Serious Mental IllnessMetSenseP&FNCT07264062
MetSense Pilot and Feasibility
A study testing MetSense Risk Flag in people with Serious Mental Illness and Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serious Mental Illness, Type 2 Diabetes
- What is being tested?
- MetSense Risk Flag
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
KPNC Division of Research
Pleasanton, California, 94588
About this study
Official title: 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.
Read the 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.
- Conditions
- Serious Mental Illness, Type 2 Diabetes
- Being tested
- MetSense Risk Flag, Usual Care
- Keywords
- serious mental illness, type 2 diabetes, diabetes prevention, prediction model, clinical decision support
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetSense Risk FlagBehavioural
The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.
Usual CareOther
Participants will receive usual care.
| Study group | Role | What they receive |
|---|---|---|
| MetSense | Active comparator | Participants will be managed by clinical pharmacists who are able to view the MetSense risk flag. Receives: 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent with completed hemoglobin A1c test within 6 months.
Laboratory test completion
Measured: 6 months
Secondary outcomes (7)
Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.
Electronic health record documentation via smartphrase
Measured: 6 months
Percent with body mass index measurement within 6 months.
Body mass index recorded in the electronic health record
Measured: 6 months
Percent with prediabetes diagnosis within 6 months.
Diagnosis documented in the electronic health record
Measured: 6 months
Percent who attended a primary care visit within 6 months.
Visit documented in the electronic health record
Measured: 6 months
Percent with metformin medication dispensed within 6 months.
Dispensing based on pharmacy records
Measured: 6 months
Average hemoglobin A1c value based on the final measurement in 6 months.
Laboratory value
Measured: 6 months
Average body mass index based on the final measurement in 6 months.
Value recorded in the electronic health record
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm pragmatic cluster-randomized pilot feasibility trial
- Masking
- None (open label)
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Esti Iturralde, Kaiser Permanente
- Investigators
- Esti Iturralde, PhD, Principal investigator, KPNC Division of Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264062
- Sponsor's protocol ID
- 1850120-11
- Other IDs
- K23MH126078
- Acronym
- MetSenseP&F
- Status last verified
- Feb 2026
- First submitted
- 24 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36569369Iturralde 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.
PubMed 38301189
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care to Prevent Diabetes and Promote Cardiovascular Health Among Younger Adults With Severe Mental Illness
- ClinicalTrials.gov ID
- NCT07264062
- Acronym / sponsor ID
- MetSenseP&F / 1850120-11
- Conditions
- Serious Mental Illness, Type 2 Diabetes
- Keywords
- serious mental illness, type 2 diabetes, diabetes prevention, prediction model, clinical decision support
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2-arm pragmatic cluster-randomized pilot feasibility trial
| Arm | Type | Receives |
|---|---|---|
| MetSense | Active comparator | Behavioral: MetSense Risk FlagParticipants will be managed by clinical pharmacists who are able to view the MetSense risk flag. |
| Usual Care | Other | Other: Usual CareParticipants will receive usual care. They will be managed by clinical pharmacists who are not able to view the MetSense risk flag. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetSense Risk FlagThe MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management. | Behavioural | MetSense |
| Usual CareParticipants will receive usual care. | Other | Usual Care |
Primary outcome
Percent with completed hemoglobin A1c test within 6 months.
Time frame: 6 months
Laboratory test completion
7 secondary outcomes
Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.
Time frame: 6 months
Percent with body mass index measurement within 6 months.
Time frame: 6 months
Percent with prediabetes diagnosis within 6 months.
Time frame: 6 months
Percent who attended a primary care visit within 6 months.
Time frame: 6 months
Percent with metformin medication dispensed within 6 months.
Time frame: 6 months
Average hemoglobin A1c value based on the final measurement in 6 months.
Time frame: 6 months
Average body mass index based on the final measurement in 6 months.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Background: PubMed 36569369Iturralde 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.
- Background: PubMed 38301189Iturralde 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Esti Iturralde, PhD principal investigator
KPNC Division of Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MetSense Risk Flag in people with Serious Mental Illness and Type 2 Diabetes, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent with completed hemoglobin A1c test within 6 months. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07264062, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.