Medtronic iPro®2 CGM Approved by FDA

From the News Wire: 


MINNEAPOLIS – November 22, 2011 – Medtronic, Inc. (NYSE:MDT) today announced the Food and Drug Administration (FDA) approval of iPro®2, a next generation Professional continuous glucose monitoring (CGM) system and the latest in a series of recent diabetes technology approvals and innovations from the company. iPro2 simplifies Professional CGM and enables healthcare providers to obtain a more complete picture of glucose control for the patients they treat.  Professional CGM is used by healthcare providers to reveal low (hypoglycemia) and high (hyperglycemia) glucose excursions that can lead to the dangerous health complications of diabetes.  These excursions often go unnoticed with traditional A1C tests and standard glucose meter measurements.

Glooko, the Grail and Audrey Hepburn

Glooko was kind enough to give me a cable to review, no string attached as it were. I’lI get to that review in the upcoming weeks because this is more an editorial Grail Quest than review.

I have been been on this search for the diabetes management version of the Holy Grail for a while.  Back in 2007 I wrote “my quests is for a diabetes management software application that is worth using. I would like the cure and the Holy Grail while I am at it too - they seem just about as likely.”

The thing about Grails is that your definition of it tends to grow while you are looking for it. Data standards became part of my Grail Quest because I want all the data, that comes from different machines, to play nice together in the diabetes sandbox. I wrote about this back a then too but what I have forgotten in my quest is that a UN translator is almost as good as data standards. If you don’t think a UN translator can be sexy, go watch Audrey Hepburn in Charade. (I am sure it will be more interesting than the rest of this post.) 

Glooko may be such a UN translator, if not as classically lovely as Ms. Hepbrun. It looks like a step in the direction from a different nations of the diabetes globe talking together perspective 

It is also a shift in the center of the diabetes data management universe. Glooko is a cable that connects a meter to an iPhone. I think data in your smart phone instead of your computer is a move closer to where folks with diabetes live their lives. 

You maybe thinking, where have I seen this before? Probably the presentation of introducing the iPhone 3 back in 2009.  Apple had J&J dummy up an cable and and app for the big unveiling. It never saw the light of day - well maybe until now.

Glooko is a cable that can connect meters, from a variety of manufacturers, to an iPhone, iPod, or iPad. The application does the translation of the data from Bayer, Abbott or OneTouch’s data format and fill in the log book. That mix of brands is part of the path to the grail. To me it is significant that Glooko plays the roll of Audrey Hepburn and translates data from different meters into one log. You can email that log right out of the device. 

That is not the only step towards the chalice. I see shifting from computer based applications to a mobile device as moving data collection, and hopefully use, closer to people with diabetes' lives. A more mobile logbook and translations of data are steps towards the grail even if they are not the goblet itself. 

Back in my UN inspired post I suggested that the makers of meters would come out ahead if they joined in a common app and data development effort. I wrote, some what flippantly, “Just think, all the manufacturers could all reduce the cost of R&D spent on the machine that listens to the Machine that goes PING if they didn’t each have to invent a new language in the process. Hey guys in expensive suits! Lower expenses means more profits and bigger bonuses for the guys in expensive suits or they could then invest that saved R&D money into better design, clearer user interfaces and compete on usability! Yeah I think it would go to bonuses too.”

The logbook is Glooko first step. They say they want to make better tools for diabetes management. Time will tell what that means. More meters and more mobile devices showing up at the UN, probably. More functionality than a basic log book, maybe - but that is an FDA regulation issue and why we all should care about mobile apps. I would love to see devices other than meters talk to the app, not that I am directly lobbying Glooko or anything. OK maybe I am. 

I still define the grail like I did back in 2007 as software that would help families adapt to varying diabetes by:

• Tracking for reporting all the data users create in their daily diabetes care without creating a lot more sets of family tasks. We have diabetes – that has enough tasks as it is.

• All the BG data, including CGM info. All the basal data. All the carbs entered into the pump to calculate all the bolus data. Any user defined flags on those carbs like pizza. User defined variables that could be things like heavy exercise, set pulled off, ketones, freaky weather, stress, menstrual cycle, weekday, weekend and what ever else people dream up. The key here is being user definable.

• Then we need reporting ability and the ability to include or exclude data based on those use defined fields. Build reports that average the midnight to 6 am BD data from meters or CGM for nights following a day with hard exercise. There you have info for tailoring basals for a post activity dip in BG.

• How about sorting the data for a school girl’s weekdays, excluding days with PE class to build a normal school day profile and one only for PE days?

To that I would add that grail should ultimately connect to devices wirelessly and store information in a cloud accessible with any modern browser. Which is fairly sophisticated and outside the mindset of the FDA. -  All of which is what makes it a Grail. 

Tandem t:slim™ FDA Approval

From the News Wire:

Tandem Diabetes Care Announces FDA Clearance of the t:slim™ Insulin Delivery System
Smallest Insulin Pump System and First-Ever with a Touch ScreenSummary:    Tandem Diabetes Care, Inc. today announced that the U.S. Food and Drug Administration has granted the Company clearance to market the t:slim™ Insulin Delivery System.
    

SAN DIEGO,  November 16, 2011—TandemDiabetes Care, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted the Company clearance to market the t:slim™ Insulin Delivery System (t:slim).  This new full-featured pump is the first-ever with a color touch screen, and is the smallest insulin pump system currently available. The t:slim is one of the first insulin pumps to be cleared under the FDA’s new Infusion Pump Improvement Initiative.
“With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a new standard in insulin infusion therapy,” said Kim Blickenstaff, president and CEO, Tandem Diabetes Care. “In creating t:slim, we spoke with more than 4,000 healthcare professionals and people with diabetes, and the clear message we heard was, ‘make it cool and make it uncomplicated to use.  Give us access to the most advanced features without extra effort.’  The t:slim’s touch screen interface has been proven in extensive user studies to be easy to learn and to use by new and experienced pump users alike.” More

Of Stem Cell and Cures:

Diabetes and the stem cell promise 

The search for a cure, or even a less-complicated treatment, is still on a long road to its goal. 

By Eryn Brown, Los Angeles Times
November 7, 2011 

Ever since scientists started talking about the medical potential of embryonic stem cells, curing Type 1 diabetes has been one of the dearest dreams.
When researchers announced in 1998 that they had derived stem cells from human embryos, their landmark report flagged juvenile-onset diabetes as a disease that might be treated by stem cell transplants. 

In the run-up to the 2004 vote on California's Proposition 71, diabetes was repeatedly mentioned as a target by scientists campaigning to form a state-backed stem cell agency. 

Years later, the promise remains. But success has been elusive. MORE

Spoiler alert: The last line of this article is the the most telling and why better treatments matter as well as cure research: "Next century, when you look back at it, two decades won't seem like much. But for those affected right now, every month is too long."


http://www.latimes.com/health/la-he-diabetes-stem-cells-20111107,0,5759144.story

Legislators push for faster FDA device review

MASSDEVICE ON CALL — Minnesota legislators penned a letter to FDA head Margaret Hamburg pushing for a faster and simpler review process for medical devices.Sens. Amy Klobuchar (D) and Al Franken (D) were joined by Reps. Erik Paulsen (R), Betty McCollumn (D), John Kline (R) and Michelle Bachman (R) in raising concerns over "increased review times, inconsistent expectations, and poor communication from the FDA."

http://www.massdevice.com/news/minnesota-pushes-faster-device-review-massdevicecom-call

CGM Sensor Trials

Most folks in the diabetes online community recognize a need for better CGM sensors. Part of getting them to market is testing them in clinical trials. Medtronic has news today about a CGM trial:
  

MINNEAPOLIS – Nov. 9, 2011 – Medtronic, Inc. (NYSE: MDT) today announced a new United States investigational device exemption study to evaluate the accuracy of six-day use in adults with diabetes of its Enlite™ Sensor, the company’s latest innovation in continuous glucose monitoring (CGM) technology for people with diabetes. The study will evaluate Enlite, a glucose sensor for CGM designed to offer improved hypoglycemic detection and comfort compared to current CGM sensors. CGM provides a more complete picture of glucose control because it can reveal high and low glucose levels that periodic fingerstick testing might miss.

The first two patients in the study were enrolled at Rainier Clinical Research Center in Seattle, Wash., and at AMCR Institute in San Diego, Calif., by the sites’ principal investigators (PI), Ronald Brazg, M.D., and Timothy Bailey, M.D., respectively. 

Full press release info here 

Trials may or may not be your thing. Full consideration is needed for joining any study, but if you are interested in participating see: http://clinicaltrials.gov/ct2/show/NCT01464346 

This is not the only CGM trial of interest.  For more on other CGM studies is also available at clinicaltrials.gov: http://clinicaltrials.gov/ct2/results?term=CGM

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.


. 

A Request from Spain

My friend Mike from DiabetesInSpain.com sent this request and I am happy join in and to pass it on.

I appreciate their are many things taking place regards to Diabetes this month, but I hope that this project will capture your imagination.

On November 11th (11.11.11), across the planet, documentary filmmakers, students, and other inspired citizens will record the human experience over a 24-hour period and contribute their voice to the second annual global day of media creation called One Day on Earth. Together, we will create a shared archive and a film.

Imagine being able to capture the world on the same day, each giving their unique perspective on Diabetes around the globe!  Anything goes! It just has to have something related to Diabetes. Please share and pass on to friends, family and anyone else you may know.

I would like to invite everyone from the DOC both online and offline to take part if possible by taking a Diabetes related image on 11.11.11 and submit them either via a Flickr group, via twitter with the #diabetes111111 hashtag or directly on my website site.

1.  Grab your camera – take your Photo/Video – 11.11.11

2.  Submit Photo via Flickr, Twitter or this website.

3.  Enjoy the photos as they appear on this site, twitter and flickr from Friday the 11th November.

Please join me and share! - http://diabetes111111.com

Links:

http://www.flickr.com/groups/diabetes111111/

http://twitter.com/#!/search/realtime/%23diabetes111111

http://diabetes111111.com/upload/

Saludos

Mike

Mice Again

Molecule That Prevents Type 1 Diabetes in Mice Discovered; Has Similar Effect On Human Cells
ScienceDaily (Nov. 1, 2011) — Researchers at the University of Colorado School of Medicine have found a specific molecule that can prevent the development of type 1 diabetes in mice and has a similar effect on human cells from diabetic patients.

More

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.

Diaversary and our #T1Din3- "Bolus for Candy"

Halloween is our (first of two) diaversary. Spell check is having a hard time with the combination of diabetes and anniversary. That is OK spell check I know how you feel.

We have felt strange about it too, every year. I have found writing about it helps.

We haven'e always the same way about diagnosis anniversaries. It is like our diabetes has varied. At first we were still a little raw and then shortly after that first diaversary we got a second diagnosis and it was as raw as the first.  By now we are so far into the "new normal" that it is fairly close to simply normal.

Still Halloween is our day and Halloween brings out different responses in type 1 families. Some don't trick or treat, some fret about it, some buy back candy and then there is us. We eat the stuff. On nurses orders.

JDRF has a hash tag fest going on on Twitter, #T1Din 3. The idea is to share a T1 thought in three words. There is even a "Flat Stanley" thing to give diabetes the finger. We are all fairly sure it is "the wrong finger." (Not to telegraph one of our #T1Din3 offerings or anything.)

So anyway in honor of Connor getting sprung from CHOP our three words are, "Bolus for Candy."

We had great support at that first diagnosis. Here is a link to the story of Connor's diagnosis and the great care we received from our nurse at CHOP. She is the one who sprung him a day early so he could trick or treat and gave him instructions to eat the candy (as part of his meal plan.)