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Acta Diabetologica

, Volume 52, Issue 6, pp 1017–1024 | Cite as

Clinical review: insulin pump-associated adverse events in adults and children

  • P. L. Ross
  • J. Milburn
  • D. M. Reith
  • E. Wiltshire
  • B. J. Wheeler
Review Article

Abstract

Aims

Insulin pumps are a vital and rapidly developing tool in the treatment of type 1 diabetes mellitus in both adults and children. Many studies have highlighted outcomes and assessed their potential advantages, but much of the data on adverse outcomes are limited and often based on outdated technology. We aimed to review and summarize the available literature on insulin pump-associated adverse events in adults and children.

Methods

A literature search was undertaken using PubMed, EMBASE, and the Cochrane library. Articles were then screened by title, followed by abstract, and full text as needed. A by-hand search of reference lists in identified papers was also utilised. All searches were limited to English language material, but no time limits were used.

Results

Current and past literature regarding insulin pump-associated adverse events is discussed, including potential metabolic and non-metabolic adverse events, in particular: pump malfunction; infusion set/site issues; and cutaneous problems. We show that even with modern technology, adverse events are common, occurring in over 40 % of users per year, with a minority, particularly in children, requiring hospital management. Hyperglycaemia and ketosis are now the most common consequences of adverse events and are usually associated with infusion set failure. This differs from older technology where infected infusion sites predominated.

Conclusions

This timely review covers all potential insulin pump-associated adverse events, including their incidence, features, impacts, and contributory factors such as the pump user. The importance of ongoing anticipatory education and support for patients and families using this intensive insulin technology is highlighted, which if done well should improve the overall experience of pump therapy for users, and hopefully reduce the incidence and impact of severe adverse events.

Keywords

Type 1 diabetes Insulin pump Continuous subcutaneous insulin infusion Adverse event 

Notes

Conflict of interest

The authors declare that they have no conflict of interest.

Ethical standard

This article does not contain any studies with human participants performed by any of the authors.

Human and animal rights

This article does not contain any studies with human or animal subjects performed by any of the authors.

Informed consent

None.

References

  1. 1.
    The Diabetes Control and Complications Trial Research Group (1993) The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med 329:977–986CrossRefGoogle Scholar
  2. 2.
    Nathan DM, Cleary PA, Backlund JY et al (2005) Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med 353:2643–2653CrossRefPubMedGoogle Scholar
  3. 3.
    Pickup JC, Yemane N, Brackenridge A, Pender S (2014) Nonmetabolic complications of continuous subcutaneous insulin infusion: a patient survey. Diab Technol Ther 16:145–149CrossRefGoogle Scholar
  4. 4.
    Guilhem I, Balkau B, Lecordier F et al (2009) Insulin pump failures are still frequent: a prospective study over 6 years from 2001 to 2007. Diabetologia 52:2662–2664CrossRefPubMedGoogle Scholar
  5. 5.
    Wheeler BJ, Donaghue KC, Heels K, Ambler GR (2014) Family perceptions of insulin pump adverse events in children and adolescents. Diab Technol Ther 16:204–207CrossRefGoogle Scholar
  6. 6.
    Wheeler BJ, Heels K, Donaghue KC, Reith DM, Ambler GR (2014) Insulin pump-associated adverse events in children and adolescents—a prospective study. Diab Technol Ther 16:558–562CrossRefGoogle Scholar
  7. 7.
    Cope JU, Samuels-Reid JH, Morrison AE (2012) Pediatric use of insulin pump technology: a retrospective study of adverse events in children ages 1–12 years. J Diab Sci Technol 6:1053–1059CrossRefGoogle Scholar
  8. 8.
    Mecklenburg RS, Benson EA, Benson JW Jr et al (1984) Acute complications associated with insulin infusion pump therapy. Report of experience with 161 patients. JAMA 252:3265–3269CrossRefPubMedGoogle Scholar
  9. 9.
    Knight G, Jennings AM, Boulton AJ, Tomlinson S, Ward JD (1985) Severe hyperkalaemia and ketoacidosis during routine treatment with an insulin pump. Br Med J 291:371–372CrossRefGoogle Scholar
  10. 10.
    Cope JU, Morrison AE, Samuels-Reid J (2008) Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events. Pediatrics 121:e1133–e1138CrossRefPubMedGoogle Scholar
  11. 11.
    Guilhem I, Leguerrier AM, Lecordier F, Poirier JY, Maugendre D (2006) Technical risks with subcutaneous insulin infusion. Diab Metab 32:279–284CrossRefGoogle Scholar
  12. 12.
    Scaramuzza AE, Dell’Acqua M, Macedoni M, Zuccotti GV (2013) Insulin pump therapy in children with type 1 diabetes: the dark side of the moon. J Diab Sci Technol 7:1095–1097Google Scholar
  13. 13.
    Schmid V, Hohberg C, Borchert M, Forst T, Pfutzner A (2010) Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diab Sci Technol 4:976–982CrossRefGoogle Scholar
  14. 14.
    Hoogma RP, Hammond PJ, Gomis R et al (2006) Comparison of the effects of continuous subcutaneous insulin infusion (CSII) and NPH-based multiple daily insulin injections (MDI) on glycaemic control and quality of life: results of the 5-Nations trial. Diab Med 23:141–147CrossRefGoogle Scholar
  15. 15.
    Hirsch IB, Farkas-Hirsch R, McGill JB (1992) Catheter obstruction with continuous subcutaneous insulin infusion Effect of insulin concentration. Diab Care 15:593–594CrossRefGoogle Scholar
  16. 16.
    Walter HM, Timmler R, Mehnert H (1990) Stabilized human insulin prevents catheter occlusion during continuous subcutaneous insulin infusion. Diab Res 13:75–77Google Scholar
  17. 17.
    Johansson UB, Adamson U, Lins PE, Wredling R (2005) Patient management of long-term continuous subcutaneous insulin infusion. J Adv Nurs 51:112–118CrossRefPubMedGoogle Scholar
  18. 18.
    Hojbjerre L, Skov-Jensen C, Kaastrup P, Pedersen PE, Stallknecht B (2009) Effect of steel and teflon infusion catheters on subcutaneous adipose tissue blood flow and infusion counter pressure in humans. Diab Technol Ther 11:301–306CrossRefGoogle Scholar
  19. 19.
    Patel PJ, Benasi K, Ferrari G et al (2014) Randomized trial of infusion set function: steel versus teflon. Diab Technol Ther 16:15–19CrossRefGoogle Scholar
  20. 20.
    Renard E, Guerci B, Leguerrier AM, Boizel R (2010) Accu-Chek FlexLink Study G. Lower rate of initial failures and reduced occurrence of adverse events with a new catheter model for continuous subcutaneous insulin infusion: prospective, two-period, observational, multicenter study. Diab Technol Ther 12:769–773CrossRefGoogle Scholar
  21. 21.
    Kerr D, Wizemann E, Senstius J, Zacho M, Ampudia-Blasco FJ (2013) Stability and performance of rapid-acting insulin analogs used for continuous subcutaneous insulin infusion: a systematic review. J Diab Sci Technol 7:1595–1606Google Scholar
  22. 22.
    Mecklenburg RS, Guinn TS, Sannar CA, Blumenstein BA (1986) Malfunction of continuous subcutaneous insulin infusion systems: a one-year prospective study of 127 patients. Diab Care 9:351CrossRefGoogle Scholar
  23. 23.
    van Bon AC, Bode BW, Sert-Langeron C, DeVries JH, Charpentier G (2011) Insulin glulisine compared to insulin aspart and to insulin lispro administered by continuous subcutaneous insulin infusion in patients with type 1 diabetes: a randomized controlled trial. Diab Technol Ther 13:607–614CrossRefGoogle Scholar
  24. 24.
    Bode BW (2011) Comparison of pharmacokinetic properties, physicochemical stability, and pump compatibility of 3 rapid-acting insulin analogues-aspart, lispro, and glulisine. Endocr Pract 17:271–280CrossRefPubMedGoogle Scholar
  25. 25.
    Kerr D, Morton J, Whately-Smith C, Everett J, Begley JP (2008) Laboratory-based non-clinical comparison of occlusion rates using three rapid-acting insulin analogs in continuous subcutaneous insulin infusion catheters using low flow rates. J Diab Sci Technol 2:450–455CrossRefGoogle Scholar
  26. 26.
    Lopez PE, King BR, Goss PW, Chockalingam G (2014) Bubble formation occurs in insulin pumps in response to changes in ambient temperature and atmospheric pressure but not as a result of vibration. BMJ Open Diab Res Care 2:e000036PubMedCentralCrossRefPubMedGoogle Scholar
  27. 27.
    King BR, Goss PW, Paterson MA, Crock PA, Anderson DG (2011) Changes in altitude cause unintended insulin delivery from insulin pumps: mechanisms and implications. Diab Care 34:1932–1933CrossRefGoogle Scholar
  28. 28.
    Conwell LS, Pope E, Artiles AM, Mohanta A, Daneman A, Daneman D (2008) Dermatological complications of continuous subcutaneous insulin infusion in children and adolescents. J Pediatr 152:622–628CrossRefPubMedGoogle Scholar
  29. 29.
    Radermecker RP, Pierard GE, Scheen AJ (2007) Lipodystrophy reactions to insulin: effects of continuous insulin infusion and new insulin analogs. Am J Clin Dermatol 8:21–28CrossRefPubMedGoogle Scholar
  30. 30.
    Saccabusi S, Boatto G, Asproni B, Pau A (2001) Sensitization to methyl methacrylate in the plastic catheter of an insulin pump infusion set. Contact Dermat 45:47–48CrossRefGoogle Scholar
  31. 31.
    Schober E, Rami B (2009) Dermatological side effects and complications of continuous subcutaneous insulin infusion in preschool-age and school-age children. Pediatr Diab 10:198–201CrossRefGoogle Scholar
  32. 32.
    Heinemann L, Krinelke L (2012) Insulin infusion set: the Achilles heel of continuous subcutaneous insulin infusion. J Diab Sci Technol 6:954–964CrossRefGoogle Scholar
  33. 33.
    Rosenbloom AL (2014) Insulin injection lipoatrophy recidivus. Pediatr Diab 15:73–74CrossRefGoogle Scholar
  34. 34.
    Hanas R, Lindgren F, Lindblad B (2009) A 2-yr national population study of pediatric ketoacidosis in Sweden: predisposing conditions and insulin pump use. Pediatr Diab 10:33–37CrossRefGoogle Scholar
  35. 35.
    Shalitin S, Phillip M (2008) The use of insulin pump therapy in the pediatric age group. Horm Res 70:14–21CrossRefPubMedGoogle Scholar
  36. 36.
    Scheen A, Castillo M, Jandrain B et al (1984) Metabolic alterations after a two-hour nocturnal interruption of a continuous subcutaneous insulin infusion. Diab Care 7:338–342CrossRefGoogle Scholar
  37. 37.
    Guerci B, Meyer L, Salle A et al (1999) Comparison of metabolic deterioration between insulin analog and regular insulin after a 5-hour interruption of a continuous subcutaneous insulin infusion in type 1 diabetic patients. J Clin Endocrinol Metab 84:2673–2678PubMedGoogle Scholar
  38. 38.
    Radermecker RP, Scheen AJ (2004) Continuous subcutaneous insulin infusion with short-acting insulin analogues or human regular insulin: efficacy, safety, quality of life, and cost-effectiveness. Diab Metab Res Rev 20:178–188CrossRefGoogle Scholar
  39. 39.
    Realsen J, Goettle H, Chase HP (2012) Morbidity and mortality of diabetic ketoacidosis with and without insulin pump care. Diab Technol Ther 14:1149–1154CrossRefGoogle Scholar
  40. 40.
    Johnson SR, Cooper MN, Jones TW, Davis EA (2013) Long-term outcome of insulin pump therapy in children with type 1 diabetes assessed in a large population-based case–control study. Diabetologia 56:2392–2400CrossRefPubMedGoogle Scholar
  41. 41.
    Yeh HC, Brown TT, Maruthur N et al (2012) Comparative effectiveness and safety of methods of insulin delivery and glucose monitoring for diabetes mellitus: a systematic review and meta-analysis. Ann Intern Med 157:336–347CrossRefPubMedGoogle Scholar
  42. 42.
    Misso Marie L, Egberts Kristine J, Page M, O’Connor D, Shaw J (2010) Continuous subcutaneous insulin infusion (CSII) versus multiple insulin injections for type 1 diabetes mellitus. Cochrane Datab Syst Rev 20(1):CD005103. doi: 10.1002/14651858.CD005103.pub2
  43. 43.
    Cooper MN, O’Connell SM, Davis EA, Jones TW (2013) A population-based study of risk factors for severe hypoglycaemia in a contemporary cohort of childhood-onset type 1 diabetes. Diabetologia 56:2164–2170CrossRefPubMedGoogle Scholar
  44. 44.
    Bode BWTW, Davidson PC (2002) Insulin pump therapy in the 21st century: strategies for successful use in adults, adolescents, and children with diabetes. Postgrad Med 111:69CrossRefPubMedGoogle Scholar
  45. 45.
    Pickup JC, Sutton AJ (2008) Severe hypoglycaemia and glycaemic control in type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diab Med 25:765–774CrossRefGoogle Scholar
  46. 46.
    Cryer PE, Davis SN, Shamoon H (2003) Hypoglycemia in diabetes. Diab Care 26:1902–1912CrossRefGoogle Scholar
  47. 47.
    Wredling R, Lin PE, Adamson U (1989) Pump, “run-away” causing severe hypoglycaemia. Lancet 2:273CrossRefPubMedGoogle Scholar
  48. 48.
    Heinemann L, Fleming GA, Petrie JR, Holl RW, Bergenstal RM, Peters AL (2015) Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diab Care 38:716–722CrossRefGoogle Scholar

Copyright information

© Springer-Verlag Italia 2015

Authors and Affiliations

  • P. L. Ross
    • 1
  • J. Milburn
    • 2
  • D. M. Reith
    • 1
  • E. Wiltshire
    • 3
  • B. J. Wheeler
    • 1
    • 2
    • 4
  1. 1.Department of Women’s and Children’s HealthUniversity of OtagoDunedinNew Zealand
  2. 2.Paediatric EndocrinologySouthern District Health BoardDunedinNew Zealand
  3. 3.Department of Paediatrics and Child HealthUniversity of Otago WellingtonWellingtonNew Zealand
  4. 4.Edgar National Centre for Diabetes and Obesity ResearchUniversity of OtagoDunedinNew Zealand

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