MetSense Pilot and Feasibility (MetSenseP&F)

February 25, 2026 updated by: Esti Iturralde, Kaiser Permanente

Optimizing Care to Prevent Diabetes and Promote Cardiovascular Health Among Younger Adults With Severe Mental Illness

People with serious mental illness have high risk for type 2 diabetes due to multiple risk factors, including the metabolic side effects of psychotropic medications that are used to treat these conditions. Type 2 diabetes is preventable through lifestyle and pharmacological interventions, but many people with serious mental illness do not receive regular screening for type 2 diabetes risk. In many health care settings, clinical pharmacists are increasingly managing patients with serious mental illness and have expertise in monitoring the metabolic side effects of psychotropic medications. This study evaluates the feasibility and acceptability of using a diabetes prediction model that is based on electronic health record data (the MetSense risk flag) to alert clinical pharmacists about patients who are at high diabetes risk, prompting these clinicians to prioritize diabetes risk management services.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

MetSense is a clinical decision support tool that is being developed to help clinicians prioritize diabetes risk management services for patients with serious mental illness who have high diabetes risk. This study seeks to evaluate the feasibility, acceptability, and preliminary effectiveness of using the MetSense risk flag to prompt further evaluation of metabolic risk factors and to prioritize other diabetes risk management services, including diabetes risk screening, care coordination with patients' primary care physicians, and pharmacological management of diabetes risk. In this pragmatic, cluster-randomized trial, patients with serious mental illness will be allocated to 1 of 2 trial arms based on which clinical pharmacist manages their care. The clinical pharmacists will be randomized to view the MetSense risk flag (intervention arm) or to not view the MetSense risk flag (control arm, i.e., usual care). The primary outcome is completion of hemoglobin A1c laboratory testing. The study will also examine differences in clinician evaluation of metabolic risk factors, body mass index measurement, prediabetes diagnosis, diabetes diagnosis, primary care visits, metformin medication dispensing, hemoglobin A1c result, body mass index result, and clinician-reported acceptability and feasibility.

Study Type

Interventional

Enrollment (Estimated)

20000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pleasanton, California, United States, 94588
        • KPNC Division of Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 or older
  • Diagnosed with schizophrenia, another psychotic disorder, or bipolar disorder
  • Included in a clinical pharmacist population management program for serious mental illness within Kaiser Permanente Northern California

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MetSense
Participants will be managed by clinical pharmacists who are able to view the MetSense risk flag.
Behavioral: MetSense Risk Flag
The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.
Other: Usual Care
Participants will receive usual care. They will be managed by clinical pharmacists who are not able to view the MetSense risk flag.
Other: Usual Care
Participants will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent with completed hemoglobin A1c test within 6 months.
Time Frame: 6 months
Laboratory test completion
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.
Time Frame: 6 months
Electronic health record documentation via smartphrase
6 months
Percent with body mass index measurement within 6 months.
Time Frame: 6 months
Body mass index recorded in the electronic health record
6 months
Percent with prediabetes diagnosis within 6 months.
Time Frame: 6 months
Diagnosis documented in the electronic health record
6 months
Percent who attended a primary care visit within 6 months.
Time Frame: 6 months
Visit documented in the electronic health record
6 months
Percent with metformin medication dispensed within 6 months.
Time Frame: 6 months
Dispensing based on pharmacy records
6 months
Average hemoglobin A1c value based on the final measurement in 6 months.
Time Frame: 6 months
Laboratory value
6 months
Average body mass index based on the final measurement in 6 months.
Time Frame: 6 months
Value recorded in the electronic health record
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average clinician acceptability score at 6 weeks.
Time Frame: 6 weeks
Questionnaires and qualitative interview
6 weeks
Average clinician acceptability score at 10 weeks.
Time Frame: 10 weeks
Questionnaires and qualitative interview
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Esti Iturralde, PhD, KPNC Division of Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Actual)

December 4, 2025

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 25, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1850120-11
  • K23MH126078 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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