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1. Instructions for Use
Information for Patients
GDm-Health is an app available for both iOS (Apple) and Android (Google) operating systems. It can be downloaded for free from the Apple App store or Google Play Store. It is designed to be accessed from a mobile phone only (i.e. it is not designed for tablet access). The GDm-Health app is designed to allow patients with gestational diabetes to record their blood glucose levels and communicate this to the team responsible for delivering care.

Indications for Use
GDm-Health V18.1 is an m-Health (mobile health) remote communication system for people with gestational diabetes mellitus (GDM), a condition in which women develop high blood sugar levels during pregnancy. GDM affects around 16% of pregnancies in the UK and can cause serious health problems for a mother and her baby.

GDm-Health V18.1 is designed for use for adults (aged 16 years and older) who are being treated by professional health care teams that are using the desktop solution. GDm-Health V18.1 is not designed to:

• Be used in isolation i.e. without a care team supporting the patient.
• Be used by patients who are under 16 years of age
• Be used for the management of any condition other than diabetes in pregnancy

GDm-Health is not a substitute for antenatal care.

What does the app do?
The GDm-Health app records your blood glucose levels. You can enter blood glucose levels in 2 ways:
• By connecting to a blood glucose meter that you have set up with the app.
• By entering a value manually.

Additionally, you can record more data with the reading:
• What time of day the reading was for e.g. before breakfast or after lunch
• What medications you took
• Any comments that you think will be helpful to your diabetes care team

The app sends all this information to your diabetes care team. Your diabetes care team will look at the data and contact you if they need to.

How do I use the app?
To use the app, follow these steps:
1. Download the app
2. Get an activation code from your diabetes care team. You will normally be given a code at your first appointment.
3. Enter the activation code into the app. This creates a secure link between your app and your record on the system.
4. You must accept our Terms of Use
5. You will then see more features including:
6. Record a blood glucose reading
7. See my blood glucose reading history
8. See messages
9. Request a call back from my midwife
10. After your treatment is complete you will be asked to complete a feedback survey

How do I know if GDm-Health has been properly installed?
On first opening the app you will be shown a quick overview of the app. You will then be presented with articles about gestational diabetes and be asked for an activation code. If this does not happen then please contact your diabetes care team. Please note, there is no maintenance or calibration needed for the safe use of this software.

What do I do if the app is not working?
Please contact your diabetes care team.

How much does the app cost?
The app is free for all patients to use.

Can GDm-Health provide a patient diagnosis?
GDm-Health is not a diagnostic tool and cannot provide a patient diagnosis. However, information communicated through the GDm-Health app may inform diagnostic decisions that are ultimately the sole responsibility of the qualified physician using the platform.

Where does the clinical information in the articles and links come from?
The information is written by a consultant in Obstetrics and Gynaecology who manages gestational diabetes. The external links included in the articles have been signed off by a doctor who manages gestational diabetes and comes from trusted sources with accurate clinical content. However, we do not monitor the pages regularly, and if there are changes or inaccurate information then we do not take responsibility for this.

How do I set up a meter in the app?
The app contains instructions for setting up a meter in the menu. Your diabetes care team will show you how to do this. If you need to set up a different meter, you can do this from the left-hand
navigation. You get to these options from the top left hand of the screen on the hub screen.

Do I need to set up a meter in the app?
Your diabetes care team will tell you the best way to record blood glucose readings. If you are using your own meter, you can enter readings by typing in the blood glucose level manually.

Can I send a message to my diabetes care team?
The app shows you messages from your diabetes care team. You may also receive SMS text messages. You cannot reply directly to these messages, but if you have questions for your diabetes care team, you can request a call back from them via the app.

How do I ask for a call-back?
You can request a call-back from the action button. The action button is in the bottom right hand of your screen.
• Tap ‘request call-back’ to place your request
• You can also request a call back from your messages.

Can I cancel a call-back?
Call-backs can be cancelled by tapping on the ‘request call-back’ option from the action button or the messages. If you have requested a call-back, you will see a reminder at the top of your screen, which you can tap to cancel the callback.

How long do I have to use the app for?
Your diabetes care team will tell you when to stop using the app. You will get a message telling you that the diabetes care team have closed your record. You may also be asked to fill in a feedback survey.

What do I do if I am worried about my pregnancy?
Please contact your diabetes care team immediately or go to the nearest Emergency Department.

What happens when my record is closed?
You will not be able to send any blood glucose readings when your record is closed. You will not be able to request call-backs. You will be able to still see your readings diary and your old messages.

Who can see my data?
Your data is shared with the health care team who provide your care. Only authorised people are allowed to see your data. The data that they hold includes:
• Data about you and your pregnancy e.g. name, hospital number, due date etc.
• Data about your diabetes e.g. diagnosis date
• Data about your blood glucose: this will include all the readings you have sent
• Data about your call-back requests
• Data about your delivery e.g. how many days you stayed in hospital

When your record is closed you may be asked to complete a feedback survey. Your diabetes care team will never see your personal answers. Your diabetes care team only ever see reports combining lots of answers without any identifiable information.

Sensyne Health have built the app but they will not access your personal data unless they specifically ask for your permission according to GDPR and Data Protection Act 2018. They may use fully anonymised data for our research and to improve the product. Their academic partners may assist them in this research – the data they see will be anonymous. They will never contact you directly or market anything to you.

How do you protect my data?
We protect your data in a number of ways:
1. Sensyne Health conform to data protection legislation.
2. All data is encrypted at all times (whether at rest or in transit)
3. Patient Identifiable Data i.e. data which can identify you as an individual is kept separate to Operation Data i.e. your blood glucose readings.
4. We continuously monitor the solution to protect against any data breaches.
5. Only authorised users are allowed to use to the website application. Users are authorised by the Hospital.

Who can I contact with questions about my data?
1. You should contact your hospital and care team initially. If you have any questions for Sensyne Health please contact our dedicated data protection officer by sending an email to [email protected]
2. More information about GDm-Health

These publications provide more information about the research behind our solution.

1. Comparing the Efficacy of a Mobile Phone-Based Blood Glucose Management System With Standard Clinic Care in Women With Gestational Diabetes: Randomized Controlled Trial Lucy Mackillop1,2, BM, BCh, MA (Oxon), FRCP, et al

2. Trial protocol to compare the efficacy of a smartphone-based blood glucose management system with standard clinic care in the gestational diabetic population Mackillop LH, Bartlett K, Birks J, Farmer AJ, Gibson OJ, Kevat DA, Kenworthy Y, Levy JC, Loerup L, Tarassenko L, Velardo C, Hirst JE BMJ Open. 2016 Mar 17;6(3):e009702. doi: 10.1136/bmjopen-2015-009702 – 2015

3. Digital blood glucose monitoring could provide new objective assessments of blood glucose control in women with gestational diabetes Hirst, JE, Loerup, L, Mackillop, LH, Farmer, AJ, Kenworthy, YM, Bartlett, KJ, Velardo, C, Kevat, DA, Tarassenko, L, Levy, JC Diabet Med. 2015 Nov 25. doi: 10.1111/dme.13035 – 2015

4. Acceptability and User Satisfaction of a Smartphone-Based, Interactive Blood Glucose Management System in Women With Gestational Diabetes Mellitus Hirst, JE, Mackillop, LH, Loerup, L, Kevat, DA, Bartlett, KJ, Gibson, OJ, Kenworthy, YM, Levy, JC, Tarassenko, L, Farmer, AJ J Diabetes Sci Technol 2015 vol. 9 no. 1 111-115 – 2015

5. Development of a Real-Time Smartphone Solution for the Management of Women With or at High Risk of Gestational Diabetes Mackillop, LH, Loerup, L, Bartlett, KJ, Farmer, AJ, Gibson, OJ, Hirst, JE, Kenworthy, YM, Kevat, DA, Levy, JC, Tarassenko, L J Diabetes Sci Technol 2014 vol. 8 no. 6 1105-1114 – 2014

6. The Utility of Digital Blood Glucose Monitoring Metrics to Predict High Birth Weight in Women with Gestational Diabetes Hirst, JE, Farmer, AJ, Loerup, L, Mackillop, LH, Levy, JC, Bartlett, KJ, Kenworthy, YM, Kevat, DA, Velardo, C, Tarassenko, L ADA 75th Scientific Sessions, Boston, MA, June 2015 (poster) – 2015

7. The Utility of Digital Blood Glucose Monitoring Metrics to Predict High Birth Weight in Women with Gestational Diabetes Mellitus Hirst, JE, Farmer, AJ, Loerup, L, Mackillop, LH, Levy, JC, Bartlett, KJ, Kenworthy, YM, Kevat, DA, Velardo, C, Tarassenko, L