Can mCPN Intervention Improve Injection Site Rotation

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 Overview

• Status: Completed
• Conditions: Diabete Mellitus; Injection Site Rotation
• Intervention / Treatment: Device: Control; Device: mCPN Intervention

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

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2X3X7
      • Shoppers Drug Mart 2335
    • Claresholm, Alberta, Canada, T0L0T0
      • Claresholm Pharamcy
    • Edmonton, Alberta, Canada, T5Z0H5
      • Rexall 7236
    • Okotoks, Alberta, Canada, T1S2N3
      • Shoppers Drug Mart 2401
  • British Columbia
    • Kamloops, British Columbia, Canada, V2C0B6
      • Kipp Mallery Pharmacy
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3B 0T2
      • Our Own Health Centre
    • Winnipeg, Manitoba, Canada, R3L1Y2
      • Shoppers Drug Mart 535
  • New Brunswick
    • Rothesay, New Brunswick, Canada
      • Kennegecasis Drugs
  • Ont
    • Sarnia, Ont, Canada, N7T5P5
      • Northgate Pharmacy
  • Ontario
    • Milton, Ontario, Canada
      • Zak's Pharmacy
    • Niagara Falls, Ontario, Canada
      • Niagara Pharmacy
  • PEI
    • Cornwall, PEI, Canada, C0A1H0
      • Murphy's Cornwall Pharmacy
  • Quebec
    • Laval, Quebec, Canada
      • Pharmacie Jacques Bourget PJC076
    • Montreal, Quebec, Canada, H4E 3J2
      • Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control; Standard of care arm - using insulin pen needles as previously prescribed	Device: Control; Use of standard of care insulin pen needle
ACTIVE_COMPARATOR: 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 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pink Pearls Inc
• Collaborators: Montméd
• Investigators: Principal Investigator: Lori Berard, Pink Pearls Inc

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2018
• Primary Completion (ACTUAL): April 8, 2019
• Study Completion (ACTUAL): April 8, 2019

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (ACTUAL): April 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 16, 2019
• Last Update Submitted That Met QC Criteria: April 12, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: mCPN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No