The table below logs the history of the steps in development of the document.

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1 Paediatric Insulin Pumps Version: 0.4 Committee Approved by: Clinical Cabinet Date Approved 5 February 2014 Author: Responsible Directorate: Janet Wilson Strategy and Commissioning (Children s) Date issued: April 2014 Review date: April 2015 Version Control Sheet The table below logs the history of the steps in development of the document. Version Date Author Status Comment V Janet Wilson Draft V Janet Wilson V Jo Hanlon V Janet Wilson

2 Treatment For the treatment of Background Paediatric Insulin Pumps Children and Adolescents with Type 1 Diabetes (up to the age of 19) During the last procurement process for insulin pumps, Mid Yorkshire Hospitals Trust (MYHT) agreed with Roche Pharmaceutical Company that the pump of choice for Wakefield patients would be the Roche pump. Prior to this the agreement for the pump of choice for Wakefield was a Medtronic pump. Following the change of companies, existing Medtronic patients were allowed to continue on this pump and use its consumables. All new patients to pump therapy were offered a Roche pump unless circumstances were such that this pump was not suitable, Medtronic would be an alternative. The needs of paediatric patients are different and the paediatric team requested consideration of a more child friendly pump as an alternative for paediatrics. However this request was refused. In light of this decision, there has been a recent increase in the number of Individual Funding Requests for an alternative child friendly pump device and numerous discussions about the availability of a different pump, if appropriate, for paediatrics. Other areas across West Yorkshire do offer a choice of pump for both children and adults. This has not been so in Wakefield but could be considered at a later date. Currently within NHS Wakefield CCG, under the care of MYHT, there are 183 children/young people aged 3 to 19 years that have Type 1 diabetes. 79 of these children/young people are managed by insulin pump therapy using a combination of Medtronic and Roche pumps. It has become evident that children/young people and parents/carers have differing needs and capabilities when learning to manage insulin pumps. Omnipod is an example of a relatively new pump on the market that potentially has a number of advantages for some children and young people. This commissioning policy seeks to allow alternative choices to insulin pumps for this cohort of patients in Wakefield. Aim of the policy To provide an insulin pump service that is equitable for the paediatric population within MYHT. The service should be developed to individually meet the needs of the child, young person and family, taking into account developmental age, cognitive level and skills of the child, young person and parents /carers. The choice of insulin pump should be made in consultation with the child/young person, family, Consultant and the paediatric diabetes nurse specialist and not specified by an historical contract agreement.

3 Scope of the policy Clinical threshold The policy refers to children and young people (up to 19 years) registered with a Wakefield General Practitioner. Continuous subcutaneous insulin infusion (CSII) 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. 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. Rationale for the policy Discussed in the aim of the policy above. If a child or young person is assessed as requiring an alternative pump to the Roche pump these requests have to be dealt with by the Individual Funding Request process. Problems encountered with the existing pump for children Complexity of pump in setting up and using functions Cannula failures Pump failures or hand set failures Young children biting or tying knots in tubing whilst playing causing insulin obstruction resulting in high blood sugars Insertion of the cannula due to sound of device used causes fear of needles and or pain Education staff on school residential unable to take responsibility for changing of cannula and reservoir change due to complexity of procedure parents have to travel to location or child does not attend Tubing becoming caught on door handles school bags etc In relation to the problems encountered with the existing pump section above the points below highlight the potential risks: High blood sugars resulting in attendance at A/E possibly admission to hospital and the worst case scenario being Diabetic Ketoacidosis (life threatening acute complication) Erratic blood sugars causing the child or young person to feel unwell If alternative pump choices are not available for Wakefield patients the families will transfer their care to the Leeds Teaching Hospitals Trust (LTHT) diabetes service where choice is available however, payment will be requested by LTHT from Wakefield CCG to fund the pump and its

4 consumables Media risk to Wakefield CCG Benefits for the Patient of Omnipod pump QIPP Quality - better for the child (child friendly) allowing more freedom to live as normal as possible life and be more active. Innovation new and advanced technology. Productivity more expensive initially to commence but potentially more cost effective. Prevention improved diabetic control reducing long term complications and difficulties in managing their diabetes. Additional potential benefits of robustly commissioning an effective insulin pump therapy service include: reducing inequalities by improving access to insulin pump therapy increasing patient choice, and improving partnership working, patient experience and engagement improving quality of life for people with type 1 diabetes enhancing ability to self care reducing the frequency and severity of hypoglycaemic episodes and thereby fear of their reoccurrence reducing the potential for hyperglycaemic episodes (Diabetic Ketoacidosis) and preventing admission to hospital increasing the proportion of patients who achieve good glucose control and achieving a target HbA1c in line with NICE clinical guideline CG15 on type 1 diabetes reducing risk of long-term diabetes complications by achieving good control of blood glucose (Additional Information if required on the Omnipod Pump) Tubing-free design prevents snagging and the need to disconnect so that the patients get truly continuous insulin delivery. Virtually pain-free, automated insertion ensures cannula inserts to a consistent depth and angle, minimizing error and tissue damage. Automatic priming purges air from the Pod, preventing blood glucose excursions from air-in-line displacement of insulin. Waterproof Pod eliminates the need to disconnect. Patients can shower or go into the bath or the pool without interrupting insulin delivery. Integrated FreeStyle blood glucose meter automatically integrates blood glucose measurements into suggested bolus calculations. Lightweight and discreet, the Pod weighs a mere 1.2 ounces with a full reservoir.

5 Not all children and young people will be eligible for this type of pump and as mentioned earlier an individual assessment will be made to ensure the right choice is made based on NICE Guidance and clinical need. Policy position Additional Information Children and young people have differing needs to adults taking into consideration the families and carers including schools and other settings where they may be cared for. Advances over the years in newer pumps have given many benefits for children and young people. Therefore, a choice of pump appropriate to that child or young person should be available. Funding for paediatric insulin pumps up to the age of 19 years old is through NHS England who have made it clear that it is up to local areas to define what choice of pumps are available. However, after 19 years the funding for pumps and the consumables is the responsibility of the CCG. As children and young people move into the adult service with an alternative pump there is a risk that other patients may request this choice of pump rather than the pump agreed by MYHT as the cost would be higher further discussions need to take place to ensure the CCG are aware of this possible risk and agree to continue funding once the patient transfers into the adult service. Effective from April 2014 Summary of evidence NICE Technology Appraisal:TA151-Continuous Subcutaneous Insulin Infusion for the Treatment of Diabetes Mellitus 2008 NICE Guidance CG15-Diagnosis and Management of Type 1 Diabetes in Children, Young People and Adults 2004 Date Policy to be reviewed by Contact for this policy

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