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Active, Not Recruiting

NCT Number: NCT05442840

Evaluation of Pharmacist Intervention 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portage Clinic

Portage la Prairie, Manitoba, R1N 3V5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Behavioral and drugs already approved and available for diabetes management

Combination Product

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2022
Registry last updated
Apr 21, 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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