Positive Clinical Trial of GDm-Health™

Positive Clinical Trial of GDm-Health™

March 26, 2018
Drayson Health in collaboration with the University of Oxford and Oxford University Hospitals NHS Foundation Trust Announces Positive Clinical Trial Results with GDm-Health™, 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
• Study showed statistically significant improvement in patient satisfaction, adherence to glucose monitoring and a reduction in caesarean sections

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™, 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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