Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes (NCT05442840) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Pharmacist Intervention for Individuals With Uncontrolled Type 2 Diabetes
Canada60 participantsStarted 2022-07-04
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Baseline Hemoglobin A1C (HbA1C) at 10 months
Timeframe: baseline and through study completion at 10 months approximately