title: Insulin pump-associated adverse events in children and adolescents--a prospective study.
abstract: BACKGROUND
  Intensive insulin regimens are now the mainstay of modern, type 1 diabetes mellitus management. Insulin pumps (CSII) are a key technique used. Although there has been considerable study of outcomes, there are few recent data on CSII-associated adverse events (AEs) and their incidence and characteristics.
  
  
  METHODS
  Phone calls to our 24-h diabetes support service were screened for CSII-associated AEs. Phone interviews were conducted with the parent/patient, within 96 h of the event. Interviews explored AE characteristics and the role of the user, as well as questions relating to outcome and the impact to the family and patient. Comparisons were made with clinic CSII patients not reporting an AE.
  
  
  RESULTS
  Over a 16-week study period, 50 confirmed AEs occurred in 45 of 405 (11.1%) patients. This was annualized to an AE incidence of 40 AEs/100 person-years. Pump malfunction and infusion set/site failures were the most common events reported, occurring in 27 (54.0%) and 18 (36.0%) AEs, respectively. A user- or education-related issue was implicated in 22 (44.0%) events. Pump replacement occurred in 19 of 50 occurrences (38.0%). Additionally, 16 (32.0%) reported a hospital admission or emergency department attendance as a consequence. When compared with those on CSII not reporting an AE, AEs were associated with age <10 years (odds ratio=3.2 [95% confidence interval, 1.7-6.1]) but not with gender, glycosylated hemoglobin, diabetes duration, or pumping duration.
  
  
  CONCLUSIONS
  This is the first prospective study to look at AEs in modern-generation insulin pumps. AEs appear common and should be anticipated. Their origin is multifactorial, with the pump, associated consumables, and the user all being important factors. Ongoing support and anticipatory education are essential to minimize pump-associated AEs and their impact.
authors.affiliation: 1 The Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead , Sydney, Australia .
authors.forename: Benjamin J
authors.initials: BJ
authors.lastname: Wheeler
authors.forename: Kristine
authors.initials: K
authors.lastname: Heels
authors.forename: Kim C
authors.initials: KC
authors.lastname: Donaghue
authors.forename: David M
authors.initials: DM
authors.lastname: Reith
authors.forename: Geoffrey R
authors.initials: GR
authors.lastname: Ambler
mesh_terms: D000293:Adolescent; D000367:Age Factors; D001315:Australia / Q000453:epidemiology; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000188:drug therapy* / Q000453:epidemiology; D004636:Emergency Service, Hospital / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data; D005260:Female; D057220:Health Literacy / Q000706:statistics & numerical data; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D015994:Incidence; D015918:Infusion Pumps, Implantable / Q000009:adverse effects; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D010290:Parents / Q000193:education / Q000523:psychology; D010353:Patient Education as Topic; D011446:Prospective Studies; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin