A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

• * Hemoglobin A1c over the first 24 months of diabetes
  

• * Frequency of hypoglycemia (mild and severe) over the first 24 months of diabetes
  
• * Frequency of morning hyperglycemia over the first 24 months of diabetes
  
• * Residual c-peptide at two years post diagnosis (stimulated c-peptide post Sustacal challenge)
  
• * Diabetes Quality of Life (DQOLY) over the first 24 months of diabetes
  
• * Family Functioning (Family Environment Scale)over the first 24 months of diabetes
  

The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a “honeymoon” period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.