Immune Cell Studies in Type 1 Diabetes (ISTID) INFORMATION SHEET FOR ADULTS WITH NEWLY- DIAGNOSED DIABETES. Sponsored by Cardiff University

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1 Immune Cell Studies in Type 1 Diabetes (ISTID) INFORMATION SHEET FOR ADULTS WITH NEWLY- DIAGNOSED DIABETES Sponsored by Cardiff University Chief Investigator Wales: Professor Colin Dayan Address: Centre for Endocrine and Diabetes Sciences, Cardiff University School of Medicine, University Hospital of Wales, Heath Park, Cardiff CF14 4XN Telephone: Fax: DayanCM@cardiff.ac.uk Research Nurse: Amanda Bishop: Tel: Alexandra Howell: Tel: You are being invited to take part in a research study which we believe may benefit young people with diabetes in the future. Before you decide, it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with friends, relatives or your GP if you wish. Ask if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part. Any travel expenses you incur in association with this project will be paid. This information sheet is for you to keep. Thank you for reading it and considering whether you would like to take part in the study. 1

2 Why is this study being done? Type 1 Diabetes (the type you have also known as insulin-dependent diabetes) is caused by the body s white blood cells (part of the immune system) damaging the insulin producing cells in the pancreas. At Cardiff University, our aim is to develop a treatment that can slow or stop this process by switching off the white blood cells causing the damage. In the present study, we will be comparing white blood cells from people who have just been diagnosed with diabetes (where the immune reaction to the pancreas is still active), with blood from people who have had diabetes for more than 1 year and less than 3 years (where there may still be an immune reaction) and with blood from people who have had diabetes for more than 3 years (in whom the immune reaction is over) and blood from people who don t have diabetes at all. We will also be studying white blood cells from the healthy relatives of people with diabetes to see if they have protective white blood cells that stop them from developing the disease. Why have I been invited to take part? You have been invited because you are aged and have been diagnosed with Type 1 diabetes in the last 12 months. Do I have to take part? No, taking part is completely voluntary. If you are interested in the study, one of the research team will meet with you to discuss the study further. Only when all your questions have been answered to your satisfaction and you are completely happy to enroll into the study will you be asked to sign a consent form. If you decide to take part you are still free to withdraw at any time and without giving a reason. If you decide not to take part or to withdraw after you have entered the study, nobody will be upset and the standard of care you receive from your doctors and nurses will not be affected. What will I be asked to do if I take part? You will be asked to give blood samples. These will be taken with a needle and syringe in a similar way to that used for any standard blood test. The blood samples will be analysed in specialist diabetes research laboratories in Cardiff University, Swansea University, Bristol University and King s College London. Depending on the results of the tests on your blood in the laboratory, we may ask you for additional blood samples. The maximum amounts of blood we will ask you to give - including all blood samples given in any other study - are shown in the table below. Amount of blood on any one occasion Max: 150mls = 1/3 rd pint Usually: 70mls 1/6 th pint Total amount of blood in any 6 week period Max: 350mls = 7/10 th pint Usually: less than 150mls = 1/3 rd pint 2

3 Total amount of blood in any 6 month period Gaps between blood samples Max: 500mls = 1 pint Usually: less than 250mls = 1/2 pint Shortest: 2 weeks Usually: 1 6 months Note for comparison: 1 pint (500mls) is the amount of blood normally given in a blood donor session for the blood transfusion service Blood samples will be taken by a trained research nurse in a place and at a time convenient for you either at your local hospital, your home or, if convenient, your work. While taking part in the study you should not also give blood to the blood transfusion service. Participants who give more than ⅓ rd pint (= 150mls) in 6 months will be checked regularly to make sure they are not developing anaemia. You may be asked for blood samples up to 2 years after entering the study. Note that you can withdraw from the study and stop giving blood samples at any time without giving a reason. You will also be asked to provide a urine sample after you have had your main meal of the day. This can be done at home and be posted directly to the laboratory in Swansea. The research nurse will provide you with all the packaging and information on how to do this. OPTIONAL PART OF STUDY [taking place in Cardiff only] Additional collection of the urine samples after the Standard Mixed Meal This test will also find out how much insulin your body is able to produce and will tell us the rate of your insulin production decline over the period of 6 months. This will help us to understand the variations in insulin production loss between individuals. The test is done in home setting and does not require presence of the research team. The test requires fasting. The urine collection is done after standard mixed meal, which is a form of build up drink already prepared. Prior to the test, the research team will give you detailed instructions regarding adjustments of your insulin regime and dose, smoking and fasting (from midnight), finger prick blood sugar measurements and amount of standard mixed meal that you need to take. Two-hours after drinking the mixed meal, you will be asked to provide a urine sample. Whilst you are doing the test, you should not eat or drink anything (apart from the standard mixed meal that you took at the beginning and water). We advise you to drink plenty of water during the urine collection period, which will enable you to produce required sample in the allocated time. Once you have completed the test you can eat and receive insulin as appropriate. There is a small possibility that you will experience low blood sugar during the fasting. We will give you advice about avoiding this and advise you to check your finger prick blood sugars regularly (every hour or sooner if you 3

4 experience signs of low blood sugar). You should stop the fast if you experience low blood sugar at any stage (capillary blood sugar less than 4mmol/l), treat your low blood sugar as usual and let us know. The contact for the research team will be available to you should you need any additional information during the test. We will ask you to repeat this test 3 times: at the entry in the study, after 3 months and after 6 months. You will have an option to decline participation in this part of the study, but still continue with the baseline study. Is there anything special I have to do? No. The blood samples do not need to be taken under any special conditions and can be taken at any time of the day. However, to allow them to be processed in the laboratory on the same day, it is most convenient to take the sample in the morning on a week day. You will be asked for a list of your medications as if you are on certain tablets for conditions other than diabetes (for example steroids) you cannot give blood to this study. Also, if you have had a recent infection the blood sampling may be delayed to a later date. You also cannot take part if you are pregnant or breast feeding. What will happen to my blood samples? The white blood cells in your blood will be extracted and used straightaway in tests of the way they work. DNA from the blood samples will be used to check your tissue-type and may be used to compare genes involved with diabetes and the immune system and the activity of your blood cells. The DNA will not be used for any other purpose without your written consent. All blood samples will be stored with only a code number on so that you can only be identified by the research team. The blood samples will be kept by the laboratory for 5 years in the first instance. It is possible that your blood samples may be kept for future diabetes research that cannot yet be specified, but we will seek ethical approval for any such potential research. If you decide to stop taking part in the study, you can ask for your samples to be destroyed but any experimental results already obtained with them will be kept. What are the possible side-effects of taking part? There may be bruising and discomfort at the site of the blood test as with any blood test. The amounts of blood we are taking are small enough that they should not make you feel faint or anaemic. What are the possible benefits of taking part? The current research project will not benefit you, but it may prevent others in the future from developing diabetes. What if something goes wrong? In the very unlikely event that you are harmed in this study, there are no specific compensation arrangements. If you are harmed due to someone s negligence, then you 4

5 may have grounds for a legal action but you may have to pay for it. Regardless of this, if you have concerns about any aspect of the way you have been approached or treated during the course of this study the Normal National Health Service complaints mechanisms will be available to you: Local NHS Complaints details as follows: Complaints Manager at Cardiff and Vale UHB is Angela Hughes, Cardiff and Vale University Health Board Headquarters, Whitchurch Hospital, Park Road, Whitchurch, Cardiff CF14 7XB, Tel: OR you should contact Chris Shaw, Research Governance Coordinator, Cardiff University, Tel: OR you should contact Chris Shaw, Research Governance Coordinator, Cardiff University, Tel: Will my identity be protected? All information identifying you will only be kept in the laboratory in Cardiff and held in the strictest confidence. All computer and paper records relating to the study will be stored in accordance with the provisions of the Data Protection Act. No other researchers, companies or individuals either in the UK or abroad will have access to information which identifies you. Your samples will simply carry a code number, which only the Research team can trace back to you. If in the course of the research, results are found that could be important for your personal health, we will contact you, and with your permission, your GP and your diabetes care team. Should this happen, your doctor may require further information or blood samples. Will my taking part in this study be kept confidential? All information collected about you during the course of the research will be kept strictly confidential. With your permission, your GP and your diabetes care team will be informed that you are taking part. What will happen to the results of the study? The full results of the studies being conducted will not be known until the last patient has been tested which may take 4 years. The results will be reported in professional publications and meetings but you will not be identified by name. If you are interested in receiving a summary of the results, please contact the Chief Investigator (Professor C. Dayan). Contact details are given at the beginning of this sheet. Who is funding and organising the study. The collection of the blood samples and the laboratory studies are being funded by EU Namit FP7 Grant Who has reviewed the study? The study has been reviewed by the Research Committees of the JDRF and the Sir Jules Thorn Charitable Trust and approved by the REC for Wales. Additional review was conducted as part of a work package in EU Namit FP7 Collaboration Programme Grant

6 What do I do now? If you are interested in taking part, please let the health care professional who provided you with this information know. Arrangements will then be made to collect the first blood sample at a time that is convenient to you. 6