Grail-like Glucagon

From the News Wire:

LATITUDE Pharmaceuticals, Inc. Develops a Stable Liquid Glucagon Formulation

SAN DIEGO--(BUSINESS WIRE)--LATITUDE Pharmaceuticals, Inc. (LPI) announced today that its scientists have developed the first ever, ready-to-inject, stable liquid glucagon formulation (Nano-G). A glucagon formulation with these properties had been a highly sought after Holy Grail of drug developers for decades. 

Currently, glucagon is indicated for emergency treatment of insulin-induced hypoglycemia and as a diagnostic aid for radiological examinations. Researchers have long been interested in evaluating glucagon for hypoglycemia prevention, the bi-hormonal insulin/glucagon pump and the treatment of obesity but have been thwarted by the absence of a stable injectable glucagon formulation. 

Glucagon is a notoriously insoluble and unstable molecule and is therefore provided as a dried powder. Before use, the glucagon is dissolved in an acid solution by following a cumbersome, eight-step procedure that becomes an outsized task during life-threatening hypoglycemia.

Glucagon, while useful stuff, kind of fall short of my Holy Grail Test. Sure cures fall into Grail status. I think prevention would come real close too. I have also written about side orders to go with the grail like some basic integration of management tools. We each seek our own Grail and I am happy that stable liquid glucagon was someone's.

I am a big fan of progress. Automation in the prevention of hypos would be progress. There are smart smart folks working to AP projects. That is great. For me this is better and Better is Better. Dual hormone pumps with very good logic tools to support them is better. Staying in range more of the time is better. Glucose responsive insulins that make hypos history would be that much more.

The Grail? Cures. Not a cure, Cures. 'cause I know enough about type 1 diabetes to know that one size doesn't fit all. I also know enough to know progress is one step at a time.

Mostly I know this about Grails, nobody ever find them (except for Sean Connery & Harrison Ford.) When you find what you thought may be a Grail you discover a new passion.

So lift your glass and toast pursuing passion.  

Dexcom Earnings Call: Diabetes CGM Crystal Ball

Dexcom management provided a quarterly update as part of their earrings call last week. It contained forward looking statements so take it with that caveat. As far as I am concerned, as the parent of two T1D teens, that is the interesting stuff.

You can play it here: Listen to webcast

• They filed a PMA for the Gen 4 sensor at the end of Q1. Terry Gregg called the product “Truly Remarkable.” They will be presenting details at ADA on June 8. Boy would I like to be there. 
• The Gen 4 sensor was said to be better in all respects than the Seven +. He said it would be 20% more accurate in general and 25% more accurate better in hypo range. 
• The Gen 4 is said to have better range up to 30 feet than the Seven +. This was reflected in the high number of data captures in the trials.
• The FDA has responded with a “Rapid Responce.” He said that the FDA is doing everything in their power to get the thing through their process. The agency has reached out and Dexcom was clear to give the FDA credit for their efforts in the approval process.
• The Gen 4 is believed to be able to function with reduced calibration needs. Dexcom is  exploring how to submit later for lower calibration requirements possibly for Gen 4 or 5. Ultimately the goal of Dexcom is to eliminate the need for calibration but lets be clear that goal not a current expectation of the Gen 4 product.
• The stand alone Gen 4 product is expected to get a CE mark and enter the market in the summer.  
• The Gen 4 membrane will be used for the Gen 5 product. 
• They may explore trials for approval for a longer life of the Gen 4 sensor. There was extensive conversation around that around the 38 minute mark.  I found it fascinating but I’m a little geeky. 
• Gen 5 is a connectivity platform; to smart phones, remote monitors and the Tandem and Roche pumps. At about 45 minutes there was more on that, data integrity and conversations with the FDA. Again good geek stuff, actual humans may find it less exciting.
• They are spending R&D to an automated inserter.
• Terry Gregg mentioned and agreement with Qualcomm to integrate GDM into the hub for transmission to the SweetSpot Cloud. Understanding that is probably worth digging around Google from more information. 

In full disclosure, I own Dexcom shares. 

Philly Adult T1D Event

Enjoy the Preakness and Party with the Phila JDRF Young Leadership Committee.

Saturday, May 19, 3pm - 6pm City Tap House.

#TwoBits Attitudes that Make me Smile.

Here TwoBits with great attitudes.

Bill Woods aka 1HAPPYDIABETIC: I am a Better Person Because of Type 1 Diabetes.

   

On Facebook: Captain Glucose's Driving instructions from Diabetes to a Cure.

Enjoy.

JDRF & Dexcom Development Agreement

This press release just went out: 

JDRF Announces Research Collaboration with Dexcom, Inc. to Develop “Smart Transmitter” Technology to Accelerate Artificial Pancreas Studies

--Novel Transmitter Will Simplify Artificial Pancreas Research by Eliminating a Separate CGM component—

NEW YORK, April 24, 2012 – JDRF, the leading global organization focused on type 1 diabetes (T1D) research, announced today that it has partnered with Dexcom, Inc. (NASDAQ:DXCM), a San Diego, CA-based medical device company focused on developing and marketing continuous glucose monitoring (CGM) systems. The goal of the partnership is to accelerate the development of a novel wireless “smart transmitter” that would allow a CGM system to communicate directly with an artificial pancreas control device currently being used for research studies, instead of only with a CGM receiver. 

JDRF will provide Dexcom up to $500,000 over 12 months in milestone-based funding to complete the development, testing, and manufacturing of a custom “smart transmitter” prototype, which will be used for studies within JDRF’s Artificial Pancreas Project academic research consortium.  The direct communication capability enabled by the smart transmitter will be an important feature for artificial pancreas trials in outpatient (real-world) settings, as it would eliminate the need for a trial participant to carry multiple devices all wired together while testing an artificial pancreas system’s ability to manage glucose levels. 

People with T1D are burdened with constantly having to determine the right amount of insulin to dose at the right time, multiple times every day. Yet even with diligent monitoring, a significant portion of the day is still spent with either high or low blood sugar, placing them at risk for devastating complications. The artificial pancreas under development will be an external device that people with T1D could use to do what their bodies cannot—automatically control their blood sugar around the clock. It will work by combining an insulin pump and a CGM, which provides glucose readings every 1-5 minutes, with sophisticated computer software that allows the two devices to “talk to each other” to determine and provide automatically the right amount of insulin at the right time. Currently, all in-hospital artificial pancreas studies use wires and cables to connect a CGM system and an insulin pump to laptop computers or smartphones, which act as the artificial pancreas controllers.

In current CGM systems, the transmitter sends real-time glucose levels from the sensor to a receiver. In comparison, Dexcom’s next generation of “smart transmitters” will have the ability to wirelessly transmit a glucose value directly to multiple devices, including several versions of an artificial pancreas controller.

“This robust wireless capability could greatly enhance the performance of closed-loop algorithms in outpatient studies, and we are proud to be working with JDRF on this exciting venture,” said Terrance Gregg, chief executive officer of Dexcom. 

“In order for us to truly achieve real-life outpatient studies of artificial pancreas systems, we need systems that will allow people the freedom and ability to move around while also providing safety, monitoring, and data collection,” said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies for JDRF. “Dexcom’s ‘smart transmitter’ will allow the sensor to talk directly to multiple artificial pancreas control devices, and essentially eliminate the hassle of being encumbered by wires and other devices while trying to be active. Now that the first outpatient studies have started, the development of robust wireless connection capability is a key step toward accelerating the delivery of an artificial pancreas to all patients with T1D.”           

About JDRF

JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.6 billion to T1D research. More than 80 percent of JDRF's expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. For more information, please visit www.jdrf.org. 

YDMV @sixuntilme

Today's YDMV post has been moved to a different diabetes channel. Tune your browsers to sixuntilme.com where I'm doing a guest post for my friend Kerri.

Here is a teaser for that piece:

My goal of parenting kids with diabetes is to make their passion in life the my first priority and to bring diabetes along as second. I don’t profess to be the model parent or a expert in diabetes (but I have a little background in both, as we have two type 1 teens, who, for the most part, talk to us).

Accu-chek Aviva or Compact Plus users - Little Help?

The folks at Glooko and Accu-chek are looking for a hand, well fingers that get checked Accu-chek style.

Here is the message from Facebook:

We are looking for 20 people to test drive a new version of Glooko Logbook before we ship it to the masses. To participate, you must have an iPhone, iPod touch or iPad. You also must use one of these meters: ACCU-CHEK Aviva or ACCU-CHEK Compact Plus. Click here to sign up! http://tinyurl.com/6mkdngm. The first 20 to apply get this sneak peek.

My two cents is if we PWD can help innovation happen it is in our interest to do so. I consider the folks at Glooko and Roche to be friends. Like all friends we help out when we can. I have no problem with friends in industry and friends who are critical of it. YDMV.  

Here's what I wrote about Glooko in November.  (And like the crappy friend that I am I never actually reviewed the thing beyond this post.)
http://www.ydmv.net/2011/11/glooko-grail-and-audrey-hepburn.html

#TwoBits Diabetes Sucks and Parents' Time

NEW FLASH: Diabetes Sucks!

I know, who would have thought it? Kelly Booth has a nice Stream of Consciousness post as part of her Wego series here. "Using insulin isn’t like taking a pill that you get 30 pills for 30 days. Every day is different and most days it is different because of things you have no control over." Well said. YDMV.

ALSO: Parents Need a Break

Sometimes Parents Get a Break When They Take a Break. Scott did. Here's a great line, "the beginning of the next step for us..." Sweet.



#TwoBits is a hash tag used to highlighting post I enjoy around the Diabetes Online Community. I think we are all stronger when our community celebrates each other. Please feel free share #TwoBits too.  

#TwoBits - One Post by @momof2T1s

#TwoBits is a way of pointing to great stuff on the DOC. Pointing out two sites helps show there is a wide span of these great ideas. I do this as much to make myself seek out other work as anything else. I feel an obligation to point stuff out. A very good friend very passionately spoke recognizing and sharing others work not competing with it at some ungodly hour in the lobby at MedtronicDAF. She was so so right. #TwoBits also helps me do that.

So here it is one link with #TwoBits. I write because… by Christina. I so love what she writes about wearing hats and when they are they are worn. It helps that Christina is a mom to two T1s. That is bit #1.

#2 is how she recognizes Kerri. It is both Funny and appropriate. That ties back to the whole idea of recognizing others. A good friend of the DOC at Medtronic spoke about borrowing from other and in a reply to my post emailed the source of that document making the point that when boldly borrowing from other to cite the source. So thank Lane Desborough for teaching me Proudly Found Elsewhere and that it came from Proctor and Gamble.

More importantly thanks Christina for expressing why I write too.  

Art and Science on the Walls of LA

My impression of MedtronicDAF and the Getty Museum.

I saw some amazing things on the walls in Los Angeles. A 1667 painting that we were convince was an endo visit but may have been an EPT and guys with leather chaps and Harley gear visiting the Flemish gallery at the Getty.

Of it all, I liked the impressionists best.

Manet’s “The Rue Mosnier with Flags” was stunning. Painted in 1878 it strikes me as a relevant critique of public displays of nationalism while the veteran with crutches shows who may bear the costs.

I found Monet’s painting of light somehow, more real than actual light. Yet it was Desborough’s Depictions on the Principles I found most hopeful. His series of single page works are fine art.

Desborough?

Lane Desborough is part of the artificial pancreas research team at Medtronic. On one wall the team has posters detailing the principles that guide their work. They all signed the posters committing to the principles. Hanging on the opposite wall are brief, one page papers, illuminating their progress to waypoints on the journey the principles inform.

Note: We were asked not to photograph the documents as some 

content is proprietary. This image was provided by Lane.

I tried to read a few of the one page abstracts. Like the works of other impressionist masters, when you look closely what seems a clear picture of an event, place or light on water is something else entirely. Something possibly outside your expectations and possibly beyond your ability to comprehend. Step back and an image appears clear again.

Lane's team are serious scientists including PhDs from domains other than diabetes, like aerospace and industrial chemical refining. One had been in defense contracting. Their art is to understand and transfer variability from one place to another where it is tweaked and adjusted. For example aerospace understands autopilots. A plane can be moved deliberately through three dimensions, safely, with input from gyroscopes and navigational instruments. Chemical plants routinely crank out refined products and we think nothing of the catalysts and complexity involved. The team's work is to defend future patients from some of diabetes variations.

It is fine art. Engineering art. This team is bringing their experience to make an autopilot to refine blood sugar. They are guided by principles, post abstracts on the walls and when you step back an look at their art you can see that maybe there is an image of the future in their art. An image of a better future.

Lane sent me a video of a trebuchet he and his son build with Legos. That too is fine art and better father, son and dog interaction that managing a boy’s insulin. Being dad, like science is an art.  That art matters most, or at least that was my impression of what I saw on the walls in LA.



Notes: 
In a future post I will share more about the guiding principles with lanes consent but for me the reality is in the impression.

Also, Lane was clear that part of his process is to consciously work past the not invented her syndrome and proudly borrow from other domains. With that in mind please see my disclosure about MedtronicDAF proudly borrowing from a friend.