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Draft SIGN Guidelines on the Management of Diabetes: Response on behalf of iPAG
Friday, 02 October 2009 21:03
Aileen
SIGN (the Scottish Intercollegiate Guidance Network) have released a draft consultation document that will shape the treatment of Diabetes in Scotland for perhaps the next 10 years. This 151 page draft encompasses a wide range of issues concerning both Type 1 and Type 2 Diabetes, and treatment of adults and children. Pages 23 and 24 address the use of insulin pump therapy.
Although this section represents only a small part of the document, iPAG is extremely concerned because it proposes criteria for eligibility that are much narrower than those set out in the NICE 2008 guidelines for insulin pump therapy. The Scottish Health Minister has publicly committed NHS-Scotland to implementing NICE-2008. This is expected to lead to 10-15% of adults (and a higher proportion of children) with Type 1 diabetes using insulin pumps by 2014.
The proposed SIGN guidelines (which are essentially a reversion to the much more restrictive NICE-2003 criteria) would greatly reduce this proportion. As a result, the percentage of Scots with Type 1 diabetes that use pumps would fall even further behind England and the rest of Western Europe.
In assessing the appropriateness of pump therapy, NICE-2008 dispensed with the criterion of “Severe Hypoglycaemia” (defined as where hospitalization or third party assistance is required) and substituted “Disabling Hypoglycaemia”, (defined as “repeated or unpredictable occurrence of hypoglycaemia that results in persistent anxiety about recurrence and is associated with a significant adverse effect on quality of life”. NICE-2008 further recommended pump therapy for children under the age of 12 wherever MDI is considered to be impractical or inappropriate.
The draft SIGN guidelines have reverted to “Severe Hypoglycaemia” as the criterion for adults. For children they introduce a new criterion of low basal requirement and remove references to MDI being impractical or inappropriate. Under the proposed SIGN guidelines, adults suffering repeated hypoglycaemia would not qualify for a pump even if these episodes were causing serious problems at work, in social situations or were substantially affecting quality of life. MDI is often not practical for younger children because primary schools typically do not permit self-injection; this is not a problem when insulin is administered by pump. The alternative, twice daily injections of mixed insulins is recognized as being outdated and having adverse long-term health implications. Some parents have been forced to give up work simply to be available to administer lunchtime injections. These children qualify for a pump trial under the NICE guidelines but would not do so under the proposed SIGN guidelines.
As part of the consultation process, iPAG has submitted a three page technical response. In formulating their guidelines, SIGN cited as evidence a small number of studies, concentrating on a particular type (randomized crossover trials). In contrast, NICE took into consideration a much larger body of evidence that they considered to be more representative of people likely to be considered for pump therapy in routine clinical practice. These studies, which SIGN appears to have ignored, provide convincing evidence of reduced hypoglycaemia and overwhelming evidence for improved quality of life with pump therapy. Further, we are at a loss to understand why SIGN propose to remove the criteria for children of MDI being inappropriate or impractical as they do not cite any evidence for this.
The proposed SIGN criteria represent a backward step for the treatment of Type 1 Diabetes in Scotland. If implemented, the guidance would have negative health implications and lead to a poorer quality of life for many adults and children with Type 1 Diabetes and their families. Given that SIGN have had to address all aspects of Diabetes care, whereas NICE were able to concentrate exclusively on pump therapy (and as a result were able to consider a much larger body of evidence and in much greater detail), iPAG see no reason to justify criteria that are more restrictive in Scotland than in England. In the absence of compelling evidence to the contrary, we believe that Scotland should continue to follow the guidelines set out in NICE-2008 with their emphasis on quality of life. The final version of the SIGN guidelines must reflect this.
