AIManage for Diabetes and Obesity

ES
Overseen ByElizabeth Stevens, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Must be taking: Incretin mimetics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called AIManage, which assists doctors in managing diabetes and obesity treatments. The tool uses artificial intelligence to recommend optimal doses of incretin mimetic medications, which help control blood sugar and weight. Adults currently taking or who have recently taken these medications and can communicate in English or Spanish might be suitable candidates. The study will evaluate AIManage's effectiveness in real-world clinics. As an unphased trial, participants contribute to pioneering research that could enhance diabetes and obesity care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves patients currently taking or having taken incretin mimetic medications, it seems likely that you can continue your current medication.

What prior data suggests that the AIManage tool is safe for use in clinical settings?

Research has shown that incretin mimetic medications, overseen by AIManage, are generally safe but can cause some side effects. Studies often report stomach issues such as nausea, vomiting, and diarrhea. These side effects are typically mild and resolve on their own.

For instance, a review of glucagon-like peptide-1 receptor agonists (a type of incretin mimetic) identified nausea and vomiting as the most common side effects. Importantly, real-world studies of these medications for diabetes and obesity found no serious safety concerns.

AIManage assists in managing these medications, so its safety largely depends on its effectiveness in controlling doses and side effects. Although AIManage is still under testing, there is no direct data on its specific safety yet. However, by managing medications that are already approved, it aims to enhance the safety and effectiveness of existing treatments.12345

Why are researchers excited about this trial?

AIManage is unique because it leverages artificial intelligence to personalize treatment plans for diabetes and obesity. Unlike traditional approaches that rely on standardized medication and diet plans, AIManage analyzes individual patient data to tailor interventions, potentially improving outcomes and adherence. Researchers are excited about this treatment because it represents a shift towards more customized care, which could lead to better management of these conditions and potentially reduce the overall burden of disease.

What evidence suggests that the AIManage tool is effective for diabetes and obesity?

Research has shown that AIManage, a tool powered by advanced technology, might help manage medications for diabetes and obesity. This trial will evaluate AIManage's effectiveness in two groups: providers prescribing AIManage for at least five adult patients and adult patients who have been prescribed AIManage in the past six months. Studies have found that using AI can lead to significant weight loss and lower body mass index (BMI) in patients with these conditions. Specifically, a study by Lee in 2023 found that AI use resulted in a noticeable decrease in BMI. Additionally, a review of multiple studies found that patients with diabetes experienced meaningful weight loss with similar AI methods. These findings suggest that AIManage could improve medication management and lead to better health outcomes for people with diabetes and obesity.12678

Who Is on the Research Team?

ES

Elizabeth Stevens, PhD, MPH

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English or Spanish, are willing to text, and either take (or recently took) certain diabetes/obesity medications (incretin mimetics), or are healthcare providers at NYU clinics caring for patients on these meds.

Inclusion Criteria

* Be willing to send/receive text messages;
Provider Eligibility Criteria (Phase 1)
I am over 18 years old.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Formative Data Collection

Formative data collection for tool refinement, focusing on perceived usefulness, usability, use challenges, and value

1 day
1 visit (in-person)

Cluster Randomized Controlled Trial

Testing the AIManage tool in a cluster randomized controlled trial setting

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after the trial

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • AIManage

Trial Overview

The study is testing an AI-powered tool called AIManage that helps manage and adjust doses of specific diabetes/obesity drugs. The research will compare usual care with the use of this tool in a randomized way across different clinics.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Providers (Phase 1)Experimental Treatment1 Intervention
Group II: Patients (Phase 1)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

AIManage Using an AI-driven CDS and Chatbot

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 ...

AIManage Using an AI-driven CDS and Chatbot | MedPath

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 ...

AIManage using an AI-driven CDS and chatbot for the ...

AIManage using an AI-driven CDS and chatbot for the management of patients on incretin mimetic medications. Funder: National Institute of Diabetes and Digestive ...

AIManage for Diabetes and Obesity · Info for Participants

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 ...

stevens, elizabeth reid

The clinical trial phase will use a hybrid type 1 RCT to evaluate the effectiveness of AIManage vs. usual care (UC) on maintenance dose achievement and ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39761578/

Efficacy and Safety of Glucagon-Like Peptide-1 Receptor ...

Conclusion: GLP-1 RAs and co-agonists are efficacious for weight loss, with reported safety concerns predominantly gastrointestinal in nature, ...

Effectiveness and Safety of Add-on Once-Daily Liraglutide ...

OBJECTIVE: This study aimed to evaluate real-world effectiveness and safety of once-daily liraglutide (1.2 mg) as an add-on to oral ...

The science of safety: adverse effects of GLP-1 receptor ... - PMC

A recent systematic review of 39 randomized controlled trials of GLP-1RAs showed a class effect of increased risks of nausea, vomiting, diarrhea ...