Clinical trial NCT03914183: Can mCPN Intervention Improve Injection Site Rotation
Official title: Can a montméd Coloured Pen Needle (mCPN) Intervention Improve Injection Site Rotation Habits in Established Insulin Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Rotation
Diabete Mellitus
Lead sponsor: Pink Pearls Inc
Sponsor class: OTHER
Collaborators: name: Montméd
First posted: 2019-04-16
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomized control study of control (current standard of care) versus mCPN intervention
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 30 - 45 days
Secondary outcomes:
measure: Does a retail pharmacy-based, pharmacist-led mCPN intervention improve the knowledge base of pharmacists around injection site rotation
timeFrame: Study duration. 30 to 90 days
measure: Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling
timeFrame: Study duration 30 to 90 days
measure: increase/change in injection zone size
timeFrame: 30-45 days
measure: percentage of participating patients who change their needles more often (patient reported),
timeFrame: 30 - 45 days
measure: the percentage of participating patients who decide to continue using mCPN upon study completion
timeFrame: 30- 45 days
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Shoppers Drug Mart 2335
state: Alberta
city: Claresholm
country: Canada
facility: Claresholm Pharamcy
state: Alberta
city: Edmonton
country: Canada
facility: Rexall 7236
state: Alberta
city: Okotoks
country: Canada
facility: Shoppers Drug Mart 2401
state: Alberta
city: Kamloops
country: Canada
facility: Kipp Mallery Pharmacy
state: British Columbia
city: Winnipeg
country: Canada
facility: Our Own Health Centre
state: Manitoba
city: Winnipeg
country: Canada
facility: Shoppers Drug Mart 535
state: Manitoba
city: Rothesay
country: Canada
facility: Kennegecasis Drugs
state: New Brunswick
city: Milton
country: Canada
facility: Zak's Pharmacy
state: Ontario
city: Niagara Falls
country: Canada
facility: Niagara Pharmacy
state: Ontario
city: Sarnia
country: Canada
facility: Northgate Pharmacy
state: Ont
city: Cornwall
country: Canada
facility: Murphy's Cornwall Pharmacy
state: PEI
city: Laval
country: Canada
facility: Pharmacie Jacques Bourget PJC076
state: Quebec
city: Montreal
country: Canada
facility: Pharmacy Jean-Coutu Raffaele Delli Colli & Gino Consolante
state: Quebec
Study officials:
affiliation: Pink Pearls Inc
name: Lori Berard
role: PRINCIPAL_INVESTIGATOR
References: