usual Care	2.98	± 2.32

Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score Secondary · Month 6

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Group	Value	95% CI
MJS DIABETES	3.68	± 2.1
Usual Care	3.1	± 2.07

Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score Secondary · Month 9

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Group	Value	95% CI
MJS DIABETES	3.54	± 2
Usual Care	3.01	± 2.06

Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score Secondary · Month 12

The SDSCA questionnaire is an assessment of diabetes self-management that includes items assessing the following aspects of the diabetes regimen: diet, exercise, blood-glucose testing and foot care. For each item on the exercise subscale, respondents provide the number of days per week (0-7) that they engage in the activity. The total score is the average of all responses and ranges from 0-7; higher scores indicate greater amounts of exercise.

Group	Value	95% CI
MJS DIABETES	3.62	± 2.09
Usual Care	3.26	± 2.16

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study.
   Schoenthaler A, Cruz J, Payano L, Rosado M, et al · · 2020 · cited 11× · PMID 32865505 · DOI 10.2196/18554
2. Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes Management: Engagement Phenotype Study.
   Mandal S, Belli HM, Cruz J, Mann D, et al · · 2022 · cited 2× · PMID 36374531 · DOI 10.2196/41140