Senseonics reveals topline implantable CGM data en route to PMA filing

Eversense transmitter patch--Courtesy of Senseonics

Diabetes player Senseonics unveiled topline results from a clinical investigation of its long-term continuous glucose monitoring implant, indicating “significant” accuracy.

The Precise II trial involved 90 adults with diabetes at 8 clinical centers and was conducted to assess the safety and efficacy of Senseonics’ Eversense continuous glucose monitoring system. It consists of a subcutaneously implanted sensor, a transmitter patch worn on the skin over the implant, and a mobile device.

The implant, a fluorescent polymer surrounded by a biocompatible material, is intended to last 90 days below the skin. It indicates changes in glucose levels by changing its light output. This change is signaled to the transmitter patch, which automatically sends alerts and alarms to a mobile device when the user’s blood glucose reaches preset low or high levels. While it requires twice-daily fingerstick calibration, Senseonics hopes to move away from that.

The topline results indicated strong accuracy for the 90-day period of continuous wear, posting a mean absolute relative difference (MARD) of 8.8% across the 400-400 mg/dL range when compared to YSI blood reference values, according to a statement.

“The early result shows that this system can be an important treatment option for our patients. Having a long lasting, 90-day CGM sensor that is safe and accurate will be a welcome addition to the diabetes community, as it will offer greater freedom of choice,” said principal investigator Dr. Mark Christiansen of Diablo Clinical Research, in the statement.

The company anticipates submitting a PMA filing within the next few months, with eyes on a U.S. launch pending approval. Eversense received a CE mark in May this year. At the time, Senseonics said it would start commercializing the device in Sweden.

- here's the statement

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