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Behavioral Intervention
Pharmacist-Led Management for Type 2 Diabetes
N/A
Waitlist Available
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (age 18 and older) with type 2 diabetes with HbA1C 10 % or above
Be older than 18 years old
Must not have
Patients less than 18 years of age
Patients with severe renal impairment or receiving dialysis treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and through study completion at 10 months approximately
Awards & highlights
No Placebo-Only Group
Summary
This trialstudies how diabetes can be improved with diet, exercise, & meds. A team of health experts will help patients manage their diabetes which will be measured over 3 months.
Who is the study for?
This trial is for adults over 18 with uncontrolled type 2 diabetes (HbA1C of 10% or higher) who are willing to adjust medications, monitor blood glucose at home, and have not had pharmacist-directed interventions before. They must be patients of the Portage Clinic and consent to participate fully.
What is being tested?
The study evaluates how effective pharmacists' interventions are in managing type 2 diabetes by looking at changes in HbA1C levels and patient self-management skills through surveys. It involves behavioral strategies and approved diabetes drugs.
What are the potential side effects?
While specific side effects aren't listed, typical ones from diabetes medications can include low blood sugar, upset stomach, skin reactions, weight gain, kidney issues, dizziness or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with type 2 diabetes and my HbA1C level is 10% or above.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am under 18 years old.
Select...
I have severe kidney problems or am on dialysis.
Select...
I refuse to change my current medications.
Select...
I have type 1 diabetes, pre-diabetes, gestational diabetes, or am pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and through study completion at 10 months approximately
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and through study completion at 10 months approximately
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Baseline Hemoglobin A1C (HbA1C) at 10 months
Secondary study objectives
Modifiable Risk Factor - Blood Pressure
Modifiable Risk Factor - Body Mass Index
Modifiable Risk Factors -Cholesterol Level
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Control ArmActive Control1 Intervention
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.
Group II: Pharmacist Intervention ArmActive Control1 Intervention
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
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Who is running the clinical trial?
University of ManitobaLead Sponsor
619 Previous Clinical Trials
206,661 Total Patients Enrolled
7 Trials studying Diabetes
3,558 Patients Enrolled for Diabetes
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.You have not received guidance from a clinical pharmacist before.I have severe kidney problems or am on dialysis.I refuse to change my current medications.I am open to changing my medications if needed.Your HbA1C level is less than 10%.I have type 1 diabetes, pre-diabetes, gestational diabetes, or am pregnant.You have recently received a lot of attention and care from a clinical pharmacist or health care professional.I am an adult with type 2 diabetes and my HbA1C level is 10% or above.
Research Study Groups:
This trial has the following groups:- Group 1: Control Arm
- Group 2: Pharmacist Intervention Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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