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."