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Can mCPN Intervention Improve Injection Site Rotation

NCT03914183 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2019-04-16

No results posted yet for this study

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.

Conditions

  • Injection Site Rotation
  • Diabete Mellitus

Interventions

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

DEVICE

Control

Use of standard of care insulin pen needle

Sponsors & Collaborators

  • Montméd

    collaborator UNKNOWN

  • Pink Pearls Inc

    lead OTHER

Principal Investigators

  • Lori Berard · Pink Pearls Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2019-04-08
Completion
2019-04-08

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03914183 on ClinicalTrials.gov