Abbott Bails

The FreeStyle Navigator is dead, long live CGM.

The best line in this is, "When we bring a product to market, it is our responsibility to consistently provide the product to customers." 

Abbott didn't live up to their self defined responsibilities and they should be ashamed.

http://www.abbottdiabetescare.com/adc_dotcom/url/content/en_US/general_content/General_Content_0000422.html

(Thanks Ellen for the link)

#TwoBits

Two great pieces from around the Diabetes Online Community for August 31, 2011:


GlucaPen: The Way Glucagon Ought To Be
Karmel Allison offers a look at a better way to deliver Glucagon. She points out that while there is a better device it isn't yet available.  


Tomorrow is Diabetes Art Day
I am a fan. A fan of diabetes art, the reasons for making it, the people who make it and the great woman who connects us with creativity. Join in. Create. 

Aug 29, 11 #TwoBits

Two Bits from around the DOC.

Both brought to my attention by good friend Ellen Ullman on her Google+ page. She's great  at finding news on type 1 and a more importantly a lovely lady. Here's today's Two Bits:

The pancreas as we’ve never seen it before


Professor Ulf Ahlgren and associates at Umea University in Sweden are a leading research team in the world in the development of optical projection tomography. With the aid of this imaging technology, they have now described aspects of how the pancreas develops during embryonic development and how the so-called islets of Langerhans are distributed in the adult organ. The findings are important for the interpretation of modeling systems for diabetes.


TEDx - PREVENTING AND CURING TYPE 1 DIABETES
OCTOBER 15, 2011

TEDxDelMar will offer a full day of talks by the country’s leading researchers and clinicians addressing the cause, the most advanced treatments and ultimately a cure for Diabetes.


Eighteen minute talks by 15-20 speakers will be simultaneously broadcast live on the web. A global audience of over 400,000 viewers is expected to hear the live talks interspersed with feature videos.

Man would I love to attend that! Oh wait I can it will be online! Yea Internet!

Ford Has My Back

I Want Their Voice.

Back in May, Ford reached to out some members of the Diabetes Online Community asking them to participate in an online chat about research to connect CGM data into their SYNC® system. I was not one of the folks their PR contractor emailed. (I assume that shows good judgement on their part.) Too bad for them, a friend shared their email with me and I got myself invited into the chat.

Who would think I would butt my way into a conversation? (OK anyone who has ever met me would think that.)

They were very nice about my butting in.

You can read the story about Ford’s research and see the chat transcript here.

Many of us who participated, myself included, came away with the impression that Ford didn’t “get it” when it comes to diabetes and diabetes social media in particular. I know I felt that the chat was a vehicle for Ford to generate positive PR about addressing diabetes health concerns with out actually doing any actual addressing.

They seemed to be ignorant of basic realities managing diabetes. I found this comment particularly difficult to take, “Our plan is to go with open standards, so we align with the healthcare industry.” As a self appointed leader of the where are the data standards for diabetes committee, I know there are no industry standards open or otherwise.

I and others worried that Ford’s PR efforts would create a bunch of stories that will be seen by people who don’t live with diabetes. Those folks will have a positive impression of Ford marketing something useful to diabetics. The reality is there is no real product, only slickly packaged remote possibilities. These false impressions could add to the existing list of multitude of misconceptions about living with diabetes. I can just imagine comments, “It must be so easy now that your car monitors your blood and tells you what to do to manage your diabetes.”

Given the way Bloomberg picked up and spun the story, the fear that Ford was in it for the buzz seemed to have merit. They wrote of Ford seeing a sales surge from such devices.

Ford’s folks were kind enough to maintain a follow up conversation with me on twitter. That lead to a phone call with the research and PR team working on the project. That call cleared up some of the questions I had about the research. Ford tried to clarify their communication approach too.

From a research perspective, this project is the investigation of possibilities that they know are way down the road. There is no product expected any time soon. They do have to start someplace and this is that start. I appreciated the candor that said that with.

Given that this research is not likely to provide actual capability in a Ford anytime soon, I questioned a communications strategy that seems to position this as more of a coming attraction than candidly remote possibility. Ford’s communication person strongly objected. He insisted that Ford’s communication made it clear this was research. In all fairness, technically, it does.

Still, Ford’s PR efforts created a number of articles in a variety of media outlets about SYNC® and health. As the whisper down the lane process evolved the far far away research aspect kind wore off. The result appears to be a vehicle for Ford to generate positive PR about addressing health concerns with out actually doing it. At least until an undefined remote future.

The last thing diabetes needs is media now about a remote undefined future. That where a a lot of better living with diabetes and even the cure lives - the undefined future. The place is crowded.

To me this raises an interesting question about how business use of social media. Many experts say the first rule for businesses using social media is to listen. There’s even books about it.

I think Ford could stand to be seen listening a little more attentively on this. Ford reached out to diabetes social media writers with a story to tell. I am not aware of them listening or joining into conversations before hand. The came in with an ad campaign and a call to support it.

The result was that in the #DSMA chat at the time, Fords PR efforts around the SYMC/CGM connection was called a “Gimmick.” Another participant said “Ford's In-Dash CGM” would be a used by, “Slime Salesman (to push a) ‘diabetic upgrade.’”

About the same time as Ford’s CGM SYNC® press releases Charlie Kimball became the first driver to race the Indy 500 with diabetes. He as Dexcom CGM mounted to the steering wheel of his car. Charlie clearly demonstrates the value of CGM information and driving.

He is a great guy with a great story: Type 1 Racer dosen’t let diabetes slow him down. His autographed picture is on my daughter’s wall. We watch Indy Car races to see him. Charlie is a role model. To be clear we should leave the 200+ mph stuff to him but we also should encourage every diabetic kid to chase their dreams just as aggressively as Charlie drives.

Sadly I don’t think in car CGM information is going anyplace other than the receiver in the cup holder or like Charlie’s attached to the steering wheel. FDA scrutiny on devices is tough. CGM data on that remote display may be seen as clinically significant information making the display a medical device. I don’t see Ford applying to the FDA for approval of each different car model configured with SYNC®.

It would be easy to be pissed at Ford for what kinda appears to be exploitive use of the diabetes community to generate PR. I don’t think that is entirely fair.

I think Ford has the diabetes community's back. - Literally.

I wear a lot of JDRF walk T shirts. You may too. Mine all have a Ford logo on the back. Ford is a big supporter.

The Ford SYNC® researcher I spoke with about the CGM/SYNC® has type 1 in the family. Type 1 impacts the lives of Ford employees across the spectrum from rank and file to executive management, just like it impacts lives across the world. I think this personal connection is the root of Ford’s research desire to make diabetes management in the car easier.

I think where they may have dropped the ball was in communicating. The impression that CGM and SYNC® will work together in the foreseeable future not a realistic expectation. It is a worthwhile effort. Ford has demonstrated they can do it - so it is not a technical issue. I suggest that sharing CGM data to other means of display is a regulatory hurdle. One that will take a lot of voices to overcome

If Ford’s goal was simply to manufacture a vehicle to generate positive PR about addressing health concerns with out actually doing any actual addressing then they have succeeded. Google can find a lot of stories about it. If Ford really want to be part of the diabetes social media that serves the families of their employees and customers living with type 1 then I think they need to be part of the dialog.

I think Ford gets diabetes because they have coworkers who live with it. Bloomburg may, or may not, be right about a sales surge from SYNC® displaying health information. I think the real motivation is a desire to contribute to better lives through their products. It is what they do. The fact is nothing can happen in an environment that restricts information from regulated health devices from being shard in innovative, useful ways.

I would love to see Ford communicate, through their lobbing team, and share their interest in making driving safer with elected officials. More and more powerful voices can only help.

I would love to be part of that conversation.

Please follow Jeffrey Brewer @JDRFceo

He is on Twitter at @JDRFceo CEO of JDRF, the largest charitable funder and advocate of type 1 diabetes science worldwide.
http://www.jdrf.org or on Facebook at http://www.facebook.com/brewerjeffrey

Pie is Important

Right now very important.





- Posted using BlogPress from my iPhone

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.

Shouldn't Better Diabetes Devices Be BIGGER News?

Pump-hack-gate, yes I am officially going with the gating of the event to signify its significance, continues to get print and now more media attention for the congress members who wrote a letter about it.

Here is the thing that bugs me. Do these same folks have the same interest in keeping people with diabetes healthy? Do they invest a similar concern that Low Glucose Suspend is available in 40 countries around the world but not here in the USA where it was engineered?  Do they cover advances that can save the lives of kids with the same attention that they cover the very unique and isolated hacking of a pump.

No. It doesn't seem so.

I though I was used to the rest of the world not appreciating the real risks of type 1 diabetes. The food police and the ignorant are one thing. One ignorant person at a time. This wholesale stuff with media that are selling their banner ads with stories about what are very marginal risks would do well to learn what the real balancing acts of diabetes are and what the risk associated with them mean in daily life.

http://abcnews.go.com/Technology/wireStory?id=14344300

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? 

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." 

Statement from Bayer on Contour Strip Recall

I just received this statement form Bayer: 

BAYER HEALTHCARE RECALLS 10-COUNT and 25-COUNT VIALS OF BLOOD GLUCOSE TEST STRIPS IN UNITED STATES

US Action Follows Stop-Ship That Began in June


Tarrytown, NY --Bayer HealthCare confirmed today that it is recalling all 10- and 25- count Contour strips and 10-count Contour TS test strips from US retail stocks, retail distribution channels and offices of US healthcare professionals. The FDA is aware of this action.

These actions are not taken as a result of any adverse events reported to Bayer.  Instead, Bayer is taking this action out of an abundance of caution to address a packaging issue which, under certain conditions, can cause some test strips packaged in some small-count vials to operate outside of US FDA-cleared performance specifications and produce a low-bias reading during blood glucose testing. In the FDA’s view, this deviation from US-approved specifications constituted a technical violation that required a field corrective action under US regulations.

50-count vials of Contour test strips are not affected, and strips used with Bayer’s Breeze™2 blood glucose meters are not affected.

This action follows Bayer’s decision in late June to stop new shipments of products containing the small-count vials of these test strips world-wide.  And with no new shipments of small count vials into the market since that time, we believe remaining unused quantities of potentially affected product in the market are likely very small.

While it resolves this issue, Bayer has increased its stocks of 50-count vials and is using these to fulfill new orders to ensure continued, uninterrupted market access to unaffected strips.

Contact:

Susan Yarin
Bayer HealthCare
(914) 366-1738
susan.yarin@bayer.com

Possible Bayer Contour Test Strips Issue

Amy at Diabetes Mine tweeted information about Bayer test strips false low readings. She wrote:

Quality issue w/ BAYER CONTOUR TEST STRIPS 4 #diabetes - some batches create falsely low #bgnow readings cot.ag/qui8Mc

Thanks Amy for brining up the issue.

I wanted more than a tweets worth of information so I called Bayer communications team. There are some possible issues strips that come in cans that shipped with small strip counts. For example: the ten count cans that came with a  new meter.

This is my less than expert understanding: The issues apparently stems from shipping the low count cans and the amount of gas in the can vs strips. It seems the fewer strips and more gas can alter the chemistry of the strips slightly. This creates the possibility of reading slightly lower than they should. For you error grid fans (and there can't be anyone who is an error grid fan) Bayer told me the possible errors are in the non clinically significant error grid ranges.

My conjecture is that the issue also involves time in the cans before being opened as well but that is pure speculation on my part.

Bayer said they have stopped shipping the low count cans.

Bayer says the 50 count cans are OK. They suggest if you have any concerns to talk with you health care team or call their Bayer support number. That number as far as my search engine knows is 1-800-348-8100.

1) Don't stop testing.
2) If you have Bayer strips in cans that came with less than 50 strips call Bayer or your health care team.
3) See #1 above. 

Aug 17, 11 #TwoBits

Here are two bits from around the DOC on stuff that isn't currently available, at least here in the US.

Shoot Up or Put Up has a bit on the OneTouch® Verio®Pro. Pay no attention to the part where they call it an Accu-Check, I think Dave may have been low. 

http://www.shootuporputup.co.uk/2011/08/review-accu-chek-onetouch-verio-pro/

Over at Corengi.com there is a post about Mankind and inhaled insulin trials. Is inhaled insulin something you would want or not so much?

http://blog.corengi.com/2011/08/interview-with-mannkind-corporation-about-new-afrezza-inhalable-insulin-trial/ 

Blue Candlelight

Our dear friend George puts words together to express the emotions behind blue candles.

I can not equal his words to express how the Diabetes Community feels when we lose one of our own.

Please take a moment and read his.
http://www.ninjabetic.com/thebadblog/2011/8/11/blue-candlelight.html

Aug 11, 11 #TwoBits

Here are two great bits from around the DOC today:

Bob on being an advocate life.
http://tminustwo.net/2011/08/10/making-room-for-advocacy/

Caroline Sweeney's letter to the editor is a great role model post for a comment to the FDA:
http://www.pressherald.com/opinion/council-should-extend-petition-limit_2011-08-11.html?pageType=mobile&id=4
(scroll down to "Keep on making progress toward artificial pancreas")

Shark Week in the DOC

It is Shark Week. - A week devoted to stoking the fear of real big fish that can eat you. Not only can sharks eat you  - they wants to eat you, they will eat you. Detailed research by John Beluchi illustrates they ARE coming to your door to deliver a candy-gram.  

One of the staples of shark week are shows by marine biologists who like to get close to big sharks. Seemingly idiotic to us viewers, they study the predators. They try to explain how sharks are beautiful animals and not a real risk to humans. To prove this they get in a cage and provoke a shark to attack said cage. Still some information about the reality of sharks get out.

We love to be scared of things that are fairly unlikely. Sharkattackfile.info list 2 fatal USA shark attacks in 2010. At that rate injury from fights over the remote, while watching shark week, are probably just as serious a risk as an being eaten in a shark attack, land sharks not withstanding. 

Media is about story telling. From the classic camp story about the convict who escaped and is hiding in these woods NOW, to sharks, scary stories sell. There is a word for this. It is sensationalism. It is a noun meaning (esp. in journalism) the use of exciting or shocking stories or language at the expense of accuracy, in order to provoke public interest or excitement. 

This week, in addition to shows about sharks, the media is writing about insulin pump hacking. From what I have seen the stories don’t much understand living with a pump and the associated risk of diabetes. The media do show good imagination in creating shock and exciting language to provoke public interest. 

Let be honest the public is not otherwise NOT interested in insulin pumps or living with diabetes. We hold theses truths to be self evident. Hell we’ll raise a bowl of ice cream in  to honor the idea. Maybe we need to take a page from the sharks and use our week to share some of the stories about really living with diabetes. 

Let’s view the hacker as the marine biologist in a cage. He is gonna see some teeth. But there are steel bars between the teeth and the camera. The hack is possible but unlikely.

The reality is diabetes is not tame. It is a real big fish that can eat you. Not only can eat you - it wants to eat you, it will eat you, unless you are constantly vigilant. (Yes I know I just mixed references to Jaws and Mad Eye from Harry Potter)

Those of us who live with diabetes have an opportunity to focus on the real risks we live not sharks.  

Repeat After Me: Dear FDA...

The FDA is seeking comments on how to evaluate diabetes related innovations, specifically, Low Glucose Suspend. In the simplest language that is stoping an insulin pump from delivering insulin into a person that is hypo. This is a step towards and artificial pancreas. 

You can read the proposed guidnace (it run 55 pages) at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM259305.pdf 

Here is my four point, overly short, version of what the FDA is seeking comments on:

• The FDA is proposing guidelines to consider approving low glucose suspend.
• Low glucose suspend can stoping delivery of insulin to people who have had too much already.
• The FDA is considering a lot of things including the risk of raising A1C with such a system. 
• The FDA are open to considering studies for people under age 18 but they are not there yet.

My feelings is the FDA is way behind the times. Systems designed and made in the USA are on sale around the world but not here. In part because the FDA doesn’t know how to approve it. 

We deserve better.

There are a lot of reasons why we all should comment. If you care about artificial pancreas you should comment. If you don’t care about artificial pancreas you should still comment.  

I think the most important reason for us all to comment is so that the FDA sees the diabetes community as a group that is capable of, and willing to, hold the FDA’s feet to the fire. The DOC should be the FDA's squeaky wheel. 

People living with diabetes needs are different than virtually all other medical conditions. This is due to the extremely high level of self-management we do daily. The FDA should come to expect the DOC to comment on diabetes issues from artificial pancreas, faster insulin, smarter insulin, encapsulation of islets, and my pet peeve device interoperability through data sharing. Our voices should be part of the regulatory process. By commenting on as many diabetes issues as the FDA opens dockets for we can exercise such a voice. 

The more - the better.

The issue at hand is low glucose suspend. Given the tragic cases of young lives lost to severe lows, providing tools that can help minimize and prevent such lows is important. 

I of beg you, please do three things

1. Learn about the FDA’s proposal.
2. Comment on it
3. Send a copy of your comment to your Congressperson

The comment space is 2000 characters. Think of it as one big-ass tweet. 

I encourage you to share what you write the FDA with the DOC - let others to use it as a template or help for their own comments. I welcome anyone willing to post what they write to the FDA as a link or comment here for others to use as inspiration and or a cheat sheet. 

To post to the FDR public docket go here: http://www.regulations.gov/#!submitComment;D=FDA-2011-D-0464-0001

Please also copy your comment into a email to your elected officials in DC. (I did mention squeaky and the more the better right?)

The following are a few sample comments that I offer up to be copied, edited and abused as form letters. Each are well under the 2000 character limit giving you room to expand, personalize and otherwise riff on the theme.

A Comment on Live Lost to Hypos:

I am a parent of a child with type 1 Diabetes.  Type 1 is extensively managed in the home by families. Yes we have a medical team of physicians, nurses, educators and more but day to day actions and decisions are made in the home by parents and teens living with diabetes.

Diabetes is difficult and stressful to manage. Diabetes varies based on a vide variety of things. The biggest risk we face and the biggest fear we have as parents is a severe hypo that results from the variety of things that impact diabetes. 

This is particularly stressful at night. As you consider low glucose suspend and it non inferiority based on A1C please keep in mind that a number of young people in the type 1 diabetes community have passed away due to over night hypos recently. Being alive with a A1C that increase due to low glucose suspend would be vastly superior than another fatality from a sever night time low. 

A Comment on Pediatric Approval and A1C Varibility:

Our family lives with type 1 diabetes. Day to day we are the primary managers of this chronic condition guided by our doctor and nurse educator. 

As the FDA considers low glucose suspend I urge you to fast track the pediatric approval of such a  device. Younger, smaller people are more sensitive to insulin as either basal or bolus injections. As such they tend to vary more than older people. Also kids face hormonal issues with growing that significantly impact and change insulin needs. Significant dose needs can change as rapidly as a few weeks. 

With the higher insulin sensitivity and more variable insulin needs due to growth, children are likely to see a wide variability in blood sugar numbers expressed as A1C. This proposal suggest non inferiority based on glycemic control as quantified by A1C. As you evaluate pediatric use please consider that kids’ glycemic control is a wider range of variability that adults. 

This higher variability means kids may see more and more severe hypos than adults. As  a result they are more at risk and are more in need of low glucose suspend. 

Please move to establish guidance for pediatric approval of low glucose suspend that recognized both the more pressing need to keep children safe and the higher variability in their glucose control. 

A Comment on FDA Proactivity:

As you consider guidelines for low glucose suspend, I urge the FDA to move from being behind the ball to being proactive. Low glucose suspend is already approved and available for patients across the world. It has been coming for some time yet the FDA seems to have been unprepared for it.

The FDA should consider developing guidelines for the more advance possibilities of an artificial pancreas. This would include the low glucose suspend now under consideration, possibly systems that introduce means glucagon for severe lows as well has high glucose insulin bolusing. Beyond the artificial pancreas the FDA should be preparing guidance for the approval of faster insulins, smart insulins, better infusion sets and data processing tools that facilitate better manual and automated glucose management. 

A Comment on Hacking and Distractions. 

In the time since the  FDA has opened this docket to consider devices to better manage type 1 diabetes through low glucose suspend, provided by multiple devices that communicate wirelessly, there have news reports about ‘hacking’ diabetes device wireless communications. 

The possibility of such interference is an appropriate issue for the FDA and device manufacturers to consider and to address in a timely manner. However such willful interference is extraordinarily unlikely. It  should not be seen as a reason to prevent far more significant advances to mitigate far more significant risks.

Specifically in the case of low glucose suspend, the risk of severe hypoglycemia is a real risk that has been made all the more tangible by the untimely death of young people living with type 1 diabetes in the past year. Developing guidance for the approval of devices that may have helped prevent such tragedies should be a FDA priority. Given that such devices are approved and available in other countries suggest that the FDA guidance, under consideration here, is in fact over due. 

I strongly urge the FDA to prioritize risks. Hypoglycemia is currently costing the lives of American children. Guidance on device such as low glucose suspend should not be overly delayed by esoteric communications risks.

Pump Hacking and What Really Matters.

In todays news: Insulin Pumps can be hacked. 

Here is one of many news links:
http://www.npr.org/templates/story/story.php?storyId=138976508

I don’t find it at all surprising that pumps and meter communications can be hacked. Nor do I have a big issue with the idea of publishing it, particularly at a hacker convention in Vegas. 

There is an appropriate flow of information. I don't think legitimate hacking is an oxymoron. People find vulnerabilities. They make them know. The folks who make the products fix the issues. I am good with that. 

I know that I ‘hacked’ the very first pump my we had - kinda. The organization of the food database was a mess. The first few categories of foods presented were not things my 5th grade son was interested in eating (Baby Food & Beans.) I wrote the manufacture about what I saw as a usability short coming - nothing came of it.

That food database was a mark up language. I found I could manually manipulate that markup language in a text editor to put foods into the more accessible beans and baby food categories that they didn’t belong in. Well unless Lucky Charms are baby food. I guess some would make the argument that they are intended to be kids'  food and go all food police on who eats what.  But the food police are not the point here, devices are. 

Even with my hack the food database was not a great set up. I would love to see a convenient food database, one that built meals like an iPod makes song lists from a library of foods but that ain’t happening. I think the kind of advancements in user interface, like that, are for the most part, prohibited by the process of getting the FDA to sign off on changes. It simply costs too much to be worth while. 

So I hacked the food database. I am not surprised to hear that someone else hacked pump communications. I don’t think the rest of you should be too worried - both of us are fairly harmless geeks. 

Short of an elaborate Colombo episode, I don’t see much incentive to maliciously hack a pump or meter. It apparently takes skill, equipment and being reasonably close to the device in question. In day to day life how often is your pump close enough to a highly skilled geek who wants to hack your pump and has a bag full of gear handy?

I think there is a risk of unintended ‘hacking’ in households with multiple people on similar devices. Say little Jane and big brother Johnny both use brand X pumps with remotes. Those remotes are basically indistinguishable. Their baby brother craws over and pulls the remotes off the table and onto the floor. There, baby pulls them out of their cases and make a general mess. (Babies do this kinda stuff for fun and they are WAY good at it.) At dinner Jane and Johnny bolus. It seems to me that in picking them up and putting them back in their pink and black cases the remotes could easily be switched. Johnny picks up Jane’s remote thinking it is his, knows he needs 12 units and fires away, shooting his little sister a bigger bolus than she needs or can reasonably eat to cover.  

I think that is a far more real risk than malicious wireless hacking. I worry that the news of the wireless vulnerability reported above will distract development and regulatory efforts from making diabetes devices more useful. Useful like say different color remotes, usable food databases, smartphone data exchange or the holy grail - data standardization. 

The real risk in my mind is a paralysis based on fear of the phenomenally unlikely that prevents the eminently useful from coming to market. Now you may think I am nuts. Many will agree with that. I don’t have much I can put up to defend myself from claims of craziness. I will however offer this:

Fear of adverse reactions, including raising A1Cs some undefined but magical amount, and a feeling that studying those fears is critical, is keeping advance diabetes management tools from people living with diabetes in the USA. Consider the auto suspend pump based on CGM data - it is available in a lot of countries other than these United States. The FDA doesn’t even have rules in place to consider approving it. 

They are afraid of the wrong thing. 

This is a year where a number of young people have passed away from overnight hypos. It seems to me that the fears around incremental changes in A1C from low glucose suspend systems are preventing tools, that may have saved lives, from getting into the homes that need them. I fear that kind of mistaken priority. I fear this hacking news could make such priority errors more common. 

There are real risks involved with living with diabetes. We know that. We manage the fear associated with that and diabetes together. We need to focus on the real issues, not unlikely ones. The risk of insulin pumps being hacked is not anywhere near as news worthy as the fact that US access to technology is behind the rest of the world's. That devices that are designed and manufactured here, are only sold overseas, is a real issues.  

I submit that the cost and delays involved with the FDA regulatory process are more harmful than a hacker in Vegas. What happens in Vegas stays in stories that don't stay in Vegas.  What doesn’t happen in Washington costs lives across America. 



Please read my good friend Kerri's post on this same subject at:
http://sixuntilme.com/blog2/2011/08/hacked_jay_radcliffe_insulin_p.html

Or Scott Hanselman's (Of Scott's Airplane Analogy in my side bar) at:
http://www.hanselman.com/blog/HackersCanKillDiabeticsWithInsulinPumpsFromAHalfMileAwayUmNoFactsVsJournalisticFearMongering.aspx

Kelly Booth: 

http://kellywpa.wordpress.com/2011/08/07/pump-hackers-revisited/#comment-2184

Mike Hoskins
http://www.thediabeticscornerbooth.com/2011/08/hacking-into-real-concerns.html

Sara Nick's
http://momentsofwonderful.com/2011/08/08/insulin-pump-hackers-do-not-care-about-me/

Matt McGuire
http://type1online.com/hacking-insulin-pump-47.html

Medtronic response on TuDiabetes
http://www.tudiabetes.org/forum/topics/pump-hack-q-and-a-posts

Animas response on TuDiabetes
http://www.tudiabetes.org/forum/topics/statement-from-animas-about-pump-hack

K2
http://diabetesaliciousness.blogspot.com/2011/08/im-not-afraid-of-my-pump-being-hacked.html