CGM improves T1D care in PWD over 65 - AACE

AACE just published a paper on CGM use in People over the age of 65. The paper concludes:

Insulin-requiring patients 65 years old and older in our retrospective study from a community endocrine practice achieved a significant and durable improvement in glycemic control when using PCGM. The improvement in glycemic control was comparable to that reported in younger patients. The substantial reduction in severe hypoglycemia may be of particular benefit in older patients. Lack of PCGM coverage by CMS was the most common reason sited to not start or to discontinue PCGM use. 

Significant
Substantial

The goal of every adult with type 1 diabetes, every parent of a child with type 1 diabetes and every person in the care teams of those people with diabetes is a long health life WAY past age 65.

To better understand why this matters, please read Kerri's excellent piece at diaTribe on CGM and Medicare. I trust you will feel moved to sign the JDRF's petition. Like Kerri says, use the #MedicareCoverCGM hashtag to help thread these stories through social media like Facebook and Twitter.

I fear it may be a long term process to help provide good diabetes care to those on Medicare. Long term processes star with a step. There first step is the petition. More steps to come.

Think about your story with CGM. Has it helped you? Here are some tips on how to tell you story as an advocate for CGM coverage:

Tips:

• Plain language. Avoid jargon and abbreviations, tell you story like you are talking with a sympathetic friend over coffee.
• Speak from the heart, and to it, your passion should be in the story, up close and personal.
• Talk about success, make your story be the uplifting example of how things can be better.
• Be concise. Use details from your success to connect passion and policy.
• Quality of life over numbers. We want to hear about you and your life. If you use statistics be sure the are accurate and relevant to your personal story.
• If possible, craft a way for policy makers to be a hero by demonstrating to them how their actions help you stay healthy and successful.

from: http://www.cgmsafely.com/stories/tell-your-story/



#MedicareCoverCGM


Links included in this post.
http://aace.metapress.com/content/t452w5j078414954/fulltext.pdf
http://diatribe.org/issues/67/sum-musings
http://www.thepetitionsite.com/takeaction/776/978/446/
http://www.cgmsafely.com/stories/tell-your-story/

JDRF in Start Up with Venture Firm to Fund T1D Companies.

From http://www.xconomy.com

PureTech Ventures, JDRF Team Up to Form Type 1 Diabetes Startup Creator 

Disease foundations often give money to startups working on treatments that might help the people they advocate for. But it’s not too often you’ll see a nonprofit foundation join with a venture firm to create their own company, as JDRF andPureTech Ventures are doing today. 

Boston-based PureTech has secured a $5 million investment from New York-based JDRF (formerly known as the Juvenile Diabetes Research Foundation) to spawn T1D Innovations. The new entity is described as a company-creation vehicle that will help form, and provide seed funding, to startups that develop innovative therapies for type 1 diabetes. The plan is to funnel as much as $30 million from other non-profits, strategic and financial investors, into T1D, and use the cash to start eight to 10 projects. Many may go by the wayside, with a few surviving and becoming new independent companies. 

“The goal is not to make a quick buck, that’s not why we’re doing this,” says David Steinberg, a PureTech partner and TID’s initial CEO. “It’s really to lower the activation energy of getting these things out of academia and out of the realm of more basic research into that translational development pipeline.”

More: http://www.xconomy.com/boston/2013/10/15/puretech-ventures-jdrf-team-form-type-1-diabetes-startup-creator/?utm_source=rss&utm_medium=rss&utm_campaign=puretech-ventures-jdrf-team-form-type-1-diabetes-startup-creator

It will be interesting to learn more about this and the relationship to JDRF's IDDP program.

JDRF Kit to Support Adults with Newly Diagnosed Type 1 Diabetes

From JDRF:

New York, NY, April 15, 2013 – JDRF announced today that it has created a new resource for adults newly diagnosed with type 1 diabetes (T1D). The Adult Type 1 Pak is a sling-style bag that will include important resources and information to educate, support, and inspire adults newly diagnosed with T1D, age 16 and above. In collaboration with JDRF’s generous sponsors—Bayer Healthcare, Medtronic, and Novo Nordisk—the kit is now available through local JDRF chapters, and is free of charge.

Adult Type 1 Pak Contents

The Adult Type 1 Pak was created as a part of an effort to ensure that all individuals newly diagnosed with T1D receive the information and support necessary to adjust to life with the disease. JDRF has found the Bag of Hope to be extremely beneficial to families of newly-diagnosed children with T1D, and is hopeful that the Adult Type 1 Pak will be just as valuable to newly-diagnosed adults. Each year in the United States alone, more than 15,000 children and 15,000 adults are diagnosed with T1D, and JDRF continues to work to expand its efforts to better support people of all ages, and at all stages of life with the disease.

More: http://jdrf.org/press-releases/jdrf-announces-new-outreach-kit-to-support-adults-newly-diagnosed-with-type-1-diabetes/

Tandem and JDRF Agreement for Dual Hormone Pump

Tandem and JDRF have entered into an agreement to develop a dual hormone pump.

SAN DIEGO, Jan. 8, 2013 /PRNewswire via COMTEX/ -- Tandem Diabetes Care, Inc. ("Tandem") announced today a partnership with JDRF, the leading global organization focused on type 1 diabetes (T1D) research, to develop a first-of-its-kind, dual-chamber infusion pump for the management of diabetes. The partnership agreement is designed to accelerate the development of a next-generation, fully automated artificial pancreas system using therapies in conjunction with insulin.

Looks a lot like a JDRF IDDP. Has all the right words, performance based milestones etc, just not the IDDP letter.  Full test here:

http://www.marketwatch.com/story/tandem-diabetes-care-announces-partnership-with-jdrf-to-develop-a-novel-dual-chamber-infusion-pump-2013-01-08

JDRF Glucose Responsive Insulin Prize

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

http://www.jdrf.org/index.cfm?page_id=117774&goback=%2Egde_129291_member_165946632

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.

Beta Cell Stress Could Trigger Type 1 Diabetes @JDRF

Before T1d Stresses patients, stress on the beta cells may trigger T1D. Which matters because understanding how it works help find cures. So knowing what you don't know helps.

Study provides important clue in type 1 diabetes; could help scientists identify and validate potential drug targets to alleviate ER stress and preserve beta cell mass in T1D
In type 1 diabetes (T1D), pancreatic beta cells die from a misguided autoimmune attack, but how and why that happens is still unclear. Now, JDRF-funded scientists from the Indiana University School of Medicine have found that a specific type of cellular stress takes place in pancreatic beta cells before the onset of T1D, and that this stress response in the beta cell may in fact help ignite the autoimmune attack. These findings shed an entirely new light into the mystery behind how changes in the beta cell may play a role in the earliest stages of T1D, and adds a new perspective to our understanding how T1D progresses, and how to prevent and treat the disease. 

More about the study, published in the March 22 issue of the journal Diabetes, the researchers, led by Sarah Tersey, Ph.D., assistant research professor of pediatrics, and Raghavendra Mirmira, M.D., Ph.D., professor of pediatrics and medicine at the Indiana University School of Medicine is online here: 

http://www.eurekalert.org/pub_releases/2012-03/jdrf-rfb032212.php 

Thanks Riva for the Shout Out in @JDRF Research Summit Column

Riva Greenberg has a write up of the JDRF Research Summit in her Huffington Post column. She nicely details the topics covered that day. She also quotes my YDMV write up saying;

What I, and more than 600 attendees with Type 1 diabetes, family members, health care providers and industry representatives, learned in a nutshell is what blogger Bennet Dunlap put so well, "I don't see a magic bullet coming but I do see different approaches to tackling things that will count as a cure. Those will happen like everything does in increments. Along that journey we'll see better care before cures. So prevention may come before restoration of beta cell function, that's cool, steps matter."

Thanks for your kind comment Riva, I am flattered.

If you missed the event please read Riva's piece to get a glimpse of what you missed. Two of the day's presentations are available on theBetesNOW.

Meet the T1D Exchange
Top 10 Things We Don’t Know About Type 1 Diabetes

JDRF Research Summit on theBetesNOW

Over on theBetesNOW.com there is one of the presentations from last weekend's Research Summit put on by the Capital Chapter. Mark Atkinson talks about the top ten things we don't know about Type1 Diabetes. Worth the 25 minutes.

Love to know your thoughts.


http://www.ydmv.net/2012/02/huge-props-to-jdrfcapitol.html

Huge Props to @JDRFCapitol

Next to CWD’s Friends for like the JDRF Capital Chapter Research Summit has to be the best type 1 event of the year. Great presentation by folk dedicated to making life with diabetes better on the way to cures. The order matters. Improving care is critical and will come as a result of searching for cures.

Cures. I don’t see a magic bullet coming but I do see different approaches to tackling things that will count as a cure. Those will happen like everything does in increments. Along that journey we’ll see better care before cures. Like everything with diabetes you better care and your cure may vary. So prevention may come before restoration of beta cell function, that’s cool, steps matter.

I get energy from this summit. The strength to keep hoping.  Maybe even believing there will be a cure someday. In the mean time life progresses is being made to better. Better understanding. Better ways of care. Better Lives. That progress requires individual involvement, starting with believing, then learning and participating from knowledge.

That is how all life works, believe, learn, act.
Why should diabetes be any different than life?

More later. First things first. Thanks and appreciation to the JDRF Capital Chapter. Until then here are some links that may be interesting:

JDRF and IDDP
Last Year's Capital Chapter Research Summit

Required Reading - JDRF on GRI in Countdown

Back in September JDRF Launched a prize to encourage people outside of diabetes research to join the hunt for a Glucose Responsive Insulin (GRI.) I wrote briefly about it in the post Know a Smart Chemist? JDRF's current edition of Countdown, their online magazine has a great story with more information about GRI and the JDRF initiative.

This is a fascinating approach to living with type 1. It is not a cure in the pure sense but if they can find ways to make Glucose Responsive Insulin work it is a Game Changer. In fact The Game Changer is the title of the piece and because of that potential, years down the way, the articles gets my vote for this weeks reading assignment.

The Game Changer: Treating type 1 diabetes with glucose-responsive insulins.
http://countdown.jdrf.org/Features.aspx?id=8589934727

@JDRF New Research #TwoBits

JDRF announced two research initiatives today. The first is a study of seeking to Reduce Cardiovascular Risk in Adults with Type 1 Diabetes. From the release:

New York, NY, December  13, 2011-JDRF-funded researchers have begun enrolling adult patients with type 1 diabetes (T1D) in the REMOVAL study, to test whether metformin-a drug commonly used to treat type 2 diabetes-could help prevent or reduce the risk of cardiovascular complications in people with T1D. 

The REMOVAL study (Reducing with MetfOrmin Vascular Adverse Lesions in T1D) is a multi-center, international trial that will study 500 patients with T1D aged 40 or older, a patient group known to be at higher risk for cardiovascular disease, one of the leading causes of death associated with diabetes. A study from the United Kingdom has shown that people with T1D aged over 40 are at much higher risk for cardiovascular disease, including heart attack and stroke.

The second is in conjunction with the firm ViaCyte and looks at Encapsulated Beta Cell Replacement Therapy for Diabetes. (This look like an IDDP but my reading of the release is not clear. I will see if I can get confirmation.) Yes it is in fact an IDDP* From the Release:

Existing cell therapies such as islet and pancreas transplantation have the potential to cure T1D by restoring normal islet function and normalizing blood glucose levels in people with T1D. Because the number of cadaveric human donors for pancreatic islets is limited, ViaCyte’s program will provide a replenishable supply of functional insulin-producing cells. Furthermore, packaging the cells in a device (“encapsulation”) creates a physical barrier around the cells and has the potential to protect the transplanted cells from immune rejection, and may eliminate the need for chronic immunosuppressive drugs. The ultimate goal of this partnership is to help patients with T1D restore their ability to regulate blood glucose, thereby reducing or eliminating the need for constant self-management and administration of insulin.
The three-year series of preclinical studies being co-funded by JDRF will help ViaCyte prepare the information necessary to apply for regulatory approvals to study the system for safety and efficacy in people with T1D.

For more see JDRF's New Room online.

Why these matter:

Most folks living with type 1 are adults. Our first goal as parents of T1D kids is to have the grow to be T1D adults pursuing their lives interest. I have heard the figure tossed around that 85% of T1Ds are adults, seems about right. So it only makes sense to study how to keep T1D adults health.

Cure can mean a lot of different things to different people. To me, in the broadest sense it is to return the biological production of insulin. That may or may not include turing off the autoimmune response that killed off the beta cells in the first place and from the little (very little) I know of how immunity works that is no small think. Encapsulation get around that problem with magic star tech like shields that protect the Starship Insulin-producing-cell from attack by evil T cells. ... or something like that. Getting beta cells is no easy matter either. This project addresses both the shield and production of beta cells form stem cells. May the Force be with you, wait wrong sci-fi flick but you get the point and the point is Live Long and Prosper.

*For some background on IDDP you can see earlier post in YDMV. 
http://www.ydmv.net/2007/07/over-last-few-months-i-have-seen-number.html
http://www.ydmv.net/2007/10/apparently-somebody-does-know-how-this.html
http://www.ydmv.net/2007/10/5-easy-pieces.html

One in Twenty / Twenty to One

Another diabetes dad sent an email asking about the JDRF New York Times Ad. Specifically if anyone knew the source of the 1:20 number it cites. I replied that I had traded emails with Aaron Kowalski and Jeffery Brewer at JDRF about the ad. 

Of the people I know in the diabetes community, and I know a lot of y'all there is nobody among us who is more passionate about with people with T1D living long, happy, well managed lives than Aaron and Jeffery, certainly including my craziness. 

Hypoglycemia can kill. Should we be less motivated to address hypos if the life time mortality risk is 1:40, 1:60 1:100? Shouldn't be just be motivated to make less of a risk, until it is not a factor at all?


The data for the ad is the based on various articles by Philip E. Cryer, MD. Significant in that is a piece in the American Journal of Medicine, Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. http://www.amjmed.com/article/S0002-9343(11)00687-5/fulltext 

That article in turn references:

The Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications Study Research Group. Long-term effect of diabetes and its treatment on cognitive function. N Engl J Med. 2007;356:1842–1852 
http://www.nejm.org/doi/full/10.1056/NEJMoa066397

Feltbower RG, Bodansky HJ, Patterson CC, et al. Acute complications and drug misuse are important causes of death for children and young adults with type 1 diabetes. Diabetes Care. 2008;31:922–926 - http://care.diabetesjournals.org/content/31/5/922

Skrivarhaug T, Bangstad H-J, Stene LC, Sandvik L, Hanssen KF, Joner G. Long-term mortality in a nationwide cohort of childhood-onset type 1 diabetic patients in Norway. Diabetologia. 2006;49:298–305  -
http://www.springerlink.com/content/f932481234766352/

All of which I have printed and am in the process of re-re-reading and formulating thoughts on. Here is a readers digest of where I am so far.

The ad is not for the diabetes community. Period.

In the diabetes community we know that insulin has risk and that those risk involve the possibility of death from excessive insulin. I often hear those who live with diabetes and "Get It" wish that the general population understood type 1 better. The non-diabetes world doesn't have a frame of reference for diabetes management risks and this ad puts that into stark terms. 

Mark Twain has a famous comments on numbers, "Figures often beguile me," he wrote, "particularly when I have the arranging of them myself; in which case the remark attributed to Disraeli would often apply with justice and force: 'There are three kinds of lies: lies, damned lies, and statistics.'" There is little reason to think Disraeli actually said that, but there is history, humor and Mark Twain. Think: The Daily Show. 

The effect of the ad statistic on some people with, and more significantly maybe some parents of T1D kids, is an increase in fear. I am not sure that is productive. (Please see ad is not for the diabetes community above.) I know a young woman who was so scared by dead in bed she disconnected her pump every night. Her parents were at a total loss as to why her night time BGs were so bad. It may not be a surprise folks who "Get It" that her A1C were through the roof. This was before blue candles and 1:20 ads in the paper. Fear is real. 

Hunter S Thompson wites of "The Fear" in Fear and Loathing in Las Vegas. "The Fear" in my mind is a character in the book. A book I found hysterical. I don't find diabetes fear so amusing. It can lead to actions, as was the case with the young woman who was disconnecting, that are dangerous. 

Many in the Diabetes On-line Community write about the phycological aspects of diabetes care.  Many say the mind game is as difficult as physiological management effort. In that context feeding the fear is a bad thing. Also turning those people (PWDs) to thinking about the statistics and motivating them into discussions about the numbers instead of discussions about doing stuff to move the ball forward on solutions is contrary to the goal of better living with T1D. 

All that said I have issues with simplifying the underlying papers to 1 in 20. Dr. Cryer writes about T2D as much or more than about T1D in Death during Intensive Glycemic Therapy of Diabetes: Mechanisms and Implications. He cites ACCORD, ADVANCE and VADT studies all of which appear to be T2D studies. In T2D there may be means of managing health other than insulin. In ACCORD the goal was A1C under 6% and the trial was stopped due to harm to T2D patients of that aggressive goal.


It also appears that the good Dr. Cryer's article was a response to another in the same journal issue that seemed to say that hypoglycemia was a comorbidity of other causes of death, seemingly downplaying hypos. So maybe he was saying, Hey you idiots hypos are dangerous in and of themselves... well he probably wouldn't say idiots, in fact I don't see that word used anyplace in his article. Maybe Mark Twain or Disraeli who used the "I" word. 

Cryer writes "Older estimates were that 2%-4% of patients with type 1 diabetes die from hypoglycemia. [16], [17] and [18] More recent estimates are that 6%,[19] 7%,[20] or 10%[21] of those with type 1 diabetes die from hypoglycemia." 

Notes 19, 20 and 21 are the ones I shared above. 20 and 21 are studies form the UK and Norway, started in 1978 and 1973 respectively. Both are T1D studies. I have concerns that studies starting then will have significant data from pre DCCT, pre Lantus and pre Pump care regimes. Who is on NPH?

One can argue that pre DCCT was typically less aggressive care and that means less hypos so these may understate the risk. - Or -  One can argue that the lack of stable basal insulin, pumps modern meters ect. made hypos more frequent due more peaky nature of the tools available. I don't know. I suggest there is grounds to wonder if the fruits of the studies is all apples. Maybe there are some oranges involved. 

We hold these truths to be self evident: the risk of fatal hypos is a lot higher if one takes insulin than if one does not. Even so that is not the only source of stress in a T1D household. 

1:20 is not an annual rate but a life time projection. Looking at the reciprocal, when they die, 19 of 20 people with T1D will not die of hypos related issues. That is a lot better than the 100% that died of DKA in pre insulin days. 



Diabetes care is about balance.

That and I hope that in my kids lives they each have 20 non-diabeteic people people in their 'get' fottaly tine.



To me that 20 to 1 is more important than 1 in 20.

I maybe wrong, I often am.


. 

JDRF & Helmsley Trust Collaboration

From the News Wire:

JDRF and the Helmsley Charitable Trust Form a Collaboration to Accelerate Innovative Type 1 Diabetes Research and Development:
NEW YORK, Nov. 2, 2011 /PRNewswire-USNewswire/ -- JDRF and The Leona M. and Harry B. Helmsley Charitable Trust, two of the largest non-government funders of type 1 diabetes (T1D) programs, announced today that they have formalized a collaboration that will foster a new level of cooperation between the organizations. The goal of the collaboration is to accelerate the pace of research and development to deliver better treatments, devices, and diagnostics for improving the lives of people with T1D. The first two co-funded grants as part of the collaboration were also announced today. More

This is good news. I know some great dads of kids with diabetes at both places. They share the passion for better lives for all kids living with diabetes that maybe unique to parents. Both organizations are substantial investors in researches to create better lives. By comparing notes and goals is more than great way to avoid re-inventing the wheel, it is a powerful way align interests.

Thanks to all the dads, moms, people with diabetes, their friends and families that are doing what they can to help innovate type 1 diabetes (T1D) care.

Artificial Pancreas and Egg Baskets

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

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

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

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

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

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

This was my response: 

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

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

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

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

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

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

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

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

Let me know if this helped any. 

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

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

Bennet 

More on JDRF GRI Prize

In the post Know a Smart Chemist? I wrote about JDRF's Glucose Responsive Insulin (GRI) prize. Here's more on the plan from JDRV:
Streaming by Ustream

I Was Wrong.

I know! Who would think I could be wrong?

(That should get a long list of comments consisting of “Me” and let me just say hi to Tim who will be prominent on that list.)

In addition to all the playing nice in the sand box with JDRF that I reported about in yesterday’s recounting of Scott and Bennet’s excellent JDRF IDDP adventure, we did have some specific questions. I know one of mine was about Amylin and leptin analogs.

As an aside I was not only wrong but also daft, I just finished a class, for which I memorized stuff about leptin but somehow couldn’t associate metreleptin with leptin but enough of my digression about being daft. (Which I am also sure Tim will appreciate.)

Leptin, is hormone produced in fat tissue that plays a key role in regulating metabolism. My text book says it does this "by affecting hunger. As your fat stores increase, leptin signals the brain to decrease your level of hunger and food intake." (Joan Blake, Nutrition and You, 2012, Benjamin Cummings, one hundred bucks but I am not bitter about the price)

Anyway, I made note of JDRF entering into an IDDP project with Amylin last November for  a study of metreleptin. I know that I was confused when Amylin and Takeda announced a suspension of trials of pramlintide/metreleptin. (Pramlintide is marketed by Amylin as SYMLIN® just in case there isn't enough name confusion.)  I was very confused, particularly when I found a JDRF newsletter in the mail that had an article on Amylin a few weeks later.

So here is the straight story. These are two different studies of the same analog, in different groups, for different reasons. The JDRF IDDP is still on.

Let me quote JDRF:

... to follow up on our conversation from last week about the recently halted metreleptin study, which you had asked about.  As we discussed, Amylin and Takeda Pharmaceutical Companies recently suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of an investigational combination therapy using pramlintide and metreleptin for the treatment of obesity. This is a separate trial from the metreleptin study JDRF and Amylin are collaborating on.

They go on to say:

As for the metreleptin study that JDRF and Amylin Pharmaceuticals are partnering on, we, along with The University of Texas Southwestern in Dallas (the institution where the trial is taking place) will continue to monitor trial participants in accordance with the team’s diligent safety monitoring strategy, which has been approved by the university’s Institutional Review Board and FDA.  Additionally, in light of the recent findings with metreleptin in the above-mentioned obesity trial, the team has consulted with the FDA and will continue to as the study proceeds.

So there you have it folk, I was wrong when I thought they were the same investigation. I don't think I wrote anything here about that confusion but I am sure I was confusing none the less. On the plus side, I now know how to get fast answers to questions like, “Hey was that the Amylin study JDRF did an IDDP with?“ when I am reading the news.


There you have it, YDMV - fairly accurate-ish.



p.s. I don't think either of these is the May 10th IDDP on mixing insulin and SYMLIN®.... maybe I better check.

Scott and Bennet’s JDRF Adventure

I have written periodically about JDRF’s IDDP program. Occasionally I have had conversations either via email exchanges on on the phone with JDRF’s communications staff about IDDP. For those less interested in alphabet soup, IDDP stands for Industrial Discovery and Development Partnerships. This is a smaller portion of JDRF’s activities as measured in dollar terms, maybe 10% of their funding budget. The goal of IDDP is to help transition discoveries from the lab to therapeutic options in the clinic.

I think the IDDP program is valuable. I am added a link in my sidebar with the Newbie link and Teens that can help anyone interested find more about what I have said about IDDP. (I realize that is probably a very small group.) In time I’ll ad a post that includes other good pieces on the projects.

There is a wide series of gaps between the discoveries we read about in laboratories and the options our care team can prescribe. Each gap being another step along a regulatory process from lab to pharmacy. This path will be followed by better care options and it will be true of any incremental steps to a cure.

Here is what those gaps cumulatively look like.  Bringing a pharmaceutical treatment to market is estimated in one research study cost $1.3 billion, yes with a “B” and take 7.9 years.¹

IDDP helps bridge gaps at strategic points. These may be points where industry is less inclined to do take some of the steps along that 1.3 billion dollar process or possibly steps where a type 1 application for a product is not seen by a pharmaceutical company. You can think of it as JDRF helping to push the processes along at key sticking points.

Even representing a fraction of JDRF’s funding budget the amounts involved are substantial. So I believe there is a need for clear communications on what these partnerships entail. I think this is one way that bloggers can serve our community. (This post is about Scott and Bennet's excellent JDRF  adventure, for a primer on IDDP here is a link.)

Last week Scott Strumello and I had the opportunity to to meet with JDRF in their New York offices for an extended conversation on IDDP. I was anxious to have Scott participate. He and I share an interest in writing about the business side of diabetes. We have both written about the IDDP process.

I think he writes in deeper detail while I write try to translate business writing into a more common vernacular. Somewhere in there, between the two of us, I hope folks get an insight they may not otherwise have. I respect and admire Scott’s writing. I consider him a friends and am proud to join him in writing about IDDP. In fact I would not have scheduled a meeting at JDRF without him as every Andy Sipowicz needs a Bobby Simone. I am not sure who is which.

Scott and I with Rachel Steingardt, Joana Casas and Gary Feit of JRFD’s communications team first. We talked about social media and more transparent means of JDRF sharing information in general and the IDDP program specifically.

We were then joined by Richard Insel, MD, JDRF’s Chief Scientific Officer and Karin Hehenberger, MD, Ph.D. Senior Vice President of Strategic Alliances. Jeffery Brewer JDRF’s CEO was going to join us but he was ill. (Insert your joke about me making people sick here.) Jeffery has since followed up with an email which was very gracious. I greatly appreciate that as sign of his openness. My good friend Kelly Kunik speaks well of him and that is high praise in my book.

I had scores of questions going in but the question that troubled me the most was this; how could I approach JDRF with detailed and potentially tough questions about IDDP projects and be seen as an advocate of people living with type 1 and not simply a critic? In fact that I think was the real goal. To open lines of communications that could facilitate better communications about these projects. To be able to learn on an ongoing basis share what we learn with the diabetes online community. I think Scott and I were received with respect and developed a level of rapport that will facilitate our future writing on IDDP.

I will close with one point that Dr. Hehenberger made very clear in our conversations. The IDDP program isn’t just about financial investments in specific projects with for profit businesses. More significantly is a sharing and networking of JDRF contacts in a wide variety of labs with a similarly wide set of contacts in industry to help bring the two together to get promising research out of the lab.

Hopefully our meeting was a similar opportunity to bring transparency to IDDP efforts. I hope we can help those of us who Walk with JDRF for a Cure to see IDDP projects as a positive step in the mix of efforts JDRF facilitates.

¹ Kaitin K, Clinical Pharmacology & Therapeutics (2010) 87 3, 356–361. doi:10.1038/clpt.2009.293

FTNW: JDRF and Amylin

From the News Wire: JDRF and Amylin Partner to IDDP to Investigate Co-Formulating Two Hormones for Treatment of Type 1 Diabetes

NEW YORK and SAN DIEGO, May 10, 2011 /PRNewswire/ -- The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) announced today that they have entered into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin, with insulin to treat type 1 diabetes. Pramlintide, marketed by Amylin as SYMLIN® (pramlintide acetate) injection, is approved for use as an adjunct treatment in patients with diabetes who use mealtime insulin therapy and who have failed to achieve desired glucose control despite optimal insulin therapy. SYMLIN and insulin are currently not approved to be mixed and must be administered as separate injections.

Read the full press release here: http://www.prnewswire.com/news-releases/jdrf-and-amylin-partner-to-investigate-co-formulating-two-hormones-for-treatment-of-type-1-diabetes-121555613.html

DC Type 1 Diabetes Research Summit

The Capital Chapter of the JDRF brought together a collection of professionals who shared the research they are doing.  In most cases they also shared a personal connection that drive them to try to improve the lives of people living with type 1 diabetes.

In addition to the speakers there were a number of tables where advocates, pharma and researches could present there work in a trade show like environment. The organizers had a full kids program to allow families to participate without kids becoming overwhelmed by the scholar’s presentations.

For those with the experience, it was like a day at Friends For Life where you do all the research track presentation while the kids hung out (with supervision.) There was even a similar buffet lunch experience - the kids ate chicken fingers.

There were maybe three to four hundred people there. Pretty impressive for a cold Saturday in January.

I was happy to join with a number of other bloggers and made my first feeble attempt at tweeting in real time. Here the thing, I don’t quite know how to condense complex ideas into 140 character synopsis and both convey meaning and still pay attention. I don’t think I did either well - fortunately that wasn’t the point of the day.

I was very happy to see a JDRF local chapter take on such a significant roll in supporting the families who walk for JDRF. I was some what gladly drove three hours to attend and was impressed by the researches both in their work an in their passion driven by personal connections to type 1.  I think that connection gets lost. I find it compelling to know the guy running the study at BU on the bionic pancreas is motivated to make his child life better.

It was also enlightening if not encouraging to hear about the process of working with the FDA. The FDA is cautious. They are slow. They are careful. That caution can be seen as slowing down the process of getting advances in care to the market. However I think it is important to know about how the FDA approaches risk. It is good to know the JDRF is in regular contact working with the FDA to keep the risks of simply living with diabetes on the table.

I think it is appropriate and useful for the JDRF to work in conjunction with industry to help promising advancements get through that review process. Particularly those products that focus more on the smaller part of the diabetes market, those living with type 1.  In that context events such as this help clarify why JDRF should be working with the for profit side of the industry. Advances need to come to market.

I think that understanding the process of research, commercialization and approval is important. I think good communication helps both develop support for innovation over the long term and inspiration to do better with what we have in the short term.

I was very pleasantly surprised by the scope and quality of the Capital Chapter’s Research Summit. I am thankful for their hard work. I am appreciative of the sponsors support. I think the Capital Chapter of JDRF offers a model for other chapters looking to engage with those living with type 1.

JDRF and BD

What was old is new again.

JDRF is in the news with another industry development agreement. This time with BD. The deal is for Micro Needle sets. See the press release with with circles and arrows and a paragraph on the back.

The idea is a better set. Better as in less painful, more rapid absorption and less set site infection, inspection and negelection. As I was looking over the 27 eight by ten glossy photographs account of the agreement (Once again my apologies to Arlo Guthrie)
I was struck that this was a flash back of sorts. Like I had heard it before. Not Arlo - I love Arlo -the micro needles.

Sure enough this new release sound a lot like a 2004 press release, about micro needles. Back then Animas did a deveolpment deal with Debiotech to licence micro needle sets. The deal also included development of a 'next generation wearable micro pump.'

Regular DOC readers may rember a mention of this pump in Amy's recent State of Patch Pumping post. I went to a presentation on coming technology back in '04 and the micro needles were talked about as a key feature of the micro pump as well as groovey new sets.

I have been holding my breath since, I swear.

Just to prove how pointless a crystal ball is at predicting when diabetes stuff comes to market back in '04 these micro gems were seen as coming to market in '07.

What happened? Your guess is as good as mine. (Probably better in fact.)

The interesting thing to me isn't so much who shot Johnny Micro Needle in 04-07 but that the technology gets a second look. I can't tell you if this is a better set technology but here is the thing, it may be. YDMV.

Were I to use my guess, I may inclined to bet that the cost and special fabrication skills needed to develop the micro needle set didn't fit into the post J&J R&D budget for Animas and maybe the deal was really all about the micro pump anyway. Animas invested in developing the wireless Ping and Dexcom integration and they gotta draw a line somewhere.

So now JDRF is stepping in and helping get micro needle sets another shot at coming to market. BD is experianced at sharpened sticks and other pointy things so ya would think they can make it work if anyone can. This has the potential to improve living with type 1. (Every little but helps) I am in favor of getting interesting ideas off the proverbial shelf and into use. Given there is an appropriate mechanism to return the investment to JDRF following commercialization this is good news.

When does the press release about the micro pump drop?