Diabetes MellitusD-PATHNCT07339852
Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies
A study testing Pharmacist-led diabetes care pathway in people with Diabetes Mellitus and Hypertension, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Hypertension, Hyperlipidaemia
- What is being tested?
- Pharmacist-led diabetes care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- 13 Oct 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 years or older.
- Individuals with type 2 diabetes.
- Individuals with type 2 diabetes not reaching HbA1c target of under 7.0%
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta
Ross Tsuyuki, BScPharm, PharmD, MSc., 780-994-8772, rtsuyuki@ualberta.ca
Stephanie Gysel, BScPharm, PharmD, sgysel@ualberta.ca
About this study
Official title: 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.
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidaemia
- Being tested
- Pharmacist-led diabetes care pathway
- Keywords
- diabetes, pharmacist, pathway, shared decision making
- Medical subject headings
- Diabetes Mellitus, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacist-led diabetes care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 6 months
Secondary outcomes (19)
Estimated cardiovascular risk
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.
Measured: Up to 6 months.
Blood Pressure
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.
Measured: Up to 6 months.
LDL cholesterol concentration
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
Measured: Up to 6 months.
Influenza vaccination
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.
Measured: Up to 6 months.
Pneumococcal vaccination
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.
Measured: Up to 6 months
Foot exam
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.
Measured: Up to 6 months
Eye Exam
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.
Measured: Up to 6 months.
Renal function screening
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.
Measured: Up to 6 months.
Vascular Protection
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.
Measured: Up to 6 months.
Pharmacist prescribed prescription medications
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.
Measured: Up to 6 months.
Pharmacist provided education on lifestyle factors
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.
Measured: Up to 6 months
Pharmacist provided education on medications and importance of adherence.
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.
Measured: Up to 6 months
Laboratory Monitoring
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.
Measured: Up to 6 months.
Continuous Glucose Monitoring
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.
Measured: Up to 6 months.
Yield of enrolment approaches
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).
Measured: Up to 6 months.
Yield of enrollment by pharmacy type
Yield of enrollment by clinic or non-clinic pharmacy type.
Measured: Up to 6 months.
Shared-decision making uptake
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.
Measured: Up to 6 months.
Patient satisfaction - standard
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.
Measured: Up to 6 months.
Patient satisfaction - change
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.
Measured: Up to 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start13 Oct 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ross Tsuyuki, BScPharm, PharmD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07339852
- Sponsor's protocol ID
- Pro00145395
- Acronym
- D-PATH
- Status last verified
- Jan 2026
- First submitted
- 9 Jun 2025
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Pharmacist-led Diabetes Care Pathway in Alberta Community Pharmacies.
- ClinicalTrials.gov ID
- NCT07339852
- Acronym / sponsor ID
- D-PATH / Pro00145395
- Conditions
- Diabetes Mellitus, Hypertension, Hyperlipidaemia
- Keywords
- diabetes, pharmacist, pathway, shared decision making
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 13 Oct 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pharmacist-led care pathway | Experimental | Other: Pharmacist-led diabetes care pathwayParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals aged 18 years or older.
- Individuals with type 2 diabetes.
- Individuals with type 2 diabetes not reaching HbA1c target of under 7.0%
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pharmacist-led diabetes care pathwayarticipants 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. | Other | Pharmacist-led care pathway |
Primary outcome
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.
19 secondary outcomes
Estimated cardiovascular risk
Time frame: Up to 6 months.
Blood Pressure
Time frame: Up to 6 months.
LDL cholesterol concentration
Time frame: Up to 6 months.
Influenza vaccination
Time frame: Up to 6 months.
Pneumococcal vaccination
Time frame: Up to 6 months
Foot exam
Time frame: Up to 6 months
Eye Exam
Time frame: Up to 6 months.
Renal function screening
Time frame: Up to 6 months.
Vascular Protection
Time frame: Up to 6 months.
Pharmacist prescribed prescription medications
Time frame: Up to 6 months.
Pharmacist provided education on lifestyle factors
Time frame: Up to 6 months
Pharmacist provided education on medications and importance of adherence.
Time frame: Up to 6 months
Laboratory Monitoring
Time frame: Up to 6 months.
Continuous Glucose Monitoring
Time frame: Up to 6 months.
Yield of enrolment approaches
Time frame: Up to 6 months.
Yield of enrollment by pharmacy type
Time frame: Up to 6 months.
Shared-decision making uptake
Time frame: Up to 6 months.
Patient satisfaction - standard
Time frame: Up to 6 months.
Patient satisfaction - change
Time frame: Up to 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ross Tsuyuki, BScPharm, PharmD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pharmacist-led diabetes care pathway in people with Diabetes Mellitus and Hypertension, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Gysel, BScPharm, PharmD (403-993-6678, sgysel@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A1C change (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.