MetSense Pilot and Feasibility

NCT07264062 | Enrolling By Invitation

• 2 other identifiers: 1850120-11K23MH126078
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Serious Mental Illness; Type 2 Diabetes

Keywords

serious mental illness; type 2 diabetes; diabetes prevention; prediction model; clinical decision support

Outcome Measures

Primary Outcomes (1)

• Percent with completed hemoglobin A1c test within 6 months.

  Laboratory test completion

  6 months

Secondary Outcomes (7)

• Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.

  6 months

• Percent with body mass index measurement within 6 months.

  6 months

• Percent with prediabetes diagnosis within 6 months.

  6 months

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

  6 months

• Percent with metformin medication dispensed within 6 months.

  6 months

Other Outcomes (2)

• Average clinician acceptability score at 6 weeks.

  6 weeks

• Average clinician acceptability score at 10 weeks.

  10 weeks

Study Arms (2)

MetSense

ACTIVE COMPARATOR

Participants will be managed by clinical pharmacists who are able to view the MetSense risk flag.

Behavioral: MetSense Risk Flag

Usual Care

OTHER

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

Interventions

MetSense Risk Flag BEHAVIORAL

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

MetSense

Usual Care OTHER

Participants will receive usual care.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

KPNC Division of Research

Pleasanton, California, 94588, United States

Location

Related Publications (2)

• Iturralde E, Fazzolari L, Shia M, Slama N, Leang J, Awsare S, Nguyen LT. Closing the Care Gap for People with Severe and Persistent Mental Illness: Collaborative Care, Telehealth, and Clinical Pharmacy. NEJM Catal Innov Care Deliv. 2022 May;3(5):10.1056/CAT.21.0417. doi: 10.1056/CAT.21.0417.

  PMID: 36569369 BACKGROUND

• Iturralde E, Fazzolari L, Slama NE, Alexeeff SE, Sterling SA, Awsare S, Koshy MT, Shia M. Telehealth Collaborative Care Led by Clinical Pharmacists for People With Psychosis or Bipolar Disorder: A Propensity Weighted Comparison With Usual Psychiatric Care. J Clin Psychiatry. 2024 Jan 29;85(1):23m14917. doi: 10.4088/JCP.23m14917.

  PMID: 38301189 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Esti Iturralde, PhD

  KPNC Division of Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist I

Model Details: 2-arm pragmatic cluster-randomized pilot feasibility trial

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)