Oxford,UK; 16th October 2018: Sensyne Health plc (LSE: SENS), the British clinical AI technology company, today announces the commercial launch of its GDm-Health™ product, the patient app-to-clinician software system for the management of gestational diabetes mellitus (GDM).
GDm-Health replaces the traditional paper-based method of management. The system comprises a smartphone application which connects to a wireless blood glucose monitor. The woman’s blood glucose measurements, any text-based commentary she wishes to log and any request for a call back she makes are transmitted directly to a web-based clinical dashboard for the multi-disciplinary team at the hospital supervising her care to manage proactively. The care team can see near real-time data that has been prioritised through appropriate algorithms and can communicate directly with patients through the system.
The app has now completed its development following a 2 year clinical evaluation in the NHS by over 1,000 women, and is currently available to pregnant women and their midwives at Oxford University Hospitals NHS Foundation Trust and Royal Berkshire NHS Foundation Trust. Three additional NHS Trusts will be implementing GDm-Health in the coming weeks, including Buckinghamshire Healthcare NHS Trust, Croydon Health Services NHS Trust and Milton Keynes University Hospital NHS Foundation Trust.
GDM is a pregnancy-related disease increasing in prevalence world-wide driven by demographic and lifestyle changes. In the UK, the rise is predicted to reach a prevalence of over 16%, from a baseline of around 4% in 2008(1) and is a condition that without tight blood glucose control can lead to adverse maternal and foetal outcomes(1). Results published in March 2018 from a randomised controlled trial for GDm-Health (203 participants), demonstrated its value to both women and the NHS including: statistically significant improvement in patient satisfaction, adherence to glucose monitoring, a reduction in caesarean sections, a trend towards reduction in pre-term births and potential for cost-savings to the NHS through improved patient outcomes.
Batoul Mustafa, a recent user of the GDm-Health app during her pregnancy, commented:
“GDm-Health is a great idea and really straightforward to use. It allowed me to better understand and manage my blood glucose levels. With the app, everything is in one place and it shares my data with my care team and allows us to communicate through the app outside my appointment times. I felt this technology was enabling me to have more personalised antenatal care.”
Dr Lucy Mackillop, Consultant Obstetric Physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford; and the clinical lead for the development of GDm-Health commented :
“I am delighted that GDm-Health has made the transition to a commercial product and is available for implementation across the NHS. This is as a result of an enormous amount of work by the clinical and academic teams at Oxford University Hospitals NHS Foundation Trust and University of Oxford and by Sensyne Health to have taken our prototype and transformed it into a sustainable scalable product.”
Bini Ajay, Consultant Obstetrician & Gynaecologist at Croydon Health Services NHS Trust commented:
“We start our large pilot of GDm-Health in October and, having seen its success in other Trusts, hope our experience will inform a decision to endorse it for widespread NHS use.”
Erum Khan, Consultant Obstetrician and Gynaecologist, Milton Keynes University Hospitals NHS Foundation Trust, commented:
“Milton Keynes University Hospitals NHS Foundation Trust are proud to be a leader in adopting innovations which will improve clinical care and patient experience. GDm-Health will allow us to provide more responsive and personalised care to our women with gestational diabetes and we are excited to be one of the first Trusts to implement GDm-Health.”
Lord (Paul) Drayson, CEO of Sensyne Health, commented:
"The overwhelming positive response to GDm-Health from the NHS and from women with gestational diabetes is testament to its clinically led design and the fact it is technology that is addressing an area of urgent, clinical need. We look forward to its wider adoption in the coming months.”
GDm-Health is one of a number of data-driven health technology applications under development by Sensyne Health in collaboration with the University of Oxford and Oxford University Hospitals NHS Foundation Trust. Anonymised data from these systems, can be made available for analysis by the Company, using its Clinical AI capabilities for the purposes of medical research and to improve patient care.
1 Development of a Real-Time Smartphone Solution for the Management of Women With or at High Risk of Gestational Diabetes - J Diabetes Sci Technol 2014 Nov; 8(6): 1105–1114.
Notes to editors:
Gestational diabetes mellitus (GDM) is defined as new onset or recognition of glucose intolerance in pregnancy which resolves following birth. Current evidence supports tight blood glucose control to prevent adverse maternal and foetal outcomes(1). Finger-prick blood glucose testing with frequent clinic review is the most common method of managing diabetes in pregnancy. GDM is increasing in prevalence world-wide driven by demographic and lifestyle changes. In the UK, the rise is predicted to reach over 16%, from a baseline of around 4% in 2008(1). GDM is usually managed by women recording their blood glucose results in paper diaries, typically 6 times a day with regular review by doctors and midwives in clinic. This manual process is time-consuming and is open to the risk of transcription errors.
GDm-Health is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of gestational diabetes and can be used to manage women with pre-existing diabetes. The system allows clinician review of patient-annotated blood glucose results in real time. It is based on a smartphone application that enables women to connect a blood glucose meter to their smartphone using Bluetooth or NFC (near field communication) and then automatically collecting blood glucose measurements. These measurements, along with any text-based commentary the woman wishes to record, are transmitted directly to the clinical team where they may be reviewed via a web-based software application. As a result, clinicians get more time to focus on the woman’s care needs rather than collecting and recording data and have the ability to prioritise care to women most at need. The system enables at a glance oversight of the patient cohort and improves communication with the women in their care.
GDm-Health is a remote communications device that allows patients to record and share data with their healthcare team. GDm-Health does not itself provide any medical diagnosis or advice or direct patient care. Instead, it provides a patient’s healthcare team with the patient’s data in a more easily readable format, which facilitates the healthcare team’s clinical decision-making and communication back to women under their care, as evidenced by the results presented in Mackillop L. et al, JMIR Mhealth Uhealth 2018;6(3):e71.
GDm-Health is a CE approved Class 1 medical device that complies with the essential requirements of the European Medical Directive and subsequent implementing legislation. GDm-Health is listed on NHS Digital’s Apps Library and has been the subject of a NICE (National Institute for Health and Care Excellence) Medtech innovation briefing [MIB131].
For more information please contact:
Consilium Strategic Communications
About Sensyne Health
Sensyne Health plc is a healthcare technology company that creates value from accelerating the discovery and development of new medicines and improving patient care through the analysis of real-world evidence from large databases of anonymised patient data in collaboration with NHS Trusts. These anonymised patient data are ethically sourced in that any analysis of anonymised patient data (and hence the Company’s access to it) must be pre-approved for each programme on a case-by-case basis by the relevant NHS Trusts. This is to ensure that the purpose of the anonymisation and the proposed analysis are subject to appropriate ethical oversight and information governance, including conformance with NHS principles, UK data protection law and applicable regulatory guidance. Sensyne Health is an early signatory to the Department of Health and Social Care’s ‘Initial Code of Conduct for data-driven health and care technology’.
Sensyne Health is listed on the AIM Market of the London Stock Exchange (SENS.L).
For more information, please visit: www.sensynehealth.com