Position statements

Insulin pump therapy

also known as continuous subcutaneous insulin infusion (CSII)

Insulin pump therapy should be offered as a treatment for diabetes to children, young persons and adults with Type 1 diabetes as part of a cohesive and comprehensive diabetes service. Appropriateness should be determined by clinical need, personal choice and suitability - not on the basis of where a person lives or ability to pay. National Institute for Health and Clinical Excellence (NICE) guidance1,2 should be locally implemented in a uniform manner putting an end to the existing UK postcode lottery.

Continuous subcutaneous insulin infusion (CSII) is an increasingly popular treatment option. It offers significant benefit over Multiple Daily Injections (MDI) for some in terms of diabetes management and quality of life3.  The forthcoming review of NICE insulin pump therapy guidance should take on board emerging evidence showing benefits to those prone to frequent hypoglycaemia and significant variability in day-to-day blood glucose levels4. Greater emphasis should also be placed on the quality of life benefits reported by people with diabetes. Implementation criteria should be incorporated to ensure access to the therapy and services.

  • Pump therapy is an alternative insulin delivery option and awareness should be raised amongst healthcare professionals and people with Type 1 diabetes alike.
  • Transparent, consistent and equitable protocols should be in place in all localities covering:
    - assessment, referral, follow-up, ongoing support, education, support during initiation, supply of consumables, discontinuation, staff training and competencies.
  • Funding for pumps and consumables should be accessible when criteria are met.
  • The development of local pump centres, with appropriate infrastructure, staff, education and training, should be encouraged. Local arrangements need to be put in place to support this. 
  • Teams delivering pump therapy services should establish databases to support quality assurance and adverse events reporting and national audit.

Background

It is estimated that around five to six thousand (2 per cent) of people with Type 1 diabetes currently use pumps in the UK. This compares to between an estimated 10-20 per cent in other European member states and around 15-20 per cent in the United States5. Thus indicating that CSII is under-utilised in the UK. Pump therapy is not a new treatment, with it first being introduced in the late 1970’s. As with any new treatment, there were initial problems, which led to safety concerns. However, the new generation of pumps have been improved with additional safety features and are widely used in Europe, suggesting that safety fears have been addressed.

Suitability

Pump therapy may not suitable for everyone. It is however being successfully used by children, teenagers6-8 and adults - including women during pregnancy9. Cases are also increasing of pump therapy being used with infants and babies10, including those that are premature11. The key to successful use of pump therapy is motivation. Those most suited must have received structured education, have a good knowledge and understanding of diabetes and of how insulin, exercise and food intake affect blood glucose levels. They must be willing to take significant responsibility for their day-to-day diabetes management or have reliable adult supervision12,13. This requires the commitment to regular testing of blood glucose levels and confidence in acting on results.


 

Cost benefits and quality of life

The main costs of CSII are associated with the capital purchase of the pump and consumables e.g. infusion sets and reservoirs.14 Estimated average yearly costs are £1650 per person.14 Benefits associated with using CSII include a reduction in HbA1c; total daily insulin; reduced incidence of and less severe hypoglycaemia; improved day-to-day and longer-term glycaemic control; reduced hospital admissions, consultant consultations and episodes of hyperglycaemia 3,15-21.

Use of pump therapy appears to derive cost benefits to local health services through a reduction in primary care contacts, reduction in hospital admissions and hospital outpatient contacts. Evidence has shown that an estimated saving of £23,532 over 2 years can be derived which offset the costs of pump therapy22. Treatment with insulin pumps has been shown to be associated with improved glycaemic control and reduced incidence of complications. This produces an incremental cost effectiveness ratio (ICER) of £25,648 per QALY, representing good value for money 23.

A recent systematic review of published literature relating to quality of life associated with insulin pump use in Type 1 diabetes reports that “existing research is flawed making a judgement about the quality of life benefits of insulin pump use difficult”24. There is however, no strong evidence that there is no benefit. Those using CSII report that it can be a much more convenient method of delivering insulin. It can reduce diabetes related worry; bring about more flexible eating habits; increase lifestyle flexibility; improve carer quality of life7 and sleep patterns3,8,16,21. The Five Nations Trial reported improvement in all diabetes quality of life scores and perception of mental health, compared to MDI therapy3.

Further research is needed to assess quality of life benefits. Limited evidence is currently available concerning benefit of pump therapy for people with Type 2 diabetes using intensive insulin therapy25. Respondents to a survey of children and young persons views about their diabetes services rated the need to improve access to insulin pumps as one of their top priorities to improve care26.


 

Local delivery of national standards

NICE1 recommends insulin pump use in cases where multiple dose insulin therapy has failed*, and the person is willing and able to use pump therapy effectively. A trained specialist team, with a specialist interest in pump therapy, should review treatment. A survey of PCTs reported 79 per cent having policies in place, but no details are available about content27. At present there is a lack of education and training to develop local competence in insulin pump management.  Organisation of pump services currently varies according to local experience and resources available where:
-  staff are aware of insulin pumps, but refer elsewhere,
-  people with diabetes using pumps are supported locally, but are trained elsewhere,
- staff are skilled in managing people with diabetes using pumps and providing education, training and support to their own patients,
- expert centres train other people with diabetes and other professionals.

Despite the existence guidance and reported policies in place, local areas are not providing services in a consistent manner28,29. Problems currently experienced by people with diabetes include not being able to get assessed; unable to access the funding for the pump/consumables or experienced specialist teams for clinical support. As a result, many pump users have to continue to self-fund the therapy. Some people already using pumps experience difficulties when moving to another area where they have to go through the assessment process again. Furthermore, some areas are restricting access by capping numbers to reduce costs.


The National Diabetes Support Team Insulin Pump Working Group is expected to publish detailed guidance to support delivery of NICE recommendations in early 2007. This will include service criteria, quality standards and examples of good practice to inform local service developments.

* Multiple dose insulin therapy is considered to have failed when a person is unable to maintain their blood glucose levels within recommended levels (HbA1c ‘no greater than 7.5% or 6.5% in the presence of microalbuminuria or adverse features of the metabolic syndrome) or without disabling hypoglycaemia occurring (repeated and unpredictable occurrence of hypoglycaemia requiring third-party assistance that results in continuing anxiety about recurrence and is associated with significant adverse effect on quality of life). This failure would be despite a high level of self-care of their diabetes. 

References

  1. Guidance on the use of continuous subcutaneous insulin infusion for diabetes. Technology Appraisal Guidance No.57. National Institute for Clinical Excellence, 2003. www.nice.org.uk
  2. Colquitt JL. Green C, Sidhu MK, Dartwell D and Waugh N. Clinical and cost-effectiveness of  continuous subcutaneous insulin infusion (CSII). Southampton Health Technology Assessments Centre.  Health Technology Assessment. 2004. Vol.8; Number 43.
  3. Hoogma RPLM, Hammond PJ, Gomist R et.al. 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. Diabetic Medicine. Original Article. 2005.
  4. Pickup JC, Kidd J, Burmiston S, N Yemane. Effectiveness of continuous subcutaneous insulin infusion in hypoglycaemia prone type 1 diabetes: implications for NICE guidelines. (Pre-publication).
  5. INPUT, Insulin Pump Therapy Briefing, 2006. www.input.me.uk
  6. Torrance T, Franklin V, Greene S. Insulin pumps. A growing option in the UK for children and young adults with type 1 diabetes. Leading Article. Endocrinology. Archives of Diseases in Childhood. 2003;88;949-953
  7. Nimri R, Weintrob N, Benzaquen R et.al. Insulin pump therapy in youth with type 1 diabetes mellitus: a retrospective paired study. Pediatric Diabetes. Abstracts for the 32nd Annual Meeting of the International Society for Pediatric and Adolescent Diabetes (ISPAD). Vol 7; Supp. 5; September 2006
  8. Stuart A, Weinzimer MD, Ahern JH, Doyea E et.al. Persistence of benefits of continuous subcutaneous insulin infusion in very young children with Type 1 diabetes: A follow-up report. Pediatrics. Vol 114 No.6 December 2004: 1601-1605
  9. A Lapolla, MG Dalfra, M Masin, D Bruttomesso et.al.  Analysis of outcome of pregnancy in type 1 diabetics treated with insulin pump or conventional insulin therapy. Acta Diabetologica. 2003 Sep: 40(3):143-9.
  10. Weinzimer SA, Swan KL, Sikes JA, Ahern JH. Emerging evidence for the use of insulin pump therapy in infants, toddlers and pre-school aged children with Type 1 diabetes. Pediatric Diabetes 2006: &(Suppl.4):15-19
  11. L. Beaumont: Rare newborns spur pioneering use of insulin pumps.. August 15, 2003. Fairfax Digital. The Age
  12. Position Statement. Continuous Subcutaneous Insulin Infusion. 2004. American Diabetes Association (ADA). Published in 2006 Care recommendations. www.diabetes.org
  13. Fisher LK. The selection of children and adolescents for treatment with continuous subcutaneoue insulin infusion (CSII). Pediatric Diabetes 2006: 7 (Suppl.4):11-14
  14. INPUT, Insulin Pump Therapy Briefing, 2006. www.input.me.uk
  15. Tamborlane WV, Bonfig W, Boland E. Recent advances in treatment at youth of type 1 diabetes: better care through technology. Diabetic Medicine. 2001; 18:864-70
  16. Tetnakaran, Heine, Hochman et al. Continuous subcutaneous insulin infusion versus multiple daily injections. Diabetes Care. Volume 27, Number 11, November 2004: 2590-2596
  17. Pickup JC. Is insulin pump treatment justifiable? In Gill G, Pickup J, Williams G. Eds. Unstable and difficult diabetes. Oxford Blackwell Science. 2003
  18. Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with Type 1 diabetes: meta-analysis of randomised controlled trials. BMJ. Volume 324; 23 March 2002.
  19. Doyle E, Ahern J, Weinzimer A, Vincent M et al. A randomised, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care, Volume 27; Number 7; July 2004:1554-1558
  20. Hirsch, Bode B, Garg, Lane W, Sussman A. Continuous subcutaneous insulin infusion (CSII) of insulin apart versus multiple daily injection on insulin apart/insulin glargine in Type 1 diabetic patients previously treated with CSII. Diabetes Care, Volume 28, Number 3. March 2005:533-538
  21. Linkeschova R, Raoul M, Bott U, Berger M and Spraul M. Less severe hypoglycaemia, better metabolic control and improved quality of life in Type 1 diabetes mellitus with continuous subcutaneous insulin infusion (CSII) therapy; an observational study of 100 consecutive patients followed for a mean of 2 years. Diabetic Medicine. 2002. 19;746-751
  22. Ulahannan T, Myint N, Lonnen KF. Effects of insulin pump therapy on healthcare utilisation. 2006. Pre Publication.
  23. Roze S, Valentine WJ, Zakreqska and Palmer AJ. Health Economic comparison of continuous subcutaneous insulin infusion with multiple daily injection for the treatment of Type 1 diabetes in the UK. Diabetic Medicine, 2005; 22; 1239-1245 
  24. Barnard KD, Lloyd CE, and Skinner TC. SYSTEMATIC LITERATURE REVIEW.  Quality of Life Associated With Insulin Pump Use in Type 1 Diabetes. In press
  25. Raskin P, Bode BW, Marks BJ et.al. Continuous Subcutaneoues Insulin Infusion and Multiple Daily Injection Therapy are equally effective in Type 2 diabetes. Diabetes Care. Sept 2003, Vol 26(9):2598-2603
  26. Children and young people’s members survey. Diabetes UK. 2006
  27. Survey of PCT diabetes services. Diabetes UK 2006.
  28. Policy Research Report. Pump therapy restrictions. Diabetes UK. September 2006
  29. Bootle S. Delivering NICE technology appraisal guidance no.57 (continuous subcutaneous insulin infusion for diabetes)- a survey of Primary Care organisations, NHS Trusts and existing insulin pump users.

Acknowledgements

Thanks to Richard Holt, Krystyna Matyka, John Davis, Felix Burden, John Taylor, June James and John Grummit

Further information

Full NICE Guidance www.nice.nhs.uk.
The national support group for pump users INPUT. www.input.me.uk
Insulin Pumpers UK is an internet based discussion group. www.insulin-pumpers.org.uk
Pump management for professionals (PUMP). www.insulin-pump.info

 

Reviewed December 2006