Report: Medtronic files for FDA approval of MiniMed 670G ‘artificial pancreas’

Diabetes Technology Insulin Pumps
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Maybe this has already been discussed, but I didn’t find anything about it, so thought I’d add it:

Link to Article

Article: (Posted June 28, 2016)
Medtronic (NYSE:MDT) has reportedly filed for pre-market approval from the FDA for its MiniMed 670G “artificial pancreas,” which is designed to automatically track and adjust blood sugar levels in patients with diabetes, and expects the federal safety watchdog to issue a decision within a year.

The device measures blood glucose every 5 minutes to keep patients within their target range, according to Bloomberg. Medtronic’s PMA bid is backed by a 124-patient trial that showed better blood glucose control than with manual testing and insulin administration. The average HbA1c blood sugar level at the start of the trial, 7.4, fell to 6.9 by the end of the study, with 58% of patients achieving that goal, the news service reported. There were no malfunctions, hyper- or hypoglycemic events or hospitalizations, lead investigator Dr. Richard Bergenstal, of Park Nicollet’s International Diabetes Center in Minneapolis, told Bloomberg.

Patients using the MiniMed 670G must still recalibrate the device every 12 hours, change out the glucose sensor weekly and refill the insulin reservoir every 3 days, but that’s still a vast improvement over hourly finger-stick tests.

“The work isn’t gone, but it seems to be a lot less,” Bergenstal said. “Patients are working 24 hours a day now. We want them to get control without spending every hour of the day worrying about their diabetes or preparing for the next event.”

“This was them, in their homes, going about their lives,” added Medtronic diabetes chief Francine Kaufman. “There was no remote monitoring. The closed loop is running the train now.”

The device proved so popular with the trial subjects that a group asked the FDA for continued access; the study went into an extended review period with more than 100 volunteers.

“It was totally mind-blowing,” Les Hazelton, who is 1 of the patients who joined the trial extension, told the newswire. “I like being in better control of my body and my disease. The more I know about what’s happening right now, the better I can manage it.”

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W00t! Go Medtronic! I’m not actually as enthused about the AP. I was fortunate to attend MasterLab and was able to speak with an AP guy there. I asked if their unit was “tweakable” to maintain my current level of control (5.1, 5.8 since pumping in '08, 5.2-5.4 on “Sof”-Sensors from 2010-2013 and 4.9-5.2 since switching to Enlites in 2013…) and he said “no, this won’t do anything for you…” But I still applaud them bringing this to market!

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Having used a Dexcom G5 for about six months now, I’m less enthused about the current state of AP development. I’m finding the thing just isn’t nearly as accurate as I thought it would be, and my lower BG readings have not corresponded to anticipated A1C rates. My A1C has dropped, but not to the level the G5 software estimates. I’ve also found out just how slow insulin is, which I never really thought about before because I was only testing 3-4 times a day, so I didn’t see how slow boluses really are to bring BG down. Perhaps, however, I will be pleasantly surprised by the ability of the logarithms to be accurately predictive and adjust insulin levels accordingly.

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I’m glad you asked that question, because it’s something I have also wondered. When I’ve read about a number of different AP’s it often seems the blood glucose levels they are aiming to keep you at are higher than what I personally aim for. My control isn’t as tight as yours but my last 4 A1c’s have been ranging between 5.3-5.6. Hopefully in the future they will allow you to set your own blood glucose limits within these artificial pancreases.

As you said then, massive step forward for diabetes technology and this will improve thousands of people’s lives, as I appreciate not everyone has such tight levels of control.

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I always wondered about the right role of government. In this case the FDA. Then I came across Ronald Reagan’s quote: “Government exists to protect us from each other. Where government has gone beyond its limits is in deciding to protect us from ourselves.”. I would like to set the AP to 85 mg/dl during the night whenever I feel that the sensor is good enough. The FDA will not allow this. This means that AP will be useless to me. I wish there was a way to opt out of government overreach.

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I agree. Any artificial pancreas system should allow us to set its parameters as we see fit. I feel the same way about this as I do about the strong advice I might receive from any medical professional to err overwhelmingly on the side of hyperglycemia. Any tool can be so over-designed to make it so safe as to render it useless.

I’m hoping that the we are not waiting movement can successfully counterbalance this notion that we need to be protected from ourselves.

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I think we need to remember these are 1st generation AP’s. We’ll get there.

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@Jim26, you have a good point. In a project like this the designers must work with the tension between safety and efficacy.

So often in the past, the patient point of view was incorrectly assumed or not even taken into account. The sooner that the project designers recognize that plenty of competence exists in the patient population that they should at least allow some level of choice and customization, even in the earlier designs.

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I am not so sure. There is a wide gap between idiot-proof and and what can be done today by an above average analytical person. I bet that there are at least a dozen people on this forum that beat the best FDA person in experience and analytical capability. Consider the outrageous FDA request to sabotage the work of Nightscout. In the case of CGM, I think we would be much better off without FDA.

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Let’s look 5 years into the future where the CGM is more accurate than finger sticks and readings are provided continuously to the AP versus today’s every 5 minutes. Also consider where insulins will acts faster and the duration of insulin is less. At that point, they will be able to shoot for a lower average glucose than today.

Obviously we are a few years out from that reality.

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I think the role of the FDA should be redefined. ‘Waiting for FDA approval’ should not prevent any company from selling. It should be any person’s decision whether or not to wait for FDA approval. If the European ‘FDA’ approves a device, why wait another couple of years for US FDA approval? Let individuals who will suffer the consequences decide. I don’t need anybody to mandate whether or not I can drink soda. I surely don’t want to pay for this overreach.

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I think that “AP guy” might be wrong. I’ve been experimenting with DIY AP (first OpenAPS, and more recently the Loop) since the beginning of the year. My a1c “improved” from 5.3 to 5.0, which I consider insignificant and almost completely irrelevant. However, with zero nighttime alerts or corrections of any type over the past almost 9 months, and with better time in range and fewer daytime manual “surfing” corrections, my quality of life has definitely improved. I do hope commercial AP systems will include similar options for more experienced users not willing to compromise on tight bg control.

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What do think the chances are that FDA will approve anything like this? It is more likely that you will end up in jail for using a medical device that is not FDA-approved. Cover your tracks !!!

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Thanks for the OpenAPS reference. All of a sudden I feel adventurous. I know that what I do can be easily automated. I will give it a try.

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@Helmut, you’ve kicked it into a higher gear tonight. I like it!

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That is very interesting. I’ve never come across the whole OpenAPS system before. I can see open APS can only be done with older pumps, what pump are you currently using Dragan? I can’t seem to find any information on ‘The Loop’ how does it differ from OpenAPS?

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Sorry to disappoint. OpenAPS does not address OmniPod. I am an OmniPod fanboy.

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I have Medtronic 523 with 2.3A firmware, which accepts remote commands via a radio link. Pumps currently suitable for DIY AP systems can be found here. Loop and OpenAPS (and a well documented AP algorithm called oref0), have been very nicely described in this post on TuD.

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This is not a direct answer to your question, but FDA is well aware of what’s going on, which is good. FDA official: We’re monitoring DIY artificial pancreas boom has just been posted in the Clinical Endocrinology News:

A Food and Drug Administration official told diabetes educators that her agency is carefully monitoring the growth of an unusual development in diabetes care: the do-it-yourself artificial pancreas.

Dr. Courtney Lias’ comments are justifiably skeptical, but measured - these are good considerations for anyone considering a DIY AP project, or any future commercial AP system for that matter. I fully agree with her statement “Artificial pancreas devices do not have to be perfect with zero risk to be beneficial.”

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