Primary Outcome Measures:
- Incidence of nocturnal hypoglycemia (< 4mmol/L) occurring between 11pm and 7am, as determined with the Continuous Glucose Monitoring System (CGMS) and hemoglobin A1c [ Time Frame: end of 3 months for each group ]
Secondary Outcome Measures:
- Nadir nocturnal BG, timing and duration of nocturnal hypoglycemia, fasting BG, lipid profile, psychosocial factors, total insulin dose, insulin sensitivity and body composition (weight, BMI, % fat, waist circumference). [ Time Frame: end of 3 months for each group ]
Nocturnal hypoglycemia is a significant side effect of insulin replacement therapy and can lead to many problems including coma and death in the most extreme cases and deterioration of glycemic control. Strategies to prevent nocturnal hypoglycemia include development of newer insulins and delivery systems and the use of specific bedtime snack compositions. Detection of nocturnal hypoglycemia, as it occurs in everyday life, has been a problem since most episodes go unnoticed and therefore untreated leading to a very dangerous situation. With the recent availability of technology which allows for continuous glucose monitoring , it has been made possible to detect nocturnal hypoglycemia as it occurs in daily life. As well, this technology allows for the possibility of better titration of therapy.
Therefore, the goal of our study was to use continuous glucose monitoring technology as a tool to optimize titration of insulin therapy and as a means to detect nocturnal hypoglycemia as it occurs in daily life. Specifically, we sought to compare the use of insulin pump therapy with no bedtime snacks and using a new type of insulin called an analogue(lispro) versus multiple daily injections of insulin, using the same type of insulin analogue, and with and without bedtime snacks. Therefore, we compared 3 groups: 1) insulin pump with no bedtime snacks; 2) multiple injections with bedtime snacks and 3) multiple injections with no bedtime snacks. The groups were primarily compared for the occurrence and frequency of nocturnal hypoglycemia. Other comparisons included: long term glycemic control (A1c), weight and body composition and quality of life.