Medtronic 770g upgrade to 780g - The Wait should be over in the U.S

Hi All. Long time Medtronic advocate starting to lose the faith. I’m trying to understand are we really waiting on the FDA for the 780g approval or has the long delay been overshadowed by quality issues in one of the Medtronic facilities disclosed a few months ago. When you add COVID and the wait - it has been a long process . Medtronic communicated to many to jump into the 770g for the last 2 years with the anticipation that much of the functionality would be be coming via upgrade. So far I have seen nothing. At the time I could have upgraded to TANDEM or Omnipod and achieved a better algorithm. However, the 780 and its algorithm is a far better system and product hands down if you look at the features and control in Europe. Did I make a mistake? It is certainly a long wait with nothing from Medtronic. Not even a letter to their existing users.

@Flynn_Simon I hear you. The device is ready except for FDA approval. The hold up is that FDA has told Medt They will not move forward until all outstanding issues related to cyber security and notifications plus the various deficiencies that arouse out of the security audits that followed. I know Medt wants it released and they have petitioned FDA for early approval. So far that has not occurred.

But soon I hope. I felt i needed to go ahead and jump to tandem mainly for things that might not be so important to others. I do really like Medt and wish the entire community the very best. Perhaps I will be be able to return some day.

By the way? The sensors are are very comparable.

I got the 670 in September 2018. I paid $400 to do the Pathway upgrade to the 770 because they made it sound as if the 780 was just around the corner. It was coming Fall 2021, Spring 2022, Fall 2022 and now I guess they’ve learned not to give a projected time. My warranty just ended last month and they called me trying to get me to get another 770, but I see no reason to.

I didn’t use AutoMode on the 670 or 770 because I hate how high it kept my BG and the inability to do a dual or square bolus. Over the summer I did look into Tandem and OmniPod. OmniPod actually doesn’t sound any better. From what I’ve read, it sounds as if their algorithm is just like Medtronic’s. They say it ignores your basal rates and it learns your needs over time. Tandem sounds much better because it’s based on your own settings. My insurance makes it hard to switch from Medtronic because of the way it covers Medtronic ($30 “diabetes management” co-pay) vs Tandem/Dexcom (DME, $2,000 deductible, 30% co-insurance after that is met) or OmniPod (Tier 3 pharmacy, and still need to pay a fortune for Dexcom). Medtronic costs me just a few hundred dollars a year for everything. The sensors work well for me, I just wish the algorithm did. I really am hoping the 780 is as good as people say.

Medtronic is stalled in the FDA until they address the manufacturing facility issues and other items outlined in their warning letter, or they are issued a variance from the FDA that will allow review to continue, despite the concerns of that warning lette. FDA language is fairly difficult for anyone outside the industry to understand. The most severe sounding reprimands, like cease and desist letters, are actually trivial (it usually just means one of your competitors complained and you have to dispute their allegations or correct a minor issue, like document wording), and mild-sounding reprimands like this warning letter are actually a severe injunction. The FDA simply won’t even look at the 780 or the new Guardian 4 sensor so long as that warning letter is actively blocking it.

The bigger problem is, their diabetes division is bleeding money. They’ve put all their energy into being the first to market for various products, and not enough energy into making the best product, so they’re losing their patient base. So many people bought into the 670, because it was the first commercial semi-closed loop, and then were so disappointed with it that they chose to abandon Medtronic at the end of their warranty. The investors are mad that the competition is rapidly growing with Medtronic conversions. When you’re one of the most lucrative medical device companies there is, you don’t keep putting money into a sinking ship. It just doesn’t make fiscal sense. I think it was in the first earnings call of this year that they openly admitted it was time to evaluate their portfolio and consider divesting the diabetes division. So now they’re playing the game “worth it or not?” game of how much money to put into addressing the warning letter. The diabetes division would be worth more to sell after the 780 and Guardian 4 approvals, but perhaps not enough to warrant the investment. The speculation is that they’re hoping to be granted the FDA variance, so they can get the FDA clearances without much further effort on their part. But it really is just speculation, because they haven’t actually announced their strategy, to my knowledge. There probably won’t be any movement at all until a decision is made on the variance, though.

So basically… Don’t hold your breath, but the approval could come at any moment if the warning letter goes away or gets ignored. We’ll never know until something happens or they reveal more information to the investors.

This isn’t quite true, if you look at the clinical data. You can’t just base this off of Facebook stories. All of the commercial systems perform similarly in terms of TIR and A1c improvement, with a slight overall advantage to Tandem because of it’s unique sleep activity and better general night time control. (Though honestly it’s really difficult to compare different clinical studies, because of different testing parameters.) Control-IQ is very conservative in modulating hyperglycemia, though. What a lot of us call “too little, too late”. The 780 is better at bringing the highs down on it’s own, while Control-IQ users often resort to manual corrections. On the other hand, Control-IQ is better at preventing low BG than the 780 and yields a better overall standard deviation (flatter glucose trends). And of course many choose to forego automatic corrections altogether and run Control-IQ continuously in sleep mode to further improve standard deviation and target a much lower, tighter glucose range… but this isn’t explored in clinical studies because it’s an off-label use of the pump. Also, Control-IQ is heavily dependent on user settings. This can be a positive or a negative, depending on the knowledge and support of the user’s medical team. You have more power to influence the algorithm and reign in control than with any of the other systems… But only if you’re able to get your settings dialed in appropriately. It can be a right mess with bad settings, a problem Medtronic and Omnipod 5 don’t face. I think it really depends on your own management weaknesses as to which is the better choice for you.

Tandem also has some Control-IQ updates in the works, promising to bring more customization and better control to the table. And they have an incredible history of actually launching software updates, so you can have faith they are coming. It’s entirely possible that Control-IQ will be better at handling the highs, too, before the 780 comes to market here. They’re also launching a new data platform in 2023, Tandem Source, which will supposedly have some settings analysis and advice, to minimize the good settings hurdle to success.

A Comparison of Two Hybrid Closed-Loop Systems in Italian Children and Adults With Type 1 Diabetes - PMC.

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Thanks for the note. I find the sensor are the same as well. I would like to see less tapeing though. I buy patches which I put over the existing sensor. I think Medtronic could save a fortune in packaging if they really examine it.

Great feedback and details. You raised some points I did not consider. Without going into too much detail, I was basing my data not from Facebook but rather attending some of the European presentations and listening to some of the control groups. I do agree that ultimately we are talking about feature functionality differences. I’m impressed with the missing meal bolus feature. I come from the android APS world and had the ultimate decision and flexibility with control. Eventually I gave up because my last older Medtronic pump died which I used with the hack. I thought I could resume with the 770 and 780 but I’m still waiting. I hope some of your conclusions are correct!

@Flynn_Simon I know I have said many times it is close. It would be on the market in the US now had the issues not been raised higher. But they were and here we sit. I think the future looks bright for Medt, provided one wants to hold on.

My worry is Dexcom in regards to the MEDT 780 launch. They are the 800lb gorilla in the cgm world and have the cash and ability to apply resources to monitor, slow, and block Medtronics every step forward. Always the annoying little reasons at FDA that stop MEDT and Dexcom never reports such barriers to development. To me Dexcom is the New England Patriots of Diabetic care. :thinking:

Interesting thought. Dexcom while a good product is a issue if you are self employed. Their business is predicated on charging as much as possible to insurance companies. Other have self pay rates. Dexcom does not. So tired of waiting on the 780 too

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???

How can you even say that with what Dexcom is going through right now?

Dexcom was literally just forced to withdraw the G7 from FDA consideration because of at least one issue the FDA raised. (I’m given to believe it’s a security issue. The FDA seems to take offense at personal devices being used as medical devices.) This is a product that already had CE Caremark approval overseas, but the FDA decided to stir the pot here. Now they’re scrambling to fix said problem before they can apply for pre-market approval on the revised product.

Security is the new issue for FDA approval. Each new device will undergo the highest scrutiny for security. It is no surprise that both the 780 and the G7 are being held in part for security issues. The flurry of issues plaguing Medt seems to have started with breaking the signal form the paradigm pumps.

While no one has broken the signal of a Dexcom device the truth is it really did not need to be broken. It has almost always been available to read. The problem is when it is used to facilitate DIY loop devices.

I think the FDA and tech companies will eventually find a path forward. But until the device companies understand that they are software companies first and hardware companies second, I think we are in for a bit of a bumpy road. Likewise until the FDA understands that data will be transmitted between devices and that cannot be totally controlled then we will likewise be in for a rocky road. I think there are acceptable risks. I believe the FDA will need to find that realization as well.