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

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes Mellitus (T2DM)

• Registration Number: NCT06861491
• Lead Sponsor: University of California, San Francisco

Brief 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. 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:

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 Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Study Start: 2025-04
• Primary Completion: 2026-03
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Utilization of Questionnaires to assess Participant Perceptions of Student Pharmacist Involvement on Chronic Disease Management	Up to 12 months	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.
Utilization of Questionnaires to assess Comprehension of Diabetes Management	Up to 12 months	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.