Type2 DiabetesNCT03652389

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

A study testing MJS Diabetes in people with Type2 Diabetes, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 90 years
Conditions the study is for: Type2 Diabetes
What is being tested?: MJS Diabetes
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 246 participants
Where: 1 siteUnited States
Study dates: 18 Dec 2018to 31 Jan 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

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.

Conditions: Type2 Diabetes
Being tested: MJS Diabetes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MJS DiabetesBehavioural
patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs

Study groups in NCT03652389
Study group	Role	What they receive
MJS DIABETES	Experimental	will receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study. Receives: Behavioral: MJS Diabetes
Usual Care	No intervention	Standard Diabetes Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

HbA1c Level at Baseline
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
Measured: Baseline
HbA1c Level at Month 12
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
Measured: Month 12

Secondary outcomes (43)

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
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.
Measured: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
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.
Measured: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
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.
Measured: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
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.
Measured: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
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.
Measured: Month 12
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
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.
Measured: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
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.
Measured: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
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.
Measured: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
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.
Measured: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
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.
Measured: Month 12
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
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 blood-glucose testing 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 more frequent weekly blood-glucose testing.
Measured: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
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 blood-glucose testing 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 more frequent weekly blood-glucose testing.
Measured: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
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 blood-glucose testing 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 more frequent weekly blood-glucose testing.
Measured: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
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 blood-glucose testing 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 more frequent weekly blood-glucose testing.
Measured: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
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 blood-glucose testing 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 more frequent weekly blood-glucose testing.
Measured: Month 12
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
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 foot care 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 more frequent completion of foot care activities.
Measured: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
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 foot care 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 more frequent completion of foot care activities.
Measured: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
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 foot care 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 more frequent completion of foot care activities.
Measured: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
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 foot care 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 more frequent completion of foot care activities.
Measured: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
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 foot care 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 more frequent completion of foot care activities.
Measured: Month 12
Michigan Diabetes Knowledge Scale Score
20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.
Measured: Baseline
Michigan Diabetes Knowledge Scale Score
20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.
Measured: Month 6
Michigan Diabetes Knowledge Scale Score
20-item assessment of diabetes knowledge. Each item has a potential response of "True," "False," and "I don't know." The total score is the number of correct responses normalized by the total number of items responded, and ranges from 0-1; higher scores indicate greater diabetes knowledge.
Measured: Month 12
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Measured: Baseline
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Measured: Month 3
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Measured: Month 6
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Measured: Month 9
Diabetes Self-Efficacy Scale Score
12-item assessment of participants' confidence in performing certain diabetes-related tasks. For each item, participants select from a Likert scale ranging from 0 (not at all confident) to 10 (very confident). The total score is the sum of responses normalized by the number of items responded and ranges from 0-10; higher scores indicate greater diabetes self-efficacy.
Measured: Month 12
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Measured: Baseline
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Measured: Month 3
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Measured: Month 6
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Measured: Month 9
Interpersonal Processes of Care Score Communication Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items are reversed. The total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher communication scores indicate better patient-provider communication).
Measured: Month 12
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Measured: Baseline
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Measured: Month 3
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Measured: Month 6
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Measured: Month 9
Interpersonal Processes of Care: Decision Making Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher decision making scores indicate more decision making).
Measured: Month 12
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Measured: Baseline
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Measured: Month 3
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Measured: Month 6
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Measured: Month 9
Interpersonal Processes of Care: Inter-personal Style Subscale Score
18-item assessment of participants' experiences talking with doctors during the study includes items assessing the following aspects of the IPC: 1) Communication, 2) Decision Making, and 3) Inter-personal style. Each item is rated on a Likert scale from 1 (never) to 5 (always). Scores in negative items were reversed. Total scale score is mean of nonmissing items and ranges from 1-5. Higher scores indicate higher frequency of the construct (higher inter-personal style scores indicate more inter-personal style).
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201831 Jan 2024

First posted29 Aug 2018
Study start18 Dec 2018
Primary completion31 Jan 2024
Study completion31 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Type2 DiabetesStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03652389
Sponsor's protocol ID: 18-01044
Status last verified: Jan 2025
First submitted: 27 Aug 2018
Last updated: 19 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

Mandal S, Belli HM, Cruz J, Mann D, Schoenthaler A. Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes Management: Engagement Phenotype Study. JMIR Diabetes. 2022 Nov 14;7(4):e41140. doi: 10.2196/41140.
PubMed 36374531
Schoenthaler A, Cruz J, Payano L, Rosado M, Labbe K, Johnson C, Gonzalez J, Patxot M, Patel S, Leven E, Mann D. Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study. JMIR Form Res. 2020 Aug 31;4(8):e18554. doi: 10.2196/18554.
PubMed 32865505

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: i-Matter: Investigating an mHealth Texting Tool for Embedding Patient-reported Data Into Diabetes Management
ClinicalTrials.gov ID: NCT03652389
Acronym / sponsor ID: 18-01044
Conditions: Type2 Diabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Study start: 18 Dec 2018 (actual)
Primary completion: 31 Jan 2024 (actual)
Study completion: 31 Jan 2024 (actual)
First posted: 29 Aug 2018 (actual)
Results: Posted 19 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
MJS DIABETES	Experimental	Behavioral: MJS Diabeteswill receive and respond to daily PROs via ttext messages and report SMBG (if insulin-dependent) over the course of the 12-month study.
Usual Care	No intervention	–Standard Diabetes Treatment

Who may qualify

Ages: 18 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.
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;

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MJS Diabetespatients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs	Behavioural	MJS DIABETES

Primary outcome

HbA1c Level at Baseline
Time frame: Baseline
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.
HbA1c Level at Month 12
Time frame: Month 12
Hemoglobin A1c (HbA1c) extracted from patient medical record. Reported means and 95% confidence intervals are model-adjusted and utilized multiple imputation.

43 secondary outcomes

Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
Time frame: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
Time frame: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
Time frame: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
Time frame: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Diet Subscale Score
Time frame: Month 12
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
Time frame: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
Time frame: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
Time frame: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
Time frame: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Exercise Subscale Score
Time frame: Month 12
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
Time frame: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
Time frame: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
Time frame: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
Time frame: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Blood-Glucose Testing Subscale Score
Time frame: Month 12
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
Time frame: Baseline
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
Time frame: Month 3
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
Time frame: Month 6
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
Time frame: Month 9
Summary of Diabetes Self-Care Activities (SDSCA): Foot Care Subscale Score
Time frame: Month 12
Michigan Diabetes Knowledge Scale Score
Time frame: Baseline
Michigan Diabetes Knowledge Scale Score
Time frame: Month 6
Michigan Diabetes Knowledge Scale Score
Time frame: Month 12
Diabetes Self-Efficacy Scale Score
Time frame: Baseline
Diabetes Self-Efficacy Scale Score
Time frame: Month 3
Diabetes Self-Efficacy Scale Score
Time frame: Month 6
Diabetes Self-Efficacy Scale Score
Time frame: Month 9
Diabetes Self-Efficacy Scale Score
Time frame: Month 12
Interpersonal Processes of Care Score Communication Subscale Score
Time frame: Baseline
Interpersonal Processes of Care Score Communication Subscale Score
Time frame: Month 3
Interpersonal Processes of Care Score Communication Subscale Score
Time frame: Month 6
Interpersonal Processes of Care Score Communication Subscale Score
Time frame: Month 9
Interpersonal Processes of Care Score Communication Subscale Score
Time frame: Month 12
Interpersonal Processes of Care: Decision Making Subscale Score
Time frame: Baseline
Interpersonal Processes of Care: Decision Making Subscale Score
Time frame: Month 3
Interpersonal Processes of Care: Decision Making Subscale Score
Time frame: Month 6
Interpersonal Processes of Care: Decision Making Subscale Score
Time frame: Month 9
Interpersonal Processes of Care: Decision Making Subscale Score
Time frame: Month 12
Interpersonal Processes of Care: Inter-personal Style Subscale Score
Time frame: Baseline
Interpersonal Processes of Care: Inter-personal Style Subscale Score
Time frame: Month 3

Results and safety

Results posted to the registry on 19 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MJS DIABETES	117	109
Usual Care	120	114

Primary outcome: HbA1c Level at Baseline

Time frame: Baseline. Mean (95% Confidence Interval). Unit: Percentage of total hemoglobin

Measure	MJS DIABETES n = 117	Usual Care n = 120
Value	8.37 (8.06 to 8.68)	8.29 (7.98 to 8.60)

Primary outcome: HbA1c Level at Month 12

Time frame: Month 12. Mean (95% Confidence Interval). Unit: Percentage of total hemoglobin

Measure	MJS DIABETES n = 117	Usual Care n = 120
Value	8.02 (7.69 to 8.35)	8.15 (7.82 to 8.48)

43 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MJS DIABETES	0 of 117 (0%)	0 of 117 (0%)	0 of 117
Usual Care	0 of 120 (0%)	0 of 120 (0%)	0 of 120

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 36374531Mandal S, Belli HM, Cruz J, Mann D, Schoenthaler A. Analyzing User Engagement Within a Patient-Reported Outcomes Texting Tool for Diabetes Management: Engagement Phenotype Study. JMIR Diabetes. 2022 Nov 14;7(4):e41140. doi: 10.2196/41140.
Derived from this study: PubMed 32865505Schoenthaler A, Cruz J, Payano L, Rosado M, Labbe K, Johnson C, Gonzalez J, Patxot M, Patel S, Leven E, Mann D. Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study. JMIR Form Res. 2020 Aug 31;4(8):e18554. doi: 10.2196/18554.
Individual participant dataSharing planned: No. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antoinette Schoenthaler, MD principal investigator

NYU Langone Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MJS Diabetes in people with Type2 Diabetes, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c Level at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03652389, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.