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Medtronic gets FDA approval for Guardian Connect CGM system for diabetes patients

Published 13 March 2018

Medtronic has secured approval from the US Food and Drug Administration (FDA) for its Guardian Connect continuous glucose monitoring (CGM) system for people with diabetes ages 14 to 75 years.

 The Guardian Connect system is the first smart standalone CGM system1 to help people with diabetes stay ahead of high and low glucose events. The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes.

Featuring our latest predictive algorithms in diabetes care, the Guardian Connect system is the only standalone CGM system that can alert patients of potential high or low glucose events up to 60 minutes in advance.

Using Guardian(TM) Sensor 3, the most advanced glucose sensor from Medtronic and the only sensor trusted to power a hybrid closed loop system, the Guardian Connect system was proven in a clinical study to accurately alert patients of 98.5 percent of hypoglycemic events2. Care partners can use the system to stay more informed about their loved ones with diabetes as well by tracking glucose in real-time or receiving text alerts.

Medtronic diabetes service and solutions president Annette Brüls said: "The FDA approval of the Guardian Connect system fills a key gap that exists in diabetes treatment today - how to predict dangerous glucose highs and lows so they can be potentially avoided.

"With predictive alerts and the Sugar.IQ assistant, the Guardian(TM) Connect system enables people to proactively manage their diabetes, so they can focus on living their life, not constantly worrying about their glucose levels."

The Guardian Connect system will be available in the first quarter of Medtronic's fiscal year 2019 (May 2018 - July 2018) for people with diabetes who are looking to take on a more proactive role in managing their diabetes

A CGM system provides continuous, real-time glucose value and trend information about glucose levels for people with diabetes. In addition, a smart CGM system predicts future high and low glucose events and provides access to additional algorithms and insights that can inform users of clinically relevant glucose patterns.

This allows for appropriate intervention (after verifying with a blood fingerstick test) to mitigate hyperglycemia (high blood glucose) or hypoglycemia (low blood glucose), increasing the patient's time in the optimal glucose target range.

 To use a CGM system, the person with diabetes inserts a tiny sensor beneath the skin, in the abdomen or upper arm.



Source: Company Press Release