Real-World Data Show Implantable Glucose Sensor Is Safe, Effective in First Commercial Users

Young woman exploring the city wearing a continuous glucose monitor and a backpack
Real-world usage of an implantable continuous glucose monitoring system shows promise for improved glycemic control, sensor accuracy, and safety.

Real-world usage of an implantable continuous glucose monitoring (CGM) system shows promise for improved glycemic control, sensor accuracy, and safety, according to study results published in Diabetes Technology & Therapeutics.

After commercial launch of the Eversense implantable CGM system (Senseonics, Inc), patient data were analyzed to assess real-world glycemic control outcomes, sensor accuracy, usage, and safety.

Deidentified data from 205 patients in the United States (45.9% women) who completed the 90-day Eversense sensor wear period were obtained from the Eversense Data Management System, which included glucose measurements, wear time, and alerts. Sensor accuracy was assessed by comparing sensor glucose data with values obtained during calibration with self-measurement of blood glucose. Agreement between sensor and self-measured values was reported as the 20/20% agreement rate: the percentage of sensor glucose values within 20 mg/dL of the corresponding self-measured blood glucose values <80 mg/dL, or within 20% of the self-measured glucose levels >80 mg/dL. Safety data were obtained through analysis of Eversense complaint call logs.

Glucometric data were derived from >3.5 million sensor glucose values over approximately 14,500 patient-days. The mean percent time spent with hypoglycemia (glucose level <70 mg/dL) was 4.1% per 24 hours — close to the 4% target recommended by previous literature. Percent time spent with mild or significant hyperglycemia was 21.9% and 11.6% per 24-hour time period, respectively. Time spent in the target glucose range (70-180 mg/dL) was 62.3%.

The overall mean absolute relative difference between the paired sensor glucose values and self-reported calibration points was 11.2%±11.3%. The mean absolute relative difference in glucose values was highest in the first week of sensor use at 14.8%±13.9%, but improved and stabilized for the remainder of the 90-day wear period (relative difference, 10.0%-11.8%). The 20/20% agreement rate was 86.3%.

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The median wear time for the Eversense system was 83.6%. Approximately 78.5% of individuals obtained a second implanted sensor after completion of the first sensor wear.

There were no serious adverse events related to use of the Eversense system. The most commonly reported complaints were transient skin irritation, redness, and swelling after sensor insertion or removal (5%); skin irritation to the transmitter patch or adhesive (2.5%); and mild infection at the site of insertion (2%). An additional 2% of patients reported failure to remove the sensor on the first attempt.

The researchers noted that demographic data for the population were limited, including information about insulin regimens and prior glucose control. In addition, data from this patient cohort may not be generalizable to all future users of the device.

“[T]he 90‐day implanted Eversense CGM system appears to be a valuable and safe tool for management of diabetes with patients reinserting and using the device the majority of the time,” the researchers concluded. “The Eversense CGM should be considered as an appropriate CGM system for those patients and providers wishing to improve diabetes outcomes.”

Disclosure: This study was funded by Senseonics Inc. Several researchers are also employees of Senseonics Inc. Please see the original reference for a full list of disclosures.

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Sanchez P, Ghosh-Dastidar S, Tweden KS, Kaufman FR. Real-world data from the first US commercial users of an implantable continuous glucose sensor [published online August 6, 2019]. Diabetes Technol Ther. doi:10.1089/dia.2019.0234