Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is a difference in blood sugar
      control (as measured by hemoglobin A1c (HA1c)), in children given twice daily insulin
      injections incorporating a new long acting insulin analogue (detemir) compared to children
      using their current three times a day insulin injections (with intermediate and rapid acting
      insulin).
    

Detailed description: 
      Children with type 1 diabetes (DM1) can only be treated with subcutaneous insulin at the
      present time in Canada. It has been shown that intensive insulin treatment using at least
      three times daily (TID) insulin injections achieves superior blood glucose control with less
      long term complications of diabetes than conventional insulin treatment using once daily (OD)
      or twice daily (BID) insulin injections. However, many patients find it difficult to adhere
      to TID insulin injections since it is an invasive and painful therapy, which results in
      frequent insulin omission.

      This study is a randomized controlled open-labeled non-inferiority trial to compare the
      glycemic control as measured by HbA1c after 6 months of a BID insulin regimen using detemir
      insulin, or the currently used TID insulin with intermediate acting insulin (Novolin NPH or
      Humulin N). Patients will be randomized to either the active control group (standard TID
      regimen) or the treatment group (BID regimen with new long acting insulin analogue). A run-in
      period of 1 month will be used to facilitate the change in insulin regimen. Insulin doses
      will be adjusted by weekly phone contact with the research nurse for one month prior to
      baseline blood work. Patients will continue on the same diet and exercise routine as
      recommended by their usual diabetes team. They will also be seen every 3 months by the
      research nurse to review blood glucose, assess height and weight and arrange for blood work
      to be done in conjunction with their routine bloodwork. All patients will continue to be seen
      by their usual diabetologist, nurse, and dietician at their regularly scheduled clinic visits
      (every 3 months).

      Outcomes include: HA1c between groups at 6 months (surrogate marker of metabolic control for
      diabetes measured through a venous or capillary blood sample), frequency of adverse events
      (severe hypoglycemia, mild hypoglycemia, episodes of diabetic ketoacidosis, weight gain),
      diabetes quality of life for youth (DQOL).
    

Intervention name(s): Detemir; Novolin NPH or Humulin N
Intervention type(s): Drug; Other
Intervention description(s): Patients will discontinue their usual bedtime dose of intermediate acting insulin and replace this with the same unit dose of detemir at supper time. The detemir will not be mixed with the rapid acting insulin and will be given as a separate injection. The patient's morning dose of intermediate acting insulin will be decreased by 20% to adjust for the longer duration of action of detemir. Doses of rapid acting insulin will remain the same at breakfast and at supper.; Patients will continue on their usual insulin regimen of insulin three times per day. Intermediate and rapid acting insulin at breakfast, rapid acting insulin at supper, and intermediate acting insulin at bedtime.
Other intervention name(s): Levemir
Intervention MeSH terms: Insulin; Isophane Insulin, Human
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; children; long acting insulin analogue; hemoglobin A1c