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Details of HTA project

Last updated: 15 July 2008 - Next update due: 22 July 2008


Research type:

NICE Technology Assessment Report (TAR)  

Project title:

Continuous subcutaneous insulin infusion for the treatment of diabetes (update of Guidance No 57) 

Project ref:

06/61/01 

Cost:

This project has been commissioned by the HTA programme on behalf of the National Institute for Health and Clinical Excellence on a call-off contract basis. 

Chief Investigator :

Aberdeen HTA Group, University of Aberdeen

Start Date:

February 2007.  

Publication date:

January 2009. This project is at the editorial review stage. Delays in the review process can cause the forecast publication date to be delayed.  

Plain English Summary

Insulin is usually given by injections several times a day, using a combination of short-acting insulins at mealtimes and long-acting insulin to cover the rest of the day. This is because the body needs a little insulin all day and night long (usually called 'basal') but more at mealtimes. Conventional insulin treatment usually involves two injections a day, each of a combination of short and long-acting. More intensive regimens may involve four injections a day, one of long-acting to provide basal insulin, with three of short-acting insulin at mealtimes. This is called MDI, for multiple daily injections.
Intensive insulin treatment also involves attention to diet, self-testing blood glucose, and self-adjustment of insulin doses.
Continuous subcutaneous insulin infusion uses a small insulin pump which is programmed by the user to give different amounts of insulin at different times of day and night. For example the basal infusion rate at night can be different from during the day. The infusion rate is boosted at mealtimes to provide the larger amounts of insulin needed then.
The device connects to the user via a catheter which is fitted to a needle or cannula inserted just under the skin. The needle under the skin is changed every few days - so in effect one injection every couple of days.
CSII gives much more flexibility, but at increased cost.

Guidance on CSII was issued by NICE in February 2003 (Guidance 57, available from the NICE website - www.nice.org.uk - go to http://www.nice.org.uk/guidance/TA57 ). The assessment report done for that appraisal is available on the NCCHTA website (www.ncchta.org), as a monograph in the Health Technology Assessment series, 2004;8:number 43, available from http://www.hta.nhsweb.nhs.uk/fullmono/mono843.pdf 

Abstract:

The current NICE guidance states;

1.1CSII is recommended as an option for people with type 1 diabetes provided that:
-multiple-dose insulin (MDI) therapy (including where appropriate the use of insulin glargine) has failed: and
-those receiving the treatment have the commitment and competence to use the therapy effectively.
1.2 People for whom MDI therapy has failed are considered to be those for whom it has been impossible to maintain a haemoglobin A1c level no greater than 7.5% (or 6.5% in the presence of microalbuminuria or adverse features of the metabolic syndrome) without disabling hypoglycaemia occurring, despite a high level of self care of their diabetes.

4.2 Questions.
The first question to be addressed will therefore be whether any evidence has emerged since the first review, which might cause a change in the present guidance on the use of CSII in people with type 1 diabetes. One change has been an increase in the use of the long-acting analogues, glargine and detemir. There have also been more trials of CSII in children, in whom recent studies report that control of diabetes in children is poor, with only about 10-20% reaching the target HbA1c of 7.5% recommended in the NICE guidelines for type 1 diabetes. (SSGCDY Diabetic Medicine 2006;23:1216-1221)

The current guidance states that CSII is not recommended for people with type 2 diabetes, treated with insulin. The second question is whether that should change.

The scope for the review mentions type 1 and type 2 diabetes, which will include pregnant women in those groups, but not gestational diabetes (GDM), which is usually treated with insulin, and where tight control is sought. For completeness, we will review the evidence on the use of CSII in GDM as part of a review of CSII in pregnancy.

The scope states that the comparators should be not only MDI, but also other regimens involving long-acting insulin or inhaled insulin. We will review the evidence on that, but are aware that no trials have been published comparing inhaled insulin with CSII. The arrival of the long-acting analogues may have reduced problems with hypoglycaemia, which was one of the reasons for using CSII.

THE HTA PROGRAMME COMMISSIONED THIS TECHNOLOGY ASSESSMENT REPORT ON BEHALF OF THE NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE  

NRR* number, if applicable:

N0484190638 (*National Research Register) 

Project Protocol:

Project protocol not available

URL of this page:

http://www.hta.ac.uk/1622
Tue, 15 Jul 2008 15:19:46 +0100

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