GERMANTOWN, Md.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of the first and only long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced the publication in Diabetes Technology and Therapeutics of their real-world data from the first 205 U.S. patients using Eversense CGM. The real-world data demonstrated that the Eversense CGM System showed strong performance and safety over a 90-day sensor wear period, especially in the low glucose ranges. This data provides real-world evidence desired by patients, healthcare providers and payers on the clinical value and benefit of Eversense.
- Wear-time – 83.6% (American Diabetes Association recommends 70% wear-time) 2,3
- Time in Range – 62.3% between the ranges of 70 to 180 mg/dL
- Time in Hypoglycemia – 1.2% at <54 mg/dL and only 4% at <70 mg/dL. Users spent only 1.7% of the nighttime in hypoglycemia (<54mg/dL)
- Safety – No device or procedure related serious adverse events over the 90 days
- Conclusion – The Eversense real-world data showed excellent glycemic results, sensor accuracy, and safety. This data demonstrates that the Eversense CGM System is a valuable tool for diabetes management.
“This real-world data reflects how the Eversense CGM functions for people who choose this innovative, implantable system to manage their diabetes,” explained Francine R. Kaufman, MD, Endocrinologist and Chief Medical Officer at Senseonics. “The data shows that glucose control, as measured by time in range, is achievable and that there is minimal hypoglycemia. The high wear time and safety record demonstrate that patients are able to rely on the Eversense System in their day-to-day setting. We’re looking forward to sharing these results with the payer community as we seek further coverage for Eversense as a clinically-proven choice in a patient’s CGM therapy.”
The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and can be removed, recharged and re-adhered without discarding the sensor. The sensor is inserted subcutaneously in the upper arm by a health care provider via a brief in-office procedure.
Patients who are interested in getting started on Eversense can sign up at www.eversensediabetes.com/get-started-today. Physicians, nurse practitioners or physician assistants interested in offering the Eversense CGM System for their patients can contact 844-SENSE4U (844-736-7348).
1 Patricia Sanchez, MS; Samanwoy Ghosh-Dastidar, PhD; Katherine S Tweden, PhD; Dr. Francine Kaufman, MD. Real-World Data from the First US Commercial Users of an Implantable Continuous Glucose Sensor. Diabetes Technology & Therapeutics. 6 Aug 2019 https://doi.org/10.1089/dia.2019.0234
2 American Diabetes Association. 6. Glycemic targets: Standards of Medical Care in Diabetes—2019. Diabetes Care 2019;42(Suppl. 1):S61–S70. Retrieved at https://hyp.is/hQ0b7rO6Eemy96878HFnAg/care.diabetesjournals.org/content/42/Supplement_1/S61
3 Battelino T, Danne T, Bergenstal R, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care 2019;42:1595–1597.
The Eversense® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. Starting this fall, the system will be used to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements will still be required for calibration twice per day, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://eversensediabetes.com/safety-info/.
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM Systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.