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?

.

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

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." 

prescient |ˈpreSH(ē)ənt, adjective

prescient |ˈpreSH(ē)ənt, ˈprē-|

adjective

having or showing knowledge of events before they take place: a prescient warning. 

It takes no prescience to guess my topic, sorry about that. I will learn a new tune, soon. There are times in life when tunes are prescient. Consider the Talking Heads Rock Movie, Stop Making Sense and insulin pump hacking. How can a 30 year old rock and roll album show knowledge of insulin pump hacking well before insulin pumps and hacking were commonly used terms? Read on my friends YDMV is going pop culture.


Jay “Pump Hack” Radcliffe wrote on Facebook that he thought this war was over.  Jay didn’t seem to expect that as the hack story lives on and in that others (a word that here means me) would continue to put forward the idea that there are other risks associated with insulin pumping that are as, or more, pressing than hacking. That is Life During Wartime Jay 


But I do not see myself as at War with Jay. In my first post on the issues I offered up the fact that I kinda hacked a pump way back when when we first started using them.  I hope I am all about the idea that pumps need to evolve and become better. Better should be prioritized in terms of advancements in improving lives and not simply be a function of what scare get the most press play. 


I do not see Jay as a Psycho Killer. On the contrary he brings up legitimate issues. Doing so, I think he is responsible to offer up suggestions on how to address the issues he found. I see him as anxious to do that. I do worry that the media attention given the hack story will suck all the oxygen out of the room and things like low glucose suspend, faster insulins, smart insulin and the glucose meter shuffle will choke for lack of attention. 


I think we would be Burning Down the House if hacking were to become the only or even primary concern around innovative diabetes care. So I speak up. I would hate to see the meter that has bolus wizards for the multiple daily injection community be kept off the market out of fear of hacking. I can’t see how the color screen on a remote is regulatory issues in any issue in any but the most minor way what so ever but it is available in Canada and not here. I look forward to seeing the Dexcom integration with Animas and Omnipod but both are in regulatory purgatory. LGS is a small first step towards automating insulin delivery and blood glucose sensing. All the laypeople in the world think that is what a pump does now but we know it does not.  Further delay keeping that innovation from the market may cost lives. 


Are the media Slippery People for publishing a compelling story without putting it into put into a wider context? No. Their job seem to me to be focusing on the next edition's Once in a Lifetime story that will sell banner advertising. For the mews media every day is Shark Week.


I fear an isolated and exaggerated risk myopia may be responsible for Burning Down the House of better diabetes care. So on second thought maybe we should focus on what really matters and Start Making Sense:


There is no war: Pumps communications should be secure. LGS matters. We all need to talk about risk in the context of life with diabetes.


Get Serious: Industry with the FCC and FDA need to figure out secure protocols for medical devices. Regulators should make these protocols easily approved as changes for device manufacturers to implement. This should be in the form of standards to spread the cost of the changes widely and efficiently. Each manufacturer should not be required to reinvent the secure communication wheel. Each consumer and insurer should not have to pay for new and different processes for each device. 


Remember Who’s Air It Is: Secure communications over the public radio spectrum should NOT be proprietary. That is no firm should have the proprietary advantage of excluding others from the spectrum's use for safe secure health care device communications. The air belongs to us all. 


Make it Work: The FDA should make it very clear how to implement secure communications and make it easy to get such communications approved into existing devices. 


Risk is not absolute: The lack of such security protocols should be balanced with the benefit of innovation. Advances such as LGS need to come to market while the FDA and FCC figure out what they will require.

FDA Q&A

Following a contentious an unproductive meeting at FFL with the FDA, for which I am as responsible as anyone else. I set out to try to have a less contentious exchange with the agency. This is one in what will probably be a series of posts based on their replies. 

The FDA’s representative at FFL suggested that if consumers are unhappy that a devices is available overseas and not in the US that we should ask industry if they have submitted it for review. I have suggested this is a little simplistic if the agency is still in the process of creating guidance for review - or at least which comes first the chicken and egg deal but with guidance and submissions. In addition there were statements that seemed to prejudge artificial pancreas. Specifically that AP would, not could, would kill somone. With that background here we go:

Q - Can you reconcile statements (at FFL) about AP and mortality with the deaths of adolescents due to nocturnal hypoglycemia our community has mourned this year. Specifically does the agency see that the lack of LGS guidance in the US market may have played a role in these cases of mortality that LGS may have prevented? 

A - The FDA is acutely aware of the struggles of diabetics, especially in children, adolescents and their parents and makes every effort to encourage and enhance the development of breakthrough medical devices, including those that suspend basal insulin delivery when blood glucose levels are thought to be in or approaching low glucose concentrations. Although guidance documents are one way of doing that, it is often challenging to provide guidance on a topic which the FDA has not yet developed the expertise necessary to do this. Recognizing the importance of cooperative efforts, the FDA has an open-door policy, and in fact encourages all manufacturers to work with us as they develop and conduct studies to evaluate new devices. The pre-submission, also referred to as the pre-Investigational Device Exemption or pre-IDE process, allows manufacturers to present the FDA with their plans for developing their products and obtain guidance.  This process is often more valuable than a generic guidance document as it is specific to the strengths and limitations of that manufacturer's product and can be developed to support the specific claims that are sought by that manufacturers for that device.

My Comments.

Here the FDA says they are open to paths to approving a device other than guidance. Specifically the pre-submission process. 

That is a timely issue for the diabetes public to consider as the FDA currently has a docket open on “Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings with FDA Staff; Availability.”

http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO%252BSR;rpp=25;po=0;D=FDA-2012-D-0530

When I looked there were three public comments. So if this is path to get diabetes devices in the market here in the USA, that are already available widely outside the US. It seems that it would be in the DOC’s interest to comment. 

Want to comment but don't know what to say? 

Here are some form letter you can use:

http://www.ydmv.net/2012/09/get-you-fda-pre-sub-docket-comments-here.html

Lastly it is somewhat disheartening to hear the FDA say, “... it is often challenging to provide guidance on a topic which the FDA has not yet developed the expertise necessary to do this.” I trust that the nuance here is about creating guidance not considering applications for the regulation innovative care. That the agency will use the pre-sub process to gain access to experts before creating wider guidance. This is how I think they meant what they said.

It does beg a comment on expertise.

We certainly didn’t have the option to develop the expertise necessary to be the parents of a T1D child before diagnosis. I worry that the FDA as an institution is never rewarded for doing well and only beat up in blogs and congressional hearings for mistakes and so becomes risk adverse to the point that lives are lost pursuing perfection beyond the good of safe and effective. How can that change? 

Artificial Pancreas and Egg Baskets

A friends asked this about the artificial pancreas (AP):

I have noticed over the past few days a lot of interest in the Artificial Pancreas project, the FDA and an online petition.  

I know nothing of the project beyond the controversy it caused when the JDRF supported it and people felt that money was better spent on a cure rather than technology.  

From what I have seen, and again, I need to do a lot more research, this will be a tool-a more advanced pump if you will.  If this is correct, are we looking at a tool that will only be available to those that can afford it or will it be looked upon as similar to a pacemaker for a heart patient?  

In Canada, we are still fighting to have insulin pumps covered in all provinces for all ages.  Very few have coverage for CGM.  How will the masses therefore afford to have access to another device...unless this is something for the masses again like an artificial limb or pacemaker. 

Please feel free to email me direct if you can help me to better understand this rather than clog up the list.   I don't mind standing behind something if I feel it will make a real difference.  At the moment, I am just not sure I understand the planned way forward with this. 

This was my response: 

There are a number of approaches to AP. Some use just insulin others, I think a study at Boston University uses something to raise BG as well as provide insulin. If you get the chance, go to a JDRF technology meeting. The Capital Chapter ran a great one last year. You will see AP is part, but by no means all of the story of making living with diabetes better.

You are correct about the tools involved - CGM and pumps. There is wide appreciation that improvement is needed in both sensing and insulin delivery. Faster insulins and better pumps sets. The benefits of those would also improve care outside of AP. Faster insulin would be good for everyone, better sets and sensors would benefit those who use pumps and CGM without AP. 

AP then is an set of algorithms, or an application if you will, that manages BG with the pump as measured buy the sensor. It certainly will be costly to develop and more so to get approved, particularly as there are currently not guidelines to get it approved. (in part this relates to the recent conversations about Low Glucose Suspend (LGS) and apps.) In fact LGS is a stepping stone to AP in that it does one AP function, stopping additional insulin with low BG. 

You are correct in noting AP is concerning to some. It is worth noting that JDRF's investment in AP is small compared to to their other research initiatives. I don't have the current numbers percentage numbers. 

I think you are legitimately concerned about costs and reimbursement. My good friend Scott Strummello often expresses the same concern. I think that AP will need to demonstrate effectiveness before insurance will cover it. To do that it will need to be approved by the FDA and tested, to be approved it
needs to be invented and go through trials. That is a lot of steps. 

Glucose responsive insulin (GRI) would make AP mute. I think GRI may be even more distant down the same path of discovery and approval as AP. Still one could argue that GRI is a better solution than AP and that it should be the focus. Others can rightly point out neither is a cure or a sure bet. 

I believe that better is better and perfect should not be the enemy of good.
So I am all for advances in type 1 diabetes care that may fit into individual's life styles in a Your Diabetes May Vary kind of way. AP may work for some while GRI works better for others. I fairly sure none of it will make diabetes care easy but it may be less hard and that's better. 

I support a diversified approach to making life better. There is a fable about putting eggs in more than one basket that explains modern portfolio theory better than most finance professors. Any one approach to making diabetes life better may fail. Most pharma development projects start with promise but don't make it to the market. So to make life better for people with diabetes a lot of different approaches need to be tried. It is in that context that I think JDRF GRI x-prize like initiative is a good idea even after the support they have put into and the promise that is still expected from SmartCell's Smart Insulin that Merk bought. 

Let me know if this helped any. 

You can learn more at the JFDR AP website: http://www.artificialpancreasproject.com/

Share you support for the AP initiative at this online petition. 

Bennet 

Get your FDA Pre-Sub. Docket Comments here!

Will you please consider commenting on an open FDA docket? I would love the FDA to see the FDA everywhere they look, particularly when they reach out for public comment.

The FDA currently has a docket open on “Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: The Pre-Submission Program and Meetings with FDA Staff; Availability.”
http://www.regulations.gov/#!docketDetail;dct=FR%252BPR%252BN%252BO...

So far there are just a few public comments. This docket is an opportunity to for the DOC to be seen by the FDA. It is a fairly dull issue and at first glance not specifically about T1D. However the FDA did bring pre-submission up in an email exchange about LGS. See this YDMV post.

In simple terms, pre-submission is a formal process of industry working with the FDA to help define issues the FDA will want to see addressed in an actual application. Think of pre-submission as meeting with a teacher to understand the rubric and go over an outline before writing a paper. This guidance is 35 pages of how that will work where the FDA is the teacher and industry is writing the term paper.

My hope is for the FDA to know the DOC is looking at everything they do. So much so that they anticipate they will get our comments. Open dockets are an official way to do that.

In addition to posting a comment to the docket consider copying your Congressmember and Senators and noting that in what you post to the FDA. YDMV, so may FDA comments. Below are a few general form letters that you could used for this particular docket. Please feel free to use them, modify them and post them to the docket. In that modification please fill out and change the the opening paragraph so it  states who you are, what your relationship to diabetes is and how long you have been living with it. 

Comment here:
http://www.regulations.gov/#!submitComment;D=FDA-2012-D-0530-0001

If you do post I would love a comment here just to know who has sent one in.

Thanks
 

General Support

Dear Sir or Madam:

First, let me begin by extending my sincere gratitude to the U.S. Food and Drug Administration (“FDA”) for this opportunity to share my perspective as an individual whose life will be directly impacted by the draft guidance document: "Draft Guidance for Industry and FDA Staff; Medical Devices: The Pre-Submission Program and Meetings with FDA Staff; Availability".

I hope FDA will give the same consideration to my perspective as it does to comments from companies that stand to profit from the FDA’s final guidance documents, and that the FDA will remember to give the patient perspective appropriate consideration when preparing the final guidance document(s).

Perhaps I should take a moment to introduce myself.  My name is {your name here}. I live in {town/state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are acceptable, there is little doubt they can be better.  Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive, and better tools will help {me/my child} live a longer and more productive life while also helping to reduce the amount of time that must be spent on routine management of blood glucose levels that {my/my child’s} body can no longer do on its own.

As the Federal Register announcement dated July 13, 2012 notes:

"The purpose of this guidance is to describe the Pre-Submission program (formerly the pre-Investigational Device Exemption [IDE] program) for medical devices reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER)."  The draft guidance document also notes that the original process was “designed to provide applicants a mechanism to obtain FDA feedback on future Investigational Device Exemption (IDE) applications prior to their submission. Over time, the pre-IDE program evolved to include feedback on other device submission program areas, such as Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) applications, and Premarket Notification (510(k)) Submissions, as well as to address questions related to whether a clinical study requires submission of an IDE.”

As I interpret these statements as a layperson, these seem to suggest that the draft guidance is describing the FDA's thinking about how this Federal agency will be handling early conversations with drug, biotechnology medicines and medical devices BEFORE the actual submission of an application.

As I noted previously, I live with Type 1 diabetes, and have done so for {specify duration of time lived with diabetes}. I know that there are a number of devices and tools available in almost every other developed nation that are not currently available here. While I’d like to believe Americans are safer as a result of this, there are valid reasons to question such a presumption.  While I support the FDA initiative to use the pre-submission process to help industry more quickly make applications for devices that the FDA can approve, as a patient {or caregiver} the specifics addressed in such premarket discussions are largely undisclosed to the public, hence the process as it has operated so far lacks transparency, which is one area I’d like to see some more specificity in the final guidance document(s).

Innovation in diabetes care is accelerating. Today, there are more options for Continuous Glucose Monitors (“CGM”) enabled insulin pumps (also known as Continuous Subcutaneous Insulin Infusion or "CSII", although I will refer to this as “insulin pump” throughout the remainder of my comments) overseas, there are more accurate CGMs, there are insulin pumps that shut of insulin delivery to hypoglycemic patients, there are mealtime insulin dosage calculating guidance wizards in meters for people who manage their diabetes with multiple daily injections (not insulin pumps) and more. Innovations are slow in coming and the options available in U.S. are falling behind.

The FDA and industry really must find ways to keep pace with other regulatory bodies around the world, such as the European Medicines Agency or Health Canada.  While I’ve seen signs of progress in this direction from the FDA, today, many companies apply for regulatory approval in Europe first because companies operating view the EMA’s approval process as more transparent, consistent and predictable than the FDA’s processes are.  My life depends on working with my healthcare team to use the best devices to help me manage my diabetes. If the best devices are not available in the USA, my care team cannot prescribe them.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}

*****
LGS comment for adolescent parents

Hi my name is {your name here}. I live in {town state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are good they certainly can be better. Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive and better tools will help {me/my child} live a longer and more productive life.  

Care options that physicians and patients can consider for type 1 Diabetes patients in the US lag behind the rest of the world. Uncertainty over regulatory processes here is a significant issue. Northwestern University reports that 76% of device manufacturers who replied to a survey on the FDA said the 510(k) process was unclear.

While the FDA, academicians and industry seek to find clarity on regulatory verbiage the lack of innovations in diabetes devices is costing American lives. One example in diabetes care is that Low Glucose Suspend devices are available in every developed nation other than the United States. A lack of clarity on how industry can apply to the FDA is part of the reason we do not have those devices.

Nocturnal hypoglycemia is killing Americans with Type 1 diabetes. The risk is particularly acute for adolescents facing hormonal changes that can significantly have an impact on glucose management. Unclear FDA process are costing the lives of American youth.

As the parent of an adolescent Type 1 child I find this delay and associated risk of life threatening  nocturnal hypoglycemia unacceptable.

The FDA must bring clarity and certainty to the US regulatory process. Robust pre-submission processes can facilitate approvals for innovative devices. The FDA must bring the clarity and transparency to the process that Northwestern demonstrated is lacking.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}

****
Short and sweet AP based comment.

Hi my name is {your name here}. I live in {town state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are good they certainly can be better. Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive and better tools will help {me/my child} live a longer and more productive life. .


The state of diabetes innovation is accelerating, as we move to more useful devices such as artificial pancreas and mobile devices that allow people with diabetes to integrate and manage their health with information from multiple diabetes tools the FDA will need facilitate bringing these innovations to physicians   and patients.

The status quo that devices are in use two to three years in other markets is unacceptable. The FDA should plan to use the pre-submission to bring the USA back to a position of leadership in seeing safe and effective devices come to market.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}


*****
Sharper T1 comment with specific guidance language

Hi my name is {your name here}. I live in {town state}. I have been living with {Type 1 / Type 2 / LADA} diabetes -or- I am the parent of a child with {Type 1 / Type 2 / LADA} diabetes. {I/he/she} was diagnosed {X} years ago. Living with diabetes is a daily balancing act that requires multiple devices to measure blood sugar and administer insulin. It is never easy and while the tools available are good they certainly can be better. Innovative diabetes devices are not an abstraction in my life, they are the means of staying alive and better tools will help {me/my child} live a longer and more productive life.  

As a diabetes patient in the United States, I am disappointed that innovations that could help my care team prescribe better self-care tools are available in other nations but not here. This is particularly concerning when these devices are designed in the USA. I fear that that gap between the introduction of innovative tools elsewhere and in the US is increasing not decreasing.

The FDA should proactively use the pre-submission process to close the gap between better care everywhere else and less innovative care in the U.S.  To do that the FDA needs to bring consistent regulatory practice to the pre-submission process and the process requires sufficient transparency so that it does not appear to work as a “black box”. Yet this draft guidance document itself is not completely clear. In one case it says the FDA does not view pre-submission responses to “decisional or binding on the agency.” Later the document says {specify page/line numbers in the draft guidance document, please}, “Modifications to FDA’s feedback will be limited to situations in which FDA concludes that the feedback given previously does not adequately address important new issues materially relevant to a determination of safety or effectiveness.”

Industry needs regulatory clarity to safely speed effective life saving devices to market. Pre-submissions should be a tool to facilitate that end.

Thanks you for the opportunity to comment.

{your name}

cc: {your Congressperson & Senators}

AP, aka LGS in NEJM

Artificial Pancreas with kids at camp is the topic of  New England Journal of Medicine article just out called, Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp. It looks like they used the Medtronic Veo.

It is a report testing AP outside of the hospital. Reader digest version: Kids had fewer lows and better control with AP.

http://www.nejm.org/doi/full/10.1056/NEJMoa1206881

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.

Congress & Pump Hacking, Who Didn't See This Coming

So it begins:

Aug 15, 2011: Eshoo, Markey Ask GAO to Study Safety, Reliability of Wireless Healthcare Tech
Senior Committee members Anna G. Eshoo (D-CA) and Edward J. Markey (D-MA) sent a letter to the Government Accountability Office (GAO) early this week calling on them to look into whether the new devices are "safe, reliable and secure. " The issue stems from a hack shown at the popular Las Vegas conference where researcher Jerome Radcliffe -- diagnosed with Diabetes 11 years ago -- demonstrated how he could tweak the dosage levels on his pump remotely.

Dear Congresswoman Eshoo and Congressman Markley

I read the press release about your letter concerning wireless health technology. I have a personal interest in insulin pumps. I am a social media writer and participant in the diabetes community online as I am the father of two teenage type 1 diabetics who lives depend on insulin pumps. I know that diabetes management is a balancing act. Insulin and activity balance with food to maintain blood sugar. It is never a perfect balance of risks but it is what families living with diabetes strive to manage.

I hope that in your efforts to publicize your letter you are aware of the relative risks involved with insulin pumping. The community of families living with type 1 diabetes has been shocked with the deaths of a number of adolescents in the past year form hypoglycemia, excessively low blood sugar. You may know the condition better as insulin shock and it can result even when people believe that have balanced all the inputs just right. 

Insulin absorption is affected by a number of variables. Physical activity can present diabetics with increased insulin efficiency as well as changes when in insulin impacts blood sugar. It is possible that healthy, active kids see blood sugars fall overnight as a result of daytime physical exertion. In those cases reducing or stoping the delivery of insulin, even normal amounts that have previously been fine, can help prevent dangerous low blood sugars.

The US Government has tightened regulation of insulin pumps to the point where innovations that are available around the world are not available for use here. Continuos glucose monitoring systems (CGM) integrated with pump systems are sold in Europe. These insulin pump systems are made by US companies. The more advanced systems can shut off insulin to people having a low glucose episode. This innovation, while made in the USA, is not available for sale here, yet it is available around the world. 

These devices have the potential to save lives. They give people living with diabetes in Europe more choices to consider with their physicians than we have in the US. Sadly the FDA does not even have guidelines for considering how to approve low glucose suspend.

Let me be clear. I am not suggesting that wireless security is unimportant. The devices should be secure. Device makers should be allowed to bring more secure devices to market without a significant regulatory delay.

I am urging you to reflect on the life saving capabilities of innovations like CGM integration and low glucose suspend with the security risk. To date there has been no reported case of any health impact from the possibility of hacking an insulin pump. Zero. 

There have been and continue to be tragic cases of severe hypoglycemia that cost young American lives. The particularly sad loss of adolescents with type 1 diabetes highlights  where LGS may have prevented the unfortunate loss of life. Unlike pump hacking, the lives of American children are been lost to hypoglycemia. Pump hacking, considered outside of the balance of risks facing insulin dependent diabetics, may increase the regulatory delay of life saving technology reaching American families.

The cumbersome FDA regulatory process for inulin pumps slows innovation to US families. Your letter uses the word proliferation. Typically politicians use the word with a negative context. We need a wider rapid adoption of life saving innovation to help keep American teens alive not the proliferation of government studies that prevent US patients from using the innovations of American companies to live healthy lives. 

How can you as senior members of the House Energy and Commerce Committee speed up not only the safety of devices but the availability of life saving tools? 

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