Comparing the Metabolic Control of Once to Twice-daily Insulin Detemir Injections
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, treat to target, intervention study in order to compare the metabolic control
      of once to twice-daily insulin Detemir injections in children and adolescence with type 1
      diabetes mellitus.

      All eligible patients will be assigned to receive insulin Detemir once daily before
      breakfast. Short acting insulin analog, Novorapid, will be used for mealtime insulin. The
      starting dose of insulin Detemir will be individually determined.Based on self-measured
      fasting blood glucose levels, insulin doses will be titrated throughout the trial, aiming at
      pre-breakfast and premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and
      80-130 mg/dl for subjects aged 13-18 years.Patients that after 4 weeks titration phase will
      not achieve the target blood glucose and up titration of insulin Detemir cannot be done, due
      to hypoglycemic episodes would be switched to treatment consist of twice daily insulin
      Detemir. If the target blood glucose are not achieved at the end of the 4 weeks titration
      phase, but further up titration is possible and patient does not suffer from hypoglycemic
      episodes, the titration period would be extended and patient would not be switched to
      treatment with 2 injections of insulin Detemir.When achieving blood glucose targets patient
      will continue until study end on the maintenance phase.
    

Detailed description: 
      An open label,treat to target, prospective, intervention study in order to compare the
      metabolic control of once to twice-daily insulin detemir injections in children and
      adolescence with type 1 diabetes mellitus.

      Study objectives:

        1. To assess the efficacy and safety of insulin detemir therapy (once or twice daily) using
           a treat to target titration protocol for initiating and maintaining therapy in children
           and adolescents with type 1 diabetes.

        2. To evaluate the percentage of patients That will achieve a reduction of 0.5% of HbA1c
           from baseline to end of study evaluation.

        3. To evaluate Incidence of sever, nocturnal, symptomatic and asymptomatic hypoglycemia and
           glucose excursions of both hyper and hypoglycemia as measured by the area under the
           curve determined by the CGMS technique.

      Treatment plan:

      Patients will be assigned to receive insulin detemir once daily before breakfast. Short
      acting insulin analog , Novorapid, will be used for mealtime insulin. The starting dose of
      insulin detemir will be individually determined. Based on self-measured fasting blood glucose
      levels, insulin doses will be titrated throughout the trial, aiming at pre breakfast and
      premeal concentrations of 90-180 mg/dl for subjects aged 6-12 years and 80-130 mg/dl for
      subjects aged 13-18 years.

      Patients that after 4 weeks titration phase will not achieve the target blood glucose and up
      titration of insulin Detemir cannot be done, due to hypoglycemic episodes, would be switched
      to treatment consist of twice daily insulin Detemir.

      If the target blood glucose are not achieved at the end of the 4 weeks titration phase, but
      further up titration is possible and patient does not suffer from hypoglycemic episodes, the
      titration period would be extended and patient would not be switched to treatment with 2
      injections of insulin Detemir.
    

Intervention name(s): Levemir (insulin detemir); Levemir twice a day
Intervention type(s): Drug; Drug
Intervention description(s): Levemir once a day; Levemir twice a day
Intervention MeSH terms: Insulin Detemir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: levemir; type 1 diabetes