PARIS--(BUSINESS WIRE)--Regulatory News:
Cellnovo Group (Paris:CLNV) (“Cellnovo” CLNV:EN Paris), a medical technology company marketing the first mobile, connected, all-in-one diabetes management system, announces the findings of a new in vitro study published in European Endocrinology. The study demonstrates that the Cellnovo Diabetes Management System is more accurate and consistent than the Insulet OmniPod® System (“OmniPod”), a tubeless insulin pump.
Dr. Chris Allender, of the School of Pharmacy and Pharmaceutical Sciences at Cardiff University and co-author of the study, commented: “This study strongly suggests that the pumping mechanism employed in the Cellnovo device may deliver significant advantage in terms of pulse accuracy and consistency when compared to other insulin patch pumps giving patients and their physicians greater reassurance.”
Sophie Baratte, Chief Executive Officer of Cellnovo, commented: “The Cellnovo Diabetes Management System is already highly differentiated in the market due to it being small, unobtrusive and user friendly. These data, obtained following an established methodology, demonstrate that the miniaturization of the pump has not been achieved to the detriment of accuracy. In fact, this study shows the much greater accuracy of the Cellnovo pump compared to the OmniPod, therefore bringing greater clinical peace of mind to patients and physicians.”
The in vitro study, titled A Comparative Pulse Accuracy Study of Two Commercially Available Patch Insulin Infusion Pumps, examined the insulin-delivery accuracy of the Cellnovo and OmniPod patch-pumps by reporting on a comparative pulse-dose accuracy study of each device.
The pumps were compared in vitro by evaluating single and average pulse-dose accuracy over clinically relevant periods of pump use. Averaged-pulse accuracy, the most clinically relevant way of assessing patch pump performance, was investigated over pre-determined observation windows of 10 pulses, 20 pulses and 40 pulses (nominally representing 0.5, 1.0 and 2.0 units of insulin). At all observation windows, the Cellnovo pump demonstrated significantly greater accuracy than the OmniPod pump. Results demonstrating the percentage of pulses delivered outside of the +/- 15% accuracy threshold over 0.5-unit, 1.0-unit, and 2.0-unit observation windows showed a significant difference between Cellnovo and OmniPod for all of these thresholds (see table below). For both pumps the averaged-pulse accuracy improved as the observation window increased.
|Mean values outside ±15% accuracy over clinically relevant periods|
|Number of pulses||10||20||40|
Data from the study show that the percentage of delivered pulses outside of the accuracy thresholds was therefore significantly lower for the Cellnovo pump at all thresholds.
The paper is available here.*
Dr. Mark Evans, Lecturer at the Institute of Metabolic Science at the University of Cambridge, commented: “Diabetes patients have to deal with constantly changing factors, such as stress, body temperature, food, exercise and general health. These variables are often difficult to control, but can have an impact on a patients’ ability to manage their condition. Having confidence that a pump is accurate and predictable in delivering the insulin needed will help patients to better control their diabetes, improving their general health and quality of life.”
* Jenna L Bowen and Chris J Allender, European Endocrinology, 2016;12(2): ePub ahead of Print
An independent medical technology company specialising in diabetes, Cellnovo has developed and markets the first mobile, connected all-in-one diabetes management system that helps make life easier for patients. Compact, tubeless, intuitive and entirely connected, Cellnovo’s insulin pump comprises a mobile touchscreen controller with an integrated blood-glucose meter. This unique device allows optimal management of insulin injections whilst ensuring extensive freedom of movement and peace of mind for patients. Thanks to the automatic transmission of data, it also allows the patient’s condition to be continually monitored by family members and healthcare professionals in real-time.
About the Cellnovo Diabetes Management System
Compact, tubeless, intuitive and entirely connected, Cellnovo’s insulin pump comprises a mobile touchscreen controller with an integrated blood-glucose meter. This unique device allows optimal management of insulin injections with drop-by-drop precision, whilst ensuring extensive freedom of movement and peace of mind for patients. Thanks to the automatic transmission of data, it also allows the patient’s condition to be continually monitored by family members and healthcare professionals in real-time.
For further information please visit www.cellnovo.com
Cellnovo is listed on Euronext, Compartment C
ISIN: FR0012633360 – Ticker: CLNV