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NCT Number: NCT07339852

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

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.

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Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Hyperlipidaemia Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. A1C change

    Time frame: Up to 6 months

    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.

Secondary outcomes

  1. Estimated cardiovascular risk

    Time frame: Up to 6 months.

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

  2. Blood Pressure

    Time frame: Up to 6 months.

    The difference in change in blood pressure from baseline to the end of the study (up to six months) between the intervention and control groups.

  3. LDL cholesterol concentration

    Time frame: Up to 6 months.

    The difference in change in serum LDL-cholesterol concentration from baseline to the end of the study (up to six months) between the intervention and control groups

  4. Influenza vaccination

    Time frame: Up to 6 months.

    The difference in the proportion of participants who receive their influenza vaccination from baseline to the end of the study (up to six months) between the intervention and control groups.

  5. Pneumococcal vaccination

    Time frame: Up to 6 months

    The difference in the proportion of participants who receive their pneumococcal vaccination from baseline to the end of the study (up to six months) between the intervention and control groups.

  6. Foot exam

    Time frame: Up to 6 months

    The difference in the proportion of participants who complete foot exams from baseline to the end of the study (up to six months) between the intervention and control groups.

  7. Eye Exam

    Time frame: Up to 6 months.

    The difference in the proportion of participants who complete eye exams from baseline to the end of the study (up to six months) between the intervention and control groups.

  8. Renal function screening

    Time frame: Up to 6 months.

    The difference in the proportion of participants who complete renal function screening (glomerular filtraion rate, albumin to creatinine ratio) from baseline to the end of the study (up to six months) between the intervention and control groups.

  9. Vascular Protection

    Time frame: Up to 6 months.

    The difference in the proportion of participants who have guideline-based vascular protection in place from baseline to the end of the study (up to six months) between the intervention and control groups.

  10. Pharmacist prescribed prescription medications

    Time frame: Up to 6 months.

    Pharmacist prescribing or changing the dose of medications from baseline to the end of the study (up to six months) between the intervention and control groups.

  11. Pharmacist provided education on lifestyle factors

    Time frame: Up to 6 months

    Education on lifestyle factors (tobacco cessation, diet, exercise) from baseline to the end of the study (up to six months) between the intervention and control groups.

  12. Pharmacist provided education on medications and importance of adherence.

    Time frame: Up to 6 months

    Pharmacist intervention of providing education on medications and importance of adherence from baseline to the end of the study (up to six months) between the intervention and control groups.

  13. Laboratory Monitoring

    Time frame: Up to 6 months.

    The difference in the proportion of participants who attend the laboratory for routine monitoring from baseline to the end of the study (up to six months) between the intervention and control groups.

  14. Continuous Glucose Monitoring

    Time frame: Up to 6 months.

    The difference in the proportion of participants who use continuous glucose monitoring devices from baseline to the end of the study (up to six months) between the intervention and control groups.

  15. Yield of enrolment approaches

    Time frame: Up to 6 months.

    The yield from each enrolment approach used (active case-finding approach vs. passive approaches such as when the patient attends the pharmacy to collect a prescription medication or through patient self-identification).

  16. Yield of enrollment by pharmacy type

    Time frame: Up to 6 months.

    Yield of enrollment by clinic or non-clinic pharmacy type.

  17. Shared-decision making uptake

    Time frame: Up to 6 months.

    Extent to which shared decision making was achieved in the intervention as measured by the validated Shared Decision Making 9-item Questionnaire (SDM-Q-9) tool. The minimum score is 0 and the maximum score is 45, where a higher score indicates a greater subjective level of shared decision making.

  18. Patient satisfaction - standard

    Time frame: Up to 6 months.

    Patient satisfaction as measured by the diabetes treatment satisfaction questionnaire standard (DTSQs). The standard version of the DTSQ consists of eight questions on a 0-6 Likert scale (where 0 is very dissatisfied and 6 is very satisfied). Minimum score = 0, maximum score = 48.

  19. Patient satisfaction - change

    Time frame: Up to 6 months.

    Patient satisfaction as measured by the diabetes treatment satisfaction questionnaire change (DTSQc). It is designed to overcome ceiling effects, where satisfaction is already high, by allowing for more precise reporting of improvements or declines, and thus must be used alongside the DTSQs to understand both the absolute satisfaction level and the change over time.

    The change version of the DTSQ consists of eight questions on a 0-6 Likert scale (where 0 is very dissatisfied and 6 is very satisfied). Minimum score = 0, maximum score = 48.

Study contacts

Contact information is provided by the study sponsor or research team.

Ross Tsuyuki, BScPharm, PharmD, MSc

CONTACT

[email protected]

780-492-8526

Stephanie Gysel, BScPharm, PharmD

CONTACT

[email protected]

403-993-6678

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Acronym: D-PATH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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