NCT03914183

Can mCPN Intervention Improve Injection Site Rotation

Can a montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits in Established Insulin Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 209 (actual)
• Sponsor: Pink Pearls Inc · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Injection Site Rotation
• Diabete Mellitus

Interventions

Type	Name	Description
DEVICE	mCPN Intervention	Each box of montméd Coloured Pen Needles (mCPN) has the following five features: i. Distinctively coloured pen needles ii. A user-defined association tool which is intended to help the patient associate each colour to a specific injection zone iii. A concise and intuitive educational message "Change color, change site" siteTM" iv. Unique packaging with educational content v. Four distinctive message-in-a-box educational sound-chips which serve to reinforce the recommended educational message on site rotation at home and come on every tenth time the pen needle box is opened
DEVICE	Control	Use of standard of care insulin pen needle

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-04-08
• Completion: 2019-04-08
• First posted: 2019-04-16
• Last updated: 2019-04-16

Locations

14 sites across 1 country: Canada