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

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ClinicalTrials.gov Identifier: NCT01024218
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetes Healthcare Professionals Delivery Systems Device: NovoFine® needle 8 mm Device: autocover needle Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2004
Primary Completion Date : April 26, 2005
Study Completion Date : April 26, 2005
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Device preference [ Time Frame: after 12 weeks ]

Secondary Outcome Measures :
  1. Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects)
  2. Comparison of the frequency of adverse device effects
  3. Comparison of the frequency of adverse events (needle stick injuries)

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024218


Locations
Denmark
Novo Nordisk Investigational Site
København, Denmark, 2400
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01024218     History of Changes
Other Study ID Numbers: AUTOCOVER
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017