Type 1 diabetes mellitus in children and adolescents MedDRA version: 9.1 Level: LLT Classification code 10012609 Term: Diabetes mellitus juvenile onset
Conditions
Interventions
Trade Name: Novorapid Insulin
Product Name: NovoRapid Insulin
Pharmaceutical Form: Solution for injection
Trade Name: Lantus Insulin
Product Name: Lantus Insulin
Pharmaceutical Form: Solution for inj
Sponsors
University of Dundee (Research & Innovation Services)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will recruit 10 children and adolescents (8 to 16 yrs). The centre will enroll subjects on the understanding that they will be allowed to continue managing their diabetes with CSII if this is the subjects choice, after completion of the study, supported by their local clinic. Each subject should have been diagnosed with diabetes for one year and currently be treated with MDI therapy for at least six months. Glycaemic control should be consistent with an HbA1c =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Diabetes diagnosed less than one year. Current glycated haemoglobin >10.5% Subjects with vascular complications of diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the prevalence and incidence of clinical hypoglycaemia in children and adolescents with Type 1 Diabetes Mellitus treated either with multiple daily subcutaneous injections of fast and long-acting insulin with fast acting insulin delivered by continous insulin infusion (CSII using an insulin pump).;Secondary Objective: ;Primary end point(s): Incidence and prevalence of hypoglycaemia as measured by home blood glucose testing using capillary blood glucose monitoring, patient diaries of clinical episodes and intermittent monitoring using continuous glucose monitoring system. | — |
Countries
United Kingdom
Outcome results
None listed