Evidence Base

Executive_Summary_Section-CSII

There is strong evidence supporting insulin pump therapy and its utility within the NHS. The National Institute for Health and Clinical Excellence (NICE) has issued guidance (Click here) for insulin pump therapy for some people with type 1 diabetes and estimates that it is likely to benefit 8 - 15% of adults and up to 50% of children under the age of 12 with this condition. However, there is considerable inequity in both access and provision of insulin pump therapyand therefore compliance with NICE guidance across England and Wales.

This section provides implementation project data (Click here) from the NTAC project implementation sites who are now routinely using this technology as a standard clinical option and all in relation to insulin pump therapy.

NTAC Insulin Pump Therapy Project Data

Methods of quantitative and qualitative measurement and evaluation of the clinical utility of implementing insulin pump therapy were developed by project teams from the three NTAC project implementation sites. These were used in the determination of the impact of the technology on patient outcomes and support requirements, hospital resource requirements and the clinical utility of adoption the technology.

The evaluation measures and values were subjected to independent analysis undertaken by the NHS Technology Adoption Centre and the NHS Information Centre for Health and Social Care.

Background to National Standards

An internationally accepted measure of good diabetes control is the glycated haemoglobin (HbA1c), which has been shown to reflect long term risk for complications. NICE Review of Technology Appraisal Guidance (Click here) and the Quality and Outcomes Framework advocate a treatment target of HbA1c ≤7.5% as this represents a level of glucose control in which the risk of micro and macro vascular disease is substantially reduced without increasing the risk of hypoglycaemia. However, the National Diabetes Audit has recently shown that 85% of children with diabetes do not meet the HbA1c target of ≤7.5%, which puts them at substantially greater risk of micro and microvascular disease.

In 2003, the National Institute for Health and Clinical Excellence (NICE) recommended the use of insulin pump therapy as an option for patients with Type 1 diabetes. This was reappraised by NICE and in 2008, the NICE Review of Technology Appraisal Guidance (Click here) (FAD) was published and stated that:

  • Continuous Subcutaenous Insulin Infusion (CSII) therapy is recommended as a treatment option for children younger than 12 years with type 1 diabetes:
    • if Multiple Daily Injection (MDI) therapy is considered to be inappropriate
    • and those receiving the treatment and their carers have the commitment and competency to use the therapy effectively.
  • CSII therapy is recommended as a treatment option for adults (including pregnant women and women planning pregnancy) and children older than 12 years with type 1 diabetes mellitus provided that:
    • MDI therapy (including, if appropriate, the use of long-acting insulin analogues) has failed to provide adequate control of their diabetes (i.e. HbA1c > 8.5% or the repeated and unpredictable occurance of hypoglycaemia that creates anxiety) and
    • Those receiving the treatment and their carers have the committment and competence to use the therapy effectively.
  • NICE have produced guidance on Insulin Pump Therapy for Diabetes  (Click here) which gives an overview of the guidance.
  • The guidance on Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus - Review of technology appraisal (Click here) is also recommended for review.

Supporting Evidence

Understanding NICE guidance - Insulin Pump Therapy for Diabetes
National Institute for Health and Clinical Excellence
Click here to view this guidance

Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus - Review of technology appraisal guidance
National Institute for Health and Clinical Excellence
Click here to view this guidance

Diabetes in the UK 2010: Key statistics on diabetes
Diabetes UK
Click here to view this publication

Continuous Subcutaneous Insulin Infusion (CSII) versus Multiple Insulin Injections for Type 1 Diabetes Mellitus
Misso ML, Egberts KJ, Page M, O'Connor D, Shaw J
Click here to view this review

Focus on insulin pumps, Diabetes Breakthrough
Juvenile Diabetes Research Foundation
Click here to view this publication

Efficacy and indications of CSII revisited: the Hotel-Dieu Cohort 
Haarat MJ, Berne C, Dorange G, Slama G, Selam JL
Click here to view this publication

Continuous subcutaneous insulin infusion. A new way to lower risk of severe hypoglycaemia , improve metabolic control, and enhance coping in adolescents with type 1 diabetes
Boland EA, Grey M, Oesterle A, Fredrickson L, Tamborlane WV
Click here to view this abstract

Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes
Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B
Click here to view this abstract

Insulin Pump Therapy: a meta-analysis
Weissberg-Benchell J, Antisdel-Lomoglio J, Seshandri R
Click here to view this abstract

Continuous Glucose Monitoring and intensive treatment of type 1 diabetes
The Juvenile Diabetes Research Foundation CGM study group
Click here to view this publication

Relevant Reports

National Service Framework for Diabetes: Standards
Department of Health
Click here to view this framework

National Service Framework for Diabetes: Delivery Strategy
Department of Health
Click here to view this framework

Insulin Pump Services - Report of the insulin pump working group
Diabetes UK
Click here to view this report

Indications and efficacy of continuous insulin infusion (CSII) therapy with Type 1 diabetes mellitus: a clinical audit in a specialist service
Rodrigues IA, Reid HA, Ismail K, Amiel SA
Click here to view this abstract

National Diabetes Audit, Executive Summary - Key findings about the quality of care for people with Diabetes in England and Wales
The Information Centre
Click here to view this audit

Making the case for insulin pump therapy
Ulahannan T, Myint NN, Lonnen KF
Click here to view this publication

World Class Commissioning
Department of Health
Click here to view this publication

Other useful Reference Papers

The cost effectiveness of continuous subcutaneous insulin infusion compared with multiple daily injections for the management of diabetes
Scuffham P, Carr L
Click here to view this publication

PBS Diabetes Prevalence model phase 3: Key findings
Yorkshire & Humber Public Health Observatory - May 2008
Click here to view this publication

Health economic comparison of continuous subcutaneous insulin infusion with multiple daily injection for treatment of Type 1 diabetes in the UK
Roze S, Valentine WJ, Zakrzewska KE, Palmer AJ
Click here to view this abstract

Reduction in severe hypoglycemia with long-term continuous subcutaneous insulin infusion in type I diabetes
Bode BW, Steed RD, Davidson PC
Click here to view this abstract

Intensive insulin therapy with insulin lispro: a randomized trial of continuous subcutaneous insulin infusion versus multiple daily insulin injection
Tsui E, Barnie A, Ross S, Parkes R, Zinman B
Click here to view this abstract

Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta analysis of randomised controlled trials
John Pickup, Martin Mattock, Sally Kerry
Click here to view this paper

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
Linkeschova R, Raoul M, Bott U, Berger M, Spraul M
Click here to view this article

Diabetes Commissioning Resource
NHS Diabetes
Click here to view this toolkit

Diabetes: state of the nations 2006 - Progress made in delivering the national diabetes frameworks
Diabetes UK
Click here to view this report

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
Hoogma RP et al, 5-Nations study group
Click here to view this publication

Useful Web Sites

Juvenile Diabetes Research Foundation (JDRF)
www.jdrf.org.uk

INPUT (Insulin Pump Therapy)
www.input.me.uk

Diabetes UK
www.diabetes.org.uk

NHS Information Centre
NHS Information Centre for Health and Social Care

Department of Health
www.dh.gov.uk

NHS Technology Adoption Centre (NTAC)
NHS Technology Adoption Centre

Quality and Outcomes Framework (QOF) 2009:
Quality and Outcomes Framework

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