MetSense Risk Flag for Type 2 Diabetes
(MetSenseP&F Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assist individuals with serious mental illnesses, such as schizophrenia or bipolar disorder, who face a high risk of developing type 2 diabetes. It evaluates a new tool called the MetSense risk flag, which uses electronic health records to alert clinical pharmacists about patients who may need additional attention to prevent diabetes. Participants will be divided into two groups: one group will have pharmacists who can access the MetSense alerts, while the other will receive regular care without those alerts. This trial suits individuals already participating in a mental health management program at Kaiser Permanente Northern California. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance diabetes prevention strategies for those with mental illness.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue them, as the study involves monitoring the effects of medications you are already taking.
What prior data suggests that the MetSense Risk Flag is safe for use in diabetes risk management?
Research shows that the MetSense Risk Flag helps clinical pharmacists identify patients at high risk for type 2 diabetes. This tool alerts healthcare providers, enabling better management of diabetes risk.
The MetSense Risk Flag requires no medication or physical treatment. It uses existing health data to predict risk, eliminating direct safety concerns for patients since it is data-based, not a medical procedure.
The goal is to enhance care by notifying doctors, not to introduce new risks or side effects. Therefore, participants using the MetSense Risk Flag should not expect any negative effects from the tool itself.12345Why are researchers excited about this trial?
Researchers are excited about the MetSense Risk Flag because it introduces a new method of managing Type 2 diabetes by providing clinical pharmacists with a risk flag tool. Unlike traditional management, which often relies on routine monitoring and medication adjustments, MetSense gives pharmacists real-time insights into a patient's risk levels, potentially allowing for more personalized and proactive care. This approach could lead to more timely interventions, helping to prevent complications and optimize treatment outcomes for patients.
What evidence suggests that the MetSense Risk Flag is effective for managing diabetes risk in patients with serious mental illness?
Research has shown that lifestyle changes and medications like metformin can often prevent type 2 diabetes. This trial evaluates the MetSense Risk Flag as a tool to help pharmacists identify patients at high risk for diabetes using electronic health records. Clinical pharmacists will manage participants in one arm of the trial with access to the MetSense risk flag, while the other arm will receive usual care without it. Studies have demonstrated that non-invasive prediction tools, such as MetSense, can successfully identify individuals who might develop diabetes. By alerting pharmacists, these tools can prompt early action, potentially lowering the risk of diabetes. Early intervention is crucial because it can lead to better health outcomes for those at risk.16789
Who Is on the Research Team?
Esti Iturralde, PhD
Principal Investigator
KPNC Division of Research
Are You a Good Fit for This Trial?
This trial is for people with serious mental illness who are at high risk of developing type 2 diabetes, often due to the metabolic side effects of their psychiatric medications. It's designed to see if clinical pharmacists can better manage these risks using a special alert system.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants are managed by clinical pharmacists with or without the MetSense risk flag to prioritize diabetes risk management services
Follow-up
Participants are monitored for safety and effectiveness after intervention
What Are the Treatments Tested in This Trial?
Interventions
- MetSense Risk Flag
Trial Overview
The study tests a 'MetSense Risk Flag'—a tool based on health record data that warns pharmacists when patients with serious mental illness face high diabetes risk. The goal is to improve early screening and management compared to usual care practices.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive usual care. They will be managed by clinical pharmacists who are not able to view the MetSense risk flag.
Participants will be managed by clinical pharmacists who are able to view the MetSense risk flag.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kaiser Permanente
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
NCT07264062 | MetSense Pilot and Feasibility
This study seeks to evaluate the feasibility, acceptability, and preliminary effectiveness of using the MetSense risk flag to prompt further ...
Use and Impact of Type 2 Diabetes Prevention Interventions
RCTs have found that type 2 diabetes can be prevented among high-risk individuals by metformin medication and evidence-based lifestyle change programs.
Non-invasive risk scores for prediction of type 2 diabetes ...
We selected non-invasive prediction models for incident diabetes developed in populations of European ancestry and validated them using data ...
Social Risks and Diabetes Care Quality, Outcomes
Social risks (e.g., food/transportation insecurity) can hamper type 2 diabetes mellitus (T2DM) self-management, leading to poor outcomes.
Selecting Core Outcomes for Randomised Effectiveness ...
The SCORE-IT study has developed patient and health professional consensus on outcomes for trials of the treatment of hyperglycemia in people ...
METS-IR Predicts Cardiovascular Risk in Type 2 Diabetes
Higher METS-IR is linked to increased risks of major cardiovascular events, heart failure, and mortality in T2D patients. The study found a dose ...
Association of METS-IR index with Type 2 Diabetes
Specifically, each unit increase in METS-IR was associated with a 7% increase in the risk of T2DM (OR = 1.07, 95% CI: 1.06, 1.08). Subgroup ...
8.
diabetesincontrol.com
diabetesincontrol.com/changes-in-risk-indicators-of-mets-severity-tied-to-t2dm-risk/Changes in Risk Indicators of MetS Severity Tied to T2DM ...
The strongest association was seen for risk for T2DM within one to five years with one-year changes in MetS-Z and waist circumference; the risk ...
213182Orig1s000 SUMMARY REVIEW - accessdata.fda.gov
The safety profile for semaglutide was previously reviewed and no new safety data was submitted. Type 2 diabetes mellitus (T2DM) is a serious, ...
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