Chief Investigator Prof. Polly Bingley Diabetes & Metabolism Southmead Hospital Bristol BS10 5NB BETA CELL FUNCTION AND ONGOING AUTOIMMUNITY IN LONG STANDING TYPE 1 DIABETES Information Sheet for Stage 1 Screening for parents Your child is being invited to take part in some new research taking place in the BOX Study. Before you decide whether or not s/he should take part, 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 others if you wish. This information sheet should help answer your questions and is yours to keep. The first part is to introduce you to this new research and gives detailed information on what participating involves. The second part contains additional information but if you still want to ask more at the end please feel free to speak to our study co-ordinator, Mrs Isabel Wilson on 0117 323 6106 or email i.wilson@bristol.ac.uk Please ask us if there is anything that is not clear, or if you would like more information. Take time to decide whether or not you wish your child to take part. PART 1 What is the purpose of the new research? Recent research has shown that some people with type 1 diabetes seem to have some insulin-making cells in the pancreas (beta cells) even many years after they have developed the condition. Also, we can now detect that insulin is being produced in more people with long-standing type 1 diabetes than we previously thought. If these observations are confirmed it might eventually be possible to protect these cells from further damage and improve blood glucose control. We are very interested in finding out more in this area of research. We want to find out. What proportion of people still produce some of their own insulin and how this relates to changes in the immune system How insulin released by the beta cells after many years of diabetes, relates to genetic factors (DNA), age and other features when diabetes was diagnosed To relate the above findings to the results of diabetes-related autoantibody tests taken around the each person was diagnosed with type 1 diabetes. 1
Why has my child been chosen? Your child has been chosen because s/he has type 1 diabetes and you and your family have been taking part in the Bart s Oxford (BOX) Study of type 1 diabetes ever since s/he developed the condition. You kindly provided us with information about her/his diabetes and your family history, and have remained in touch with the study for many years. As part of the BOX study, we also measured diabetes-related autoantibodies in a sample of blood collected around the time s/he was diagnosed. This background information means that assessing whether s/he is still making insulin would be particularly informative for our research. Does my child have to take part? No. It is up to you and your child to decide whether or not to take part. If you decide to take part you will be given this information leaflet to keep and be asked to sign the assent/consent form (included with the information for participants under 16 years) to confirm that you understand what is involved when taking part in this study. If you decide to take part you are free to leave the study at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the quality of care you receive. What will happen to my child if s/he takes part? This study involves 2 separate phases the first stage screening is explained in this information leaflet. In this phase s/he will be asked to provide urine samples collected two hours after their main meal on 1-3 days and return them to us by post. This test will allow us to see whether there is evidence that s/he is still making some of their own insulin. We may also ask your permission to contact your child s diabetes consultant after we have the results of their urine test. We will ask for permission if we think that these results might help her/his diabetes treatment. We will ask your child to collect a finger prick blood sample on to filter paper to allow us to determine whether s/he still has some of the autoantibody markers of type 1 diabetes. We will ask your child (with your help) to provide some details about their diabetes clinical treatment. Depending on the results of Stage 1 screening, you may be invited to take part in Stage 2 of the study. Stage 2 will provide us with more detailed information on the function of immune cells in people who have had type 1 diabetes for many years, and how this relates to any remaining insulin production by the pancreas. This involves collecting a blood sample from her/his arm to examine the immune cells and a test to measure insulin levels after a mixed meal drink (like a milkshake). If your child is are invited to take part in Stage 2, our Specialist Research Nurse will explain that part of the study in detail and we will ask you to sign another consent form. Your child would be under no obligation to take part in stage 2 if selected. 2
What are the tests and what are they for? Autoantibody test: This test looks to see if you have proteins called autoantibodies in your child s blood. These are made by the body's immune system and are a sign that the immune system is active against insulin-making cells. In Stage 1 we will measure autoantibodies in blood collected from a finger prick on to filter paper. Urine C-peptide:creatinine ratio (UCPCR): This urine test allows us to see whether your child s pancreas is still producing any insulin. C-peptide is a protein that is produced alongside insulin and makes it possible to tell the difference between insulin you inject and insulin coming from your own insulin-making cells. We will provide you with a small pot, and ask your child to provide a sample of her/his urine 2 hours after their main meal of the day for 1-3 days. These samples will need to be posted back to the laboratory as soon as possible (the same day or next day) in a normal postbox. We will provide full freepost packaging and instructions for their return. Will anything else happen to my child s samples? The samples that your child gives will be labelled with your BOX study number as soon as they are received in Bristol. All tests are performed on samples that are identified only by this code. Your BOX study number and name are kept by the study administrator and are not supplied to the laboratory or to anyone analysing the results. It is not therefore possible to identify or link results back to a particular person. It is however possible for us to link the results with the health information that you have previously provided us with. You will not routinely be provided with test results from stored samples Samples could be stored for a number of years, but we cannot say for how long. As long as the BOX study continues, your child s sample could be used by BOX researchers and other researchers working with them. They will be used to help us learn more about how the immune system might cause type 1 diabetes. Mouth swab samples will only be used for the analysis of genes relating to type 1 diabetes and associated conditions such as thyroid disease, and will only be made available to scientists studying these conditions. Even if you do not want to have your child s samples stored, s/he can still participate in the rest of the study. What are the risks of taking part in this study? There are no risks for taking part in stage 1 screening, although as a parent of someone with diabetes, you will know that collecting blood from a finger prick can sometimes be sore. 3
Are there any benefits? No benefit can be promised you from taking part in this study. This research program might eventually increase knowledge about the process underlying type 1 diabetes and might contribution to the development of therapies to help preserve insulin-making beta cells in the future. What s the alternative? Taking part is voluntary. It is up to you to decide whether or not to take part. If you do decide to take part we will ask you to sign the assent and parental consent forms provided and we will give you a copy to keep. If you decide to take part you are still free to withdraw at any time. If you decide not to take part you do not have to give a reason, and the standard of care you or your family receives will not be affected. There are no alternative routine tests or treatments available for protecting insulin-making cells in long-standing type 1 diabetes Will payment be available? No payment will be given for being in this study. By signing the consent form, you acknowledge and agree that, in the event that this research project results in the development of any marketable product, you will have no ownership interest in the product and no right to share in any profits from its sale or commercialisation. PART 2 What if there is a problem? It is highly unlikely that anything will go wrong. If taking part in this research project harms your child, there are no special compensation arrangements. If your child is harmed due to someone's negligence, then you may have grounds for a legal action but you may have to pay your legal costs. Regardless of this, if you wish to complain, or have any 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 should be available to you. What will happen to my child s data? You must give your consent in order to participate in this study. Your consent gives the researchers permission to collect personal details about your child and study data, and to record this information on paper and in a computer database. These study records will be used only as needed for the purposes of this study. Personal details are information such as your name that directly identifies you. This personal information will be kept in a database at the University of Bristol. It will be kept separate from study data obtained during this study. Your child will keep the same unique study code number that was given when you first 4
joined the BOX study. It will identify the study information collected from you from study examinations and procedures. The data will be entered into a database that will be used for statistical analysis. Your child s stored samples and test results will also be coded with a unique study code number. They will not be kept with their name but researchers will still be able to find out if a sample belongs to them. This will only happen if it is necessary for reasons of your health or to contact you about participating in a future research study. The results of this study may be published for scientific purposes but your individual records and results will not be identified in any publication. Will my child have to stay in the study until the end? S/he is free to stop being in this study at any time. Her/his current or future care or that of your family will not be any different if you decide not to be in this study or to stop being in this study at any time. As long as the BOX study continues, you can have your stored samples destroyed at any time if you wish Who has reviewed the study? The BOX study was given favourable ethical opinion for conduct in the National Health Service by East Midlands Leicester Research Ethics Committee. The sponsor of the study is the University of Bristol. Who can I ask for more information? You are encouraged to ask any and all questions which come to your mind about the study. The staff of the research program will be happy to discuss any questions with you. If you wish, the staff will discuss with you the test results when available. Our Freepost address is: Professor Polly Bingley Freepost SWB322 Diabetes & Metabolism Southmead Hospital Bristol BS10 5FA Telephone: 0117 323 6106 or 0117 323 5335 Email: i.wilson@bristol.ac.uk 5