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Enrolling by Invitation

NCT Number: NCT07264062

MetSense Pilot and Feasibility

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KPNC Division of Research

Pleasanton, California, 94588, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MetSense Risk Flag

Behavioral

The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.

Usual Care

Other

Participants will receive usual care.

Primary outcomes

  1. Percent with completed hemoglobin A1c test within 6 months.

    Time frame: 6 months

    Laboratory test completion

Secondary outcomes

  1. 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

  2. Percent with body mass index measurement within 6 months.

    Time frame: 6 months

    Body mass index recorded in the electronic health record

  3. Percent with prediabetes diagnosis within 6 months.

    Time frame: 6 months

    Diagnosis documented in the electronic health record

  4. Percent who attended a primary care visit within 6 months.

    Time frame: 6 months

    Visit documented in the electronic health record

  5. Percent with metformin medication dispensed within 6 months.

    Time frame: 6 months

    Dispensing based on pharmacy records

  6. Average hemoglobin A1c value based on the final measurement in 6 months.

    Time frame: 6 months

    Laboratory value

  7. Average body mass index based on the final measurement in 6 months.

    Time frame: 6 months

    Value recorded in the electronic health record

Other outcomes

  1. Average clinician acceptability score at 6 weeks.

    Time frame: 6 weeks

    Questionnaires and qualitative interview

  2. Average clinician acceptability score at 10 weeks.

    Time frame: 10 weeks

    Questionnaires and qualitative interview

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: MetSenseP&F

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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