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Breaking News: FDA Approves the MiniMed 670G System, World’s First Hybrid Closed Loop System

This post originally appeared on The LOOP blog on September 28, 2016 written by Karrie Hawbaker.

Today we have fantastic news to share – Medtronic has received FDA approval of the world’s first hybrid closed loop system! The MiniMed® 670G system is the most advanced insulin pump and sensor system designed to help people with type 1 diabetes spend less time worrying about their glucose levels and more time living their lives.

We know that people with diabetes can live amazing lives and achieve incredible things – you show us that every day! But we also know it takes an incredible amount of work to get and keep those glucose numbers in range. Our vision is to transform diabetes care together, for greater freedom and better health. Part of that means helping you spend more time in range so that instead of worrying so much about your diabetes, you can feel your best and focus on running that marathon, walking across that graduation stage, or just hanging out with friends and family on the beach.

There’s still more to do as we continue our work toward even more advanced solutions like a fully closed loop system. But the MiniMed 670G system is a big step toward that vision and we couldn’t be more thrilled to bring it to you.

SmartGuard HCL Technology. Less Worry. More Time in Range.

With our exclusive SmartGuard HCL technology, MiniMed 670G is a hybrid closed loop system. But what does that mean and how does it work? Well, when in Auto Mode, the pump automatically adjusts the delivery of your basal insulin (all that insulin your body needs when you’re not bolusing for food) based on our new, most advanced Guardian® Sensor 3. Auto Mode uses a target of 120 mg/dL and you do still have to enter carbs when you eat and enter blood glucose (BG) readings to calibrate the sensor– that’s why it’s called a hybrid closed loop system. But by automating that basal insulin, the MiniMed 670G system is requiring a lot less input from you than previous pumps and sensors.

Our New Guardian Sensor 3. Trusted to Power a Hybrid Closed Loop System.

The MiniMed 670G system includes our newest and most advanced CGM, the Guardian Sensor 3 and the Guardian Link 3 transmitter. In addition to enhanced accuracy and performance and a 7-day life, the Guardian Sensor 3 incorporates diagnostic technology that continuously monitors how the sensor is doing, resulting in a CGM system trusted to power the hybrid closed loop system. It’s the only sensor approved to drive the amount of insulin delivered by a pump.

We Hear You. You Need Options.

If there’s one thing that you’ve taught us, it’s that you like options! So if you’re not quite ready for Auto Mode available in SmartGuard HCL technology (and you probably won’t be if you’re first starting out on a pump and sensor), the system has two additional versions of SmartGuard technology available to you:

  • The Suspend on low feature (also available in the MiniMed 530G and MiniMed 630G systems) stops insulin delivery for up to two hours when the CGM sensor reaches a preset low.
  • The Suspend before low feature stops insulin delivery when the sensor is predicted to reach a low limit and resumes after sensor glucose levels recover.

A Spring 2017 Arrival.

While we’ve been working closely with the FDA on this product submission for the last several months, the approval did come much earlier than expected. Given this and the novel nature of the technology, we won’t be ready to ship the MiniMed 670G system until spring of 2017. In the meantime, we’ll be taking on important work such as getting our manufacturing lines ready, working with payers to secure reimbursement, and training our employees, physicians and diabetes educators on the new system to bring you the best possible onboarding experience.

Get On the Fast Track.

If you want to be first in line to receive the new system, check out the Priority Access program. Anyone who purchases a MiniMed 630G system between August 11, 2016 and when we ship the MiniMed 670G system will be eligible to upgrade to the new system for $299. In addition, if you want to take advantage of your end-of-year insurance benefits, you can buy your MiniMed 630G system between now and December 31st and pay $0 to upgrade, provided you participate in an approved System Access program. (Restrictions may apply.)

This is a great way for you to get used to our new pump platform via the MiniMed 630G system and be first in line once we’re able to ship the new system. You can find out more about the program here http://www.medtronicdiabetes.com/products/priority-access.

The MiniMed Family

The MiniMed 670G system is approved for people with type 1 diabetes, age 14 and older. Built on the same pump platform as the recently launched MiniMed 630G system, it also comes in our latest pump design with more customizable options and convenient features like a waterproof design and a color screen.

The MiniMed 670G system is the latest addition to a family of advanced diabetes management products. We’ll continue to offer other systems such as the MiniMed 630G system and the MiniMed 530G system with the MiniMed® Connect mobile app, which allows you and your loved ones to see your pump and CGM information right on your phone.

MiniMed 670G System, Hybrid Closed Loop

IMPORTANT SAFETY INFORMATION

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, fourteen 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 HCL 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 Medtronic MiniMed 670G System consists of the following devices:

MiniMed 670G insulin pump, the Guardian Link (3) transmitter, the Guardian Sensor (3), One-Press Serter, and the Contour NEXT Link 2.4 glucose meter. 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. All therapy adjustments should be based on measurements obtained using a home blood glucose monitor and not on values provided by the Guardian Sensor (3).

WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.

The MiniMed 670G system is not approved for use in pregnant women and patients with impaired kidney function. For complete warnings, precautions, and contraindications, please consult the User Guide.

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