FTNW: Continua

FTNW for those who don't know but may care, and that is a small small group I am sure, is From The News Wire. My short hand for stuff that may be of interest.


This one is about the Continua Heath Alliance. It is something I keep an eye on as it may be a source of data standardization.

So for my few fellow geeks, here is a link to the latest state of the Alliance bit from Continua.

Vote Jen

The DOC's own Jen Hanson (See Crazy Cool Canucks) has been selected as a finalist in 2011's Explore Magazine Top 30 Under 30 Outdoor Adventurer Contest!

The winner will be announced next week, and chosen based on the finalist with the most number of votes (facebook likes). Here how to show Jen some of that DOC Love Ya / Mean It vibe:

1. First, 'LIKE' the Explore Facebook Page (found here: www.facebook.com/exploremag)
2. Click on, and 'LIKE' Jen photo (by following this link: http://on.fb.me/jVr5ye )



Do your DOC thing. Vote Jen.

FTNW: Interoperablity

Ran into this blog post today:

Lack of Interoperability Limits Personal Health Solutions

One of the key recommendations is that the buyers of personal health solutions need to understand and value interoperability, and demand it from vendors.

“The project partners share the belief that if Europe wants to reap the full benefit of personal health systems, health stakeholders must understand the benefits of interoperability, and be empowered to demand those systems from vendors”, says Veli Stroetmann, researcher at Empirica. “Only if there are buyers who demand interoperable systems, vendors will bring them to market.”

 I would to have the option of demanding systems instead of systems being demanded by type 1. Veli, I don't think you get it, that kind of influence exists in discretionary markets, where folks can choose not to use products. Type 1 diabetics don't have the option of not choosing a glucose meter.  

FTNW: Medtronic Research

When Medtronic held their social media summit in April one of the topic of conversation was the wealth of data that the CareLink system creates. An obvious question is how is that data studied and is it open to folks outside the big M.?

Today Medtronic with ADA announced such studies. These are anonymous, hippa compliant uses. You can read more at the ADAlink:
http://www.diabetes.org/for-media/2011/Medtronic-Research-Grant-Release-2011.html

FTNW: Pearl Insulin Pump 510k Cleared

New Pump gets 510(k) clearance. From their web site: http://www.asantesolutions.com

Pearl Insulin Pump.  It’s designed to simplify diabetes care for the more than 500,000 people worldwide who use an insulin pump -- or are considering it.  The small and sleek Pearl is the only pump that uses a pre-filled 300-unit insulin cartridge. That’s right . . . no more reservoir filling. No need to handle syringes to fill our pump. No battling pesky air bubbles from filling reservoirs. It’s a simple yet elegant pump solution – Asante Solutions.

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

Somewhere in the Pump Market

Sometimes I wonder if folks remember the stuff they write. Wait I better be careful, that is a standard that I could be guilty of not living up to too. My Ramblings May Vary.

That said I was interested by articles at massdevice.com. This week there was some gloom and doom about Medtronic restructuring and their commitment to diabetes devices. It quotes David Kliff of diabetic Investor saying "Looking ahead, it will be interesting to see whether the company is serious about change, or will they once again become bogged down in the Medtronic corporate meat grinder," Kliff wrote. "The folks at Medtronic corporate in Minneapolis view the diabetes unit as a cash cow and see little reason to invest precious dollars upgrading the Paradigm line or getting things right with the patch pump.”

I tend to be skeptical of just about everything so it isn’t real hard to think, maybe there is something to this. On the other hand there hasn’t been anything exactly innovative in the pump market in the last few years in the US since Medtronic integrated CGM into the pump. Sure Animas hooked up a meter remote but that isn’t exactly earth shattering. Despite rumors of Accu-Chek / Solo and Medtronic working on patch pumps nobody else had a pod like product on the market. So it easy to think, “Hey these guys (and gals) are getting lazy.”

Maybe but maybe not.

Last April the same blog, massdevice.com wrote that, “The Food & Drug Administration launches an initiative to institute stricter pre-market requirements infusion pumps, issuing new guidance and advising manufacturers they'll likely be required to "conduct additional risk assessments to support clearance of new or modified pumps."”

In Europe Medtronic has a pump / CGM combination available that shuts of insulin in hypos. Animas is expected to have a pump / CGM combination product for sale in Europe with Dexcom shortly. Even massdevice.com reports that Insulet has the much talked about Pod 2.0 into the FDA. Solo is, well, somewhere. So is Cellnovo.

Somewhere could be a lot of places. It could be back burnered as Kliff seems to suggest. There is a song about somewhere being over the rainbow. Somewhere is also, and I hope this is the case, being in with the FDA. Funny thing when stuff is into the FDA folks follow the rules, at least to some extent, and shut up.

Shutting up isn’t so great for bloggers. Well OK, in all honesty, there are a lot of folks at J&J, Medtronic, Roche, WaveSense, Sanofi, JDRF and the like that would probably think it would be GREAT to see me shut up. What I mean to suggest is that when the industry shuts up, news letters and blogs don’t have as much fodder to write about (but we as in I, Kliff and Massdevice.com keep writing anyway.)

I will continue to advocate for innovation. I have and will carp on about the pace on innovation and less than ideal products. I would love to see Mac OS software, data standards, devices that work together, the death of proprietary cables, respect for customer loyalty and a lot of other stuff that doesn’t seem all that hard.

However when the noise about a innovative product stops, does that mean it is dead or into the FDA for review? Honestly we don’t know.

Massdevice.com also noted that reported that Medtronic “diabetes sales were up 8 percent to $979 million during the first nine months of its fiscal year.” Not bad in this economy. So I emailed Medtronic about the news. I know they can’t talk about stuff that is into the FDA but they sent an official reply about restructuring. Here is their reply, Your Diabetes News May Vary.

“Yes, as Medtronic previously announced, we are globally restructuring our business to align with our customer needs and the current business environment. We are continuing to invest where business is growing and see strong growth in the diabetes division. However, we are restructuring the diabetes business in order to increasing operating efficiencies, while creating the infrastructure to grow and serve more customers.
 
“For example, we decided that a single facility focused solely on customer experience excellence will best meet the needs of our customers, so that means moving some positions from Northridge, CA to our Customer Care Center in San Antonio, TX. 
 
“Our customers can rest assured that we're committed to continuing to advance technology and innovation, while leading the industry in education, service and support to improve the lives of people with diabetes around the world.”

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

Peeping in on Dexcom and the FDA

Dexcom released an earnings call yesterday.

Here is my voyeur's disclaimer: I listen to Dexcom’s earning calls more as Peeping Tom looking in a window into what seems to me to be strange courtship of of industry and the FDA around integrating of sensor and pumps. That is more interesting to me than the perspective of a Dexcom shareholder. I think my bias as a parent of diabetic kids is more pronounced than my vested interest in a few Dexcom shares. That said, as you read this, know I write from personal interests and make no bones about them.

This peep and tell used to be a lot easier when the call was available transcribed on Seeking Alpha. I recommend to anyone foolish enough to take my interpretation of the call as fair and balanced to re-think that and listen to the call themselves. They can find it here:
http://investor.shareholder.com/dexcom/events.cfm
While many, if not most folks may find earnings calls only slightly less dull than watching paint dry, listening for yourself will free you from my slant.

The call starts with new board members and a new president as symbols of plans to grow, whoopee. Wait I own shares that should be: Whoopee!

Somewhere in the call was a mention, in passing, of a type 2 CGM study. I opened another window to peep through and found a link and have posed an abstract of that study.

Dexcom talked about working with the FDA collaboratively to define what they need to do to get trials done for the gen 4 sensor. It sounds like Dexcom is hoping to get clarity from the FDA and have trials and the PMA for the 4th generation product started this year. This is significant because gen 4 is this product that will be paired up with pumps from Animas and Omni Pod. As I understood the call the gen 4 product studies are expected to take 60 to 90, under the heroic assumption that Dexcom has a clue about what the FDA wants. (Sorry, was that too sarcastic about FDA intent?) Dexcom is hoping to have a PMA supplement to the FDA by late summer.

Dexcom said on the call, they continue to expect the Animas / Dex integrated product to be introduced in Europe before it comes to market in the USA. In fact they said they expect the combo product to be marketed before the end of this quarter in Europe.

The Pod product is expected to be the new Pod and the gen 4 sensor. Neither of which as far as I can tell FDA blessed. So while both apparently are in works that sounds a bit further down the road. (Insert you favorite piece of FDA timing skepticism here.)

Dexcom seem to think that US products are in the time frame of end of this year or beginning of next year. If I am not mistaken that has been the expected time frame on each call back over a number of years. (Insert you favorite piece of product timing skepticism here. Which is why parents shouldn’t speculate on this stuff - but hey these tools are possibly a means to better lives for our kids - I mentioned we’re parents right?)

Hold not thy breath, lest ye die.


In the ‘interesting conversation’ side bar realm one of the issues the FDA may worry about is the risk of dosing insulin based on a device that isn’t indicated for that use and may not be sufficiently accurate. {Cough: meters} Far be it from me to point out that meter accuracy has been something that advocates have been calling for an improvement in since the late 80s.  Before the DCCT - the bench mark study on tight control taht got the world chasing tight control with meters that were not designed for that.

Granted meters may be more accurate than sensing but the simple fact of living with type 1 is that it is a balancing act. Part of that balance is coping with less than perfect sources of information. Sensing can ad trend to the over all mix of information. Trend can inform urgency. More importantly studies show sensing makes for better results.

So FDA repeat after me: "Perfect is not be the enemy of better."

I feel a number of my typical rants coming on and am looking around to borrow Glen Bech chalk board. If that isn’t a sign I have carried on too long I don’t know what is.

Diabetes Data Standards - Scholar's Edition

In the Journal of Diabetes Science and Technology Volume 5, Issue 3, May 2011

Rachel L. Richesson, Ph.D., M.P.H.

Abstract
Widespread adoption of electronic health records (EHRs) and expansion of patient registries present opportunities to improve patient care and population health and advance translational research. However, optimal integration of patient registries with EHR functions and aggregation of regional registries to support national or global analyses will require the use of standards. Currently, there are no standards for patient registries and no content standards for health care data collection or clinical research, including diabetes research. Data standards can facilitate new registry development by supporting reuse of well-defined data elements and data collection systems, and they can enable data aggregation for future research and discovery. This article introduces standardization topics relevant to diabetes patient registries, addresses issues related to the quality and use of registries and their integration with primary EHR data collection systems, and proposes strategies for implementation of data standards in diabetes research and management.
J Diabetes Sci Technol 2011;5(3):476-485

http://www.journalofdst.org/May2011/PDF/Abstract/VOL-5-3-SYM1-RICHESSON-ABSTRACT.pdf

CGM in Non Insulin Using T2

There is a study in the May 2011 issue of Journal of Diabetes Science and Technology.

Conclusions:
Real-time continuous glucose monitoring significantly improves A1C compared with SMBG in patients with T2DM not taking prandial insulin. This technology might benefit a wider population of people with diabetes than previously thought.

You can read an abstract at:

http://www.journalofdst.org/May2011/PDF/Abstract/VOL-5-3-ORG1-EHRHARDT-ABSTRACT.pdf