A 90-day trial involving patients with Type I and Type II diabetes showed that Senseonics‘ (NYSE:SENS) implantable continuous glucose monitor was safe and accurate compared to reference glucose values, according to a study published in Diabetes Technology & Therapeutics.
The single-arm study enrolled 90 participants and implanted them with Senseonics’ Eversense device, which sends glucose data every five minutes to a transmitter. The transmitter then communicates that data to a mobile app, which displays the values in real-time. The system also includes alarms to warn the user if they’re approaching hyper- or hypoglycemia.
The Precise II trial’s primary endpoint was the mean absolute relative difference between the data collected by Eversense and reference measurements. Researchers reported a MARD of 8.8%, adding that 93% of CGM values from Eversense were within 20% of reference values.
The study’s authors also found that 91% of sensors were functional through 90 days. A number of device-related adverse events came up in seven participants, including bruising and discomfort. In one patient, the sensor was implanted too deeply and necessitated surgical intervention.
“The results from this study demonstrate that the use of a long-term, 90-day, implantable continuous glucose sensor is accurate and safe with high rates of adherence to use. Additional clinical studies will be required to evaluate the accuracy and usability of the Eversense CGM system among pediatrics, with reduced calibration frequency, and for extended durations through 180 days,” the authors wrote.
Senseonics told MedScape that it expects an FDA committee will gather in the first quarter of this year to discuss the company’s premarket approval application and come to a decision in the first half of this year. Eversense has already landed regulatory approval in Europe.
The company also reported today that people using the Eversense CGM in EMEA markets now have the option to invite other people to remotely monitor their real-time glucose readings.
The updated Eversense app allows up to 5 people to use the remote monitoring feature.
“We are thrilled to bring this new product to people with diabetes, their families, and friends. The extra peace of mind and sense of community that comes when someone else can see your real-time glucose data is an important part of a comprehensive solution we want to offer to our customers,” Tim Goodnow, CEO & president of Senseonics, said in prepared remarks.