13. Before we decide if we should conduct a detailed investigation of a complaint, we look at whether there are signs the organisation has got something wrong. We do this by comparing what should have happened with what did happen. We have done this, and we consider the Trust has correctly applied the guidelines when deciding Mr F is not eligible for an insulin pump. This means we can see no indication that anything went wrong.
14. Mr F explains he has bilateral tunnel syndrome and cannot administer his own insulin. He tells us he relies on his daughter to administer his insulin and support his diabetes, but this is becoming unsustainable as she gets older. He says he has had to restrict his diet to manage his diabetes which is impacting his health.
15. Mr F states he meets the criteria for an insulin pump because he cannot self-administer insulin and relying on family support is not a long-term option.
16. The Trust says Mr F does not meet the eligibility criteria set out in NICE guidelines for an insulin pump. The Trust explains he is not eligible as he has type 3c diabetes (not type 1), his diabetes is very well controlled and he only has one insulin injection a day. The Trust also states that an insulin pump may be considered for type 3c diabetes if it mimics type 1 diabetes.
17. Hybrid closed loop systems for managing blood glucose levels in type 1 diabetes TA943 states that a pump is recommended as an option for managing blood glucose levels in type 1 diabetes for adults who have an HbA1c of 58 mmol/mol (7.5%) or more, or have disabling hypoglycaemia, despite best possible management.
18. The guidance also says that the clinical benefits in people with type 3c diabetes were likely to be similar to the clinical benefits for people with type 1 diabetes. It concluded that HCL systems could be useful for type 3c diabetes but this was outside the scope of HCL systems in type 1 diabetes.
19. Although the guidance relates to the management of type 1 diabetes, it recognises an insulin pump could have clinical benefits for type 3c diabetes. The Trust also acknowledges this. We therefore consider that Mr F is not automatically ineligible for an insulin pump solely based on having type 3c diabetes.
20. HbA1c is a blood test showing the average level of blood glucose over the previous two to three months. Mr F’s HbA1c level has never been over 58 mmol. Mr F’s test results show he has consistently demonstrated effective management of his diabetes. Mr F cites the adaptations to his diet and his careful management as a reason for needing a pump, but this is not the case. All types of diabetes require a careful approach to diet. Indeed, in order to be eligible for the pump, a person with diabetes has to demonstrate high HbA1c or disabling hypoglycaemia despite ‘best possible management’, which would include appropriate dietary modifications.
21. Hypoglycaemia is when blood glucose level drops below 4 mmol. Mr F’s libre sensors (a device that provides continuous glucose monitoring) shows low blood sugar 17% of the time, which had previously been at 5% of the time. NICE guidelines TA943 defines disabling hypoglycaemia as when hypoglycaemia occurs frequently or without warning, so the person is constantly anxious about having hypoglycaemic episodes. Mr F’s libre sensor readings do not indicate disabling hypoglycaemia, nor did he report experiencing it as part of his complaint.
22. Mr F does not appear to meet the eligibility criteria of having an HbA1c of 58 mmol/mol (7.5%) or more, or having disabling hypoglycaemia. Therefore, we are satisfied that the Trust applied the guidance correctly when determining that he is not eligible for a pump.
23. We are sorry to hear about the pressure and distress that managing his diabetes has placed on both Mr F and his daughter. We hope he finds the explanation for our decision helpful and he is reassured the Trust did correctly apply the guidelines.