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Discussion Paper on the recommendation of TA151 that children using an Insulin Infusion Pump undergo a trial of MDI between the ages of 12 and 18 years.

The recommendation only appears for those children who start insulin pumps BEFORE the age of 12 years ie –

CSII therapy(insulin pump) 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.

Furthermore, if the document is read further, the committee obviously discussed this and agreed that this would ONLY be necessary in those children who had NEVER had a trial of MDI (see 4.3.8 and 4.3.9).  In addition, there are concerns about stopping a pump and reverting to insulin injections if a child/young person has never used this before so these should always be discussed with the PCT.

4.3.8    The Committee paid special attention to the use of CSII therapy in children. It heard from the clinical specialists about the importance of this treatment in very young children. It was also aware of the difficulties and delay that a trial of MDI therapy, to prove that such therapy was ineffective, would entail in this young patient group. The Committee was concerned that the CORE model was not validated in children and the data from adults used in the model could not be extrapolated to children. However, the Committee considered that all the factors relevant to favouring CSII therapy for adults in whom MDI therapy had failed to achieve an acceptable HbA1c level, or who experienced disabling hypoglycaemia, applied as least as much to children. In addition, the Committee heard from the clinical specialists that managing the delivery of small insulin doses in very young children and delivering midday doses of insulin to young school children are difficult or impractical, leading to ineffective glycaemic control. The Committee therefore decided that, on balance, CSII therapy should be recommended for children younger than 12 years with type 1 diabetes mellitus as a treatment option without an intensive trial of MDI therapy if such a trial was felt clinically inappropriate or impractical. This recommendation is consistent with NICE clinical guideline 15 (Type 1 diabetes: diagnosis and management of type 1 diabetes in children, young people and adults).

4.3.9    In developing the recommendations for children, the Committee considered that children 12 years and older would normally be competent to self-inject an afternoon dose of insulin at school which would allow for a proper trial of MDI therapy. The Committee also agreed that because MDI therapy based on long-acting analogues is more efficacious for type 1 diabetes mellitus than MDI therapy based on older insulins, MDI therapy should be judged to be unable to attain the required HbA1c levels only if it is based, if clinically appropriate, on long-acting insulin analogues. The Committee considered its approach for children on insulin pumps who reach the age of 12 years and who, following this guidance, would not have had a trial of MDI. The Committee considered that the continuation of CSII could not equitably be supported without a trial of MDI after that stage. The Committee was mindful that making such a recommendation too strict could mean a change in insulin regimen for children who had achieved satisfactory control of their blood glucose level. The Committee discussed the implications of undergoing such a trial, especially during a period where children experience many developmental, social and educational changes. It concluded that such a trial of MDI would normally need to be undertaken sometime before a child reached adulthood at the age of 18 years.

This last sentence of the discussion does not seem to follow from the preceding discussion and therefore we are not clear how and why such a trial should be undertaken in young people who have good diabetes control using an insulin pump.  We suggest that in those young people with the following characteristics, a trial of 8 weeks of MDI using long-acting insulin analogues may be useful, but that it should NOT be considered to be routine that such a trial is undertaken in young people without these characteristics.

·        Poor control ie HbA1c >8.5%

·        Recurrent DKA

·        Persistent non-adherence to recommendations

·        Persistent failure to attend clinics

For the general group of children and young people using insulin pumps, the body of consultant paediatricians looking after them believes that there is no justification for a trial of MDI before funding is agreed in adult life.  To insist that a child or young person with good metabolic control using an insulin pump should have a complete change of insulin therapy to multiple injection therapy purely for administrative purposes risks causing significant emotional distress and a possibility of a significant deterioration of control. This cannot be justified on either clinical or ethical grounds.

Julie Edge, Bill Lamb and Fiona Campbell, on behalf of the National Paediatric

Diabetes Networks.   June 2012

You can email your comments to: angela@diabetespower.org.uk

or direct to Dr Fiona Campbell or Dr Julie Edge