A Prospective, Multi-Center Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor

The Senseonics CGM System consists of : (1) a small Sensor, (approximately 3.3 mm [0.130”] diameter x 15.7 mm [0.620”] length) which has a ring that elutes the steroid dexamethasone; (2) a battery-powered external Transmitter (“Transmitter”); and (3) a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD). Accessories to the system include a blunt dissector for creating a pocket under the skin and an insertion tool used to place the Sensor into the pocket. The Transmitter, worn externally over the Sensor insertion site, powers the Sensor and receives signals from the Sensor across the skin. The Sensor does not contain a battery or other stored power source; instead it is powered discretely, as needed, by a simple inductive magnetic link between the two components. Between readings, the Sensor remains electrically dormant and fully powered down. At each query (set to a default of approximately every two minutes with a duration of 60 milliseconds) the Transmitter first sends the power (via magnetic link) to activate the Sensor, then uses this same magnetic link to capture the reading. This operational mode is commonly referred to as “speak when spoken to.” Finally, the Transmitter calculates the measured glucose value, the rate of change in glucose and all alarms that need to be alerted to the user. This information is then transmitted via Bluetooth Low Energy with AES-CCM encryption to the Mobile Medical Application and the subject is alerted to the alarms through activation of the vibratory motor within the Transmitter. The Mobile Medical Application displays glucose values, trends, and graphs as well as alerts. The Transmitter also contains digital storage media that enable extended data and profile information to be retrieved, downloaded to a computer or other electronic device, and reviewed by the physician or subject.

The purpose of this clinical investigation is to evaluate the accuracy of the Senseonics Continuous Glucose Monitoring System (Senseonics CGM System) measurements when compared with reference standard measurements (YSI glucose analyzer). The investigation will also evaluate safety of the Senseonics CGM System usage, while in the clinic and during home use.

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