#TwoBits: ThreeBits and Ice Hockey, DSMA & DiabetesMine

Here are a Two Bits from the DOC that are worth a look today:

Cherise (aka Charisse according to my iPad's voice recognition) one ups two bits with three:

DOC Survey, HIPAA and Clinical Trial on a Diabetes App 

I am coping the first 'cause doing this survey can help DHF help us all. Win win.

Michelle Litchman is NP, doctoral student and a big supporter of the diabetes online community. For her dissertation, she is focusing on the Diabetes Online Community and Health Outcomes Research as it relates to peer-to-peer health. Michelle will donate $2  (up to $2,000) to the Diabetes Hands Foundation for every survey completed. For more information and to complete the survey,  http://www.tudiabetes.org/forum/topics/doc-and-health-outcomes-research.

Thanks Charisse (even my iPad can't spell.)

Will has a good piece at Diabetes Mine on Andy Suhy, ice hockey player and diabetes motivator. I particularly liked this part:

Andy describes diabetes as a “very complicated balancing act” that’s 95% about emotions and taking ownership, and only 5% about carb-counting and insulin dosing. 

Will closes with a little nuance around T1D vs T2D attitudes and maybe motivating the motivator:

Still, we have to be united in our front against diabetes — of all types. None of us can afford to have a “blame the patient” attitude, because that effects everyone. 

And you can’t be a good cheerleader if you don’t like the team.

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? 

t:slim in the Wild: Bill's New Insulin Pump

Friend of the DOC and Glu Community Guru Bill Woods has the earliest review of a t:slim pump in the wild I have seen. You can read about his first impressions here. While you are clicking about Like Glu on Facebook http://www.facebook.com/MyGlu

I like this I had to recycle it. 

A lot of other folks have written coming attractions pieces for this thing. Including:

Like Bill good friend Bernard Farrell is moving from a Cosmo to a t:slim. I haven't seen his review but here is one of his posts about the choosing pump at Diabetes Daily.
http://www.diabetesmine.com/2012/07/tandems-tslim-up-close-and-personal.html
http://www.ydmv.net/search?q=t%3Aslim

I think more options is good news. YDMV so pump choices do too. 

Gridlock Jeopardizing FDA User Fees?

I babbled about MDUFA in July.  I likened MDUFA to the movie Lion King, in which case this story is about Scar leaving Simba to die.

The readers digest version is that MDUFA is Medical Device User Fee Amendment. It is a way for fees to be collected to fund FDA reviewing medical devices. This summer's version of MDUFA put some time tables on the FDA reviews. In simple terms the idea is industry pays a fee to fund reviews of devices and the FDA has a clock running to do those reviews.

Why does it matter in diabetes land? When and if there is a requirement for BG meters to be +/- 15% the regulatory review of those new meter will be funded by fees paid by industry and the FDA will do the reviews timely. PWD get more accurate meters. Yay.

Maybe not. 

Mass Device reports on a Bloomberg Newsweek story (sorry I haven't found that Bloomberg/NW piece yet) that the deal may be in trouble due to congress's in ability to act on the budget. The FDA can't spend the user fee money without trigger funding from Congress.

From MassDevice.com

The $610 million deal between the FDA and the medical device industry is in jeopardy as Congress dithers over the federal watchdog agency's budget, meaning that product reviews for devices and drugs could slow or even grind to a halt, according to Bloomberg BusinessWeek. 

That's because the FDA can't spend a dime of the user fee money until it receives trigger funding from Congress, an FDA spokeswoman told the news service. With Democrats and Republicans perpetually at odds on Capitol Hill, this time over a proposed $1.2 trillion in budget cuts over the next decade, that all-too-familiar Beltway stasis "could result in the loss of whole user fee programs, programs that have become essential to public health and medical product innovation," the spokeswoman wrote in an e-mail.

More: https://www.massdevice.com/news/medical-devices-fdas-user-fee-deal-rocks

T2D? Take the Diabetes Mine Meter Survey

Diabetes Mine has interesting survey about T2D and meters. They are seeking to learn how T2D live with and relate to BG meters.  What were we taught to do with the information the meter produces and how does all that impact taking care of our diabetes.

I am interested to know the results and of course the more people take the short survey, the more interesting the results will be.  So my fellow T2s hop on over and fill it out.

http://www.diabetesmine.com/2012/09/call-for-input-glucose-monitoring-experiences-of-type-2s.html

Worsening Outlook for 2013 FDA Budget

From FDA News: Device Daily:

Worsening Outlook for 2013 FDA Budget: Estimate of Budget Reductions GrowsThe FDA will likely see its budget reduced by $294 million if across-the-board cuts to federal programs go into effect on Jan. 2, 2013, as currently planned; the cuts are needed to comply with a congressional mandate to reduce the federal deficit. The FDA is planning for a budget reduction of roughly 8 percent. Initially, industry observers had thought the FDA reduction would total about $200 million, reflecting reductions to just the $2.5 billion taxpayer-funded portion of the FDA budget. 

Editorial
Congress' in ability to fill its constitutional role as the source of all spending bill has brought our country to the point of these across the board cuts. The house in particular seems to put partisan gamesmanship and striving to star in simplistic sound bites in front of working as whole body to produce a workable national budget. I don't see how the FDA will be able to do its job assuring safe and effective food, medicine and devices with out the funding to accomplish it. 

Please Respond to These Patient Advocate Question at Linked

Hi Friends

Here is a chance to share you views with the FDA through a patient advocate:

http://www.linkedin.com/groupAnswers?viewQuestionAndAnswers=&discussionID=161349966&gid=129291&trk=eml-anet_dig-b_nd-pst_ttle-cn&ut=0ldkPeXf8TERo1

Here is the post from Linked In. 

Hi All - Through my role as a diabetes patient advocate/advisory committee member with FDA, I was invited to participate in a series of FDA meetings about setting up a process for doing medical device comparative effectiveness research and post-marekting surveillance. FDA is working on creating a system to collect and analyze medical device data that will provide a way to understand/monitor the safety and the "comparative effectiveness" of medical devices, once they have been approved and are on the market. My role is to provide the patient perspective on the development of the program and give input into the type of information patients need/would like to have about medical devices.
I would love to get your input, so that I'm representing not just my point of view, but that of others within the community. Toward that end, I've posted a couple of questions below. I would love to get your responses to the questions, as well as any other input you might have on the topic. 
For those of us with type 1, our lives depend on our devices. I'm hoping you'll take a couple of minutes to help me include your voice in my remarks. You can respond privately via linked (or her email linked there). Thanks so much! - Anna
___________________________________________
Where do you get information about the medical devices you use to control your diabetes?
Have you ever searched for information on safety/effectiveness of your pump and/or meter?
Have you ever had the sense that a lack of information about device safety/reliability affected your treatment decisions and or health care?
If you have had meter/pump malfunctions in the past, have you ever reported your malfunction to:
-FDA's Medwatch Web site?
-Your doctor?
-Your device manufacturer?
Have you ever changed devices (pump or meter) based on issues related to device reliability, malfunctions or errors?
If so, where did you go to find information about the new product you selected?
As a patient/caregiver, are you aware of any diabetes device registries where you can access information about diabetes device safety/relative effectiveness?
As a patient/caregiver, if the government and industry were working to create a nationwide device database:-What types of information would you like it to provide?-Would you want to be able to access the information directly?-Would you prefer to rely on medical researchers/diabetes societies to fund research based on the registry database?

Little Help for PWD in Gulf?

This post is just s flat out copy of Tom's from Diabetes Dad

I have an extra meter and strips from a trade show. I can sen them to help out. Who else can lend a hand? 

http://diabetesdad.org/2012/09/08/dire-need-of-diabetes-supplies-due-to-hurricane-isaac/

Dire Need of Diabetes Supplies Due to Hurricane Isaac

Hurricane Isaac slammed into the United States leaving behind a land of ruin and devastation.

A while ago I reached out to the LIONs Club International Foundation(a service organization that helps those in need and also has diabetes as a priority)(LCIF).The LIONs have boots-on-the-ground around the world and the idea was that if there was ever a need due to a natural disaster; we would work together in supplying diabetes supplies to the impacted area.

I called it the I.D.E.A. Plan. International Diabetes Emergency Action Plan.

NEVER, did I think a need would come so fast.

Hurricane Isaac ravaged the areas it hit and destruction was left in its wake. And the call came.

KaSondra L. Byrd, Manager, Humanitarian Programs for the LCIF reached out and there is a dire need for diabetes supplies.

I have listed the information below to ship diabetes supplies; you can help.

They are presently in need of:
Meters, Lancets, Strips, Alcohol Swabs, and Gloves (Medium size) (again no insulin is needed at this time)
Requested meters are those which require no coding—any brand will do.
PLEASE—ONLY SEND THE ITEMS LISTED
You should know that these supplies will be given at no charge to those in need.

They are attempting to give people a 30-60 day supply of items and as a starting point; figure for about 400 people (we will gauge again and reevaluate in about a week to ten days).

Send to:
Dr. Miriam J. Gray
Gulf Coast Health Educators
212 E, Second Street
Pass Christian, Mississippi 39571
Again, this is a 501 (c) 3 agency helping those with diabetes (both type 1 and type 2).

IMPORTANT: IT IS IMPORTANT TO KEEP AN INVENTORY OF WHAT IS BEING SENT.  VIA A COMMENT ON THIS TOM's BLOG, KINDLY INFORM ME WHAT YOU ARE SENDING AND I WILL NOT POST THE RESPONSE, I WILL USE THE REPLIES TO KNOW WHAT IS BEING SENT AND THEN DELETE. 

Any questions, let me know.

Anything that you can send will help someone in need and remember kindly ONLY SEND what is requested and please inform me of what is being sent. Thank you for caring. I am a Diabetedad.

 13 0 78

#TwoBits from Industry. Glucagon Training App and Bayer Meter Talks to Medtronic Pump.

#TwoBits of news today. I use to call this stuff From the News Wire!

Bayer / Medtronic 

Bayer and Medtronic have a press release out today announcing the Contour Next Link.  Think Bayer USB that connects to a Medtronic meter - except this is charcoal grey not black. It uses new, improved and more accurate strips. I hope to read up on the more accurate part at a later date. I will be back when I do. Mean time read Riva.  

Groovy Photo from: http://diabetesselfcare.blogspot.com/

Review of the meter:  http://diabetesselfcare.blogspot.com/2012/04/medtronic-trial-bayer-contour-next-link.html

From the Press Advisory: 

Medtronic, Inc. (NYSE: MDT) and Bayer HealthCare today announced that Bayer’s CONTOUR^® NEXT LINK, a new blood glucose meter, is now available in the U.S. with Medtronic’s compatible integrated diabetes management systems. 
Bayer’s new meter provides exceptional accuracy utilizing high-performance CONTOUR^® NEXT test strips, helping optimize insulin delivery through wireless communication with the MiniMed^® Paradigm™ REAL-Time Revel™ insulin pump and the MiniMed^® Paradigm™ REAL-Time insulin pump. People with diabetes can have greater confidence that seamless integration with Medtronic’s Bolus Wizard^® makes bolus calculations quick and easy, eliminating inaccuracies due to manual entry errors.

This will be available to new Medtronic pump users starting now. The expectation is that existing customers can get it over the "next few months." I think you should look for the Bat Signal or a message from Medtronic in January. 

OK Bat Signal aside - here is the real text from the release:

Starting today, new Medtronic customers will receive CONTOUR^® NEXT LINK with any new pump order. Existing customers will be contacted by Medtronic and provided with new meters over time, beginning in January of 2013.

More from Medtronic:
http://www.loop-blog.com/blog/Update-on-Linking-Blood-Glucose-Meters-for-Medtronic-Insulin-Pumps

Lilly

Lilly Diabetes today announced the release of a new mobile application designed for caregivers and healthcare providers who support people with type 1 diabetes. The Lilly Glucagon Mobile App is a tool to teach how to use Glucagon for Injection, through simulated practice. 

The app is here:

http://itunes.apple.com/us/app/glucagon/id553314007?mt=8

More information is available from the Lilly press release here: 

https://investor.lilly.com/releaseDetail.cfm?ReleaseID=704061

Pediatric Trial Dexcom G4 Recruiting.

Details at:

http://clinicaltrials.gov/ct2/show/NCT01667185