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Completed

NCT Number: NCT03914183

Can mCPN Intervention Improve Injection Site Rotation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shoppers Drug Mart 2335, Calgary, Alberta, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mCPN Intervention

Device

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

Device

Use of standard of care insulin pen needle

Primary outcomes

  1. 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.

    Time frame: 30 - 45 days

Secondary outcomes

  1. Does a retail pharmacy-based, pharmacist-led mCPN intervention improve the knowledge base of pharmacists around injection site rotation

    Time frame: Study duration. 30 to 90 days

    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)

  2. Does a retail pharmacy-based, pharmacist-led mCPN intervention increase confidence in providing injection site rotation counselling

    Time frame: Study duration 30 to 90 days

    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)

  3. increase/change in injection zone size

    Time frame: 30-45 days

    Assessment of injection rotation from pre to post survey patient reported

  4. percentage of participating patients who change their needles more often (patient reported),

    Time frame: 30 - 45 days

    Assessment of needle reuse or lack of reuse from pre to post survey patient reported

  5. the percentage of participating patients who decide to continue using mCPN upon study completion

    Time frame: 30- 45 days

    Willingness to continue with intervention needle from post survey - patient reported

Sponsors and collaborators

Lead sponsor

Pink Pearls Inc

Other

Collaborators

  • Montméd

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Apr 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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