An important new FDA Approval for Pediatric Patients with Type 1 Diabetes

I am delighted to share that our MiniMed™ 670G hybrid closed loop system has been FDA approved for children with Type 1 diabetes aged seven years and older!

This is a very important milestone for younger patients and their caregivers, as access to this groundbreaking therapy will help alleviate some of the burden associated with managing this unrelenting disease. It will undoubtedly have a meaningful impact on the lives of families with younger children who can rest easier knowing this first-of-its kind automated system will take care of their loved ones throughout the day and night.

As a pediatric endocrinologist, this milestone has deep personal meaning for me. I know too well how much of a struggle it can be to keep glucose levels of these younger children in range. I also hear too often the stories of parents who make enormous sacrifices to ensure the well-being of their children. This entails many sleepless nights checking sugar levels in the middle of the night to safeguard against life-threatening lows, and restless days worrying about whether their children are ok when at school or away from home. It can be physically, mentally and emotionally draining so to know we are able to offer such meaningful innovation that helps improve both Time in Range and quality of life gives me great pride and joy.

There was a tremendous amount of work that went into making this happen ― from our clinical and medical affairs teams who led the evaluation of this therapy, to our regulatory teams who worked diligently to get this through rigorous FDA reviews. And, I want to offer a special thanks to the clinicians, families, and most importantly the patients, who participated in the clinical trial.

I extend deep gratitude to the many people who supported this important approval.

For more details, view our multimedia news release announcing this important milestone and watch my video message below.

Fran

Important Safety Information: MiniMed™ 670G System

The Medtronic MiniMed™ 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, seven years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed™ 670G system includes SmartGuard™ technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The system requires a prescription. The Guardian™ Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. A confirmatory finger stick test via the CONTOUR®NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR®NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian™ Sensor (3).  Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on the CONTOUR®NEXT LINK 2.4 blood glucose meter. Do not calibrate your CGM device or calculate a bolus using a blood glucose meter result taken from an Alternative Site (palm) or from a control solution test. It is not recommended to calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise.  If a control solution test is out of range, please note that the result may be transmitted to your pump when in the “Always” send mode.

WARNING (For MiniMed™ 670G System Users Ages 7-13: The low sensor glucose alert functionality is distinct from the automated insulin dosing function of the MiniMed™ 670G system. When used in Auto Mode, the MiniMed™ 670G system has been shown to be safe and effective for its intended use in this population. However, do not rely solely on the use of a low sensor glucose (SG) value for “Alert on Low” or “Alert before Low” for alerts set at 50 mg/dL and 60 mg/dL. A low sensor glucose alert may not reflect the user’s true blood glucose at these levels or may not alert. Do not ignore symptoms of low glucose.  Always confirm your sensor glucose readings with your blood glucose meter and treat according to the recommendations of your healthcare professional. Solely relying on these sensor glucose alerts and readings for treatment decisions could result in missing severe hypoglycemia (low blood glucose) events.

Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed™ 670G system has not been studied in pregnant women. For complete details of the system, including product and important safety information such as indications, contraindications, warnings and precautions associated with system and its components, please consult http://www.medtronicdiabetes.com/important-safety-information#minimed-670g and the appropriate user guide at http://www.medtronicdiabetes.com/download-library

© 2018 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. Ascensia, the Ascensia Diabetes Care logo, and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care.

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