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FDA Grants Approval for Simplera Sync Sensor Compatibility with MiniMed 780G Insulin Pump

Medical device manufacturer Medtronic secures FDA authorization for integrating the Simplera Sync sensor with the MiniMed 780G diabetes management system.

FDA grants approval for Simplera Sync sensor for MiniMed 780G diabetes management system
FDA grants approval for Simplera Sync sensor for MiniMed 780G diabetes management system

FDA Grants Approval for Simplera Sync Sensor Compatibility with MiniMed 780G Insulin Pump

The MiniMed 780G system, an advanced insulin delivery system for people with diabetes, has been making waves in the healthcare industry. Developed by Medtronic, a company committed to driving innovation to make life easier for those living with diabetes, the system has shown promising results in real-world data.

Global users consistently achieve time in range above international targets of 70% when using optimal settings with the MiniMed 780G system. This is a significant improvement, as it indicates better management of blood sugar levels.

The MiniMed 780G system's key feature is its adaptive algorithm, which automatically adjusts glucose levels every 5 minutes, 24/7. This feature, coupled with the system's "treat to target" approach and flexible glucose targets as low as 100 mg/dL, contributes to its effectiveness.

The system's latest addition, the Simplera Sync sensor, is designed to improve diabetes management through continuous glucose monitoring (CGM) with several useful features and benefits.

The Simplera Sync sensor, with a wireless communication directly with the MiniMed 780G pump, enables real-time glucose data to guide insulin delivery. It has a sensor life of up to 6 days, with a 24-hour grace period indicated by a red clock icon on the device. After expiry, the sensor icon turns solid black with an "x," and remaining sensor life is always visible on the Status screen.

The sensor is designed for specific placement on the back of the upper arm, with clear guidelines to avoid areas that may cause friction, bending, scarring, or proximity to insulin infusion or injection sites to maintain accuracy and reduce risk of errors. It comes individually packaged in an all-in-one inserter kit and requires simple steps for insertion, emphasizing smooth, firm motion to activate the inserter.

When paired with the MiniMed 780G system, the Simplera Sync sensor provides automated, real-time glucose data that powers the system’s hybrid closed-loop insulin delivery, improving glycemic control by adjusting insulin doses automatically. This reduces the need for frequent fingersticks or manual glucose checks, helping reduce user burden.

The sensor’s connectivity with the MiniMed 780G supports an integrated diabetes management experience with alerts and status information easily accessed on the pump screen for timely decision-making. The MiniMed 780G system itself has demonstrated clinical improvements in glycemic control, including during special populations such as pregnancy, thus the Simplera Sync sensor plays a central role in these outcomes through reliable glucose monitoring.

The Simplera Sync sensor is a disposable, all-in-one sensor requiring no fingersticks with SmartGuard or overtape, and features a simple, two-step insertion process. As of the current date, the MiniMed 780G system can only be used with the Guardian 4 sensor, but Medtronic has received FDA approval for the Simplera Sync sensor to be used with the MiniMed 780G system.

However, it's important to note that the MiniMed 780G system is not specifically designed for people with Parkinson's disease, and the MiniMed 780G system's adaptive algorithm automatically adjusts glucose levels every 5 minutes, 24/7, not the adaptive deep brain stimulation system approved by Medtronic for people with Parkinson's.

The limited launch of the Simplera Sync sensor will begin in the U.S. in the fall of 2025, and the MiniMed 780G system has received CE Mark, allowing it to be sold in Europe. The MiniMed 780G system offers more flexibility for users of Medtronic's advanced insulin delivery system, and the system works with the world's only infusion set that lasts up to 7 days, reducing the number of injections compared to multiple daily injections.

In summary, the Simplera Sync sensor with the MiniMed 780G system offers an advanced, user-friendly CGM solution with a 6-day sensor life, specific placement requirements for accuracy, and wireless integration enabling automated insulin delivery and improved diabetes management outcomes. Medtronic continues to drive innovation in the field of diabetes technology.

[1] Medtronic. (2022). Simplera Sync sensor. Retrieved from https://www.medtronicdiabetes.com/products/continuous-glucose-monitoring/simplera-sync-sensor [3] Medtronic. (2022). MiniMed 780G system. Retrieved from https://www.medtronicdiabetes.com/products/insulin-pumps/minimed-780g-system

  1. The Simplera Sync sensor, a new addition to the MiniMed 780G system, is designed to revolutionize digital health by providing continuous glucose monitoring (CGM) and real-time glucose data, catapulting medical-condition management into the realm of health-and-wellness innovation.
  2. By improving glycemic control, reducing user burden, and fostering a more effective hybrid closed-loop insulin delivery system, the MiniMed 780G system, combined with the Simplera Sync sensor, is spearheading the integration of science into the healthcare industry, enhancing life for those living with diabetes.

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