Senseonics reveals topline CGM data Eversense 90 day CGM sensor. MARD 8,8%. PRECISE II Study

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

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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

Senseonics Reports Topline Accuracy Results from U.S. Pivotal Study of Eversense CGM System.

Topline Accuracy of 8.8% MARD (Mean Absolute Relative Difference) over 90 Days.August 09, 2016 04:05 PM Eastern Daylight Time

 

GERMANTOWN, Md.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE-MKT:SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today announced topline results of the PRECISE II (A Prospective, Multicenter Evaluation of the Accuracy of a Novel Continuous Implanted Glucose Sensor) Clinical Investigation.

“The promising results and compelling accuracy data shown in the PRECISE II study represent a major milestone for the company”

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Results from the 90 adults with diabetes generated over 16,000 comparative glucose data points and demonstrated strong accuracy for the 90-day continuous wear period with a mean absolute relative difference (MARD) of 8.8% across the 40-400 mg/dL range when compared to YSI blood reference values.

According to the Principle Investigator, Dr. Mark Christiansen of Diablo Clinical Research, “The accuracy result is quite significant with the device. This was an important study and we are thankful to all the patients and clinics who participated. 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.”

The PRECISE II U.S. investigational device exemption trial enrolled 90 participants at eight clinical centers. The objective of the study was to determine the safety and effectiveness of the Eversense® CGM system over 90 days of continuous glucose sensor wear.

Participants in the study underwent unilateral (n=75) or bilateral sensor (n=15) insertions in the clinic and used the system’s smart transmitter and mobile app at home for the next 90 days. Sensor glucose readings were calculated prospectively. Calibration with a standard home blood glucose meter was performed twice a day but real-time glucose readings and trends were not made available to participants. Clinic visits were scheduled at approximately 30-day intervals in order to obtain lab reference glucose values for comparison with the sensor values and to evaluate hyperglycemic and hypoglycemic challenges in a controlled setting.

“The promising results and compelling accuracy data shown in the PRECISE II study represent a major milestone for the company,” said Tim Goodnow, PhD., CEO and President of Senseonics. “We are quite excited to complete the full analysis and report on other outcomes in the coming months. Pending FDA review and approval, we look forward to bringing this exciting technology to the U.S. market and to people with diabetes.”

Senseonics expects to submit its Pre-Marketing Approval (PMA) package to the U.S. Food and Drug Administration in the next few months. Subject to receiving FDA regulatory approval, Senseonics plans to initiate sales in the United States. The company currently markets the system under the brand name Eversense in select European countries.

About Senseonics

Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics’ first generation continuous glucose monitoring (CGM) system, Eversense®, includes a small sensor, smart transmitter and mobile application. Based on fluorescence sensing technology, the sensor is designed to be inserted subcutaneously and communicate with the smart transmitter to wirelessly transmit glucose levels to a mobile device. After insertion, the sensor is designed to continually and accurately measure glucose levels. For more information on Senseonics, please visit www.senseonics.com.

 

Senseonics 

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