Comparison Study of Two Types of Insulin Pen Needles

Not Applicable

• Conditions: Diabetes

• Registration Number: JPRN-UMIN000012303
• Lead Sponsor: Diabetes Center Kitasato University Kitasato Institute Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-12-02
• Study Completion: 2014-06-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

*Subjects who are using FlexTouch (Novo Nordisk Pharma Ltd.) for insulin pen injector. *Subjects who are pregnant or may be pregnant. *Subjects who are breastfeeding. *Subjects with serious neuropathy. *Subjects with a physical condition which precludes them from carrying out study procedures (such as patients who cannot administer self-injection). *Subjects who are currently participating in another clinical study. *Subjects who have already had a full discussion with staff of BD Japan or other subjects of this clinical study. *ubjects whose doctor in charge or doctor in partial charge decided that participating in this clinical study would involve risk for the subject. *Subjects who may have become confused in their interpretation of the study results. Or subjects who have a possibility of such. *Subjects who are staff of a pharmaceutical company or medical equipment company.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Preference for the ease of pushing the injection button when injecting insulin.

Secondary Outcome Measures

Name	Time	Method
*Pain when administering injection (at the time of the insertion). *Smoothness when inserting the needle. *Pain when injecting insulin. *Overall preference. *Whether the needle bend/breakage or not when administering injection (at the time of the insertion). *Whether pain or resistance is felt when removing the needle or not. *Whether there is any leakage of insulin from the skin or not. *Whether there is any leakage of insulin from the needle tip after removal of the needle or not. *Whether the needle tip is bend/breakage after removal or not. *Relationship between needle preference and the background of diabetic subjects.