Can mCPN Intervention Improve Injection Site Rotation

Pink Pearls Inc

Status: Completed

Conditions: Injection Site Rotation; Diabete Mellitus

Treatments: Device: mCPN Intervention; Device: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03914183

mCPN

Details and patient eligibility

About

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.

Full 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

Enrollment: 209 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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209 participants in 2 patient groups

Control

Other group

Description:

Standard of care arm - using insulin pen needles as previously prescribed

Treatment:

Device: Control

mCPN intervention

Active Comparator group

Description:

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.

Treatment:

Device: mCPN Intervention