The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on Implantation of a duodenal-jejunal bypass liner for managing type 2 diabetes, in March 2015.
January 2018: The device used in this procedure (EndoBarrier) no longer has a current CE mark. The CE mark is necessary for medical devices to be marketed in the European Union. A non CE marked device can only be used in the context of clinical investigations with MHRA and research ethical approval.
Type 2 diabetes is caused by insulin resistance with or without inadequate pancreatic insulin secretion. It is most commonly seen in people with obesity or who are overweight. Presenting symptoms include polyuria, polydipsia, and fatigue. Type 2 diabetes is commonly associated with raised blood pressure, abnormal blood lipid levels and a tendency to atherosclerosis. This combination is often described as the ‘metabolic syndrome’, which is associated with fatty liver and abdominal adiposity (increased waist circumference).
Type 2 diabetes is managed by lifestyle and dietary changes, exercise or antidiabetic drugs (as recommended in NICE’s guideline on type 2 diabetes). If blood glucose levels remain poorly controlled, subcutaneous insulin injections may be needed.
This guidance represents the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, healthcare professionals are expected to take this guidance fully into account, and specifically any special arrangements relating to the introduction of new interventional procedures. The guidance does not override the individual responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or guardian or carer.
All problems (adverse events) related to a medicine or medical device used for treatment or in a procedure should be reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card Scheme.
Commissioners and/or providers have a responsibility to implement the guidance, in their local context, in light of their duties to have due regard to the need to eliminate unlawful discrimination, advance equality of opportunity, and foster good relations. Nothing in this guidance should be interpreted in a way that would be inconsistent with compliance with those duties. Providers should ensure that governance structures are in place to review, authorise and monitor the introduction of new devices and procedures.
Commissioners and providers have a responsibility to promote an environmentally sustainable health and care system and should assess and reduce the environmental impact of implementing NICE recommendations wherever possible.