to transmit continuous information about blood glucose levels for people with diabetes.
The sensor-mobile app combo, called the Eversense Continuous Glucose Monitoring (CGM) system, is designed to supplant the need for frequent blood sampling to monitor blood glucose levels.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA commissioner Scott Gottlieb, MD, in the agency’s press release announcing the approval. The sensor, which is roughly 1.5 cm long, is coated with a material that fluoresces when exposed to glucose; the sensor uses the amount of light emitted to calculate blood glucose levels. Patients use an adhesive patch, changed daily, to attach a “smart” transmitter that overlies the area where the sensor is implanted. This rechargeable transmitter sends blood glucose levels to the mobile app every 5 minutes, and also powers the sensor.
The FDA’s approval was based on data from 125 patients with type 1 and type 2 diabetes who used the CGM system. The bulk of clinical data was acquired from PRECISE II, which enrolled 90 patients with type 1 and type 2 diabetes. When compared with levels returned from concurrently performed conventional home glucose monitoring, the CGM system achieved a mean absolute relative difference (MARD) of 8.8% (95% confidence interval, 8.1%-9.3%). This was less than the prespecified accuracy goal of 20% MARD (P less than .0001).
During the nonrandomized, blinded, prospective PRECISE II trial, 91% of the implanted sensors were functioning through the end of 90 days. A variation of the Eversense CGM, the Eversense CGM XL, has been approved for use up to 180 days in Europe.
The overall rate of serious adverse events among patients participating in the Eversense CGM trials was less than 1%. “The safety of this novel system will also be evaluated in a post-approval study,” wrote FDA officials in the press release.
In addition to adverse effects related to the outpatient procedure in which the glucose sensor is implanted subcutaneously, the FDA said that allergic reactions, ongoing pain, discomfort, scarring, and skin changes are possible with use of the CGM. Though the system sends frequent blood glucose measurements to the accompanying mobile app, missed alerts might still result in hypo- or hyperglycemia.
The Eversense CGM is marketed by Senseonics, which funded the studies underpinning approval.