BACKGROUND: Type 1 diabetes (T1D) is a life-threatening autoimmune disease affecting approximately 27 per 100 000 Canadian children, making it one of the most common chronic illnesses affecting children. Results of the Diabetes Control and Complications Trial suggest that youth with T1D should be treated with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII) using insulin pumps, to obtain optimal metabolic control and prevent health complications.

RATIONALE: Studies of children with T1D have focused primarily on metabolic outcomes and while good metabolic control reduces complications it requires intensive management, potentially having negative consequences for health-related quality of life (HRQOL). Possible advantages of insulin pump therapy over MDI include ease of insulin administration, improved blood glucose control with reduced swings in glucose levels, decreased risk of hypoglycemia, increased flexibility in daily living, improved coping and enhanced HRQOL. Thus, a rigorous randomized controlled trial (RCT) is needed to answer the question of the effect, if any, of CSII on health-related quality of life in children with Type 1 diabetes compared to MDI.

METHODS: Participants will be recruited from a Pediatric Diabetes Clinic in the Greater Toronto Area and will be eligible for the study if aged 5–12 years, diagnosed with T1D for at least 6 months, and willing to perform at least 4 blood glucose tests per day. Children will be excluded who have poorly controlled thyroid or celiac disease and/or have previously used CSII. Informed consent/assent will be obtained and eligible children will be seen for baseline assessment of: (1) health-related quality of life (PedsQL-Generic Core Scale and Diabetes Specific Module), (2) impact of disease on the family (PedsQL-Family Impact Scale) and (3) metabolic control (HbA1c; frequency of hypoglycemic and diabetic ketoacidosis (DKA) episodes). Children will then be randomized using an online randomization program to: (1) experimental group (CSII)-receive insulin pump; attend pump initiation sessions or (2) comparison group (MDI)-continue current insulin regime. Children will then be seen at 3- and 6-months, where HbA1c will be measured and blood glucose records analyzed to assess metabolic control, including frequency of hypoglycemia and DKA. At 6-months (conclusion of study), health-related quality of life for children and impact of disease on the family will again be measured.

RELEVANCE: This research is relevant to diabetes care and management for several reasons. First, children who experience improvements in metabolic control may be more likely to adhere to their insulin regime and may be less likely to experience long-term health complications, including retinopathy, neuropathy, nephropathy, and heart disease. Second, improvements in metabolic control and psychosomatic effects, including health-related quality of life, help to reduce the burden of care placed on the Canadian health care system by children with poorly controlled diabetes most commonly associated with use of MDI. Lastly, diabetes nurse educators and endocrinologists will be made aware of the potential advantages and/or disadvantages associated with the use of CSII compared to MDI, thus utilizing evidenced-based care in practice.