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NCT01024218 Clinical Trial

Preference Study Between NovoFine® Autocover™ and a NovoFine® 8 mm Needle

Diabetes Clinical Trial

Official title:
An Open-label, Multicenter, Handling Test and Prospective Cross-over Study on Nurse/Health Assistants Preference Between NovoFine® Autocover™ and 8 mm NovoFine® Needle

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01024218
Other study ID # AUTOCOVER
Secondary ID
Status Completed
Phase Phase 4
First received November 30, 2009
Last updated February 22, 2017
Start date December 1, 2004
Est. completion date April 26, 2005

Study information
Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this clinical trial is to assess the preference of 2 different needles used by nurses and health assistants. The trial consists of a handling test followed by a 12 week cross-over study.

Recruitment information / eligibility
Status Completed
Enrollment 78
Est. completion date April 26, 2005
Est. primary completion date April 26, 2005
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- The participant must have been either a diabetes nurse or a diabetes health assistant with competence in subcutaneous injections of insulin for at least 4 weeks

- Participants must demonstrate proficiency with the injection device in the handling test prior to testing the NovoFine® Autocover™ Needle in patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NovoFine® needle 8 mm

• autocover needle

Locations
Country Name City State
Denmark Novo Nordisk Investigational Site København

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Device preference after 12 weeks
Secondary Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)
Secondary Comparison of the frequency of adverse device effects
Secondary Comparison of the frequency of adverse events (needle stick injuries)
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