This guidance updates and replaces NICE tecnology appraisal 57 (published in February 2003).
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.
Continuous subcutaneous insulin infusion or ‘insulin pump' therapy is recommended as a possible treatment for adults and children 12 years and over with type 1 diabetes mellitus if:
- attempts to reach target haemoglobin A1c (HbA1c) levels with multiple daily injections result in the person having ‘disabling hypoglycaemia', or
- HbA1c levels have remained high (8.5% or above) with multiple daily injections (including using long-acting insulin analogues if appropriate) despite the person and/or their carer carefully trying to manage their diabetes.
Insulin pump therapy is recommended as a possible treatment for children under 12 years with type 1 diabetes mellitus if treatment with multiple daily injections is not practical or is not considered appropriate. Children who use insulin pump therapy should have a trial of multiple daily injections when they are between the age of 12 and 18 years.
‘Disabling hypoglycaemia' is when hypoglycaemic episodes occur frequently or without warning so that the person is constantly anxious about another episode occurring, which has a negative impact on their quality of life.
Insulin pump therapy should only be started by a trained specialist team. This team should include a doctor who specialises in insulin pump therapy, a diabetes nurse and a dietitian (someone who can give specialist advice on diet). This team should provide structured education programmes and advice on diet, lifestyle and exercise that is suitable for people using insulin pumps.
Insulin pump therapy should only be continued in adults and children 12 years and over if there has been a sustained improvement in the control of their blood glucose levels. This should be shown by a decrease in the person's HbA1c levels or by the person having fewer hypoglycaemic episodes. Such goals should be set by the doctor through discussion with the person or their carer.
Insulin pump therapy is not recommended for people with type 2 diabetes mellitus.