Delivery Systems, Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. This trial aims to ensure that there is no substantial clinically relevant difference between the two Novo Nordisk needles NovoFine® 6 x 0.30 mm and NovoFine® 8 x 0.30 mm on reflux of insulin back to the surface of cutis.
Interventions
DEVICENovoFine® needle 6 mm
DEVICENovoFine® needle 8 mm
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children/adolescents with type 1 diabetes mellitus * Usage of NovoPen® 1.5 for at least 3 months * Duration of insulin treatment more than 1 year * Normal weight according to Tanner scales * The means of the last 2 HbA1c measurements taken within the last 6 months must be less than 10.5%
Exclusion criteria
* Pregnancy or desire to become pregnant * Clinical relevant peripheral neuropathy as judged by the investigators * Pronounced lipodystrophy in accordance with investigator's evaluation * Use of drugs that can influence the trial * Coagulation disorders (use of anti-coagulants) * Serious, chronic diseases, making it highly unlikely that the subject can complete the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weighing of reflux of insulin | 6 seconds after injection |
Secondary
| Measure | Time frame |
|---|---|
| Pain perception | after 6 weeks of treatment |
| Number and severity of bleedings | after 6 weeks of treatment |
| Reactions at injection sites | after 6 weeks of treatment |
Countries
Italy
Outcome results
None listed