Introduction and Objective: The use of continuous glucose monitoring (CGM) improves glycemic control in people with diabetes (PwD). The availability of multiple systems with high accuracy allows PwD and their health care professionals to choose the best option for each individual based on respective needs. This study aimed to evaluate the clinical performance of a novel CGM system, the Accu-Chek® SmartGuide device, in PwD on insulin therapy.
Methods: An open label, single-arm, prospective, non-randomized, multi-center clinical study was performed to evaluate the performance of the Accu-Chek® SmartGuide device in adults aged ≥18 years with type 1 or type 2 diabetes on insulin therapy. Participants wore 3 sensors at the back of the upper arms for 14 days and CGM data was compared with capillary glucose measurements (Accu-Chek® Guide) in in-clinic sessions throughout the wear time of the device. The study included glucose manipulations into hypo- and hyperglycemic ranges and the 20/20 agreement rate (percentage of values within ±20 mg/dL (< 100 mg/dL) as well as ±20% (≥ 100 mg/dL)) was evaluated as primary endpoint. In addition, secondary endpoints included the evaluation of the mean absolute relative difference (MARD) e.g. overall, for different time points and for dynamic (absolute rate-of-change ≥1 mg/dL/min) and stable glucose phases as well as safety endpoints.
Results: In total, 48 participants (20 females, 28 males; 40 type 1, 8 type 2) were included into the study. The 20/20 agreement rate was 90.5 % (CI: 0.90 - 0.91). The overall MARD was 9.2 % over the entire run-time, 8.3 % for the beginning, 9.0 % for the middle and 10.8 % for the end of the wearing time as well as 8.8 % and 10.6 % for stable and dynamic glucose periods. No serious adverse events were reported during the study. A total of 15 device-related adverse events were reported, all due to application site reactions.
Conclusion: In this study, the Accu-Chek® SmartGuide device has been proven to be safe and demonstrated a robust accuracy over a 14-day wear period including glucose manipulations.
J.K. Mader: Advisory Panel; Becton, Dickinson and Company. Speaker's Bureau; Becton, Dickinson and Company, A. Menarini Diagnostics, Boehringer-Ingelheim, diaTribe. Other Relationship; Diabetes UK. Stock/Shareholder; decide Clinical Software GmbH. Advisory Panel; embecta. Speaker's Bureau; embecta, Viatris Inc., Eli Lilly and Company. Advisory Panel; Eli Lilly and Company, Medtronic. Speaker's Bureau; Medtrust. Advisory Panel; Novo Nordisk A/S. Speaker's Bureau; Novo Nordisk A/S. Advisory Panel; PharmaSens, Roche Diabetes Care. Speaker's Bureau; Roche Diabetes Care. Board Member; Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Sanofi-Aventis Deutschland GmbH, Sanofi, Dexcom, Inc., Viatris Inc. Advisory Panel; Viatris Inc. Speaker's Bureau; Ypsomed AG. Research Support; European Union. Stock/Shareholder; elyte Diagnostics GmbH. Other Relationship; elyte Diagnostics GmbH. Board Member; European Association for the Study of Diabetes. Research Support; European Union Aviation Safety Agency. G. Freckmann: Advisory Panel; Abbott. Research Support; Ascensia Diabetes Care. Advisory Panel; Boydsense, Dexcom, Inc., Lilly Diabetes. Speaker's Bureau; Novo Nordisk. Advisory Panel; Perfood, PharmaSens. Consultant; Roche Diabetes Care. Research Support; Roche Diabetes Care. Consultant; Sinocare. Speaker's Bureau; Terumo Corporation. Consultant; Ypsomed AG. T. Forst: Speaker's Bureau; AstraZeneca, Daiichi Sankyo. Research Support; Johnson & Johnson Medical Devices Companies. Speaker's Bureau; Lilly Diabetes, Novo Nordisk. G. Vogt: Employee; Roche Diabetes Care. M. Angstmann: Employee; Roche Diabetes Care. S. Moceri: Employee; Roche Diabetes Care. D. Militz: Employee; Roche Diabetes Care.
