title: Insulin pump-associated adverse events are common, but not associated with glycemic control, socio-economic status, or pump/infusion set type.
abstract: OBJECTIVE
  While there have been many outcome-focussed studies examining insulin pump therapy, only a few have looked at potential adverse events (AEs), with none examining the relationship between AEs and pump/infusion set type, ethnicity or socio-economic status. In addition, current data on the incidence and characteristics of pump-associated AEs are confined to one paediatric centre. We aimed to describe the incidence, characteristics and potential predictors of insulin pump-associated AEs in New Zealand adults and children with T1DM.
  
  
  METHODS
  We approached adults and families of children with T1DM on insulin pumps in four main New Zealand centres. Participants completed a questionnaire examining pump-related issues they had experienced in the preceding 12 months.
  
  
  RESULTS
  Response rate was 64 % with 174 of 270 eligible people participating in the study. 84 % of subjects reported one or more AEs, with an overall AE incidence of 3.42 per person/year (95 % CI 3.14, 3.73). An event serious enough to require a hospital presentation occurred in 9.8 %, all but one reporting high ketones or diabetic ketoacidosis (DKA). Set/site problems were the AE most commonly reported (by 53 % of respondents), followed by cutaneous complications (43 %) and pump malfunction (38 %). Few predictors of AEs (of any type) were found; however, a negative binomial regression model found that a longer duration of pumping (p = 0.018) and age <18 years (p = 0.043) were both associated with fewer AEs (all types combined).
  
  
  CONCLUSIONS
  Insulin pump-associated AEs are very common. However, few variables are predictive of them with no relationships seen with glycaemic control, socio-economic status, pump manufacturer or infusion set type. Based on these findings, AEs should be anticipated in both adults and children, with anticipatory patient education and training recommended for their successful and safe use.
authors: Department of Women's and Children's Health, University of Otago, PO Box 913, Dunedin, 9054, New Zealand.
authors: P
authors: P
authors: Ross
authors: Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand.
authors: A R
authors: AR
authors: Gray
authors: Paediatric Endocrinology, Southern District Health Board, Dunedin, New Zealand.
authors: J
authors: J
authors: Milburn
authors: Diabetes Centre, Auckland District Health Board, Auckland, New Zealand.
authors: I M
authors: IM
authors: Kumarasamy
authors: Diabetes Centre, Auckland District Health Board, Auckland, New Zealand.
authors: F
authors: F
authors: Wu
authors: Department of Endocrinology, Southern District Health Board, Dunedin, New Zealand.
authors: S
authors: S
authors: Farrand
authors: Department of Paediatrics, Tauranga Public Hospital, Tauranga, New Zealand.
authors: J
authors: J
authors: Armishaw
authors: Department of Children's Health, University of Otago, Wellington, New Zealand.
authors: E
authors: E
authors: Wiltshire
authors: Paediatric Endocrinology, Southern District Health Board, Dunedin, New Zealand.|Department of Endocrinology, Southern District Health Board, Dunedin, New Zealand.
authors: J
authors: J
authors: Rayns
authors: Department of Women's and Children's Health, University of Otago, PO Box 913, Dunedin, 9054, New Zealand.
authors: P
authors: P
authors: Tomlinson
authors: Department of Women's and Children's Health, University of Otago, PO Box 913, Dunedin, 9054, New Zealand. ben.wheeler@otago.ac.nz.|Paediatric Endocrinology, Southern District Health Board, Dunedin, New Zealand. ben.wheeler@otago.ac.nz.
authors: B J
authors: BJ
authors: Wheeler
mesh_terms: D000293:Adolescent; D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D002648:Child; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000188:drug therapy / Q000453:epidemiology; D016883:Diabetic Ketoacidosis / Q000453:epidemiology / Q000209:etiology; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000009:adverse effects; D015994:Incidence; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects; D007332:Insulin Infusion Systems / Q000009:adverse effects / Q000706:statistics & numerical data; D008297:Male; D008875:Middle Aged; D009520:New Zealand / Q000453:epidemiology; D012923:Social Class; D013997:Time Factors
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Adverse event; CSII; Insulin pump; Malfunction; Safety