RECOGNISE - Patient Information

We know that keeping blood sugars under control helps to improve the health of mother and baby in women who have gestational diabetes by reducing complications, the possibility of a large-for-dates baby, and the need for interventions during the birth.  There are different ways to monitor and manage blood sugars, and we want to see which method is better at helping women with gestational diabetes who are given medicine to help with this.

In the RECOGNISE study we will compare our current normal care (which is finger-prick glucose monitoring) with continuous glucose monitoring (also known as “flash” monitoring). This is done with a small sensor, worn on the arm, which is scanned by an app on your phone (or a special reader) to get the results. Some women in the study will use finger-prick testing, and the rest will use flash monitoring.

RECOGNISE is a small-scale study (called a feasibility study), to help us test the processes and help us design a large-scale study.

We are inviting all women who have been newly diagnosed with gestational diabetes who are in the care of North Bristol NHS Trust, which is why you have been given this information. When you return for your next appointment (usually in about a week’s time), your Diabetes Specialist Team will assess your blood sugar diary and talk to you about how to manage your gestational diabetes. If you need medicine to help control it, you may be offered the opportunity to take part in RECOGNISE.

1. Take some time to read this leaflet and watch our study video and think about whether RECOGNISE is right for you

2. A Research Practitioner will call you at home to discuss the study and answer your questions

3. At your next diabetes appointment (in about a week), you and your Specialist Team will decide if you need medicine to help you manage your blood sugars. If you do need medicine, you may be offered the opportunity to take part in RECOGNISE

4. If you are eligible and interested in learning more, a Research Practitioner will talk to you and help you decide if you'd like to take part in RECOGNISE. If you would like to, they will ask you to complete a consent form and ask some questions about you and your gestational diabetes

5. The Research Practitioner will then ask a computer to randomly allocate you to one of two groups. This means you can't choose the group, nor can your Care Team.

   The groups are: 

   •EITHER Using a flash monitor for the rest of your pregnancy

   •OR Using finger-prick testing for the rest of your pregnancy AND wearing a flash monitor for two 14-day periods

Taking part in this study may help some women to better manage their blood sugars during pregnancy. Your taking part will help us to design the large-scale study that will follow RECOGNISE. We hope that the study will help us understand more about the best way to care for women, so your contribution will be greatly appreciated by our team and by women who are diagnosed with Gestational Diabetes in the future.

To track your Gestational Diabetes, you will need to take blood samples and check your glucose levels. The normal way to do this is by using finger-prick testing approximately 4 – 6 times a day. The flash monitor is an alternative device which is worn continuously.

It is a small, flat sensor, about the size of 2-pence piece, worn on the back of your upper-arm which measures your blood glucose levels. The sensor sticks to your arm with adhesive and a small filament (or tube) sits just under your skin.

For most people it is painless, and your care team will help instruct you on how to apply the monitor to reduce the chance of discomfort.  You can wash and swim as normal as it is waterproof.

Some flash monitors require the wearer to “swipe” the device a few times a day using a smartphone or a special reader (shown below). Others don’t need to be swiped.

We have designed the study to take as little extra time as possible. This is what is involved for women in each group.

If you are allocated to continue with finger-prick monitoring this is what will happen: 
 

If you're allocated to finger-prick monitoring:

•You will fill in some study questionnaires

•A Research Practitioner will help you apply a flash monitor which you will wear for 14 days. You will NOT need to swipe it or have access to the data

•You will post the flash monitor back to us after 14 days

Monitoring your sugar levels at home:

 •You will use finger-prick testing to monitor your blood sugar levels every day for the rest of your pregnancy

•You will enter the results into your GDM Health App or GDM diary 

At your routine monthly Diabetes Clinic visits:

•Your Care Team will use your diary/app information to help you manage your diabetes

At your 34-36 week Diabetes Clinic visit:

•You will fill in some study questionnaires

•You will wear a flash monitor for another 14 days. You will NOT need to swipe it or have access to the data

•You will post the flash monitor back to us after 14 days

When your baby is born:

•We will collect some information from your medical records about your birth and the health of you and your baby

•You can stop your finger-prick testing when your care team tells you to

When you're home:

•We will collect some information from your GP about your baby's growth (usually at 6-8 weeks old) and your glucose levels (usually at 13 weeks postnatal)

If you are allocated to the flash monitor group, this is what will happen:

If you are allocated to flash monitoring:

•You will fill in some study questionnaires

•You will watch  a few short videos to learn how to apply and change the flash monitor (sensor), how to  scan it, and what to do with the results.

•If you have a smartphone, you will need to download the LibreLink app. If you use a reader and have access to a computer and internet at home, you can sign up to LibreView

Monitoring your sugar levels at home:

•You will wear a flash monitor for the rest of your pregnancy, and scan it using your smartphone or a reader

•You will need to change the flash monitor every 14 days

At your routine monthly Diabetes Clinic visits:

•Your care team will use your flash monitor information to help you manage your diabetes

At your 34-36 week Diabetes Clinic visit:

•You will fill in some study questionnaires

When your baby is born:

•We will collect some information from your medical records about your birth and the health of you and your baby

•You can stop wearing the flash monitor when your care team tells you to

•You will return any equipment to the research team

When you're home:

•We will collect some information from your GP about your baby's growth (usually at 6-8 weeks old) and your glucose levels (usually at 13 weeks postnatal)

“LibreLink” and “LibreView” are both provided by the company who make the flash monitors. They are commonly used by people with diabetes who already use the Libre2 sensor. You’ll need to enter some of your personal details and a password and enter your Hospital’s ID number so that they can see your sugar levels too. Using your own smartphone may incur roaming charges, so we recommend using home or Hospital wi-fi when using “LibreLink” and “LibreView”.

You can change your mind and withdraw from this study at any time and without giving a reason, but we will keep information about you that we already have. It will not affect the medical care that you receive. However, if you are in the flash monitoring group you will be asked to stop using the flash device and you will restart finger-prick monitoring.

If you choose to stop taking part in the study, we would like to continue collecting information about your health from your Hospital and GP medical records. If you do not want this to happen, tell us and we will stop. We will ask you to let us know your preference by completing a study withdrawal form.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the research data we hold about you. If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

North Bristol NHS Trust is the Sponsor for this study, based in the UK. This means they are responsible for looking after your information and using it properly.

We will need to use information from you and your medical records for this project. This information will include your NHS number, name, and contact details. We will contact you by either phone, email, or text. We will also access your Hospital and GP medical records to gather information about your and your baby’s care and about your birth. People will use this information to do the research or to check your records to make sure that the research is being done properly. We will keep all information about you safe and secure. People who do not need to know who you are will not need to see your name or contact details. Your data will be given a code number instead.

Once we have finished the research study, we will keep some of the data so that we can check the results. We will store study data for up to 5 years after the end of the project, as per standard protocol at North Bristol NHS Trust. We will write our reports in such a way that no one can work out who took part in the study.

We will write to your GP to let them know you are taking part in the study.

We may also contact you about an interview about your participation in the study.

North Bristol NHS Trust is the sponsor for this study. You can find out more about how we use your information at www.hra.nhs.uk/information-about-patients. You can also:

• • Read our leaflet available from www.nbt.nhs.uk/patientresearchdata
• Ask one of the research team
• Contact Helen Williamson (Head of Information Governance) at helen.e.williamson@nbt.nhs.uk or by calling 0117 4144767

NHS-sponsored research such as this study is covered by NHS indemnity (the same indemnity that applies to any patient in the NHS). In the unlikely event that you feel you have been adversely affected by taking part in this study, you should contact the research team as soon as possible (details at end of leaflet).

Should you wish to complain about any aspect of the way you have been approached or treated during the study, the normal NHS complaints mechanisms are available to you.

Please visit www.nbt.nhs.uk/patients-carers/feedback for further information about how to make a complaint or contact the North Bristol NHS Trust Hospital Patient Advice and Liaison Service (PALS): Telephone 0117 414 4569. PALS can also provide confidential advice and support to patients, families and their carers.

This study is being carried out by staff at North Bristol NHS Trust, Somerset Foundation Trust, the University of Bristol and the University of Warwick.

This study is funded by the NIHR Research for Patient Benefit programme (Funding reference: NIHR 203182)

The Health Research Authority and Berkshire B Research Ethics Committee have reviewed and agreed to this study.

The study is being led by Dr Christy Burden at Southmead Hospital (North Bristol NHS Trust). If you have any questions about the study please contact Dr Christy Burden, Consultant Obstetrician, Southmead Hospital on the study email address RECOGNISE@nbt.nhs.uk.