Student Pharmacist Non-Pharmacological Intervention on Type 2 Diabetes Management in Older Asian Adult Populations (SPY-DM)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Non-pharmacological

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:

1. 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.
2. If participants perceived any value and effect of student pharmacist involvement in managing chronic diseases.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Crystal Zhou, PharmD; Phone Number: (415) 476-2354; Email: crystal.zhou@ucsf.edu
• Study Contact Backup: Name: Jerril Jacob, BS in Biochemistry; Phone Number: (510) 320-4977; Email: jerril.jacob@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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)
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-pharmacological intervention and education by student pharmacists; 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.	Behavioral: Non-pharmacological; This intervention will be provided by student pharmacists. It will focus on lifestyle modifications, adherence, and education of disease state.; Other Names: Exercise; Diet; Lifestyle; Adherence
No Intervention: Control; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood glucose control	This will assess the average blood glucose change over the course of the study.	Up to 12 months
A1C	To assess effect of student pharmacist non-pharmacological intervention on A1C levels	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Crystal Zhou, PharmD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: February 17, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; glucose control; management; Asian; non-pharmacological; Older adult; student pharmacist; SPY-DM
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: 24-42131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No