Medtronic MiniMed 780G Approved by FDA

Medtronic’s most advanced hybrid closed-loop system, the MiniMed 780G, has been approved by the FDA. The Medtronic 780G system features SmartGuard technology that automatically adjusts your insulin pump’s output based on CGM readings.

The FDA on April 21 approved the MiniMed 780G, paving the way for Medtronic to distribute its latest insulin pump in the United States. As a hybrid closed-loop system, the MiniMed 780G can connect to the Guardian Connect continuous glucose monitor (CGM) and use its readings to adjust insulin dosing.

The MiniMed 780G was submitted for FDA approval in 2021 but faced a delay in 2022 due to quality control issues at Medtronic’s manufacturing facility. The 780G has been approved in Canada since November 2022 and was previously approved in Europe in 2020.

"Mealtimes prove to be one of the biggest challenges for people living with type 1 diabetes and now for the first time, the MiniMed 780G system addresses this unmet need with automatic, real-time insulin corrections," said Que Dallara, president of Medtronic Diabetes, in a statement. "A lot can happen to blood sugars in the span of an hour or even just a few minutes, so we've designed our system for real life – the algorithm adapts to the user and helps compensate for everyday challenges that are quite common around mealtimes."

Medtronic MiniMed 780G features

The MiniMed 780G is Medtronic’s most advanced insulin pump system and includes the following features:

SmartGuard – This protective technology, which aims to automatically anticipate and correct highs as well as prevent lows, automatically adjusts insulin delivery every 5 minutes, up to 288 times per day, and is the most significant improvement to the existing MiniMed 670G system. A study conducted by Medtronic found that SmartGuard autocorrections can compensate for inaccurate carb counts: 72% of clinical study participants reported less effort to avoid highs, and 70% reported less effort to avoid lows.
Automatic Correction Boluses – Unlike Medtronic’s previous pump, 770G, the 780G includes automatic correction boluses.
MiniMed Mobile App – Glucose levels can be viewed using Apple or Android smartphones. The app allows users to track blood glucose levels and provides alerts for trending highs or lows.
Adjustable Diabetes Goals – While the default target glucose range is set at 120 mg/dL, it can be adjusted to 110 or 100 mg/dL.
CareLink Connect App – This app allows for sharing real-time diabetes data in each user’s CareLink support network. By seeing glucose levels and insulin pump information remotely, as many as five care partners can check on how you are doing and make sure you are safe.

The MiniMed 780G system is composed of three separate but connected devices:

Continuous glucose monitor – The Guardian 4 Sensor measures blood glucose every 5 minutes and sends these readings to the insulin pump. The CGM is designed to be replaced every 7 days.
Infusion set – The MiniMed Mio Advance infusion set is a pre-loaded insertion device with a 90-degree soft cannula and automatic needle retraction; it can be inserted with just one hand. The Mio Advance infusion set needs to be changed every 2-3 days. The newer Extended infusion set can be worn for up to 7 days.
Insulin pump – The 780G pump is waterproof and makes automatic adjustments and corrections to insulin delivery, releasing more insulin if the user is trending toward high blood glucose and less or no insulin when blood glucose is low or trending low.

How much does the MiniMed 780G cost?

Current MiniMed 770G users can upgrade to the MiniMed 780G at no additional cost through a remote software update.

MiniMed insulin pump users who are not currently using the 770G may qualify for Medtronic’s standard four-year replacement warranty. Those who purchased a MiniMed insulin pump between Nov. 14, 2018, and April 11, 2019, may be able to upgrade for $99; Medtronic pump users with more than six months of warranty remaining can upgrade to the 780G for $399.

Medtronic MiniMed users whose insulin pumps fall outside the 4-year warranty period can still trade in devices in exchange for a $500 credit toward the 780G. Device users wearing an in-warranty pump from another company also qualify for the $500 trade-in credit. The final cost of the Medtronic MiniMed 780G may vary based on insurance.

How to upgrade from the MiniMed 770G or 670G

The MiniMed 780G system is approved for people with type 1 diabetes age 7 and above. Eligible users who are interested in upgrading to the

MiniMed 780G should contact Medtronic for help purchasing, shipping, and scheduling in-person training sessions.

Speak with your healthcare provider about the options available for upgrading to the newest MiniMed system. To learn more about advocating for yourself in the doctor’s office, read our article, “How to Talk to Your Doctor About Getting New Medications” which also covers new devices.

In the U.S. pivotal trial of the MiniMed 780G system, users experienced 75% time in range (between 70-180 mg/dL), with overall time below range of 1.8%. Additionally, the system was effective overnight, with users’ average overnight time in range at 82%, and overnight time below range of 1.5%. These results are mirrored by the real-world evidence across Europe, where the MiniMed 780G system has been approved since 2020.

Learn more about Medtronic’s MiniMed systems, hybrid closed-loop technology, and automated insulin delivery:

MiniMed 770G Automated Insulin Delivery Cleared for Children
New Delivery Devices Make Taking Insulin Easier
Automated Insulin Delivery
New Recommendations on Automated Insulin Delivery
Promising Research Shows Automated Insulin Delivery Improves Time in Range
Automated Insulin Delivery: Six Universal Observations and Understandings
Exercising Well with Diabetes Using Automated Insulin Delivery

by Arvind Sommi
From diaTribe Learn

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