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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01024218
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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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
Actual Primary Completion Date : April 26, 2005
Actual Study Completion Date : April 26, 2005

Resource links provided by the National Library of Medicine

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)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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

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 identifier (NCT number): NCT01024218

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Novo Nordisk Investigational Site
København, Denmark, 2400
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT01024218    
Other Study ID Numbers: AUTOCOVER
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017