Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies

NCT07339852 | Recruiting

• 1 other identifier: Pro00145395
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

As of 2024, nine percent of Albertans are living with Type 2 diabetes, which increases their risk for cardiovascular disease, stroke, blindness, and kidney failure. Unfortunately, less than half of patients have controlled Type 2 diabetes. We are well aware of the factors which lead to worsening diabetes, but need to give people more support to help them manage their diabetes. Pharmacists are respected health care professionals who are often easier to see that doctors and can help people with diabetes to stay as healthy as possible. This research project aims to see whether a pharmacist service can help improve diabetes management in people with type 2 diabetes compared to usual care from their family physician or nurse practitionner. The potential impact of this project is to empower people with type 2 diabetes to understand their condition, it's management, and to achieve target blood sugar levels, which will ultimately reduce the risk of diabetes-related complications.

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidaemia

Keywords

diabetes; pharmacist; pathway; shared decision making

Outcome Measures

Primary Outcomes (1)

• A1C change

  The primary outcome is the difference in change in A1C calculated from baseline to the end of the study (up to six months) between the intervention and control groups.

  Up to 6 months

Secondary Outcomes (19)

• Estimated cardiovascular risk

  Up to 6 months.

• Blood Pressure

  Up to 6 months.

• LDL cholesterol concentration

  Up to 6 months.

• Influenza vaccination

  Up to 6 months.

• Pneumococcal vaccination

  Up to 6 months

Study Arms (2)

Pharmacist-led care pathway

EXPERIMENTAL

Participants in the intervention arm will receive the care using a shared decision-making pharmacist care pathway approach designed to guide type 2 diabetes management to achieve target A1C levels and reduce the risk of diabetes-related complications. The pharmacist care pathway is modelled after the Canadian Diabetes Association Guidelines. This pathway (tool) will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to achieve target A1C levels and reduce the risk of diabetes-related complications. This will occur through follow-ups every 6 weeks for six months duration.

Other: Pharmacist-led diabetes care pathway

Usual Care

NO INTERVENTION

The control group will involve facilitated relay of information to participants' family physician or nurse practitioner. Participants in the control group will have their pharmacist collect information informing the patient's current diabetes control. Participants will then be given a letter that contains their A1C value, and they will be advised to present it to their family physician or nurse practitioner. No specific suggestions for diabetes management will be detailed in the letter. In the case where the patient does not have a family physician or nurse practitioner, they will be referred to a physician walk-in clinic. A follow-up appointment will be booked for all participants in the control group at 3-months to discuss dietary and lifestyle interventions in the management of type 2 diabetes to maintain participant interest in the study and again at 6-months' time for a final visit.

Interventions

Pharmacist-led diabetes care pathway OTHER

articipants in the intervention arm will receive the care using a shared decision-making pharmacist care pathway approach designed to guide type 2 diabetes management to achieve target A1C levels and reduce the risk of diabetes-related complications. The pharmacist care pathway is modelled after the Canadian Diabetes Association Guidelines22. This pathway (tool) will be built into a computer web-based program and include step-by-step, algorithm-guided patient assessment to achieve target A1C levels and reduce the risk of diabetes-related complications. This will occur through follow-ups every 6 weeks for six months duration.

Pharmacist-led care pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged 18 years or older.
• Individuals with type 2 diabetes.
• Individuals with type 2 diabetes not reaching HbA1c target of under 7.0%

You may not qualify if:

• Individuals with type 1 diabetes, gestational diabetes, or other forms of diabetes that are not type 2 diabetes.
• Pregnant individuals.
• Individuals at their HbA1c target (HbA1c under 7.0%) or those with a limited life expectancy, frailty, or lack hypoglycemic awareness (i.e., those with an A1c target above 7.0%) .
• Individuals unable to provide consent or who are unwilling to attend follow-up visits.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Ross Tsuyuki, BScPharm, PharmD, MSc

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Gysel, BScPharm, PharmD

CONTACT

403-993-6678; sgysel@ualberta.ca

Ross Tsuyuki, BScPharm, PharmD, MSc

CONTACT

780-492-8526; rtsuyuki@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: January 14, 2026
• Study Start: October 13, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)