The Integrated Continuous Glucose Monitoring System (ICGM) is a device that continuously tracks glucose levels in people with diabetes. It consists of a sensor placed under the skin, a transmitter that sends data wirelessly, and a receiver (such as a smartphone or insulin pump) that displays the readings, helping users manage their glucose levels in real-time.

Intended Use of the Integrated Continuous Glucose Monitoring System

An integrated continuous glucose monitoring system (ICGM) is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.

Intended Use

The Integrated Continuous Glucose Monitoring System (ICGM) is intended to replace fingerstick testing for diabetes management, using glucose trends and multiple readings for interpretation. It detects hyperglycemia and hypoglycemia, aiding therapy adjustments. ICGMs can connect to digitally integrated devices, including automated insulin dosing systems, to enhance diabetes management.

Device Description

An Integrated Continuous Glucose Monitoring System (ICGM) measures glucose levels in bodily fluids and transmits the data to connected devices, like insulin dosing systems, to manage glycemic control. It can be used alone or with other digital medical devices for disease management.

The device consists of a glucose sensor, transmitter, and primary receiver, with embedded software to calculate glucose values. It employs a factory-calibrated transcutaneous glucose sensor, which is inserted by the user at home, and works in conjunction with the transmitter and receiver to monitor glucose levels for diabetes management.

Integrated Continuous Glucose Monitoring System for Non-Intensive Diabetes Management

Intended Use

An Integrated Continuous Glucose Monitoring System for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk of severe hypoglycemia. The device also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating long-term therapy adjustments. The device is also intended to autonomously communicate with digitally connected devices.

Device Description

The Integrated Continuous Glucose Monitoring System (ICGM) includes a sensor that converts glucose into electrical signals, a transmitter that sends these signals to a mobile app, and an app that displays real-time glucose readings, tracks trends, and alerts users, while also supporting data sharing and remote monitoring. The device can be used alone or in conjunction with these digitally connected devices or services for the purpose of managing diabetes.

The device consists of a glucose sensor, transmitter, and primary receiver, with built-in software to calculate glucose values, utilizing a factory-calibrated transcutaneous sensor that the user inserts at home to monitor glucose levels for diabetes management, in conjunction with the associated transmitter and receiver.

Integrated Continuous Glucose Monitoring System for Professional Retrospective Use

Intended Use

An Integrated Continuous Glucose Monitoring System for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2 and older for use by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

Device Description

The Integrated Continuous Glucose Monitoring System (ICGM) consists of two main components: a sensor/applicator delivery system and a transmitter. The sensor, a small flexible wire, is inserted under the skin to convert glucose into electrical signals. The transmitter, connected to the sensor, samples these signals and converts them into glucose readings using an onboard algorithm. It logs estimated glucose values every 5 minutes during the sensor wear period, typically lasting up to 10 days.

The device consists of a sensor, transmitter, and receiver, and stores glucose data for later use by healthcare practitioners to aid in diabetes management.

Integrated Continuous Glucose Monitoring System for Professional Directed Retrospective Or Real-Time Use

Intended Use

An Integrated Continuous Glucose Monitoring System for professional-directed retrospective or real-time use is a continuous glucose recording device indicated for use as directed by a physician either for the real-time management of diabetes at home or for the retrospective discovery, analysis, and interpretation of glycemic variability in persons aged 2 and older by healthcare professionals to guide appropriate patient management. The system is also intended to interface with digitally connected devices.

Device Description

The Integrated Continuous Glucose Monitoring System (ICGM) introduces glucose monitoring under healthcare professional supervision, consisting of a sensor, transmitter, and mobile app. The sensor, inserted under the skin, converts glucose into electrical signals, which the transmitter samples and sends as real-time readings or stores for later use. The app displays updated glucose readings every 5 minutes and tracks trends up to 24 hours.

The device comprises a sensor, transmitter, and receiver, with integrated software to calculate glucose values. It stores glucose data for later use by healthcare providers or for real-time monitoring at home, as directed by a healthcare provider.

Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not for use with Automated Insulin Delivery Systems

Intended Use

An Integrated Continuous Glucose Monitoring System for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.

Device Description

The Integrated Continuous Glucose Monitoring System (ICGM) provides real-time glucose measurements, trends, and alarms. Intended for home use with a prescription, it consists of a sensor, transmitter, and mobile app compatible with Android. The system calculates glucose values using a factory-calibrated sensor and transmits data via Bluetooth Low Energy (BLE). It displays real-time glucose readings, trends, and historical data, enabling informed treatment decisions. Additionally, the system features alarms for low or high glucose and signal loss, supporting effective diabetes management.

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over The Counter

Intended Use

An Integrated Continuous Glucose Monitoring System (ICGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels in persons who are not on insulin and do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose monitoring are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices. Device output should not be used to make treatment decisions without consulting with a qualified healthcare professional.

Device Description

The Continuous Glucose Monitoring (CGM) System is an interoperable, home-use device designed for real-time diabetes management. It consists of a Glucose Sensing Subsystem (GSS) with a sensor, transmitter, and applicator, and a Mobile Application Subsystem (MAS) that displays glucose data. The sensor measures glucose levels in subcutaneous tissue, transmitting data via Bluetooth to the MAS app, which provides real-time readings, trends, and insights. The sensor lasts several days, with a grace period for replacement, and uses factory calibration and secure data transmission for effective monitoring and management. The system integrates software to calculate and display glucose values, empowering users to monitor their condition efficiently.

Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter

Intended Use

An Integrated Continuous Glucose Monitoring System (ICGM) for non-intensive glucose management is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and dysglycemic glucose levels across the range spanning clinically significant hypoglycemia and hyperglycemia levels in persons who are not on insulin and who do not have a significant risk of problematic hypoglycemia. iCGM systems for non-intensive glucose management are designed to reliably and securely transmit glucose measurement data to digitally connected devices, excluding devices intended to control the delivery of insulin, and are intended to be used alone or in conjunction with these digitally connected medical devices.

Device Description

The Continuous Glucose Monitoring System is an integrated ICGM designed for over-the-counter home use, providing continuous glucose measurements every minute along with trend and historical data. The system includes a glucose sensor, transmitter, and primary receiver, with embedded software to calculate and display glucose values. The sensor transmits data via Bluetooth Low Energy (BLE) to a mobile application (Libre Rio App) compatible with iOS and Android smartphones, allowing users to effectively monitor and manage their glucose levels at home.

Biocompatibility

Testing should comply with ISO 10993 standards, considering the type, duration, and frequency of patient contact.

Performance Testing (Analytical) for Integrated Continuous Glucose Monitoring System

• Amperometric measurements
• Software verification and validation
• Firmware and hardware testing
• Sterility
• Shelf-Life, Packaging Integrity, and Shipping
• Electromagnetic Compatibility and Electrical Safety
• Chemical/Material Characterization (not Biocompatibility-related)
• Wireless Coexistence
• Operating Environmental Conditions Testing
• Mechanical Engineering
• Cybersecurity
• Human factor
• Interoperability

Clinical Testing

No Guidance available for 510k submission