Table 15:

Guidance on Islet Transplantation for Patients with Type 1 Diabetes Mellitus

Author	Country	Statements
Canadian Diabetes Association, 2013 (Paty et al (27))	Canada	Individuals with type 1 diabetes with preserved renal function, or who have undergone successful kidney transplantation but have persistent metabolic instability characterized by severe glycemic lability and/or severe hypoglycemia despite best efforts to optimize glycemic control, may be considered for pancreas or islet allotransplantation (Grade D recommendation: [expert] consensus)
American Diabetes Association, 2014 (Chiang et al (93))	United States	Consider referral to research centers for protocolized islet cell transplantation in patients with type 1 diabetes and debilitating complications of diabetes who are interested in research possibilities and fit the criteria for the research protocol (Grade E recommendation: expert consensus or clinical experience)
Spanish National Health System, 2012 (Working Group (92))	Spain	Nowadays, islet transplantation is only recommended in the context of controlled trials (Grade C recommendation: a body of scientific evidence consisting of studies rated as 2+ [well-conducted case-control or cohort studies with low risk of bias and a moderate probability of establishing a causal relationship], directly applicable to the target population of the guide and demonstrating overall consistency of results; or extrapolated evidence from studies rated as 2++ [high-quality systematic reviews of case-control or cohort studies; cohort or case-control studies with very low risk of bias and with high probability to establish a causal relationship])
National Institute for Health and Clinical Excellencea, 2008 (94)	United Kingdom	The evidence on allogeneic pancreatic islet cell transplantation for type 1 diabetes mellitus shows short-term efficacy with some evidence of long-term efficacy. The evidence on safety shows that serious complications may occur as a result of the procedure. The long-term immunosuppression required is also associated with a risk of adverse events. In units with established experience in allogeneic pancreatic islet cell transplantation, the procedure may be used with normal arrangements for clinical governance During consent, clinicians should ensure that patients understand the potential complications of the procedure and the uncertainty about its efficacy in the long term. They should provide patients with clear, written information. In addition, use of the Institute's information for patients is recommended Patient selection for this procedure should involve a multidisciplinary team. Selection criteria should take into account that the procedure is particularly indicated for patients with hypoglycaemia unawareness and/or those already on immunosuppressive therapy because of renal transplantation Further audit and research should address the effect of the procedure on quality of life and its long-term efficacy, particularly in relation to the complications of diabetes

^aNow the National Institute for Health and Care Excellence, or NICE.