FDA approves the MiniMed™ 670G system for children 7-13

The Big News 

I have been personally touched by the inspiring stories of children and their families. Juggling school tests and carb counts. Middle of the night finger pokes. Highs and lows, physically and emotionally. And while my three children don’t have diabetes, I know the feeling of wanting the very best for them (to say nothing of wanting to fix their every hurt even when you can’t). This is why I’m thrilled to announce the FDA approval of the MiniMed^TM 670G system with SmartGuard^TM technology for children ages 7-13.
 

It’s More Than The Numbers 
 

With incredibly strong clinical results and fantastic feedback, we’re looking forward to making the first and only automated insulin delivery system available to children. We tested the system with 105 people aged 7-13 wearing insulin pumps. This is a unique time of self-discovery and dynamic hormones, so we knew it would be a more complex trial than the previous phase. Here are the results of 15,353 days of data:

1. Less highs and lows, with NO severe lows or DKA throughout the study.
2. More time in range.
   • 24-hour: 8.8% increase in time in range (up to 65%)
   • Overnight: 14.3% increase (to 70.9%)

To me, these aren’t just numbers, but countless opportunities to focus on what matters most. A day at the park with a sibling, sleepover, the ability to excel in science class or win a championship game — pursuing passions without thinking about diabetes all of the time. 

Ten-year-old Ambar shares, “My MiniMed^TM 670G helps me feel free, preventing many highs and many lows. It helps me in class and when I’m doing things I love, like roller skating and going to theme parks.” 

The biggest difference has been better quality sleep for the whole family. Ambar has stable nighttime numbers and wakes up with more energy in the morning. Her parents have experienced a difference, too. They used to worry about lows, so they took turns doing a nighttime routine of blood checks. Now they can enjoy their well-deserved rest. 

What’s Next

1. We want to hear more stories from children leading inspiring lives like Ambar! Share personal stories on social media using #LiveInspired.
2. We’re finishing the clinical trial for younger than 7 and will keep you posted as we have any updates.
3. We’re going to continue to work on making our products easier to use and more connected for families.

I hope you see that this is just another example of how we’re listening to you and are inspired by you. Editors note: If you’re interested in learning more about the MiniMed^TM 670G system for your child, visit our website or call us at 1.800.646.4633, option 3. 

Important Safety Information 

Clinical data on file. 

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 the 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 also 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. 

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-6… and the appropriate user guide at http://www.medtronicdiabetes.com/download-library