DiabetesNCT07546357
AIManage Using an AI-driven CDS and Chatbot
A study testing AIManage in people with Diabetes and Obesity, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations. The study will take place across primary care and obesity medicine clinics at NYUH. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Obesity, Medication Side Effects
- What is being tested?
- AIManage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Provider Eligibility Criteria (Phase 1)
- Primary or bariatric care provider (MD/DO, NP) practicing at the participating NYULH clinics,
- Provide care to at least 5 patients prescribed an IMM.
- Patient Eligibility Criteria (Phase 1)
- (Phase 1) Currently taking an IMM or have taken an IMM in the past 6 months;
- Fluency in English or Spanish;
- Be willing to send/receive text messages; and
- Be > 18 years of age.
Who cannot join
- Provider Exclusion Criteria (Phase 1) • Refuse to participate
- Patient Exclusion Criteria (Phase 1)
- Refuse or are unable to provide informed consent;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: AIManage: Using an AI-driven CDS and Chatbot for the Management of Patients on Incretin Mimetic Medications
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations. The study will take place across primary care and obesity medicine clinics at NYUH.
The study is currently conducting formative data collection for tool refinement (Phase 1). Once completed, a cluster randomized controlled trial of the AIManage tool will be undertaken (Phase 2).
- Conditions
- Diabetes, Obesity, Medication Side Effects
- Being tested
- AIManage
- Keywords
- GLP-1, Incretin mimetic, medication management, side effect management
- Medical subject headings
- Diabetes Mellitus, Obesity, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIManageOther
GenAI-powered CDS tool that provides a range of IMM management services, such as personalized guidance for patients on side effects management and clinical advisement to optimize dose titrations.
| Study group | Role | What they receive |
|---|---|---|
| Providers (Phase 1) | Experimental | Providers prescribing IMM for at least 5 adult patients in primary care and obesity medicine clinics. Receives: Other: AIManage |
| Patients (Phase 1) | Experimental | Adult patients prescribed an IMM in the past 6 months. Receives: Other: AIManage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness
In Phase 1, qualitative data regarding perceived usefulness will be collected.
Measured: Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Usability
In Phase 1, qualitative data regarding perceived usability will be collected.
Measured: Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Use Challenges
In Phase 1, qualitative data regarding perceived use challenges will be collected.
Measured: Day 1 (60 minutes)
Percentage of Patients who Complete Qualitative Measure - Perceived Value
In Phase 1, qualitative data regarding perceived value will be collected.
Measured: Day 1 (60 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Stevens, PhD, MPH, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546357
- Sponsor's protocol ID
- 25-00594
- Other IDs
- 1R01DK144008
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Elizabeth.Stevens@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIManage: Using an AI-driven CDS and Chatbot for the Management of Patients on Incretin Mimetic Medications
- ClinicalTrials.gov ID
- NCT07546357
- Acronym / sponsor ID
- 25-00594
- Conditions
- Diabetes, Obesity, Medication Side Effects
- Keywords
- GLP-1, Incretin mimetic, medication management, side effect management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 22 Apr 2026 (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.
The objective of this project is to define and test the GenAI-powered Clinical Decision Support (CDS) tool, AIManage, providing a broad range of incretin mimetic medication management services to optimize dose titrations. The study will take place across primary care and obesity medicine clinics at NYUH.
The study is currently conducting formative data collection for tool refinement (Phase 1). Once completed, a cluster randomized controlled trial of the AIManage tool will be undertaken (Phase 2).
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Providers (Phase 1) | Experimental | Other: AIManageProviders prescribing IMM for at least 5 adult patients in primary care and obesity medicine clinics. |
| Patients (Phase 1) | Experimental | Other: AIManageAdult patients prescribed an IMM in the past 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Provider Eligibility Criteria (Phase 1)
- Primary or bariatric care provider (MD/DO, NP) practicing at the participating NYULH clinics,
- Provide care to at least 5 patients prescribed an IMM.
- Patient Eligibility Criteria (Phase 1)
- (Phase 1) Currently taking an IMM or have taken an IMM in the past 6 months;
Key exclusion criteria (3 listed)
- Provider Exclusion Criteria (Phase 1) • Refuse to participate
- Patient Exclusion Criteria (Phase 1)
- Refuse or are unable to provide informed consent;
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 |
|---|---|---|
| AIManageGenAI-powered CDS tool that provides a range of IMM management services, such as personalized guidance for patients on side effects management and clinical advisement to optimize dose titrations. | Other | Patients (Phase 1), Providers (Phase 1) |
Primary outcome
Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness
Time frame: Day 1 (60 minutes)
In Phase 1, qualitative data regarding perceived usefulness will be collected.
Percentage of Patients who Complete Qualitative Measure - Perceived Usability
Time frame: Day 1 (60 minutes)
In Phase 1, qualitative data regarding perceived usability will be collected.
Percentage of Patients who Complete Qualitative Measure - Perceived Use Challenges
Time frame: Day 1 (60 minutes)
In Phase 1, qualitative data regarding perceived use challenges will be collected.
Percentage of Patients who Complete Qualitative Measure - Perceived Value
Time frame: Day 1 (60 minutes)
In Phase 1, qualitative data regarding perceived value will be collected.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon reasonable request beginning 9 to 36 months after publication or as required by a condition of awards or supporting agreements, provided the requesting investigator executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: Elizabeth.Stevens@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Elizabeth Stevens, PhD, MPH 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 AIManage in people with Diabetes and Obesity, 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 3 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: opening soon, as of the sponsor's last update on 22 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elizabeth Stevens, PhD, MPH (646-501-2558, Elizabeth.Stevens@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients who Complete Qualitative Measure - Perceived Usefulness (time frame: Day 1 (60 minutes)). The study lists 4 primary outcomes in all. 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 22 Apr 2026.