Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. This is a single-centre, retrospective trial aiming at comparing the antibody levels in children and adolescents.
Interventions
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities * Any subjects at onset of Type 1 Diabetes * Treatment with either Insulin Aspart and Soluble Human Insulin or Soluble Human Insulin and Isophane Human Insulin / Mixtard® for at least 9 months from the time of diagnosis of diabetes
Exclusion criteria
* Treatment with immunosuppressive agents * For the Insulin Aspart + Isophane Human Insulin: Treatment with insulin analogues other than Insulin Aspart or treatment with fast acting human insulin for a period of 7 days or more during the treatment period * For the Soluble Human Insulin and Isophane Human Insulin group: Treatment with insulin analogues * Other diseases influencing immune response * Unable or unwilling to provide consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Insulin aspart specific, human insulin specific and cross reacting antibodies | measured up to at most 2.5 years after diagnosis |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | — |
| Insulin requirements | — |
| Incidence of hypoglycaemic episodes | — |
Countries
Sweden
Outcome results
None listed