RESUMO
BACKGROUND: Increasing numbers of individuals with diabetes are adopting use of continuous glucose monitoring (CGM) in their daily self-management. Many of these individuals have advanced heart disease. Implantable cardioverter defibrillator (ICD) devices can effectively reduce arrhythmic death and all-cause mortality in individuals with advanced heart disease. However, the potential impact of ICD devices on CGM system accuracy and functionality has not been well studied. METHODS: This evaluation assessed whether FreeStyle Libre (FL) CGM systems can coexist and function within the same patient in the presence of wireless interference devices, including current ICD devices. Interferer sources included Wi-Fi devices, Bluetooth devices, cellular mobile devices, implantable medical devices, Bluetooth Low-Energy (BLE) devices, BLE accessory devices and BLE mobile devices, and ICD-programmer interferers. Five testing methodologies were used to evaluate the accuracy and functionality of the CGM systems when exposed to ICD functions: high-energy emergency shocking, pacing modes, anti-tachycardia pacing mode (ATP), and DC Fibber mode. RESULTS: All acceptance criteria and testing requirements were met for the CGM and ICD system for wireless coexistence evaluation. CONCLUSIONS: Our findings demonstrated that coexisting ICD devices and FL CGM systems provide safe and effective wireless communications with functional and accurate transfer of data during scenarios expected in clinical use.