Patient selection criteria

It is important to understand that these islet transplantations are still part of a research trial and therefore carry risks, especially since anti-rejection drugs have to be taken after the transplantation. The long-term effect of these potentially harmful drugs is not known. The risks of taking part in the research project will be discussed thoroughly with every individual by a series of healthcare professionals.

Patient selection criteria:

  • you must have Type 1 diabetes
  • you must be aged between 18 and 65
  • your insulin and healthy diet therapy regimen must be failing to control your blood glucose levels despite your best efforts, often causing severe hypos.

You must match all the above criteria and this will be based upon the judgement and previous knowledge of healthcare professionals in your diabetes care team.

  • In addition, you may also have early microvascular complications (eg retinopathy) that are quickly getting worse despite best efforts in following and taking treatments for these (including best efforts in managing blood glucose levels with insulin).

If you match the above criteria but have any of the following you will not be considered for this initial phase of the research project:

  • you have kidney disease (the anti-rejection drugs used after the transplantation may make this worse)
  • you have insulin resistance
  • you have experienced repeated episodes of DKA (diabetic ketoacidosis / hyperglycaemia).

There is a complex series of investigations and procedures that each accepted volunteer will have to go through. There is no guarantee that at the end of these tests volunteers will be offered an islet transplantation, or that the islet transplantation will be successful.

Diabetes UK is not involved in the selection of volunteers for the project. People with diabetes cannot put themselves forward as volunteers – this can only be done by a healthcare professional from your diabetes care team. If you think you match the patient selection criteria, please discuss this with your diabetes care team. Your diabetologist can contact the Consortium for more detailed inclusion/exclusion patient selection criteria by writing to:

Jo Brodie
Islet Project Coordinator
Macleod House
Diabetes UK
10 Parkway
London
NW1 7AA.

Only people with Type 1 diabetes mellitus are being considered for transplantations in the initial phase of the research project. At the moment people with Type 2 diabetes are not being considered for the islet transplantation research. Severe hypoglycaemic episodes and limited therapeutic options (ie insulin and diet only) available to people with Type 1 diabetes mean that these individuals are at a disadvantage compared to most people with Type 2 diabetes, who can be treated with a range of tablets as well as insulin.

However, that is not to say that in years to come this won’t change, especially when more information will be known as a result of the current research work. For example, the more we understand about how islets and islet transplantations work, the more we will know about how diabetes develops and can be treated, or even cured. In the meantime, considerable funds are being ploughed into researching the mechanisms behind insulin resistance, a characteristic of Type 2 diabetes. Such research could hold the key to a future cure for Type 2 diabetes.