An interventional study of MetSense Risk Flag and Usual Care in Serious Mental Illness and Type 2 Diabetes, sponsored by Kaiser Permanente. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Prevention
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.
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.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Kaiser Permanente is the lead sponsor of 385 studies on the registry; 41 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants will be managed by clinical pharmacists who are able to view the MetSense risk flag.
Behavioral: MetSense Risk Flag
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
The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.
Participants will receive usual care.
Percent with completed hemoglobin A1c test within 6 months.
Laboratory test completion
Time frame: 6 months
Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.
Electronic health record documentation via smartphrase
Time frame: 6 months
Percent with body mass index measurement within 6 months.
Body mass index recorded in the electronic health record
Time frame: 6 months
Percent with prediabetes diagnosis within 6 months.
Diagnosis documented in the electronic health record
Time frame: 6 months
Percent who attended a primary care visit within 6 months.
Visit documented in the electronic health record
Time frame: 6 months
Percent with metformin medication dispensed within 6 months.
Dispensing based on pharmacy records
Time frame: 6 months
Average hemoglobin A1c value based on the final measurement in 6 months.
Laboratory value
Time frame: 6 months
Average body mass index based on the final measurement in 6 months.
Value recorded in the electronic health record
Time frame: 6 months
Average clinician acceptability score at 6 weeks.
Questionnaires and qualitative interview
Time frame: 6 weeks
Average clinician acceptability score at 10 weeks.
Questionnaires and qualitative interview
Time frame: 10 weeks
Plan to share: No
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