Frequently Asked Questions
What are the possible disadvantages and risks of taking part?
We do not think doing this study exposes you to new risks. There is the inconvenience of the time the courses take to do, but this is no longer than undertaking an existing structured education programme in flexible intensive insulin therapy. As one of the courses explores your thoughts and beliefs around diabetes control and hypoglycaemia, strong feelings may be provoked. Your educators are trained to help you deal with such feelings. Indeed, there is evidence that exploring such feelings and beliefs in a sensitive and constructive way is likely to help you achieve your goal of reducing your hypoglycaemia risk.
Because this is a research study, and you may provide us with information that you would not otherwise have given, such information will be treated in confidence. The study protocol provides for anonymised reporting of your hypoglycaemia experience, in parallel with open reporting. The anonymised data will be recorded directly into the study database, in which individual participants cannot be identified. Any information you give us otherwise, through open questionnaires or during the course of interactions with your educators or the researchers, will be treated as confidential, as would be usual for any clinical interaction. If you describe to us a greater problem with your hypoglycaemia than you have previously reported, we will discuss with you the risks that this may create for you and for others, discuss with you what you can do to reduce those risks and advise you of your legal responsibilities, which may include the need to inform other authorities such as Driving and Vehicle Licencing Agency (DVLA).
Who is organising and funding this study?
The doctor in charge of this study is Prof Stephanie Amiel, diabetes consultant at King’s. The study is funded by the JDRF (Juvenile Diabetes Research Foundation) and is being jointly sponsored by King’s College London and King’s College Hospital NHS Foundation Trust. The research team are not receiving any financial reward for undertaking this study.
How have patients and the public been involved in this study?
Reducing the risk of severe hypoglycaemia and tackling impaired awareness of hypoglycaemia were topics listed as priorities for research in type 1 diabetes by a national exercise involving people with diabetes, their families and their health care professionals in 2012. People with type 1 diabetes helped develop the HARPdoc intervention, both by participating in the original design of its curriculum and by providing feedback that has led to its present form. People with type 1 diabetes have also reviewed the questionnaire packs and this patient information sheet. One of them will continue to be involved in the study as part of the research team and will chair a group of people with type 1 diabetes who will assist in monitoring the progress of the study and the analysis of the data.
Who has reviewed this study?
The study protocol was reviewed by a research review committee of the JDRF and was developed with them. All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by London-Dulwich Research Ethics Committee. It has also been approved by the Health Research Authority and each local hospital will also give confirmation that the study can go ahead. The American site will have been reviewed and approved by its own local Investigation Review Board, the US equivalent of the Research Ethics Committee.
Expenses and Payments
There are funds available for you to claim back travel expenses for attending study visits.
What happens when the research study stops?
The study ends two years after your course. At the end of that time, you will return fully to your usual diabetes care team. We hope that any improvement in your hypoglycaemia experience gained from your course will persist but we cannot be sure that this will be the case.
What if new information becomes available?
Sometimes we get new information about the treatment being studied. If this happens, your study doctor will tell you and discuss whether you should continue in the study. If you decide not to carry on, your study doctor will make arrangements for you to leave the study and return to your usual diabetes care team. If you decide to continue in the study he/she may ask you to sign an agreement outlining the discussion.
This new information that becomes available might specifically affect you and your health. If this happens, your study doctor might consider that you should withdraw from the study. He/she will explain the reasons for withdrawing from the study and arrange for your care to continue with your usual diabetes care team. If the study is stopped for any other reason, we will tell you and you will continue your care with your usual diabetes care team.
What will happen if I don’t want to carry on with the study?
You are free to withdraw from the study at any time; and if you would like to do so; please speak to your study nurse or doctor. Your decision to withdraw from the study will not affect the usual health care you receive.
If you withdraw your consent to continuing in the study, we would ask you to allow us to use information we have already collected from you. We would also like to keep in contact with you through your doctor or GP so that we can know about your progress. Specifically, we will ask if we may collect information about your awareness of hypoglycaemia, the number of severe hypoglycaemic episodes you are having and your HbA1c. NICE recommends that this information is collected routinely for every person with diabetes, at least once a year, so allowing us to collect this information will not need to involve you in any extra effort. We would ask that we may collect these data at 12 and 24 months after your course. You may withhold your permission for this if you wish and you can ask that your entire data collection be deleted from the study files.
What if there is a problem?
If you have a concern about any aspect of this study, you should ask to speak to your study doctor (Please see contact details at the end of this document) who will do their best to answer your questions. If you remain unhappy and wish to complain formally, you can do this through the NHS Complaints procedure by contacting your local Patient Advice Liaison Service (PALS) office. Details of your local office can be obtained by asking your study doctor, GP, telephoning your local hospital or looking on the NHS choices website. http://www.nhs.uk/pages/home.aspx
Every care will be taken in the course of this study. However in the unlikely event that you are injured by taking part, compensation may be available.
In the event that something does go wrong and you are harmed during the research and this is due to someone's negligence then you may have grounds for a legal action for compensation against King’s College Hospital NHS Foundation Trust. 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 by members of staff or about any side effects (adverse events) you may have experienced due to your participation in the study the normal National Health Service complaints mechanisms are available to you. Please ask your study doctor if you would like more information on this.
Will my taking part be kept confidential?
Information collected by us as part of the study protocol is confidential. In the research records, your data will be identified only by a number that you will be given when you start the study. The list linking that number to you will be kept separately in an NHS data system. You will not be identifiable in the publications of the results of the study. Only anonymised data will be kept in the research data base.
Because we are interested in how long the benefits of each intervention last, we will want to keep your data for about 10 years after the study is finished. We ask that you allow us to review your records for hypoglycaemia experience and diabetes control at any time during this period but we will let you know if we are doing this and give you the opportunity to withdraw your consent. If we want to do any other research around your experiences of the study, we will ask you separately for your consent. We will ask for ethical committee approval before asking you about any new use of your data.
It is common practice now to allow other researchers access to study information.
We will not keep the blood samples you give during the study. Data sharing with other researchers is useful to ensure that research is open to peer scrutiny, to optimise the use of good quality research data and to support policy and other decision-making. Only the anonymised data will be open to other researchers.
Prof Amiel will be the custodian of the data collected in this study.
Because we have an American centre in the study, your data will be merged with the US data and our US collaborators will be able to work with the data base. This data base will only contain the anonymised data set, so you will not be identifiable to the US researchers.
If you consent to take part in the research, any of the information collected about you may be inspected by the sponsor (including representatives of the sponsor). These inspections are solely for the purposes of the research and analysing the results. Your records may also be looked at by the regulatory authorities or ethics committees to check that the study is being carried out correctly.
The organisations listed above will keep information about you confidential and secure. Your name will not be used in any reports about the study and all data is stored in accordance with the principle of the Data Protection Act 1998. However, your study doctor may tell your GP about your participation if you agree to enter the trial.
We appreciate that you may not want data on your severe hypoglycaemia experience to be shared outside your diabetes care team. We expect participation in our study to reduce your rate of severe hypoglycaemia and we have to measure this benefit accurately. It is therefore very important for us to know how much hypoglycaemia you are having before you start the study and after your courses. This information will be kept confidential. If you tell us about an amount of severe hypoglycaemia that poses a danger to you or to people around you we will discuss this with you, advise you about how to reduce the risks and what your responsibilities are. It is your responsibility to inform other authorities about your hypoglycaemia experience.
Involvement of the General Practitioner/Family Doctor (GP)
With your consent, your GP and your usual diabetes care team will be informed of your involvement in the trial and will be contacted for study related information, specifically data he/she has received about emergency service call-outs and hospital admissions for hypoglycaemia.
What will happen to any samples that I give?
The only samples you give are blood samples for measurement in a laboratory of your diabetes control, and at the start of the study, for measuring things such as liver, kidney and thyroid function that might be increasing your risk of hypoglycaemia. These samples will be destroyed using the usual procedures of the measuring laboratory once the data are obtained.
Will any genetic tests be done?
We are not including any genetic studies in this proposal
What will happen to the results of the research study?
We will let you know the results of the study when we have completed the analysis. We will do this with a written report drafted specifically for study participants as well as offering you copies of the scientific papers we write. We hope the participants in in the study will also publicise it and its results using social media. Individuals will not be identifiable from any report or publication placed in the public domain