Can mCPN Intervention Improve Injection Site Rotation

Diabete Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03914183
• Other study ID #: mCPN
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: April 8, 2019

Study information

• Verified date: April 2019
• Source: Pink Pearls Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: April 8, 2019
• Est. primary completion date: April 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Injection Site Rotation

Intervention

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
• Control
Use of standard of care insulin pen needle

Locations

Country	Name	City	State
Canada	Shoppers Drug Mart 2335	Calgary	Alberta
Canada	Claresholm Pharamcy	Claresholm	Alberta
Canada	Murphy's Cornwall Pharmacy	Cornwall	PEI
Canada	Rexall 7236	Edmonton	Alberta
Canada	Kipp Mallery Pharmacy	Kamloops	British Columbia
Canada	Pharmacie Jacques Bourget PJC076	Laval	Quebec
Canada	Zak's Pharmacy	Milton	Ontario
Canada	Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante	Montreal	Quebec
Canada	Niagara Pharmacy	Niagara Falls	Ontario
Canada	Shoppers Drug Mart 2401	Okotoks	Alberta
Canada	Kennegecasis Drugs	Rothesay	New Brunswick
Canada	Northgate Pharmacy	Sarnia	Ont
Canada	Our Own Health Centre	Winnipeg	Manitoba
Canada	Shoppers Drug Mart 535	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
Pink Pearls Inc	Montméd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	increase/change in injection zone size	Assessment of injection rotation from pre to post survey patient reported	30-45 days
Secondary	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
Secondary	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