Delivery Systems, Diabetes, Healthcare Professionals
Conditions
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.
Interventions
DEVICENovoFine® needle 8 mm
DEVICEautocover needle
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device preference | after 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the adverse device effects (occlusion/activation/locking problems/manufacturing defects) | — |
| Comparison of the frequency of adverse device effects | — |
| Comparison of the frequency of adverse events (needle stick injuries) | — |
Countries
Denmark
Outcome results
None listed