Drayson Health in collaboration with the University of Oxford and Oxford University Hospitals NHS Foundation Trust Announces Positive Clinical Trial Results with GDm-Health(TM), its Digital Therapeutic Product Powered by Smart Algorithms for the Treatment of Gestational Diabetes
- Study showed statistically significant improvement in patient satisfaction, adherence to glucose monitoring and a reduction in caesarean sections
- Trend towards reduction in pre-term births
- Potential for cost-savings to the NHS through improved patient outcomes
- One of a number of data-driven health technology applications under development by the company in collaboration with the University of Oxford and Oxford University Hospitals NHS Foundation Trust
Significantly higher patient satisfaction with care
[(Median 43, IQR 39-46) in the GDm-Health group versus (median 44.5, IQR 41-46) in the control group, (Kruskal-Wallis x2(1)=3.9, P=.049)]
Significantly better adherence to blood glucose monitoring
[mean 3.80 readings per day, (SD 1.80) in the GDm-Health group and mean 2.63 readings per day, (SD 1.71) in the control group P<.001]
Significant Reduction in caesarean sections
[(27/101, 26.7%) in GDm-Health group versus (47/102, 46.1%) in the control group, P=.005]
Reduction in pre-term births
[(5/101, 5.0%) in GDm-Health group versus (13/102, 12.7%; OR 0.36, 95% CI 0.12-1.01) in the control group]
Oxford, UK; March 26 2018: Drayson Health, in collaboration with the University of Oxford and the Oxford University Hospitals NHS Foundation Trust, today announces positive results from a study into the safety and effectiveness of GDm-Health(TM), a digital therapeutic product powered by smart algorithms for the treatment of gestational diabetes. The results were published in JMIR Mhealth and Uhealth following a 21-month study (NCT01916694).
The 203-patient randomised control study demonstrated equivalent glycaemic control between the GDm-Health group and the control group (rate of change of blood glucose (-0.16 mmol/L in the GDm-Health group and -0.14 mmol/L in the control group per 28 days) and statistically significant improvements in patient satisfaction with care (P=.049); adherence to blood glucose monitoring (P<.001) and reduction in caesarean sections (P=.005). There was also a reduction in pre-term births in the GDm-Health group which did not reach statistical significance. The difference in mean health care costs between the GDm-Health group and the control group was -£1044 (95% CI -£2186 to £99), i.e. the GDm-Health group was less expensive, on average, by more than £1,000, although this did not reach statistical significance. There were no adverse events.
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; trial leader, lead author of the paper and clinical lead for the development of GDm-Health said: "GDm-Health was developed in partnership with patients, clinicians and engineers. This trial was conducted in real-world conditions within the NHS and demonstrates the potential utility of GDm-Health to improve care and outcomes for women with gestational diabetes and their babies."
Lord Drayson, Chairman and CEO of Drayson Health, commented: "We are delighted with these clinical trial results, which underline the GDm-Health product's safety and efficacy in improving patient outcomes in gestational diabetes. The progress we are making in our partnership with Oxford University and Oxford University Hospitals NHS Foundation Trust to develop clinically validated software applications powered by artificial intelligence is very encouraging. Our focus now shifts to working with regulators to make GDm-Health widely available across the UK and internationally, helping to improve maternal and neo-natal outcomes as prevalence of diabetes in pregnancy continues to increase."
The trial was made possible by funding and scientific input from the NIHR Oxford Biomedical Research Centre, whose Technology and Digital Health Theme is led by Professor Lionel Tarassenko, Head of Engineering Science, University of Oxford. He commented: "This trial is another example of how self-management by patients using digital health tools can be secure, gives them greater control of their condition and reduces the number of times they have to visit clinic. It improves communication between patient and clinical staff, reduces the amount of time spent by nurses and midwives on administrative tasks and allows for accurate auditing of data about care and outcomes."
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Notes to Editors:
About Drayson Health
Drayson Health is a healthcare technology company focussed on accelerating medical research and improving patient care. The Company works in partnership with the University of Oxford and Oxford University Hospitals NHS Foundation Trust developing clinically validated software applications powered by artificial intelligence including Prescribed Digital Therapeutics & Hospital Systems for Clinical Care. Our products connect patients, clinicians and researchers, generating large databases of phenotypic data, enabling discovery research and improving patient outcomes. Drayson Health is the exclusive partner for the commercialisation of certain digital health innovations, including GDm-Health developed within research programmes undertaken at the University of Oxford and the Oxford University Hospitals NHS Foundation Trust.
Drayson Health is based in the Big Data Institute (BDI) at the University of Oxford's Old Road Campus. Lord Drayson leads the Drayson Health team, which combines experience in AI, digital health and life sciences. The team is advised by an eminent Scientific Advisory Board, chaired by Professor Sir John Bell.
Drayson Health is offering UK NHS trusts responsible for the care of women with GDM, the opportunity to use the GDm-Health system on a zero-cost licence basis for the first year; upfront set-up and support fees for organisations will apply and are subject to contract. The app is free of charge to women. For more information please contact Drayson Health at: firstname.lastname@example.org. http://www.draysonhealth.com
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 outcomes1. 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 20081. 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(TM) is a direct patient-to-clinician blood glucose monitoring management system specifically designed for the management of diabetes in pregnancy which 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.
The configuration of GDm-Health evaluated in this clinical study is a remote communications device that allow 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 as evidenced by the results presented in Mackillop L. et al, JMIR Mhealth Uhealth 2018;6(3):e71.  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 vol. 8 no.
Oxford University Hospitals NHS Foundation Trust is one of the largest acute teaching trusts in the UK, with a national and international reputation for the excellence of its services and its role in patient care, teaching and research. The Trust is a designated NHS Global Digital Exemplar.
The Trust supports world-leading research programmes in cardiovascular diseases, musculoskeletal disorders, neurological disorders such as Parkinson's and Alzheimer's disease through its designation as one of the UK's five comprehensive biomedical centres. It works in close partnership with the University of Oxford and is a leading centre for cancer, neurosciences, diabetes, genetics and many other fields. Research themes of particular strength are: cancer, cardiovascular science, diabetes, endocrinology & metabolism, infection and immunology, musculoskeletal science, neuroscience and reproduction and development.
This brings together academic research expertise with clinical teams to translate medical science into better healthcare treatments. Patients benefit from world-class discovery and innovation supported by the NIHR Oxford Biomedical Research Centre, a partnership between the Trust and the University of Oxford, funded by the National Institute for Health Research.
The Trust employs over 12,000 staff and consists of four hospitals: the Churchill Hospital, John Radcliffe Hospital and Nuffield Orthopaedic Centre in Oxford and the Horton General Hospital in Banbury. On 1 October 2015 the Trust was awarded Foundation status and became Oxford University Hospitals NHS Foundation Trust. www.ouh.nhs.uk
The University of Oxford's Medical Sciences Division is one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK's top-ranked medical school. From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery. A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions. https://www.medsci.ox.ac.uk/
The National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) is based at the Oxford University Hospitals NHS Foundation Trust and run in partnership with the University of Oxford.
The aim of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. Established by the Department of Health, the NIHR:
- funds high quality research to improve health
- trains and supports health researchers
- provides world-class research facilities
- works with the life sciences industry and charities to benefit all
- involves patients and the public at every step
For further information, visit the NIHR website www.nihr.ac.uk.