What will happen to me if I take part?
If you agree to take part and are eligibile, we will want to make a record of how you are, how you manage your diabetes, how much hypoglycaemia you are having and what impact that is having on your life. We will take a medical history and do a physical examination to check for possible complications of diabetes.
We will ask you about your hypoglycaemia (hypo) experience – for example, how often you have hypos, how well you feel when your blood sugar is falling are and how many severe episodes (ones in which your blood sugar fell so low you could not treat yourself and someone else had to give you treatment).
We will take blood to check that you have no medical reason, apart from diabetes, increasing your personal risk of hypoglycaemia and to measure your diabetes control and we will ask you to fill in a questionnaire booklet that will tell us about how you think about your hypoglycaemia, how much you worry about it and how you try to avoid it.
There are also questions about how much your diabetes and your hypoglycaemia affect your mood and your quality of life. The questionnaires have been reviewed by people with type 1 diabetes and they take about 30 minutes to complete. You will notice that the blood sugar values used to define hypoglycaemia may differ between questionnaires in the booklet, and sometimes even within one questionnaire. This reflects either differences in international definitions for hypoglycaemia or the context of each question, which may be exploring the clinical effects of different degrees of hypoglycaemia. For the interventions, this will be much clearer as there will be only one blood sugar threshold defined as hypoglycaemia. We will download your glucose meter and look at the results together. We will then ask you to keep us informed of any bad hypos by completing a one page questionnaire if you have an episode and send us a different one page questionnaire each month describing your experience of hypoglycaemia in that month. We will want you to keep doing that as long as you are involved in the study.
We will then ask you to book into two of our six-week courses. You will however only do one of them. Each course includes four days (one a week on weeks one, two, three and six) spent with one or more senior diabetes educators (nurses and dietitians) and about five other people with type 1 diabetes and problems with hypoglycaemia. There will be formal one-to-one contact with the educators using telephone or face to face visits (your choice) in weeks four and five for one of the courses. Neither we, nor you, will decide which course you do. This is done using a system for random allocation. In this way we can be sure that any difference we may find in the number of severe hypos people have in the two years after the courses is due to the difference in the course content. We will let you know which of the dates you have booked you will be asked to attend as soon as we can.
It is important for us to know how accurately the diabetes educators deliver each intervention, and in particular we need to assess how well the techniques that are novel to the HARPdoc intervention are used in either course. This is called assessing the fidelity with which each intervention is given. We will therefore be asking all participants on a course to allow us to make video-recordings of sessions, with the camera focussed on the educators. The recordings will be reviewed only by the researchers for the purpose of assessing the accuracy with which each intervention is being delivered and for no other purpose.
After your course, you can keep in touch with your course educator to get on-going support for your diabetes self-management. We will continue to ask you for monthly reports and you will have a formal review and update with the other people who were in your group at the hospital at 3, 6, 12, 18 and 24 months after the your group was first run. Your involvement in the study ends with your last visit, 24 months (2 years) after you had your course.
We will check your blood HbA1c (glycated haemoglobin, the blood test that tells you about your sugar control over the last couple of months) as a marker of your diabetes control at each visit. Three times in the study, at the start of the course, year 1 and year 2) we will ask you to re-do all the questionnaires and we will take a blood sample from an arm vein to send to the King’s Clinical Chemistry Laboratory for measurement of HbA1c. This is to make sure that at these times in the study, we have a measurement done on everyone in the study made using the same laboratory methods.
During the study, you will be discussing your diabetes self-management with your course educators. We will send clinical information, including the HbA1c measurements, to your GP and your usual diabetes care team. You may be able to reduce the frequency with which you visit your usual care team during the study, as you can get advice about your insulin management from your educators.
We are asking some people to take part in a subgroup study (24 participants in total). If you are going to do this, you will be asked to wear a blinded continuous glucose monitoring system for a week before participating in the course and approximately one year later. The system is made up of a very thin, flexible glucose sensor that is inserted into the fat pad under the skin of your abdomen with the help of a small needle which will be removed immediately after insertion, and a small flat recording device attached to the sensor, secured with adhesive dressing. You will not be able to see the glucose readings which will be examined later in order to detect episodes of low blood glucose you may not capture with finger prick measurements.