WILSONVILLE, Ore., June 21, 2018 /PRNewswire/ -- WaveForm Technologies, Inc. a developer of novel products for continuous glucose monitoring, announced completion of the 12th human clinical trial for its proprietary continuous glucose monitor ("CGM"), which is based on several pioneering patented innovations in glucose sensor technology.
Earlier this year, WaveForm announced favorable findings from four human clinical studies in 2017, one of which included a performance comparison to the Dexcom G5 CGM. In this study, subjects simultaneously wore two WaveForm CGM sensors and a Dexcom G5 Platinum CGM sensor for a period of seven days. The WaveForm CGM, using an early phase calibration algorithm, demonstrated accuracy that was consistent with the Dexcom G5. As the CGM values from each system were compared with corresponding YSI plasma glucose values, the WaveForm CGM demonstrated a Mean Absolute Relative Difference (MARD) of 11.1%, as compared to 12.2% for the Dexcom G5. The Dexcom G5 comparison study methodology and findings will be presented in a poster at the American Diabetes Association's 78th Scientific Sessions this week.
The latest generation of the WaveForm CGM system includes several innovations and modifications to enable a significantly longer sensor wear life. WaveForm anticipates an initial usability of the CGM sensor for 14 days, which doubles the wear time, compared to previous clinical studies with seven day use.
In clinical study 12, WaveForm tested extended sensor usability, including modifications to the adhesive patch and power requirements for the transmitter (control unit), with a secondary aim to compare performance against the Abbott FreeStyle Libre flash glucose monitoring system. The study was performed in Europe where the FreeStyle Libre is commercially available for 14-day use.
In the 14-day comparison study, 12 subjects wore two WaveForm CGM sensors and one FreeStyle Libre sensor. On the first day of the study, the WaveForm CGM sensors were applied to the abdominal area, while the FreeStyle Libre sensor was applied to the back of the upper arm. The performance of each system was assessed by comparison to YSI plasma glucose values over the course of the five in-clinic days (1, 4, 7, 10, and 14) of the study. The WaveForm CGM demonstrated a MARD of 12.1% and a Mean Absolute Difference (MAD) of 13.1 mg/dl, as compared to a MARD of 14.5% and MAD of 9.9 mg/dl for the FreeStyle Libre.
"We feel that recent clinical trials of the WaveForm CGM system demonstrate a powerful combination of extended wear, performance, and ease of use, unmatched by current industry leaders," said Mihailo Rebec, Ph.D, Chief Technical Officer of WaveForm. "Our technical innovations will enhance not only the current WaveForm CGM system, but also position us for rapid product evolution in the market."
The WaveForm CGM offers several potential advantages as compared to currently marketed CGMs, including: rapid, easy and painless on-body sensor insertion, limited interferences (for example, for patients taking acetaminophen), a rapid "warm up" time (one hour or less), frequent glucose measurements (data reported every minute), and limited calibrations. The potential for significantly longer wear life (14 days) combined with the competitive manufacturing cost profile provides the opportunity to offer a CGM solution to patients at a more affordable cost per day.
WaveForm Technologies is continuing to conduct human clinical studies for their CGM and expects to file for CE mark approval for the product in the second half of 2018.
About WaveForm Technologies, Inc. WaveForm Technologies Inc. discovers and develops novel and proprietary technologies for diabetes care. WaveForm's products under development include an innovative continuous glucose monitoring technology, which is currently undergoing human clinical trials, and related firmware, software and data storage platforms. WaveForm is also developing a proprietary "artificial pancreas" or "closed loop" insulin delivery platform designed to provide a complete solution for patients living with diabetes.
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For Additional Information Contact Cara Mottolo, AgaMatrix Holdings LLC and WaveForm Technologies, Inc. (603) 328–6000 [email protected]