Technology Appraisal Guidance No. 151
Source: National Institute for Health and Clinical Excellence
NOTE: This guidance replaces ‘NICE technology appraisal guidance 57’ issued in February 2003.
The Institute reviews each piece of guidance it issues.
The review and re-appraisal of the use of continuous subcutaneous insulin infusion for the treatment of diabetes mellitus has resulted in a change in the guidance. Specifically there has been a change to the recommendation on the use of continuous subcutaneous insulin infusion in children younger than 12 years with type 1 diabetes mellitus.
1. Guidance
1.1 Continuous subcutaneous insulin infusion (CSII or ‘insulin pump’) therapy is recommended as a treatment option for adults and children 12 years and older with type 1 diabetes mellitus provided that:
- attempts to achieve target haemoglobin A1c (HbA1c) levels with multiple daily injections (MDIs) result in the person experiencing disabling hypoglycaemia. For the purpose of this guidance, disabling hypoglycaemia is defined as the repeated and unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and is associated with a significant adverse effect on quality of life
or - HbA1c levels have remained high (that is, at 8.5% or above) on MDI therapy (including, if appropriate, the use of long-acting insulin analogues) despite a high level of care.
1.2 CSII therapy is recommended as a treatment option for children younger than 12 years with type 1 diabetes mellitus provided that:
- MDI therapy is considered to be impractical or inappropriate, and
- children on insulin pumps would be expected to undergo a trial of MDI therapy between the ages of 12 and 18 years.
1.3 It is recommended that CSII therapy be initiated only by a trained specialist team, which should normally comprise a physician with a specialist interest in insulin pump therapy, a diabetes specialist nurse and a dietitian. Specialist teams should provide structured education programmes and advice on diet, lifestyle and exercise appropriate for people using CSII.
1.4 Following initiation in adults and children 12 years and older, CSII therapy should only be continued if it results in a sustained improvement in glycaemic control, evidenced by a fall in HbA1c levels, or a sustained decrease in the rate of hypoglycaemic episodes. Appropriate targets for such improvements should be set by the responsible physician, in discussion with the person receiving the treatment or their carer.
1.5 CSII therapy is not recommended for the treatment of people with type 2 diabetes mellitus.
The guidance shown above constitutes Section 1 of the full document. A copy of the full document and a summary of the evidence is available on the Internet at http://www.nice.org.uk/guidance/index.jsp?action=byID&o=12014
An abridged version of this guidance (a 'quick reference guide') is also available. Printed copies of the quick reference guide can be obtained by contacting 0845 003 7783 or emailing publications@nice.org.uk and quoting reference number N1634. It is also available on the Internet at http://www.nice.org.uk/Guidance/TA151/QuickRefGuide/pdf/English
This guidance represents the view of the Institute which was arrived at after careful consideration of the available evidence. Health professionals are expected to fully take it into account when exercising their clinical judgement. This guidance does not, however, override the individual responsibility of health professionals to make appropriate decisions in the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
© Copyright National Institute for Health and Clinical Excellence. All rights reserved. This material may be freely reproduced for educational and not for profit purposes within the NHS. No reproduction by or for commercial organisations is permitted without the express written permission of the Institute.
Enquiries concerning the guidance should be addressed to: National Institute for Health and Clinical Excellence, MidCity Place, 71 High Holborn, London WC1V 6NA. email: nice@nice.nhs.uk
Continuous Subcutaneous Insulin Infusion for the Treatment of Diabetes Mellitus (review of technology appraisal guidance 57).
Issue Date: July 2008
Review Date: February 2011
