The purpose of the study is to investigate the tolerability of different injection/infusion volumes and speed compared to standard practise. The order in which the different volumes and injection speeds will be given to participants will be allocated by chance. Participants will be in this clinical study for about 1 week.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
Device used for delivery of subcutaneous injections and infusions of NaCl solution.
Novo Nordisk Clinical Innovation Centre A/S
Gentofte Municipality, Denmark
RECRUITINGInjection pain rated on a Visual Analogue Scale (VAS)
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in millimetres (mm).
Time frame: 1 minute (±1 minute) from the injection initiation
Injection pain rated on a VAS
The VAS scale consists of a 100 mm line on a paper where 1 will be no pain and 100 being the worst pain imaginable. The VAS response will be recorded in mm.
Time frame: 9 minutes (±1minute) from the injection initiation
Acceptance of pain for each injection (including the needle insertions only) as a binary measure
Measured as binary response (Acceptable/Not acceptable).
Time frame: 1 minute (±1 minute) from the injection initiation
Back flow at the injection site
Measured in microlitres (μL).
Time frame: 5 minutes (±1 minute) from the injection initiation
Number of acute injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation) after each injection
Measured in injection site reactions (events).
Time frame: 9 minutes (±1 minute) from the injection initiation
Number of long term injection site reactions (haematoma, haemorrhage, bruising, erythema and oedema formation)
Measured in injection site reactions (events).
Time frame: 16-40 hours after all injections with an additional 36 hours if a clinic visit is needed
Number of adverse events
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Measured in events.
Time frame: Up to 40 hours after completing all the injections with an additional 36 hours if a clinic visit is needed