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OpenTrials
Completed

NCT Number: NCT01024218

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

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.

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Key information

Conditions

Diabetes Delivery Systems Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthcare Professionals Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NovoFine® needle 8 mm

Device

autocover needle

Device

Primary outcomes

  1. Device preference

    Time frame: after 12 weeks

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 2, 2009
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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