Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes

April 16, 2026 updated by: University of Manitoba

Evaluation of Pharmacist Intervention and Education in a Patient-Centered, Multidisciplinary Approach for Individuals With Uncontrolled Type 2 Diabetes

Type 2 diabetes is a chronic disease that can lead to a number of complications if uncontrolled and there is a projected increase of 33% patients living with diabetes over the next 10 years. There can be improvements to modifiable risk factors such as diet and exercise, in addition to medications. Treatment often involves a multidisciplinary approach with a physician, endocrinologist, dietitian, pharmacist and other support health professionals as required. This study will evaluate the effects of the pharmacists (or pharmD interns) intervention, looking at changes to the patients HbA1C, which is a measure of the patients blood glucose control over the previous 3 months as well as the patients understanding and comfort with managing their own diabetes via participant survey.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Recruitment will begin in July 2022, potential participants can self-refer or another healthcare provider may discuss the study and provide contact information to the study team for all interested potential participants. These potential participants would then be screened for eligibility by the pharmacist or PharmD (Doctor of Pharmacy) Intern. The goal is to enroll 60 participants in the study. All participants must provide consent to participate and will be asked to complete a participant survey.

All participants who consented will then be randomized into a control group which will not receive pharmacist intervention during the study period, or the intervention group which will receive pharmacist/PharmD Intern led intervention which includes a medication review, optimizing medication treatment options and frequent follow up and diabetes education. The control group participants will be offered pharmacist intervention following the study period. All participants will be asked to complete a participant survey at the start and end of the study. All participants will also have standard care from their physicians and other healthcare team members as required which would be standard of practice. All participants would also be asked to repeat their blood work at the end of the study period.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Portage la Prairie, Manitoba, Canada, R1N 3V5
        • Portage Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients whose primary care physician is within the Portage Clinic
  • Adults (age 18 and older) with type 2 diabetes with HbA1C 10 % or above
  • Patients whom have not had previous clinical pharmacist directed intervention
  • Agree to participate in the study, including frequent follow up, blood glucose home monitoring as directed and repeat lab work
  • Willing to consider medication adjustments as deemed appropriate
  • Willing to review and sign the Research Participant Information and Informed Consent Form

Exclusion Criteria:

  • Patients less than 18 years of age
  • Patients with type 1 diabetes, pre-diabetes or gestational diabetes (or whom are pregnant)
  • Patients whom have had recent or ongoing clinical pharmacist directed intervention or intensive health care professional monitoring and guidance
  • Patients with HbA1C less than 10%
  • Patients whom refuse medication adjustments
  • Patients with severe renal impairment or receiving dialysis treatments

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
The participants in this arm will receive standard of care from their physician as they would have been doing previously. This still may involve blood work, referrals to other health providers (except pharmacist) and medication adjustments driven by the pharmacist.
Active Comparator: Pharmacist Intervention Arm
The participants in this arm will receive standard of care from their physician in addition to pharmacist intervention. The pharmacist or pharmD intern leads the diabetes care for the patient typically, conducting a medication review, recommending medication changes, frequent follow up and requesting blood work and providing referrals to other health care providers as needed,which is standard care
Combination product: Behavioral and drugs already approved and available for diabetes management
Pharmacists will review the patients information and medical history as well as drug coverage to discuss preferred treatment options to manage diabetes based on recommendations from Diabetes Canada treatment guidelines; all drugs have been approved and are available on the market; pharmacists will offer frequent follow up and provide basic diabetes education to the patient at each follow up appointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Hemoglobin A1C (HbA1C) at 10 months
Time Frame: baseline and through study completion at 10 months approximately
Measure of blood glucose control at the lab
baseline and through study completion at 10 months approximately

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modifiable Risk Factors -Cholesterol Level
Time Frame: baseline and through study completion at 10 months approximately
evaluating changes in modifiable risk factors such as cholesterol levels reported in mmol/L
baseline and through study completion at 10 months approximately
Modifiable Risk Factor - Body Mass Index
Time Frame: baseline and through study completion at 10 months approximately
evaluating changes in modifiable risk factors such as weight and height which will be combined to report body mass index in kg/m^2
baseline and through study completion at 10 months approximately
Modifiable Risk Factor - Blood Pressure
Time Frame: baseline and through study completion at 10 months approximately
evaluating changes in modifiable risk factors such as blood pressure reported in mmHg
baseline and through study completion at 10 months approximately
Participant Survey
Time Frame: baseline and through study completion at 10 months approximately
Evaluating the patients knowledge of diabetes management, comfort with managing their own diabetes care, perception of the pharmacist's role
baseline and through study completion at 10 months approximately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 20, 2022

First Submitted That Met QC Criteria

June 28, 2022

First Posted (Actual)

July 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS25460 (B2022:031)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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