FLIPS FreeStyle Libre in Pregnancy Study Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System Use in Pregnancy Label Extension Study (CE) Section 1: PARTICIPANT INFORMATION SHEET We would like to invite you to take part in a research study. Before you decide whether to take part, it is important you understand why we are doing this research and what it will involve. WHY ARE WE DOING THIS STUDY? Many companies are trying to find alternatives to finger pricking for measuring blood glucose. This study compares finger prick blood glucose levels with glucose measurements obtained from the Abbott Sensor Based Glucose Monitoring System 1 ; a new system for monitoring your glucose levels. This system is already being used by adults with diabetes. The data collected during this study will be used to check that the system is accurate for use during pregnancy. 1 The Abbott Sensor Based Glucose Monitoring System is the same as the FreeStyle Libre Flash Glucose Monitoring System which is CE approved for measuring glucose levels in adults aged 18 years and older. Page 1 of 9
WHY HAVE I BEEN ASKED TO TAKE PART IN THIS RESEARCH? We are asking you to take part because you are at least 12 weeks pregnant and check your blood glucose levels regularly. We aim to recruit at least 80 women with diabetes from various locations within the UK and Austria, including this hospital. Unfortunately if you are allergic to plasters you will not be able to take part in this study and you should tell your doctor about this now. DO I HAVE TO TAKE PART? No, participation in this study is completely voluntary. You can leave at any time without giving a reason. WHAT IS THE DEVICE THAT IS BEING STUDIED? The Abbott Sensor Based Glucose Monitoring System measures glucose continuously and has 4 main parts: This Sensor pack and applicator consists of a disposable applicator which applies the Sensor to the back of your arm. The Reader which is used to scan the Sensor and read and store glucose data. It can also be used as a blood glucose meter into which you can insert a finger prick testing strip to obtain a blood glucose reading. A disposable Sensor that has a small, flexible Sensor tip that is inserted just under the skin. Computer-based software that can be used to upload information from the Reader. Page 2 of 9
The Sensor is worn continuously, with the tip under the skin. The Reader is scanned over the Sensor at any time to give a glucose reading. For this study, the Reader is masked ; this means it will not show you your glucose value when scanning the Sensor so you won t be able to use it to make decisions about treatment. This is because we don t yet know whether the system is accurate during pregnancy. However you will be able to see and use your blood glucose results when you do a finger prick test using the Reader as a glucose meter. During your final visit you will be able to use the unmasked Reader for about 30 minutes. When the system is unmasked you will be able to look at the graphs of the glucose data collected by the Sensor over the last 14 days on the Reader. WHAT DOES THE STUDY INVOLVE? If you would like to take part, we will arrange to meet you where we can discuss and explain the device. You will need to visit us each week for 3 weeks. You will also need to: Wear the sensor for 14 days. Test your blood glucose at least 4 times per day by finger pricking before every meal and at bedtime as well as testing your blood glucose as advised by your standard care team at other times of the day (eg post meal) using the Reader provided. Scan the Sensor at least every 8 hours and everytime you do a blood glucose test. Record food, exercise and insulin using the notes log on the Reader every time you test your blood glucose. Record any other events related to your pregnancy or diabetes in the paper diary provided. At some point after you have given birth, we will collect information, from your medical notes, about the outcome of your current pregnancy to include, gestational age at birth, mode of delivery, 5 minute Apgar score, infant birth weight, head circumference and if the infant is large for gestational age. You do not need to come to clinic for this activity. Page 3 of 9
Visit 1 (2-3hrs) Day 1 WHAT WILL I HAVE TO DO? We will talk about the research and answer any questions you may have. We will ask you to sign a consent form to say you are happy to join our study. We will ask some questions about your lifestyle (smoking and alcohol consumption), your diabetes history and any previous pregnancies. We will measure your height, weight and blood pressure. We will take a blood sample to measure your HbA1c, Fructosamine and haematocrit levels (These blood tests indicate your average glucose levels). The Sensor will be applied to the back of your arm and we will show you how to use the system including how to test your blood glucose and how to record meals, exercise and insulin on the Reader. We will ask you a couple of questions about having the Sensor applied. Call 1 (½hr approx) Day 2 A short call to check you have not had any problems and you are happy to carry on with the study. Visit 2 (½hr approx) Between Days 5 and 8 This is a quick visit to upload data from your Reader onto a study computer and check there have not been any problems and you are happy to carry on with the study. Visit 3 (2hr approx) Between Days 12 and 15 The data will be uploaded onto a study computer. We will then unmask the Reader and let you use the system unmasked for approximately 30 minutes. You will be asked to complete a questionnaire about your experience of using the system. We will take a blood sample to measure your HbA1c, Fructosamine and haematocrit levels. Page 4 of 9
WHAT ARE THE POSSIBLE DISADVANTAGES AND RISKS OF TAKING PART? When the sensor is applied it may be a bit uncomfortable, but from previous studies done we know that sensor insertion is almost painless (most say it is less painful than a finger prick). Once it has been inserted you will probably not notice it after a while. You may experience some mild or moderate symptoms associated with Sensor insertion or the adhesives used to keep the Sensor in place. These include infection, redness, swelling, rash, itching, bruising, pain and bleeding. There is also a possibility that unknown symptoms occur. Blood glucose testing on the Reader will require a few drops of blood per day. The risks are the same as your current blood glucose testing. These risks are small but could include pain, bruising, local infection and fainting caused by the lancet to obtain a blood sample. There are similar small risks with the collection of a blood sample for the HbA1c, Fructosamine and haematocrit blood test, plus possible dizziness. The amount of blood taken for this test may be up to about 2 teaspoons. If you have a medical appointment during the study, that includes strong magnetic or electromagnetic radiation e.g. an X-ray, MRI or CT Scan, you will have to remove the Sensor before the procedure and apply a new Sensor afterwards. WILL TAKING PART IN THE STUDY HELP ME? Taking part in the study may not benefit you; however this study will provide information about whether the glucose monitoring system is accurate during pregnancy and this may help people in the future. If you have Type 1 or Type 2 diabetes and your doctor or Nurse agrees it would be useful we will provide you with a new Reader and 2 sensors for your personal use after your pregnancy. WHAT ALTERNATIVES ARE AVAILABLE? The alternative is to carry on using your current glucose monitoring system. Page 5 of 9
EXPENSES AND PAYMENTS You will receive a payment of 25 per visit on completion of your final visit. These payments are to cover your travel expenses between home and the clinic including other costs incurred as part of study participation. If your travel expenses for the 3 visits are greater than 75 then additional expenses can be reimbursed on presentation of valid receipts. WILL MY INFORMATION BE KEPT PRIVATE? All information collected about you as a result of participation in the study will be kept strictly confidential. Your personal and medical information will be kept in a secured file and be treated in the strictest confidence. You may ask to see your personal information at any time. Some parts of your medical records and the data collected for the study may be looked at by people carrying out the study or people checking that the study is being carried out correctly. Except for notification to your GP of your participation in the study, nothing that could reveal your identity will be disclosed outside of the hospital. Data collected as part of this study will be looked at by authorised people from Abbott Diabetes Care who may be outside the European Union; where the laws to protect your privacy maybe different, Abbott Diabetes Care will take all reasonable steps to protect your privacy. We will seek your consent to inform your GP of your participation in this study. WHAT IF RELEVANT NEW INFORMATION BECOMES AVAILABLE? If new information becomes available that could significantly affect your future health and medical care that information shall be provided to you in writing. If necessary, you may be asked to confirm your continuing informed consent in writing. WHAT HAPPENS TO THE RESULTS OF THE RESEARCH STUDY? The results of the study will be anonymised and you will not be identified from any of the data produced. When the results of the study are available they may be published in peerreviewed medical journals and used for medical presentations and conferences. Page 6 of 9
WHAT WILL HAPPEN IF I DON'T WANT TO CARRY ON WITH THE STUDY? You have the right to withdraw from the study at any time. Any data/samples already collected will be retained for use in the study; however you can request that data/samples already collected are not used and are destroyed. This does not adversely affect your future medical care. The investigator may also withdraw you from the study for medical reasons or if you no longer meet the inclusion and exclusion criteria. This does not adversely affect your future medical care. WHAT IF SOMETHING GOES WRONG? If you have any cause to complain about any aspect of the way you have been approached or treated during the course of this study we suggest that you contact your study site staff or your Patient Advice and Liaison Service (PALS) at your hospital: Patient Advice and Liaison Service, John Radcliffe Hospital, Oxford University Hospitals NHS Foundation Trust, Headley Way, Oxford, OX3 9DU, Email: palsjr@ouh.nhs.uk, Tel: 01865 221473 Abbott Diabetes Care (ADC), the Sponsor, will provide compensation for any injury caused by taking part in this study, beyond those described as possible risks above. ADC would not be bound to pay compensation where injury resulted from a drug or procedure outside the study protocol. Please speak to your doctor or nurse to report any injury caused by taking part in this study. WHO IS ORGANISING AND FUNDING THE RESEARCH? The study is being organised and funded by Abbott Diabetes Care Limited, the manufacturers of the system being studied. WHO HAS REVIEWED THE STUDY? All research within the NHS is reviewed 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 NRES Committee Yorkshire & The Humber - Sheffield. Page 7 of 9
If you have any questions regarding this study please contact: Name of Doctor: Address: Dr Lucy Mackillop Oxford University Hospitals NHS Trust, Level 6, Women s Centre, Telephone: 01865 851165 John Radcliffe Hospital, Oxford OX3 9DU Name of Study Nurses: Address: Sarah Harding, Nicola Higgins and Katy Bartlett Nuffield Department of Obstetrics & Gynaecology, Telephone: 01865 572258 University of Oxford, Level 3, Women's Centre, John Radcliffe Hospital, Oxford OX3 9DU Thank you for taking the time to read this information sheet. You will be given a copy of this information sheet and a signed consent form to keep. Page 8 of 9
FLIPS FreeStyle Libre in Pregnancy Study Evaluation of the Accuracy of the FreeStyle Libre Flash Glucose Monitoring System Use in Pregnancy Label Extension Study (CE) Section 2: PARTICIPANT CONSENT FORM Participant ID: Name of Researcher: Dr Lucy Mackillop 1. 2. 3. Please INITIAL in the box I confirm that I have read and understood the information sheet version 1.1, dated 20 October 2015 for the above study and have had the opportunity to consider the information, ask questions and have had these answered satisfactorily. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. I agree to the use of my personal data for the purpose of this study and understand that relevant sections of my medical notes and data collected during the study may be looked at by responsible individuals from Abbott Diabetes Care, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this study. I give permission for these individuals to have access to my records. 4. I agree to my GP being informed about my participation in the study. 6. I agree to take part in the above study. 7. I agree to return all study devices and materials at the end of the study. Please circle yes or no I agree to the collection of information from my medical notes, about the outcome Yes / No of my pregnancy Name of participant Signature Date Name of person taking consent Signature Date By signing above the person taking consent confirms they have checked the form to ensure it is complete. When completed: Original for Investigator s study file, 1 copy for participant and 1 copy to be kept in medical notes. Page 9 of 9