Clinical trial NCT06861491: Student Pharmacist Non-Pharmacological Intervention on Type 2 Diabetes Management in Older Asian Adult Populations
Official title: Student Pharmacist Intervention on Type 2 Diabetes Management in Older Adult Populations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: student pharmacist
non-pharmacological
diabetes
management
SPY-DM
glucose control
Asian
Older adult
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood glucose control
timeFrame: Up to 12 months
measure: A1C
timeFrame: Up to 12 months
Secondary outcomes:
measure: Utilization of Questionnaires to assess Comprehension of Diabetes Management
timeFrame: Up to 12 months
measure: Utilization of Questionnaires to assess Participant Perceptions of Student Pharmacist Involvement on Chronic Disease Management
timeFrame: Up to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Crystal Zhou, PharmD
role: PRINCIPAL_INVESTIGATOR
References: