Can mCPN Intervention Improve Injection Site Rotation

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Injection Site Rotation, Diabete Mellitus

Intervention / Treatment
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* Device: mCPN Intervention
* Device: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus or type 2 diabetes mellitus who have been using daily insulin therapy for 1 year or more Able to read the English text on the boxes of the pen needles Exclusion Criteria: Individuals currently treated with a glucagon-like peptide 1 receptor agonist (GLP-1RA) Current or previous user of mCPN Individuals who are unable to understand or communicate in English Pregnant women Individuals with serious mental illnesses eg. dementia, schizophrenia disorders, bipolar disorders, major depression, etc.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open label randomized control study of control (current standard of care) versus mCPN intervention
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control<br>Standard of care arm - using insulin pen needles as previously prescribed | Device: Control<br>* Use of standard of care insulin pen needle<br>|
| Active Comparator: mCPN intervention<br>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 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. | Device: mCPN Intervention<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of participants in the mCPN group who demonstrate an improvement (vs baseline performance) in the recommended site rotation techniques relative to the proportion of that in the control group. |  | 30 - 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Does a retail pharmacy-based, pharmacist-led mCPN intervention improve the knowledge base of pharmacists around injection site rotation | The change the level of knowledge about the importance of site rotation as (importance scale) as measured by a 5 point likert scale; Unimportant (1) Slightly Important (2) Neither (3) Slightly Important (4) Very Important (5) | Study duration. 30 to 90 days | 
| Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling | The change in the level of confidence in providing injection site rotation counselling (Confidence Scale) using a 5 point likert scale: Not confident (1) Little Confidence (2)Neither (3) Somewhat Confident (4) Very confident (5) | Study duration 30 to 90 days | 
| increase/change in injection zone size | Assessment of injection rotation from pre to post survey patient reported | 30-45 days | 
| percentage of participating patients who change their needles more often (patient reported), | Assessment of needle reuse or lack of reuse from pre to post survey patient reported | 30 - 45 days | 
| the percentage of participating patients who decide to continue using mCPN upon study completion | Willingness to continue with intervention needle from post survey - patient reported | 30- 45 days |