Comparison of a Twice Daily Versus a Three Times Daily Insulin Regimen in Children With Type 1 Diabetes
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparison of Insulin Detemir in a BID Insulin Regimen Versus a TID Insulin Regimen in Children With Type 1 Diabetes: A Randomized Controlled Trial|
- Hemoglobin A1C [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Number of episodes of hypoglycemia (severe and mild) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Number of episodes of diabetic ketoacidosis (DKA) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Body Mass Index (BMI) kg/m2 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Diabetes Quality of Life Questionaire-youth version [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: BID insulin with LA analogue
Treatment Group: BID Insulin Regimen with Long Acting Insulin Analogue (Detemir)
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.
Other Name: Levemir
Active Comparator: Standard TID insulin
Active Control Group: Usual TID Insulin Regimen (intermediate insulin- Humulin N or Novolin NPH)
Other: Novolin NPH or Humulin N
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00522210
|Alberta Children's Hospital|
|Calgary, Alberta, Canada, T3B 6A8|
|Principal Investigator:||Josephine Ho, MD||University of Calgary|