NCT06861491

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 6, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

March 6, 2025

Status Verified

February 1, 2025

Enrollment Period

11 months

First QC Date

February 17, 2025

Last Update Submit

February 28, 2025

Conditions

Keywords

student pharmacistnon-pharmacologicaldiabetesmanagementSPY-DMglucose controlAsianOlder adult

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Utilization of Questionnaires to assess Comprehension of Diabetes Management

    Up to 12 months

  • Utilization of Questionnaires to assess Participant Perceptions of Student Pharmacist Involvement on Chronic Disease Management

    Up to 12 months

Study Arms (2)

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.

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.

Interventions

This intervention will be provided by student pharmacists. It will focus on lifestyle modifications, adherence, and education of disease state.

Also known as: Lifestyle, Diet, Exercise, Adherence
Non-pharmacological intervention and education by student pharmacists

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

DietExercise

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Crystal Zhou, PharmD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Zhou, PharmD

CONTACT

Jerril Jacob, BS in Biochemistry

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2025

First Posted

March 6, 2025

Study Start

April 1, 2025

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

March 6, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share