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

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Behavioral: Non-pharmacological

Study type: Interventional

Funder types: Other

Identifiers

NCT06861491

24-42131

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Non-pharmacological intervention and education by student pharmacists

Experimental group

Description:

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.

Treatment:

Behavioral: Non-pharmacological

Control

No Intervention group

Description:

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.