The Alberta Health and Wellness’ Executive Committee accepted the Alberta Health Technology Decision Program’s Advisory Committee’s recommendation to undertake a STE analysis of insulin delivery systems. The purpose of this report is to address the following questions of interest:
T1DM, characterized by high blood glucose levels that require lifelong insulin therapy, can cause short- and long-term complications in different organs such as the heart, eyes, kidneys, and blood vessels. It may cause neuro-cognitive dysfunction and behavioural changes in children. In pregnant women high glucose levels are associated with increased risk of fetal congenital malformation, perinatal mortality, obstetric complications, and neonatal morbidity.
Although T1DM usually accounts for only a minority of the total burden of diabetes in a population (approximately 10%), it is the most predominant form of the disease in younger age groups in most developed countries. It can develop at any age but usually appears in childhood or adolescence. Males and females tend to be equally vulnerable.
Over 240,000 Canadians live with T1DM. In 2007 the estimated number of prevalent cases of T1DM among Canadian youth (0 to 14 years) was 8400. The incidence rate for this age group was estimated at 21.7 per 100,000 cases in 2007. The estimated incidence rate increases with age from 14.7 for 0- to 4-year-olds, to 24.0 for 5- to 9-year-olds, and 26.3 for 10- to 14-year-olds.
Intensive management of T1DM delivered by MDI is the accepted standard of care for achieving and maintaining near-normal blood glucose in order to reduce the risk of complications. Despite recent advances in intensive insulin therapy, fear of inducing hypoglycemia remains a major barrier in achieving optimal glycemic control safely in all age groups. Guidelines for intensive insulin therapy of T1DM recommend an individualized, intensive insulin regimen using either MDI or IPT. IPT is usually considered after MDI has been tried but has failed to optimize glycemic control safely.
An insulin pump is a complex computerized electronic device used for continuous subcutaneous insulin infusion. IPT consists of a basal-bolus injection; i.e., continuous infusion of low-dose rapidacting insulin analogues (such as insulin lispro or insulin aspart) and pre-meal bolus injections of rapid-acting insulin analogues. There are three main insulin pump manufacturers whose pumps are available on the Canadian market with licence approval from Health Canada: Animas Canada, Disetronic Medical Systems, and Medtronic of Canada.
Both MDI and IPT are available in Alberta and, according to Alberta experts, most individuals with T1DM are MDI users (approximately 12% of youth and 13% of adults are IPT users). The key components of a high-quality IPT service are identifying individuals with T1DM suitable for IPT, ensuring appropriate composition of the specialist team (physician with a special interest in IPT, a diabetes nurse specialist, and a dietitian), and monitoring and supporting IPT users.