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Published on: February 28, 2012
Accuracy and Functionality of Select Continuous Glucose Monitoring Systems Are Not Impacted by Implantable
Dylan Lazar1, Michael Tao2, William Matievich2
1Cardiac Rhythm Management, Abbott, Sylmar, CA, USA.
Insights
Continuous glucose monitoring (CGM) systems and implantable cardioverter defibrillator (ICD) devices can safely coexist. This study found that ICDs do not interfere with the accuracy or functionality of FreeStyle Libre CGM systems during clinical use.
Area of Science:
- Biomedical Engineering
- Medical Device Technology
- Endocrinology
Background:
- Continuous glucose monitoring (CGM) is increasingly used by diabetic patients for self-management.
- Many diabetic patients also have advanced heart disease requiring implantable cardioverter defibrillator (ICD) devices.
- The interaction between ICDs and CGM systems is not well understood.
Purpose of the Study:
- To evaluate the wireless coexistence and potential interference between FreeStyle Libre (FL) CGM systems and implantable cardioverter defibrillator (ICD) devices.
- To assess the accuracy and functionality of FL CGM systems when exposed to various ICD functions and wireless interference sources.
Main Methods:
- Tested FL CGM systems alongside ICD devices and various wireless interference sources (Wi-Fi, Bluetooth, cellular, BLE, ICD programmers).
- Utilized five testing methodologies to assess CGM accuracy and functionality under ICD operations like high-energy shocking, pacing modes, and ATP.
- Evaluated wireless communication and data transfer integrity between the devices.
Main Results:
- All acceptance criteria and testing requirements for wireless coexistence were met for both CGM and ICD systems.
- No significant interference was observed that compromised CGM accuracy or functionality.
Conclusions:
- Coexisting ICD devices and FL CGM systems demonstrate safe and effective wireless communication.
- Data transfer from FL CGM systems remains functional and accurate in the presence of ICDs during simulated clinical scenarios.
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.
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