Type 2 DiabetesNCT05884775
Novel Digital Patient-Reported Outcomes Tool for Diabetes Management
A study testing Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool in people with Type 2 Diabetes, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2025to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Fluency in English or Spanish;
- Be willing to send/receive text messages; and
- Be > 18 years of age.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management
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).
- Conditions
- Type 2 Diabetes
- Being tested
- Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Health (mHealth) Patient-Reported Outcome (PRO) toolOther
Also called iMatter2
Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits.
| Study group | Role | What they receive |
|---|---|---|
| iMatter2 | Experimental | All the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2. Receives: Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool |
| Usual Care (UC) | No intervention | All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Hemoglobin A1C (HbA1c)
HbA1c will be extracted from lab data available within the EHR
Measured: Baseline, Month 12
Secondary outcomes (12)
Percentage of Patients Eligible for Participation in Trial who Enroll
Measured: Up to Month 14
Percentage of PCP Practices Eligible for Participation in Trial that Enroll
Measured: Up to Month 14
Percentage of Providers who View PRO Reports
Measured: Up to Month 14
Percentage of Patients who Respond to PRO Text Messages
Measured: Up to Month 14
Percentage of Patients who View PRO Interactive Dashboard
Measured: Up to Month 14
Mean Number of EHR Reports Viewed by Providers
Measured: Up to Month 14
Total Number of EHR Reports Viewed by Providers
Measured: Up to Month 14
Percentage of PRO Messages Responded To by Patients
Measured: Up to Month 14
Mean Number of PRO Messages Responded To by Patients
Measured: Up to Month 14
Total Number of PRO Messages Responded To by Patients
Measured: Up to Month 14
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard
Measured: Up to Month 14
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard
Measured: Up to Month 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start4 Nov 2025
- Primary completion19 May 2026
- Study completion19 Jun 2026
Why it stopped: Funding was terminated for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devin Mann, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884775
- Sponsor's protocol ID
- 23-00608
- Status last verified
- Aug 2026
- First submitted
- 23 May 2023
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD collected in this study will be available only to: • The research team, including the Principal Investigator, study coordinators, and personnel responsible for the support or oversight of the study
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iMatter2: An Artificial Intelligence (AI)-Driven Approach to Supercharge a Novel Digital Patient-reported Outcomes Tool for Diabetes Management
- ClinicalTrials.gov ID
- NCT05884775
- Acronym / sponsor ID
- 23-00608
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was terminated for the study.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- 19 May 2026 (actual)
- Study completion
- 19 Jun 2026 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iMatter2 | Experimental | Other: Mobile Health (mHealth) Patient-Reported Outcome (PRO) toolAll the patients within a primary care provider (PCP) randomized to the intervention will receive iMatter2. |
| Usual Care (UC) | No intervention | –All patients within PCPs randomized to UC will receive standard Type 2 diabetes (T2D) care by their PCP. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- 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 (7 listed)
- 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
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 |
|---|---|---|
| Mobile Health (mHealth) Patient-Reported Outcome (PRO) toolAlso: iMatter2Once the program begins, the AI chatbot sends daily text messages that include the PRO questions; a link to a library of educational resources tailored to their responses and personalized motivational messages with support. Participants will also be sent links to the interactive web-based dashboard that visualizes their daily PRO and HbA1c data. PCPs will be able to view reports of patients' PRO and A1c data through the EHR interface, which can be reviewed during visits with the patient or asynchronously to track patient PROs between visits. | Other | iMatter2 |
Primary outcome
Change in Hemoglobin A1C (HbA1c)
Time frame: Baseline, Month 12
HbA1c will be extracted from lab data available within the EHR
12 secondary outcomes
Percentage of Patients Eligible for Participation in Trial who Enroll
Time frame: Up to Month 14
Percentage of PCP Practices Eligible for Participation in Trial that Enroll
Time frame: Up to Month 14
Percentage of Providers who View PRO Reports
Time frame: Up to Month 14
Percentage of Patients who Respond to PRO Text Messages
Time frame: Up to Month 14
Percentage of Patients who View PRO Interactive Dashboard
Time frame: Up to Month 14
Mean Number of EHR Reports Viewed by Providers
Time frame: Up to Month 14
Total Number of EHR Reports Viewed by Providers
Time frame: Up to Month 14
Percentage of PRO Messages Responded To by Patients
Time frame: Up to Month 14
Mean Number of PRO Messages Responded To by Patients
Time frame: Up to Month 14
Total Number of PRO Messages Responded To by Patients
Time frame: Up to Month 14
Mean Number of Reports Viewed by Patients via PRO Interactive Dashboard
Time frame: Up to Month 14
Total Number of Reports Viewed by Patients via PRO Interactive Dashboard
Time frame: Up to Month 14
Results and safety
The study was stopped early (reason given: Funding was terminated for the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No. IPD collected in this study will be available only to: • The research team, including the Principal Investigator, study coordinators, and personnel responsible for the support or oversight of the study
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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.
Devin Mann 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 Mobile Health (mHealth) Patient-Reported Outcome (PRO) tool in people with Type 2 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 9 inclusion and 7 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: stopped early, as of the sponsor's last update on 27 Aug 2026. 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?
The study was stopped early (reason given: Funding was terminated for the study.). Results are not available in the source record.
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?
Change in Hemoglobin A1C (HbA1c) (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2026.