PMID- 24796368
OWN - NLM
STAT- MEDLINE
DCOM- 20150609
LR  - 20220409
IS  - 1557-8593 (Electronic)
IS  - 1520-9156 (Linking)
VI  - 16
IP  - 9
DP  - 2014 Sep
TI  - Insulin pump-associated adverse events in children and adolescents--a prospective 
      study.
PG  - 558-62
LID - 10.1089/dia.2013.0388 [doi]
AB  - 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. 
      SUBJECTS AND 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.
FAU - Wheeler, Benjamin J
AU  - Wheeler BJ
AD  - 1 The Institute of Endocrinology and Diabetes, The Children's Hospital at 
      Westmead , Sydney, Australia .
FAU - Heels, Kristine
AU  - Heels K
FAU - Donaghue, Kim C
AU  - Donaghue KC
FAU - Reith, David M
AU  - Reith DM
FAU - Ambler, Geoffrey R
AU  - Ambler GR
LA  - eng
PT  - Journal Article
DEP - 20140505
PL  - United States
TA  - Diabetes Technol Ther
JT  - Diabetes technology & therapeutics
JID - 100889084
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Insulin)
SB  - IM
MH  - Adolescent
MH  - Age Factors
MH  - Australia/epidemiology
MH  - Child
MH  - Diabetes Mellitus, Type 1/*drug therapy/epidemiology
MH  - Emergency Service, Hospital/*statistics & numerical data
MH  - Equipment Failure/statistics & numerical data
MH  - Female
MH  - Health Literacy/statistics & numerical data
MH  - Hospitalization/*statistics & numerical data
MH  - Humans
MH  - Hypoglycemic Agents/*administration & dosage
MH  - Incidence
MH  - *Infusion Pumps, Implantable/adverse effects
MH  - Insulin/*administration & dosage
MH  - Male
MH  - *Parents/education/psychology
MH  - Patient Education as Topic
MH  - Prospective Studies
MH  - Risk Factors
MH  - Surveys and Questionnaires
MH  - Treatment Outcome
EDAT- 2014/05/07 06:00
MHDA- 2015/06/10 06:00
CRDT- 2014/05/07 06:00
PHST- 2014/05/07 06:00 [entrez]
PHST- 2014/05/07 06:00 [pubmed]
PHST- 2015/06/10 06:00 [medline]
AID - 10.1089/dia.2013.0388 [doi]
PST - ppublish
SO  - Diabetes Technol Ther. 2014 Sep;16(9):558-62. doi: 10.1089/dia.2013.0388. Epub 
      2014 May 5.