Diabete Mellitus Clinical Trial
Official title:
Can a montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits in Established Insulin Users
The current research study has accordingly been designed to determine if a "pharmacist-dispensed montméd Coloured Pen Needle (mCPN) intervention" will improve injection site rotation relative to the standard dispensing of non-mCPN insulin pen needles.
Study Design and Conduct This is a 30-day, two-arm, randomized, controlled study.
Enrolled participants will be randomly assigned to one of the following study arms:
- Control group: participating pharmacists will dispense boxes of standard insulin pen
needles to the patient participants
- mCPN group: participating pharmacists will dispense boxes of montméd Coloured Pen
Needles to the patient participants
Study Sites and Participating Pharmacists All pharmacies in Canada that provide services to
individuals with diabetes who use injectable insulin therapy will be eligible to participate
in this study. All participating pharmacists who will play an active role in participant
enrollment and the follow-up visits will be required to complete a participation consent form
and 2 surveys. The first (Pre-study survey) should be completed after they have been fully
trained on the study protocol and their study obligations, and before commencement of study
enrollment. The second (Post-study survey) should be completed after the last patient has
completed the 30-day follow-up visit. (Refer to Section 11 for the Study Flow).
Randomization Process Participating pharmacists will dispense one of the two study pen
needles according to a computer-generated list that will be provided to the participating
pharmacy upon site activation
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