Diabetes
Conditions
Interventions
Subjects shall use two needles for one (seven day) week each in turn. TERUMO NANOPASS Pen Needle II 34Gx4mm ->
BD Micro-fine Ultra 32Gx4mm
Subjects shall use two needles for one (seven day) week each in turn. BD Micro-fine Ultra 32Gx4mm ->
TERUMO NANOPASS Pen Needle II 34Gx4mm
Sponsors
Diabetes Center Kitasato University Kitasato Institute Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: *Type 1 and Type 2 diabetic patients who are 20 years old and over. *Subjects who have been using an insulin pen for injecting insulin for one year or more. *Subjects who are getting injections in the abdomen twice daily or more. *Subjects have every intention of completing all of the survey procedures. *Subjects who are able to fill in their results in a CRF. *Subjects understand the contents of the consent form information and are willing to participate in this study.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preference for the ease of pushing the injection button when injecting insulin. | — |
Secondary
| Measure | Time frame |
|---|---|
| *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. | — |
Countries
Japan
Contacts
Public ContactShusaku Tozaka
Nippon Becton Dickinson Company, Ltd. Medical Affairs
Outcome results
None listed