Medtronic LGS Approved!

Just saw a press release that Medtronic has FDA clearance for the 530G Low Glucose Suspend (LGS) system. This is good news. It is the first step on the path to AP.

LGS uses a sensor to stop delivering insulin when the system detects a low. That seem only logical.

Regular YDM readers may have seen these posts on LGS

Approval is good news. It shows FDA has figured out how to allow an innovative step to better diabetes management. Before people start quibbling about sensors sensitivity and perfection, let's remember that diabetes perfection is not possible. Better is.

This is a significant step to better.

Your Diabetes May Vary

An AP by Any Other Name: Animas HHM

Artificial Pancreas is in the news again. This time the press release is from Animas. Yesterday the news was of an article in the New England Journal of Medicine.

Everyone's favorite bard said, "A Rose by any other name would smell as sweet." Sorry Bill,  I am beginning to think you were wrong.  I think the first steps of AP smell sweeter with different names.

My experience talking with other parents is that the term Artificial Pancreas is all wrapped up expectations of it doing what they really, really want. That is magically managing diabetes so well they don't need to worry about it. Being reasonably smart people, who are regularly frustrated by their child's diabetes varying in inexplicable ways, the discrepancies of life, liberty to eat and CGMs, they conclude that the present technology can't deliver that magic.

No kidding. It can't.

There is a whole bit on this in Forbes by David Kliff, Stretching The Truth About An Artificial Pancreas to which others and I replied.

Here is what matters to me as a dad of T1D kids - the NEJM article says the first steps of AP can lessen the number of hypos and keep kids in range longer. This is where the Animas release kicks in, remember the Animas press release? This is a story about the Animas press release.

In the Animas release they don't call it AP. Go ahead go read it. Search it for the word Artificial. It ain't there.

The story is about, "a first-generation closed loop insulin delivery system." I will give you that AFGCLIDS is no rose. They got that.  They call it HHM for Hypoglycemia-Hyperglycemia Minimizer. I would call it Hypblurglycimic Minimizing System. Then I would go for a whole Gilbert and Sullivan operetta - HMS Pancreas.  But I digress.

Like LGS (Low Glucose Suspend) the idea isn't to manage precisely to target. The goal is to help minimize bad sh*t from happening. Preventing bad sh*t, is a good thing.

Progress happens incrementally. Regulators are gonna be more comfortable regulating incrementally and payers will probably be more likely to pay if academia (see NEJM above) can show incrementally better outcomes and hopefully incremental savings in the reduction of expensive hospital visits.

Staying in range more means better long term outcomes. That may not be actually magic but it is a nice parlor trick.


Oh and my apologizes to centuries of British culture.

LGS in USA?

Medtronic announced today that their Low Glucose Suspend pump is into the FDA for a PMA aka blessing. Good news and a step towards innovation in insulin pump care. 

FDA to Review World’s First Insulin Pump with Threshold Suspend – Another Significant Step Toward the Artificial PancreasMINNEAPOLIS – June 8, 2012 –In the next step toward the development of an artificial pancreas, Medtronic, Inc. (NYSE:MDT) today announced that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration for the MiniMed® 530G system featuring Threshold Suspend Automation. If approved by the FDA, the MiniMed® 530G system will be the only integrated insulin pump and continuous glucose monitor in the United States that automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value.

Read more about it here:

http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1339159198703&lang=en_US

We Hold TheseTruths to be Self-Evident, Except Trials are Required.

Medtronic has a press release out today that says with Low Glucose Suspend (LGS) folks spend less time in hypos. That seems kind of intuitive to me but hey the studies need to be done. It it wasn't a small difference IHMO. 19% less time in hypos.

You can read the press release here or click this graphic to see what is said in markets that aren't the USA and where people with diabetes can get a LGS pump.

YDMV has burned a fair number of electrons on and around LGS. Here is hoping this helps the FDA focus on the value this step brings living safe lives with insulin infusion.

What do yo think?
Would you like LGS?
Would you use it?

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News on LGS

Medtronic Receives IDE Approval to Conduct Aspire In-Home Study of First Insulin Pump with Low Glucose Suspend for US Market

A Grievance

I have a Grievance with the FDA

It take them too darn long to approve better stuff for diabetes care. Someone should do something about that...

... and there is an opportunity to do something right now. The FDA docket on Low Glucose Suspend (LGS) is open for just a few more weeks. Take advantage of this chance to share your views with the regulators and congress.

You can click here to comment.

You may feel that you are not qualified. You may fear that you do not know all the ins and outs of medical studies and that is what this seems to be about.

I think this is about more than ins and outs of studies. This is about timely approval of devices that can help manage diabetes. You may not use a CGM, you may not pump,  you may have doubts about artificial pancreas but if you live with diabetes regulatory delay puts you at risk. 

I think we should have an expectation that the FDA will preform their regulatory duties with alacrity.  That doesn’t seem to be the case with LGS. Here is a product that is in use in 40 different countries and the FDA still doesn’t have a process for considering applications to approve it here. That is more than a little late to the party.

If nothing else the FDA should hear from people with diabetes saying that devices should not come to the US market years after they are approve else where. The FDA needs to do its thing in a timely, citizen friendly and focused manner.

I think LGS can save lives. Particularly lives lost to sever overnight lows. I

That could mean fewer blue candles on Facebook. There are few things I hate seeing more than that symbol of grief and remembrance of a life lost to diabetes. Further delay moving forward on devices to that may keep kids alive is unacceptable. 

LGS is not a magic bullet. It is no cure. 

It does offer a means of lowering potentially tragic risks. What there is NOT is a means of the FDA will considering these and other pump / sensor advances as they are created.

Please comment on the Docket. I view it is one way of avoiding blue candles. I hope it is only ONE of MANY ways of avoiding blue candles. We need all the ways we can get to keep them out. The FDA should be our ally not an impediment in those efforts.

Comment to the FDA and share those thoughts with your member of Congress. Be someone who does something. As it says in the first amendment, “petition the government for a redress of grievances.” 

Repeat After Mike: Dear FDA...

Mike Ratrie left a new comment on the post "Repeat After Me: Dear FDA..." that I think is so good it should be a stand alone post. He wrote:

Bennet,

Here is a copy of the what I posted on the FDA comments link you provided. I also sent it along to my Congressperson (Mica) and Senators (Nelson, Rubio).

Cheers,
Mike

"Having read the draft guidance regarding Investigational Device Exemption (IDE) and Pre-Market Approval Applications (PMA) for Low Glucose Suspend (LGS) Device Systems, there are at least two areas that stand out for me.

The first and most obvious one is why is the FDA putting together this lengthy and dense type document when these devices have been approved in over 40 countries AND have been in use for over three years. Surely in this time of near instantaneous communication of results, the companies who market these devices have already answered most if not all of the questions and concerns raised by the FDA. If not, the remaining questions and concerns should be relatively minor and not worth the time and expense of undergoing full-blown trials.

Note that by time and expense, I refer to not only the time and expense for both the FDA and the LGS manufacturers, but also the time and expense to the patient community that would benefit by having these devices immediately available. Indeed, delays like this strike at the heart of the public's confidence in the FDA's ability to follow its mandate.

The second issue that stands out is the HB1AC guideline for a successful trial. It seems to me that the FDA is being overly technical here and is missing the bigger picture - the avoidance of hypoglycemic events. In other words, a T1DM patient who has a 0.4% lower HB1AC without using a LGS system, doesn't just have a lower "number" without meaning to their quality of life, and in all likelihood they are not "healthier", because this lower number means they are spending more time with blood glucose levels that are too low. I urge the FDA to revisit this parameter of trial success, with a more expanded, less technical view.

There are other minor issues with the draft such as spelling and grammar, inappropriate links (there is one that literally links the reader to the very next paragraph) and language that just cannot be followed."