September 30, 2012

Of Kayla and Chenmistry

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Tom Kayla friend and fellow dad of T1D kids has a great post up called, “Parents, Diabetes, IS Not Yours, Give it Back.” In that article he talks about diabetes and families. This is my response, compliment, echo and building from his piece. You should probably read his first so feel free to click over there, this will still be here when you are finished.
http://diabetesdad.org/2012/09/29/parents-diabetes-is-not-yours-give-it-back/ 

Also you should be warned now I like Mr. Wizard, Bill Nye the Science Guy, Magic School BusThrough the Wormhole and many other similar TV shows. (Feel free to suggest  more to the list in comments, riffing on TV shows is fun.) If a tiny amount of science isn't your thing, bail out now.



I have often said Diabetes is a catalyst.  In chemistry that is something that makes reactions happen that would not have happened or makes reaction happen faster. Folks often talk about family chemistry. So it is my bet then is that catalysts are true of families as with petri dishes.

Diabetes, in many ways, makes kids grow up faster and take on responsibilities that parents may not be ready to give up. I think all parents struggle with giving kids appropriate and increasing amounts of independence.

Diabetes is a catalyst for that. More responsibility, sooner is hard. Diabetes often speeds the process of independence. Kids start independently dealing with their day to day diabetes care long before we give them keys to a car and other freedoms in their lives.


In ways that is perverse or at least reveres of what we would want. Think about it. What would you rather see your kid do first; dose and take a lifesaving but potentially fatal drug multiple times a day or drive and be responsible with a curfew? I am willing to take odds on drive and curfew.

So many of us T1d parents have had to do that the other way around. It is hard to believe we are sane. Honestly, I am willing to take odds few of us are sane or at least many are overly cautious.

It is hard to give that independence and maybe see BG rise. Hopefully that is a short term thing that leads to long terms successful self management. We would rather strive for a false perfection reflected in hour to hour numbers than the uncertainty of independence.

Many parents of T1D kids, who share my age and cultural habits, are likely to face diabetes ourselves, T2D. The day to day management of T2D is different than T1D and it is oh so easy to see T2 as less significant for those differences. Diabetes is a rat bastard as well as a catalyst. In my own case that rat bastard, and my parental inclinations are to do for my kids first, meaning I am tempted put aside my own care to worry about the kids’. Again to betting on a false short term misconception and giving T2D odds in the long term.

I am trying to not to let my understanding of T1D be the an inhibitor of T2D care.  That is the opposite of a catalyst. Something that slows down a reaction, my reaction to my own diabetes. I am not doing very well at it.

There is a different diabetes. One that is mine. One I should care as much about it as I do my kids'.  

September 29, 2012

GAO on Medical Device Security

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Here is the recommendation from the GAO study of FDA Should Expand Its Consideration of Information Security for Certain Types of Devices

Recommendation for Executive Action
Recommendation: To better ensure the safety and effectiveness of active implantable medical devices, the Secretary of Health and Human Services should direct the Commissioner of FDA to develop and implement a more comprehensive plan to assist the agency in enhancing its review and surveillance of medical devices as technology evolves, and that will incorporate the multiple aspects of information security. This plan should include, at a minimum, four actions, such as determining how FDA can (1) increase its focus on manufacturers' identification of potential unintentional and intentional threats, vulnerabilities, the resulting information security risks, and strategies to mitigate these risks during its PMA review process; (2) utilize available resources, including those from other entities, such as other federal agencies; (3) leverage its postmarket efforts to identify and investigate information security problems; and (4) establish specific milestones for completing this review and implementing these changes.


http://gao.gov/products/GAO-12-816

September 28, 2012

Participatory Medicine

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Here is my readers digest collection of quotes that show why I found the article worth sharing. I particularly like the last one. It is create a to do for the patient side; talk about what to do not just complain. 


"...trying to transform the way doctors and others throughout the health care system relate to every patient with every disease. 
"Activists accustomed to being lonely voices crying for change mingled with others who were like-minded, made common cause and laid a foundation, perhaps, for speaking with one voice. 
"...a glimpse of what the future might be in health information technology.... a personal health record and an interoperable electronic medical record might be tied together to improve care and lower cost while keeping patients and their families at the center. 
“When patients tell their stories, they need to tell us what to do about it.”

September 26, 2012

#TwoBits one Link Karen & Kim

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Should Diabetes be on the Agenda of Upcoming FDA Public Meetings?

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Please share your voice. Ask the FDA to include diabetes in their public meeting process. 

The FDA is asking for public comments on twenty topics in meetings on patient-focused drug development. The FDA says the idea is a systematic way of getting patient views on the severity and treatments for a set of disease areas. They have a preliminary list of nominated diseases. Diabetes per say and the specific types of diabetes are not on the list. Two specific diabetes complications are; diabetic ulcers and diabetic foot infections. 

Twenty diseases and diabetes isn't on the list. That does not seem balanced. I think the DOC should get diabetes on the FDA's list. 

I would like to see this PDUFA effort consider diabetes in a manner similar to how they propose treating cancer. If you do too please comment to the FDA.

The proposed cancer areas are a more divers perspectives. For example the draft offers to consider; melanoma, lung cancer, cancer and young patients, cancer treatment in pregnancy, cancer and sexual dysfunction, cancer and depression. So how about T1D, T2D, diabetes and young patients, Gestational and other diabetes and pregnancy, diabetes and sexual dysfunction, diabetes and depression.

If the FDA is holding meeting on twenty diseases one topic should be diabetes. The FDA is open to diseases not on the proposed preliminary list. They ask when offering an additional disease for condition for consideration the following criteria be used:
  • Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
  • Disease areas that reflect a range of severity;
  • Disease areas for which aspects of the disease are not formally captured in clinical trials;
  • Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
  • Disease areas that represent a broad range in terms of size of the affected population; or
  • Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.

There is a public meeting. More information is available in the Federal Register: 
Comments can also be sent before Nov 1 2012.
http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0967-0001

My comments are:



I thank the FDA for this opportunity to share views as a patient on the development of medications. I am a parent of two type 1 teens and a pre type 2 patient myself. We are just few of the over 25 million Americans that the CDC estimates live with diabetes.  I urge the FDA to consider a wide perspective on diabetes in this PDUFA meeting process. Specifically I hope the FDA will dedicate one of the twenty planned disease topics to diabetes. That should include at all forms of diabetes and their related complications. Specifically diabetes should be viewed by its different types, Type 1, Type 2 LADA and gestational. 

Type 1 and LADA are chronic autoimmune diseases that have a significant impact on patients’ lives. All forms of diabetes require daily behavioral changes. Bond et. al. write in the May/June 2010 Diabetes Educator, “Despite advances in treatment regiments now available for care, the self management activities of diabetes remain complex, with treatment recommendations difficult to incorporate into existing lifestyles. The daily management of diabetes can be overwhelming.”1 

The severity of changes to live with diabetes vary. For some, like myself, healthy activity and diet may manage blood sugar. For other, including my teens, significant effort is required through out every day to replace insulin destroyed in the autoimmune form of the disease. For all there are significant life changes.

Innovative medications offer the promise of better outcomes. Glucose responsive insulins (GRI) may help minimize potentially fatal hypoglycemic risk of using insulin. The FDA should be preparing the expertise needed to efficiently evaluate this innovation. By doing so the agency can expeditiously consider GRI applications.

The FDA can help foster evaluation of better treatments for the very young T1D patients. Little children respond to very small amounts of insulin. Their developing communication skills make it difficult for them to share with parents and care givers when they are experiencing hypoglycemia. Many children and adolescents are not aware of theses symptoms. 

Mental Health issues are more common with people with diabetes.2,3,4  Van Bastelaar et al site estimations that as many as “20% of diabetes patients suffer from clinical depression.”

Diabetes is a significant public health issues. As such, I hope the FDA will consider a board evaluation of the issues diabetes patients face in the PDUFA meeting process. 



1 Bond, G. E., R. L. Burr, F. M. Wolf, and K. Feldt. "The Effects of a Web-Based Intervention on Psychosocial Well-Being Among Adults Aged 60 and Older With Diabetes: A Randomized Trial." The Diabetes Educator 36.3 (2010): 446-56. Print. 

2 Van Bastelaar, Kim, Pim Cuijpers, Fran├žois Pouwer, Heleen Riper, and Frank J. Snoek. "Development and Reach of a Web-based Cognitive Behavioural Therapy Programme to Reduce Symptoms of Depression and Diabetes-specific Distress." Patient Education and Counseling 84.1 (2010): 49-55. Print. 
3 Anderson RJ, Freedland KE, Clouse RE, Lustman PJ. The prevalence of comorbid depression in adults with diabetes: a meta-analysis. Diabetes Care 2001;24:1069–78.
4 Mosaku K, Kolawole B, Mume C, Ikem R. Depression, anxiety and quality of life among diabetic patients: a comparative study. J Natl Med Assoc 2008;100:73– 8





September 25, 2012

Glooko expands meter line

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Glooko is has added more meters to the list they and download.

·      Bayer's CONTOUR® NEXT EZ
·      Bayer's CONTOUR® XT
·      GLUCOCARD® 01
·      GLUCOCARD® VitalTM
·      ReliOn® Confirm
·      ReliOn® Prime

http://us4.campaign-archive1.com/?u=3818427fadb6a6b6db4ecc9c8&id=aed08d0498&e=1f23a1c583

FDA Notice on PDUFA

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Attached is a notice from the FDA on Prescription Drug User Fee Act. It seeks to set up public meetings for 20 different disease areas. The candidates are:


Pulmonary arterial hypertension. 
Heart failure.
Primary glomerular diseases.
Narcolepsy.
Huntington’s Disease. 
Depression.
Autism.
Peripheral neuropathy. 
Fibromyalgia.
Obesity.
Nocturia.
Chronic fatigue syndrome.
Irritable bowel syndrome.
Inflammatory bowel disease.
Alopecia areata.
Diabetic ulcers.
Female sexual dysfunction.
Interstitial cystitis/painful bladder syndrome.
Fracture healing.
Diabetic foot infections.
Hepatitis C.
HIV.
Patients who have experienced an organ transplant.
Sickle cell disease.
Chronic graft versus host disease.
Amyloidosis.
Aplastic anemia.
Melanoma.
Lung cancer.
Cancer and young patients.
Cancer treatment in pregnancy.
Cancer and sexual dysfunction.
Cancer and depression.
Clotting disorders (e.g., hemophilia A (factor VIII deficiency) and von Willebrand disease).
Thrombotic disorders (e.g., antithrombin deficiency and protein C deficiency).
Primary humoral immune deficiencies (e.g., common variable immune deficiency).
Neurologic disorders treated with immune globulins (e.g., chronic inflammatory demyelinating polyneuropathy).
Hereditary angioedema.
Alpha-1 antitrypsin deficiency. 

The FDA notice reads as follows:

As part of the performance commitments of the fifth authorization of the (PDUFA V), FDA has published a notice in the Federal Register related to Patient-Focused Drug Development, an initiative that provides for a more systematic approach to obtaining the patient perspective on certain disease areas in PDUFA V.  

Over the next five years, FDA will conduct public meetings for 20 different disease areas. The meetings will focus on the patient perspective regarding two key considerations in FDA’s regulatory decision-making: the severity of the disease and the currently available treatment options. In determining the disease areas that will be addressed in these meetings, FDA has published a preliminary list of nominated diseases in a Federal Registry notice. The public is invited to comment at a public meeting on October 25, 2012, where FDA will provide an overview of Patient-Focused Drug Development. Registration to attend this meeting must be received by October 18, 2012. For more information about this meeting, including the list of nominated diseases, see the Federal Register notice (http://www.gpo.gov/fdsys/pkg/FR-2012-09-24/pdf/2012-23454.pdf). The public is also invited to submit written comments into the public docket FDA-2012-N-0967 (http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=pdufa). Written comments are due by November 1, 2012.  

In addition to the October 25th meeting to “kick off” planning for the 20 disease-related meetings under the PDUFA V performance commitment, FDA will also conduct periodic consultation meetings with patient stakeholders regarding process issues related to the agency’s implementation of Patient-Focused Drug Development. The consultation meetings will address important considerations and challenges in establishing and conducting a process that will be useful to both the patient community and FDA. The first of these consultation meetings will take place on October 10, 2012. Notification of intention to participate in this series of meetings must be submitted by October 3, 2012. For more information about these meetings, see the Federal Register notice  (http://www.gpo.gov/fdsys/pkg/FR-2012-09-24/pdf/2012-23453.pdf).

We look forward to your participation in this process. If you have any questions, please feel free to contact the Office of Special Health Issues at301-796-8460.

Mobile Health "Significant" for Low Income PWDs

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Mobiheathnews has an interesting report on the possible impact of mobile health for lower income PWDs. I was a little confused as to who was going to pay for what. Particularly in an environment where the value of BG testing is questioned and number of strips restricted in to low income patients.

http://mobihealthnews.com/18518/report-mobile-significant-development-for-low-income-diabetics/

For me the real issues with diabetes care, for any economic group, are; will there be good education and support for the changes that education promotes. Mobile gizmos are cool but better health will come from teaching people how to take care of themselves and supporting them in making those changes.


For the T2D community that may well mean better access to health foods and safe walkable environments that promote more active living. An anonymous 'mobile health' text message to walk is not going to be anywhere near as effective as a group at church or on the block that is mutually supportive of getting together to walk and eat a more healthy diet. Admittedly that isn't as sexy but






September 24, 2012

Celebrate Diabetes Art Day! #DArtDay

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Celebrate Diabetes Art Day!


Diabetes Art Day
Click the picture. Browse the Galleries. Enjoy.

Celebrate. Today is  #DArtDay.

Diabetes Art Day is Celebration. Not of diabetes but of the diverse individuals who live with it. Diabetes is a daily challenge. Living well with diabetes requires connections and creativity. So does art. Today is the day to stretch that creativity in different ways. 

Join the fun. See thing differently. Celebrate creativity. 



Here is My Piece

Diagnosis Detonation



A diabetes diagnosis seems like a massive blast. A mushroom cloud of confusing terms and responsibilities seems all consuming. All kinds of strips, sets and scrips seem to create a cloud that blocks out all else. Hopefully, in time that cloud shrinks. This one less than a foot tall and was made with laughs and smiles as well as strips, sets and scrips. 

Here's to shrinking explosions.  

September 21, 2012

Make Art This Weekend.

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Diabetes Art Day
I found I could say things with color and shapes that I couldn’t say any other way – things I had no words for. ~Georgia O’Keeffe
Diabetes Art Day is a web-based initiative for the Diabetes Online Community to “tell a story” about life with diabetes though creative visual expression. It’s a way for us to tell our stories so we can connect and share with each other and with our loved ones. It’s a way to generate diabetes awareness outside of the DOC by sharing artwork on Facebook, Twitter, blogs and community websites. Diabetes Art Day is for people young and old with any type of diabetes and their families, so children, spouses, parents, siblings, or anyone who is affected by diabetes can participate. For this one day, you’re encouraged to break out of your linguistic comfort zone, bust out some art materials, and make a piece of artwork – painting, drawing, collage, sculpture, an installation piece, a mixed media something or other, or whatever you can imagine. Whether you have lots of experience making art or none at all, Diabetes Art Day is for you to show the world what it’s like to live with diabetes in that “a picture is worth 1000 words” kind of way.
Diabetes Art Day 2012 is September 24.
Please note that starting in 2013, Diabetes Art Day will be the first Monday in February. The next Diabetes Art Day will be February 4.

September 20, 2012

Get your FDA Pre-Sub. Docket Comments here!

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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}

JDRF Glucose Responsive Insulin Prize

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JDRF Announces Winners of the Theoretical Phase of Its Agnes Varis Glucose-Responsive Insulin Grand Challenge Prize:


New York, NY, September 17, 2012-JDRF, the leading global organization focused on type 1 diabetes (T1D) research, announced today the winners of the Theoretical Phase of its first-ever public challenge, which called for novel theoretical ideas to approach the discovery and development of glucose-responsive insulin (GRI) to treat diabetes. GRI has been an elusive goal for diabetes researchers. The treatment would deliver a precise amount of insulin needed in response to circulating blood glucose levels 24 hours a day, reducing or eliminating high and low blood sugars and much of the daily burden of managing diabetes. For people with insulin-dependent diabetes, including those with T1D, current insulin treatment demands constant monitoring and arduous administration. 

JDRF launched the challenge one year ago in partnership with InnoCentive, Inc., a pioneer in open innovation and crowdsourcing. From a pool of 63 applications, 23 were selected for final review. Three of those ideas were selected to receive the Agnes Varis GRI Grand Challenge Prize, a project made possible with support from The Agnes Varis Charitable Trust.
The winners of this stage of the challenge include one individual scientist and two teams of scientists: Luz Blanco, Ph.D., owner of Light White Innovation Technology in Ann Arbor, MI; Xi Chen, Ph.D., a doctorate fellow at The University of Texas at Austin, and research partner Siqian Feng, Ph.D., also a doctorate fellow at The University of Maryland, College Park; and Mohsen Chitsaz and Alborz Mahdavi, both graduate students at California Institute of Technology. 

JDRF conducted a rigorous, blinded review of every application and assembled an external panel of judges to also review each application. The panelists' areas of expertise were diverse, including clinical pharmacology, diabetes research, endocrinology, regulatory, biochemical engineering, material sciences, and others. Together, JDRF and the panel selected three winning proposals. The decisions were unanimous.

September 18, 2012

#TwoBits: ThreeBits and Ice Hockey, DSMA & DiabetesMine

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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.