Background: Continuous glucose monitors (CGMs) have had a significant impact on the management of diabetes mellitus. We present the results of a multinational evaluation of the Cascade CGM (“C-CGM”) over 14 days of in-clinic and home use. Method: Each of the 57 enrolled type 1 diabetes mellitus and type 2 diabetes mellitus subjects wore 2 C-CGMs on the abdomen for 14 days. One part of the evaluation was the performance versus reference glucose values generated for 12 -hour in-clinic sessions on days 1, 4, 7, 10, and 14. Glucose blood samples were drawn every 15 minutes and analyzed with the Yellow Spring Instruments (YSI) 2300 glucose analyzer. The performance assessment on in-clinic days was based on paired YSI/CGM data points and on home-use days was based on paired fingerstick BGM (blood glucose monitoring)/CGM data points. Results: A total of 17 823 CGM/YSI data points during in-clinic use was analyzed. The mean absolute relative difference for glucose values between 100 and 400 mg/dL (MARD) and mean absolute difference for values between 40 and 100 mg/dL (MAD) were 11.5% and 15.1 mg/dL, respectively. The system accuracy during home use was 12.7% and 15 mg/dL for MARD and MAD, respectively. There were no serious adverse events or infectious complications reported. A modified algorithm “Hybrid Algorithm” was used in a prospective analysis of the in-clinic data, resulting in a MARD of 9.9% and MAD of 14.5 mg/dL. Conclusions: The performance of the C-CGM device over 14 days meets the safety and efficacy standards of CGM systems for managing blood glucose levels in people with diabetes. This was further confirmed when the C-CGM system was given approval for CE Mark in October 2019.

Objective: WaveForm is actively pursuing a commercial launch with a new trocar-free CGM system. The Cascade CGM device is based on a variant of an amperometric GOx-based technology. Finishing the algorithm and validating the clinical performance of the device is the final development stage. We are reporting on the outcome of a 10-day clinical study that was used to compare the accuracy of the Dexcom G5 CGM device and our Cascade CGM. Method: The Clinical study that was used to evaluate the two CGM systems included 15 subjects with type 1 and 2 diabetes. On day 1, 4, 7 and 10, 12-hour in-clinic CGM accuracy studies were performed. Each subject wore two Cascade CGM devices and one Dexcom G5 sensor in the abdominal area. YSI glucose measurements were performed on plasma from venous blood sampled every 15 minutes. The Dexcom device was inserted at the beginning of day 4 in-clinic day and was worn through day 10 of the study (7 days). The overall MARD and MAD calculation for the Cascade CGM was evaluated for the four in-clinic days by prospectively applying an advanced algorithm to data generated during the study. The comparison of accuracy performance between the Cascade and the Dexcom G5 sensors was conducted over 7 days which included 3 in-clinic days for each CGM device. Result: Head-to-head MARD comparison between the WaveForm and Dexcom sensor over 7 days showed that MARD for the Cascade CGM was better (11.0% vs. 12.2%). Consensus error grid analysis for Cascade device showed that 99% of data points were in zone A and B, with the remaining 1% in zone C. Conclusions: Overall performance of the Cascade CGM device over 10 days meets the clinical expectations of a commercial device. Direct comparison with the Dexcom G5 sensor - regarded as the current benchmark in the CGM market - shows that the WaveForm device met and even surpassed the performance level of it in this study. The Cascade CGM will be launched as 14-day wear CGM system. Disclosure M. Rebec: Employee; Self; Agamatrix LLC. E.M. Anderson: Employee; Self; AgaMatrix LLC. R. Dutt-Ballerstadt: Employee; Self; WaveForm Technology. A. Haidar: Consultant; Self; Eli Lilly and Company. Research Support; Self; AgaMatrix, Medtronic MiniMed, Inc.. A. Janez: None.