Clinical Practice Recommendations on the Routine Use of Eversense, the First Long-Term Implantable Continuous Glucose Monitoring System

Abstract

Background: The use of real-time continuous glucose monitoring (rtCGM) systems has proved to positively impact the management of type 1 diabetes with the potential to lower HbA1c, reduce frequency and time spent in hypoglycemia, and lower glycemic variability. Nevertheless, the acceptance of rtCGM remains below expectations and the dropout rate within the first year has been reported to be 27%. Besides financial reasons due to limited reimbursement, reasons include the need for frequent sensor replacement, the discomfort of wearing a sensor, the presence of adverse skin reactions, or privacy. Thus, novel approaches to rtCGM are desired to overcome these barriers. The first long-term implantable rtCGM system diversifies the field of glucose monitoring further. However, due to its novelty, there are no published clinical practice guidelines available. Aims: The aim of this article is to set the foundation for a best clinical practice for the everyday clinical care using a long-term implantable CGM system. Methods: An international expert panel for the long-term implantable CGM system developed this best practice guidance. All participants were certified and experienced in the use of the Eversense ® long-term implantable CGM system. The workflows from the respective clinics were presented, discussed and are summarized in an ideal care workflow outlined in these practice recommendations. Results: The participants agreed on the following aspects: definition of the patient population that will benefit from a long-term implantable CGM device; real-world experience on safety and accuracy of a long-term CGM; definition of the ideal sensor position; description of the optimal process for sensor insertion, removal, and replacement.

Toward Long-Term Implantable Glucose Biosensors for Clinical Use

“…This easy access to CGMS makes it has been developed small-sized, all-integrated, fully implantable CGMS, and obtained FDA approval in 2018. Eversense ® (Senseonics) is designed to implant under the skin of upper arms for 90 days [43,44]. The wearable transmitter wirelessly activates a light source in the system.…”

“…Another big step forward in CGMS is the FDA-approved, fully implantable, 90-day CGMS by Senseonics [43,44]. Although CGMSs with enzyme electrochemical sensors have reached to 14-day use with zero finger-pricking, efforts on long-term CGMS have been conducted, mainly due to the short lifespan of enzyme-based CGMS.…”

Monitoring of Pediatric Type 1 Diabetes

“…At the present time, the Eversense CGM is approved for patients ≥ 18 years of age; however there are ongoing studies aimed at seeking approval for patients as young as 6 years. Unlike other CGM devices wherein the sensor is inserted percutaneously, the Eversense CGM is surgically implanted in the upper arm (45). The transmitter sits on top of the skin, overlying the implanted sensor, and has a larger profile than other CGM devices on the market.…”

Experts opinion: implantable continuous glucose monitoring system — innovation in the management of diabetes

“…Patients treated with intensive insulin therapy have a wide choice of glucose monitoring devices according to their personal preferences. The proposition of the decision algorithm for the use of specific devices for glucose monitoring was presented in Table 1 [20].…”

“…Even though, at first sight, the required minimally invasive procedure exceeds the area of experience for many diabetologists, the technique is easy to learn when performed with proper training, oversight, and attention to detail. Therefore, any physician interested in undertaking the procedure should be accompanied and consequently certified by the company's clinical training manager during the first several insertions and removals to ensure the required training to comply with the highest quality standards [20]. Recently in Poland, there are 32 doctors who have sufficient exper ience (3 training insertions of a sensor) to carry out of implementation procedure.…”