March 30, 2011

Dear Depressed In The West

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Kelly Kunik aka K2 has an emotional response to a letter from a reader about diabetes worry. It a great little piece and if you haven't seen it yet go read it now. Anything I have to say, can wait.

So now that you have read it this next bit is redundant because it is my comment there:

I'll jump in with the not particularly sage observation that Diabetes is in fact a rat bastard. It likes to play mind games with the goal of keeping PWD less than they can be.

All too often diabetes care is talked about in terms of numbers and compliance. Who the hell wants to be a number? As for the compliance bit I have seen enough science fiction to know that the robot overlords from outer space want us to be compliant.

Those robots are not the only ones. Yesterday I wrote about The Good, The Bad and The Ugly. I wish I had read this first because I would have cast the idea that diabetes care is about numbers and compliance as The Bad. (MTV's casting call would still be The Ugly.) The Bad doesn't see that living with diabetes takes an emotional toll. The Bad doesn't see the whole person with diabetes. It cuts out the emotions, well except the bad stuff like guilt and depression. I think emotional support is every bit as necessary as insulin and from what I hear around the DOC so do a lot of other people who are smarter than I am.

Don't let the the rat bastard focus on The Bad and The Ugly. You are entitled to have The Good too.

March 28, 2011

Verio 510k Clearance

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Anyone know anything about this meter? I was bored and started looking through the FDA 510k approvals. Yeah that bored. Anyway I came across this:


DEVICE: ONE TOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
LIFESCAN, INC.                    510(k) NO: K093745106(TRADITIONAL)
ATTN: LISA  MCGRATH               PHONE NO : 408 956 4446
1000 GIBRALTAR DR., MS 2C         SE DECISION MADE: 11-FEB-11
MILPITAS CA 95035 6312            510(k) SUMMARY AVAILABLE FROM FDA

I found an Australian page at: http://www.onetouch.com.au/

March 27, 2011

The Good, the Bad and the Ugly

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I watched the Indy Car opener toady. Delaney was psyched to see Charlie Kimball’s car. We were all sad to see him leave the race early.

I think he is a roll model for her and a lot of other kids with type 1. I don’t expect many of those kids to have an interest in becoming Indy Car drivers.  That isn’t what a roll model is about. Charlie is a roll model because he is living his dream and bringing diabetes along kicking and screaming whether it likes it or not.

Diabetes is a rat bastard. It doesn't want kids with type 1 to dream. It wants to limit and define the lives it touches. Charlie shows that with hard work, character and a Dexcom screwed on the high tech steering wheel of life they can chase down their dream at a few hundred miles an hour. Chasing dreams is more than simply good.

At some commercial break during the race I saw a tweet that MTV is casting a reality bit with someone with diabetes. They are looking for a bad diabetic. Here in part is their casting call:
Does your diabetes hold you back from living the life the way you want? Do you have an extreme form of the disease which requires you to constantly inject yourself with insulin? Does it make you feel different from your peers? How is your situation more difficult than your friends' at school? Are you embarrassed by your diabetes?
It sure seems like they are looking to help that rat bastard diabetes limit and define lives. That my friends is just another case of the ugly.

In reality, we have a choice. We can tune into MTV and wallow in diabetes or what ever the find that limits and defins lives. On the other hand Indy Car has races trough the fall. We can watch Charlie strap the Dexcom to the steering wheel and take diabetes where no one has taken it before. Where fast matters and diabetes doesn't.

Charlie is a rookie in the professional big league of his sport. He is a dedicated, hard working and pleasant. Those traits are the reality of what makes him a roll model.

I am looking forward to the next race. I'll be watching. As for MTV well I will maintain my perfect record of tuning them out. Diabetes isn’t the only thing that wants to limit and define the lives it touches. Unlike being diagnosed with diabetes we have a choice as to what we get on TV.

Use the powers of your remote only for good.

March 26, 2011

@CharlieKimball: Go Fast Insulin

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We hold theses truths to be self evident; that fast cars are cool. The type 1 community's own professional race car driver Charlie Kimball is racing in his first Indy Car even this weekend driving the Chip Ganassi Racing Levemir and NovoLog FlexPen Honda Dallara. A.K.A No. 83. This is the Big Leagues sports fans.

Here is Charlie in a video he made for theBeteNOW.


24/7 On Track Charlie Kimball from thebetes now on Vimeo.

He will be speeding around the streets of St. Petersburg in the Honda Grand Prix. There is great behavior to teach your insulin using kids to emulate... wait... maybe not so much unless the speeding around the streets is in an actual sanctioned racing event. Better for your car insurance premiums than getting a fist full of tickets - you can tune in on ABC tomorrow at 12:30 pm to watch.  Learn more on IndyCar.com.

Delaney and I are looking forward to the watching the race. She as an autographed picture of Charlie on the wall along with other type 1 athletes. He's cool. He goes fast. He is type 1. He  signs pictures for kids at Friends For Life. All that and he is crazy nice.

He is also the closest thing to the Stig we've ever met.

You can follow him on Twitter, maybe even Tweet him good luck on his first Indy Car race.
 

March 18, 2011

Rx: Kiss-a-Pig

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That is official medical advice. Well in so far a doctor suggests, well actually request, it.

The doctor in question is Andreas Stuhr. He is about as nice a guy as I've met and a real good sport. He did a bit for theBetesNOW in German only come to think of it now, I have no idea what he said...

Rumor has it he's been walking around the office in a pig costumer drumming up support for this fund raising event. Nobody should get away with behavior like that without their friends mocking them on the internet. I have spies trying to get pictures and I will post them when and if I get them.

In them mean time, if you are so inclined, join me in chipping in a little.

March 16, 2011

Tolerx Phase 3 Did Not Meet End Points

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From The News Wire: Disappointing news for people hoping for a suppression of the autoimmune causes of type 1. I am not a rocket scientist or expert on how any branch pf science progresses so I look forward to reading  what more capable writers have to say. I am sure good friend of the blog Scott Strummello will have enlightening comments when he has had time to get all the facts. In the mean time here is the opening of the recent press statement and a link to the full release. 

Tolerx and GlaxoSmithKline Announce Phase 3 Defend-1 Study of Otelixizumab in Type 1 Diabetes Did Not Meet Its Primary Endpoint

CAMBRIDGE, Mass. and LONDON, March 11, 2011 /PRNewswire/ -- Tolerx, Inc. and GlaxoSmithKline (GSK) today announced that the Phase 3 DEFEND-1 study of otelixizumab, an investigational humanized anti-CD3 monoclonal antibody, did not meet the primary efficacy endpoint of change in C-peptide at month 12 in patients with new-onset autoimmune type 1 diabetes.  
Following preliminary review of the data, no new or unexpected treatment-related safety concerns have emerged during the DEFEND-1 study. Study investigators and regulatory agencies have been notified of the DEFEND-1 study outcome.

FTNW: Biodel

Links
From the News Wire
DANBURY, Conn., Mar. 14, 2011 /PRNewswire/ -- Biodel Inc. (Nasdaq: BIOD) announced today that it has selected two new formulations of recombinant human insulin for clinical testing and is accelerating clinical development plans of these mealtime insulin drug candidates.  The new formulations, BIOD-105 and BIOD-107, are designed to result in more rapid insulin action compared to currently marketed meal time insulin analogs while maintaining an injection site tolerability profile comparable to currently marketed insulins.  Biodel plans to test these formulations in a Phase 1 clinical trial of approximately 18 patients with Type 1 diabetes.  This study is designed as a double blinded, three-period cross over trial in which patients will receive one subcutaneous injection of BIOD-105, BIOD-107 and Humalog® each on separate occasions.  This study, expected to be completed in the third calendar quarter of 2011, will evaluate pharmacokinetic, pharmacodynamic and tolerability profiles of the two experimental insulins relative to that of Humalog®.  In parallel with this subcutaneous injection study, Biodel plans to utilize a similar design to conduct a clinical pump study this year.
for more see this link

Health News - RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients

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Health News - RETAIN Trial for Newly Diagnosed Type 1 Diabetes Enrolls Patients

March 10, 2011

Check Up and Check In

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We did the diabetes equivalent of the 3,000 mile oil change this week - you know check the A1C level and rotate the infusion sites. Being real diabetics as opposed to some sprinkle sharing unicorn like mythological perfect diabetics there were ideas on things to do better and a recognition of the things that being done well.

Before the meeting with the CDE started she introduced a women I didn’t recognize. I wondered if it was the the dietician we had scared away a year or two ago with our dedication to the SWAG method of carb counting. Nope. It turns out she was with the research team. Here name was Tammy and she wanted to know if we would participate in a database study...

I cut her off. Sure. We are in.


When I was at the JDRF Capital Chapter event a few weeks ago one of the geniuses (I don’t use that term lightly, these scientist were sharp as a fresh lancet, if anyone remembers what a fresh lancet is like. I mean daylight saving time is a way off... But I digress.) One of the geniuses presenting was talking about the lack of a database type 1. There is no registry of folks with type 1 diabetes in these United States so it is a little hard to say with accuracy if is it increasing and if so where and why.

So there we were at the next endo visit and they want to know if we will participate in a database project. Hell yes. The geniuses need it. It is in our interest. If you are reading this it probably in your interest too.

The data exchange called T1D Exchange is a project sponsored by the  Helmsley Charitable Trust.  These folks are making some wonderful commitments to make lives touched by type 1 better. Cool stuff is coming and I look forward to hearing and sharing more about their efforts. That’s later.

Right now we have a roll to play. Sixty clinical sites are working to help build the data exchange. If at your next endo visit there is a visitor looking to get you to participate - step up  ...err... make that sit down at a computer fill out a few screens of data. The sharp as a lancet dudes need a registry and we all should be in it.

 We are in. Are You? 

March 8, 2011

FTNW: IV PREP Recall

Links
http://www.fda.gov/Safety/Recalls/ucm239219.htm

http://www.pharmabiz.com/NewsDetails.aspx?aid=61752&sid=2

I don't see any instructions about what to do other than toss the stuff out. Smith didn't have any alternative other than wait. I was told to contact our supplier for a refund.
Smith & Nephew recalls selected lots of IV PREP Antiseptic Wipes from US markets

St. Petersburg, Florida
Tuesday, March 08, 2011, 14:00 Hrs [IST]

Smith & Nephew's Advanced Wound Management division announced a US voluntary nationwide recall of selected lots of IV PREP Antiseptic Wipes (product number 59421200) manufactured for Smith & Nephew by The Triad Group.

This Smith & Nephew recall follows an earlier nationwide recall initiated by The Triad Group for alcohol prep products, pads, wipes and swabs due to concerns about potential microbial contamination with Bacillus cereus. Use of contaminated alcohol prep pads, wipes and swabs could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.

Smith & Nephew has halted all shipments of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. All customers and patients are advised to discontinue use of IV PREP Antiseptic Wipes immediately, as their use could result in localized or systemic infection. All customers should dispose of or return IV PREP Antiseptic Wipes to Smith & Nephew.

Smith & Nephew is advising all distributors and kit packers who utilize IV PREP Antiseptic Wipes as a part of their kit components to discontinue use of IV PREP Antiseptic Wipes immediately, and issue a sub-recall to their customers.

The specific lot numbers involved in the recall are: 9K141, 9K142, 9K143; 0F131; 0F140; 0G249; 0G255, 0G256; 0G259; 0K139, 0K140, 0K141; 0K193; 0M180; 0M216; 1A212, 1A213. IV PREP Antiseptic Wipes represent a small part of Smith & Nephew's overall advanced wound management business.

As a precautionary measure, and out of concern for patient safety, Smith & Nephew contracted an independent laboratory to test all lots of IV PREP Antiseptic Wipes manufactured for Smith & Nephew by The Triad Group. The results showed there is no data to suggest that Smith & Nephew's IV PREP Antiseptic Wipes have been compromised. To date, there have been no reported adverse events related to this voluntary recall.

Smith & Nephew is committed to providing customers with high quality, reliable product and has issued this voluntarily recall as a prudent, cautionary and conservative measure to assure patient safety and product performance. Smith & Nephew is working closely with the US Food and Drug Administration (FDA) on this recall.

For preparation of the skin prior to injection or venipuncture. It is flammable, keep away from fire or flame. Do not use with electrocautery procedures. For external use only. Do not use in or near the eyes. Discontinue use if irritation or redness develop. If condition persists for more than 72 hours, consult a physician.

Smith & Nephew is a global medical technology business with global leadership positions in Orthopaedics; including Reconstruction, Trauma and Clinical Therapies; Endoscopy; including Sports Medicine; and Advanced Wound Management. Smith & Nephew is a global leader in arthroscopy and advanced wound management and is one of the leading global orthopaedics companies.

March 7, 2011

Editorializing Conjecture on CGM Pump Intergration

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Europe is going to see Dexcom integration into insulin pumps before those of us on the left side of the pond, or so it seems from Dexcom’s earning call. We have to deal with Zombies first. Oh and it is going to named after a Pontiac.

Dexcom’s earrings call is online. You are welcome to go give it a click. I did. It's here: http://biz.yahoo.com/cc/0/121120.html

I listened for news on the integration of CGM into insulin pumps. Dexcom is working on that with both the Pod People and Animas. (I wish I had as good a nick name for Animas as Pod People is for Insulet with visions of the classic 1956 movie Invasion of the Body Snatchers, if you think of one post it as a comment - must be a 50s B movie.)

Where was I other than Zombie Invasions?

Oh Yeah! Earnings calls, the bit on the next generation of Dexcom sensor and combination Dexcom/pump products starts at about 11 minutes into the call. The good news: Dexcom received a CE mark for the 4th generation sensor. That is the one that will be integrated into the pumps. Dexcom expects it to launch in Europe with a Animas pump in the first half of 2011. The call even mentioned the combo pump thing has a name, “The Vibe.” Well, if you are going to name something after a Pontiac, Vibe is better than Aztec but it is no GTO.

Meanwhile the zombie invasion continues within the FDA or at least as far as getting pump/sensor approvals is concerned. Oops, that was a forward looking editorial statement based on conjecture. What I mean to say is that Dexcom publicly reported actual “constructive discussions” with the FDA on what it may take to get a gen. 4 sensor approved here in these United States.

The bit that confused the heck out of me (not that it is all that difficult to confuse me) is apparently in trials the FDA now considers glucose level manipulation a significant risk.

Really?

Hello FDA - Those living with type 1 kinda hav’ta to manipulate glucose levels 24/7. The manipulating blood glucose up is called eating. Bringing, sorry, manipulating blood sugar down is the whole insulin thing. What you are calling significant risk is what families living with type 1 diabetes call daily living. While I appreciate all the carefulness, I kinda, hav’ta, wanta call BS on the FDA for acting like a bunch of zombies pretending they don’t know there is a lot of glucose manipulation going on already.  Better tools would minimize the whole diabetes varies thing and therefor risk in actual daily lives. Doh! that was editorializing conjecture too.

So it seems commercialization of Dexcom / Pump combo is 6 moths off for Europe.  For us, just like it has been for the last few years, best case is a year here. Seems like the same time system as the cure - you know the one that has been ten years down the road for decades.

disclosure
I have two T1 teens, own a few shares of Dexcom and like movies more than earnings calls.
/disclosure

March 2, 2011

Find Balance Through Experiments

Links
(Hint: Read the Book, Get the Coach)

   Ginger Vieira’s path from a 13 year taking her first insulin shot to a champion athlete surprises even herself. “Ten years ago, if you told me I could set 15 powerlifting records as a person with diabetes, I would’ve laughed!” Yet she did it. Ginger set fifteen records in drug-tested powerlifting. While proud of the records it is the joy of learning and practice that leaded to her achievements that she loves. In her new book, “Your Diabetes Science Experiment,” Ms. Vieira shares her process of setting and achieving goals to live successfully with diabetes.

   Ginger draws parallels between her athletic training and managing diabetes. One key similarity is setting goals.  She break up challenges into steps then starts to take those steps. In this way a record isn’t one championship lift, it is the art of refining technique and enjoying the how each phase of training feels. Diabetes isn’t a life of shots, it is learning to experiment with management to, as she says in the subtitles of her book, “Live your life with diabetes, instead of letting diabetes live your life.”

    Type 1 diabetes is disease in which the cells that make insulin are destroyed by the body’s immune system. Insulin is needed to get energy from the food a person eats into the cells of their body. Without the ability to make their own insulin a person with type will require insulin injections everyday for the rest of their lives.

    Some of  what Ginger learned about diabetes came from a classmate, ‘I diagnosed myself at my 7th grade heath fair,” she explained. “A boy in my class did a poster on diabetes. I read it and said, ‘I’m everything listed on his board.’ My mom didn’t believe it. A week later I was in the hospital.”

   Those first days Ginger was overwhelmed by diabetes and self care. She remember crying in the hospital and still recalls the feeling of intimidation when her doctor first asked her to give herself an insulin shot.  “She just told me, ‘You’re gonna do it.’ I thought she was crazy but I did it,” Ginger said.

   That shot was an early accomplishment but she, like many with diabetes dealt with misconceptions from others. As a youth she enjoyed activities but her participation in organized sports stopped not long after her diabetes diagnosis. Ginger recalls her basketball coach would make off hand comments about her condition. “I noticed that if the coach saw me test my blood I would be kept out of the games.”

   Her experience with coaching changed. Following the feelings of successfully taking control of her heath in college Ginger became more serious about lifting. In the summer before her senior year of college she challenged herself to get healthier. “I cleaned up my diet, stopped drinking and started working out.” After a a few weeks at the gym. She loved the way she felt and felt empowered by those feeling. She also found the amount of insulin she required decreasing. She still needed insulin but less of it.

   Ginger hired a personal trainer and fell in love with weight lifting. Through lifting she found a new feeling of control of her health. Her trainer was familiar with diabetes form his physiology background. He challenged her to understand how her blood glucose levels impacted training. She began to discover relationships blood sugars and desired results. Ginger began tracking these relationships and how different types of exercise led to different outcomes.

   She learned high blood sugars prevented recovery and building muscle. Aerobic and anaerobic activity, which describe different exercises in terms of oxygen use, effected sugar levels different. This has implications for successful training. Ginger explains these differences and more in her book. She also provides guidance to improve both athletic and diabetes control outcomes.

   The Diabetes Online Community's favorite Diet Coke addict, Scott Johnson had lived with type 1 diabetes for three decades before finding motivation working with Ginger as a coach.  “It’s easy to think that her coaching is all about exercise and fitness,” he said. Yet only one of the three goals he set working with her was about exercise. The other two were about balance in diet and insulin use.  Scott says that as he broke down steps around his diet and insulin balance goals he uncovered anger about the amount of effort he faced, as a diabetic, around food. His appreciation of these deep emotions helped Johnson progress toward his exercise, eating and insulin goals. Ginger’s coaching of Scott follows the lessons she learned on her own journey.   Through her book Vieira coaches diabetics to systematically experiment their way to success.



   Learn more at Living In Progress, ginger web site. While you are there check out her video series.