Type 2 Diabetes Mellitus (T2DM)SPY-DMNCT06861491
Student Pharmacist Non-Pharmacological Intervention on Type 2 Diabetes Management in Older Asian Adult Populations
A study testing Non-pharmacological in people with Type 2 Diabetes Mellitus (T2DM), run by University of California, San Francisco.
Trial summary
This study is being done to assess the impact of student pharmacist involvement on blood glucose control through non-pharmacological interventions in people of Asian and Asian descent over the age of 50 with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Non-pharmacological
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥ 50 years old
- Asian or Asian-descent
- Diagnosed with T2DM
- A1C >7.0% (uncontrolled)
- Take blood glucose measurements as prescribed by their physician, or consistently (defined as missing no more than 1 reading from their regular routine).
Who cannot join
- Age < 50 years old
- Not diagnosed with type 2 diabetes, or have diagnoses such as type 1 diabetes, gestational diabetes, or medication induced diabetes
- Patients that are on medications that affect glycemic control
- Corticosteroids
- First-generation antipsychotics (e.g. chlorpromazine, perphenazine, phenothiazines)
- Immunosuppressants (e.g. tacrolimus, cyclosporine)
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- Experiencing acute disease states
- Recent surgery/hospitalized within the last 3 months
- Active infections
- Non-adherence to blood glucose monitoring (defined as missing > 1 reading from their regular routine or not taking readings as prescribed by their doctor)
- Patients with late stage T2DM requiring insulin therapy
- Diagnosed with cancer, end-stage renal disease, end-stage liver disease
- Received any organ transplant
About this study
Official title: Student Pharmacist Intervention on Type 2 Diabetes Management in Older Adult Populations
This study is being done to assess the impact of student pharmacist involvement on blood glucose control through non-pharmacological interventions in people of Asian and Asian descent over the age of 50 with type 2 diabetes. This study team is trying to advance the field of pharmacy and expand the roles of student pharmacists.
Read the detailed description
This study aims to assess the clinical impact of student pharmacist-led interventions on glycemic control in adult populations. This study will specifically target adults aged 50 years and older of Asian or Asian-descent with diagnosed type 2 diabetes, residing in San Francisco. The goal of the study is to demonstrate the utility of pharmacy students in a community setting on chronic disease management through patient-specific education and interventions. The aims of this study are to compare glycemic control in patients with type 2 diabetes who receive continuous assessment and non-pharmacological counseling from student pharmacists versus those who do not. Specifically, this study will evaluate:
- The impact of student pharmacist assessments and personalized recommendations on diet, exercise, and adherence to treatment regimens, and their lasting effects on blood glucose control.
- If participants perceived any value and effect of student pharmacist involvement in managing chronic diseases.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Non-pharmacological
- Keywords
- student pharmacist, non-pharmacological, diabetes, management, SPY-DM, glucose control, Asian, Older adult
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacologicalBehavioural
Also called Lifestyle, Diet, Exercise, Adherence
This intervention will be provided by student pharmacists. It will focus on lifestyle modifications, adherence, and education of disease state.
| Study group | Role | What they receive |
|---|---|---|
| Non-pharmacological intervention and education by student pharmacists | Experimental | Student pharmacists will provide non-pharmacological recommendations to participants about lifestyle modifications, including exercise and diet, as well as provide information about current medications the participant is taking. Receives: Behavioral: Non-pharmacological |
| Control | No intervention | Student pharmacists will collect data on participants, but will not provide recommendations on non-pharmacological management. However, they will provide online resources on diabetes management if prompted. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose control
This will assess the average blood glucose change over the course of the study.
Measured: Up to 12 months
A1C
To assess effect of student pharmacist non-pharmacological intervention on A1C levels
Measured: Up to 12 months
Secondary outcomes (2)
Utilization of Questionnaires to assess Comprehension of Diabetes Management
Student pharmacists will be assessed on their change in understanding of type 2 diabetes management through an assessment that will be scored. Study participants will also be assessed on their comfort and understanding of type 2 diabetes as a disease state, as well as basic management through a form that will be scored.
Once the questionnaire is finalized, participants will be asked to complete the form with higher scores indicating better level of understanding.
Measured: Up to 12 months
Utilization of Questionnaires to assess Participant Perceptions of Student Pharmacist Involvement on Chronic Disease Management
Study participants will be asked to complete a questionnaire to reflect on their experiences with student pharmacists. Overall perception of their experience will be collected utilizing a combination of short-answer and multiple-choice questions. Multiple-choice questions will be analyzed using Likert Scale with higher values representing favorable outcomes. Short-answer questions will be coded to identify overall themes of the study to address areas for improvement.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study startApr 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crystal Zhou, PharmD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861491
- Sponsor's protocol ID
- 24-42131
- Acronym
- SPY-DM
- Status last verified
- Jul 2026
- First submitted
- 17 Feb 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Student Pharmacist Intervention on Type 2 Diabetes Management in Older Adult Populations
- ClinicalTrials.gov ID
- NCT06861491
- Acronym / sponsor ID
- SPY-DM / 24-42131
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- student pharmacist, non-pharmacological, diabetes, management, SPY-DM, glucose control, Asian, Older adult
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 6 Mar 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.
This study is being done to assess the impact of student pharmacist involvement on blood glucose control through non-pharmacological interventions in people of Asian and Asian descent over the age of 50 with type 2 diabetes. This study team is trying to advance the field of pharmacy and expand the roles of student pharmacists.
Detailed description
This study aims to assess the clinical impact of student pharmacist-led interventions on glycemic control in adult populations. This study will specifically target adults aged 50 years and older of Asian or Asian-descent with diagnosed type 2 diabetes, residing in San Francisco. The goal of the study is to demonstrate the utility of pharmacy students in a community setting on chronic disease management through patient-specific education and interventions. The aims of this study are to compare glycemic control in patients with type 2 diabetes who receive continuous assessment and non-pharmacological counseling from student pharmacists versus those who do not. Specifically, this study will evaluate:
- The impact of student pharmacist assessments and personalized recommendations on diet, exercise, and adherence to treatment regimens, and their lasting effects on blood glucose control.
- If participants perceived any value and effect of student pharmacist involvement in managing chronic diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological intervention and education by student pharmacists | Experimental | Behavioral: Non-pharmacologicalStudent pharmacists will provide non-pharmacological recommendations to participants about lifestyle modifications, including exercise and diet, as well as provide information about current medications the participant is taking. |
| Control | No intervention | –Student pharmacists will collect data on participants, but will not provide recommendations on non-pharmacological management. However, they will provide online resources on diabetes management if prompted. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults ≥ 50 years old
- Asian or Asian-descent
- Diagnosed with T2DM
- A1C >7.0% (uncontrolled)
- Take blood glucose measurements as prescribed by their physician, or consistently (defined as missing no more than 1 reading from their regular routine).
Key exclusion criteria (13 listed)
- Age < 50 years old
- Not diagnosed with type 2 diabetes, or have diagnoses such as type 1 diabetes, gestational diabetes, or medication induced diabetes
- Patients that are on medications that affect glycemic control
- Corticosteroids
- First-generation antipsychotics (e.g. chlorpromazine, perphenazine, phenothiazines)
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 |
|---|---|---|
| Non-pharmacologicalAlso: Lifestyle, Diet, Exercise, AdherenceThis intervention will be provided by student pharmacists. It will focus on lifestyle modifications, adherence, and education of disease state. | Behavioural | Non-pharmacological intervention and education by student pharmacists |
Primary outcome
Blood glucose control
Time frame: Up to 12 months
This will assess the average blood glucose change over the course of the study.
A1C
Time frame: Up to 12 months
To assess effect of student pharmacist non-pharmacological intervention on A1C levels
2 secondary outcomes
Utilization of Questionnaires to assess Comprehension of Diabetes Management
Time frame: Up to 12 months
Utilization of Questionnaires to assess Participant Perceptions of Student Pharmacist Involvement on Chronic Disease Management
Time frame: Up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- 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. This study is not recruiting at the moment.
Crystal Zhou, PharmD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Non-pharmacological in people with Type 2 Diabetes Mellitus (T2DM), run by University of California, San Francisco.
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 5 inclusion and 13 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: withdrawn, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Blood glucose control (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2026.