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

Ambar and her sister

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 MiniMedTM 670G system with SmartGuardTM 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%)

Sisters in park wearing Medtronic insulin pumpTo 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 MiniMedTM 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. 

girl sleeping with Lenny Lion

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 MiniMedTM 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. 
WARNING: Medtronic performed an evaluation of the MiniMed™ 670G system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

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

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Blog comments

Submitted by PERRY CHAHAL (not verified) on

In reply to by Commenter (not verified)

Mr. Dias, (Louis)
I have a very specific question about the FDA Approval process for the 630G pump and wish to clarify the aspects of the process for Canadians and myself, as I am not an expert in any capacity and am a simple user of your product.

Within the United States the 501k Fda process is applicable, as you are aware if a prior version of a medical device has been approved the next version is automatically approved.

Hence 100G is approved due to the 100F was approved within the United States by th FDA

My question pertains to the process in Canada, does Health Canada undertake individual testing for the newer versions of pumps or is the approval by Health Canada mirrored with approval due to the FDA's approval:

For example
100E is approved by the FDA for use
100F is approved by the FDA (without testing) under the 501k due to the approval of 100E
100G is now approved by the FDA b/c the 100F was approved (again without testing)
the 100G is approved by Health Canada for patient use b/c the FDA approved 100F (again was not tested and has not been tested since the 100E model)

Please clarify, if Health Canada TEST's the new pumps?

Perry Chahal

Submitted by Karrie Hawbaker (not verified) on

In reply to by PERRY CHAHAL (not verified)

Thanks for reaching out, Perry. Louis is currently traveling, but we appreciate the questions. We are the US team, so our knowledge of the approval process for our Canadian customers is limited. I encourage you to connect with your local team for specifics, as well as updates. Good luck!

Submitted by Mohsen Moharam (not verified) on

In reply to by Karrie Hawbaker (not verified)

Hi Karrie, My name is Mohsen, I stay in the UAE. My daughter 9 yrs old was diagnosed with type 1 diabetes last March. Now I am looking to buy the insulin pump. Only the 640G is available in the ME, the 670G is not yet available at the ME. My question; is it possible to buy the 670G from you directly and buy the supplies every 3 months?

Submitted by Karrie Hawbaker (not verified) on

In reply to by Mohsen Moharam (not verified)

Hi there, Mohsen. While we are working with regulatory agencies worldwide, we are the US team and unable to fulfill orders for customers outside the US. I encourage you to continue working with your local team for updates on availability.

Submitted by Diane Hamilton (not verified) on

In reply to by Commenter (not verified)

What is the latest insulin pump covered by medicare?

Submitted by Karrie Hawbaker (not verified) on

In reply to by Diane Hamilton (not verified)

Great question, Diane. Currently, our Medicare customers have access to our MiniMed 630G insulin pump. If you'd like to learn more or get an order started, please give our team a call at 800.646.4633, option 3.

I cannot find written the size of the pump, the usual location it is attached, whether I will need loose fitting clothes to cover it, if I wear it 24-7, how often it is moved to a new location, and other practical info.

Patricia, the pump dimensions are 3.81 length x 2.11 width x0.98 depth. You can find approved infusion set and sensor insertion sites here http://bit.ly/2Zb6Ntq on our website. Infusion sets should be changed every 2-3 days depending on your infusion set type and sensors are approved for use for up to 7 days. If you have additional questions, please give our therapy specialists a call at 800.646.4633, option 3.

Submitted by Mia Huge (not verified) on

In reply to by Commenter (not verified)

Very interesting reaf

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