P050020/S011
4/13/09
180-Day FreeStyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care
Alameda , CA
94502 Approval for a sterilization site located at Nutek Corporation, Hayward, California, to perform sterilization of the Sensor Delivery Unit.
P050020/S013
4/9/09
Real-Time FreeStyle Navigator Continuous Glucose Monitoring System, CoPilot Health Management System for FreeStyle Naviator Abbott Diabetes Care
Alameda , CA
94502 Approval for an updated version of the CoPilot Health Management System for FreeStyle Navigator Labeling and help files in the application to add windows Vista as an operating system that the application can be installed on as well as adding the necessary steps to allow the application and device to be used with Vista.
P980022/S048
4/9/09
Real-Time Medtronic MiniMed Continuous Glucose Monitoring System, SOF-SENSORS on Phillips Base Models MMT-7002, MMT-7003 Medtronic MiniMed
Northridge , CA
91325 Approval for design changes to the MMT-7002 and MMT-7003 glucose sensors models and a new supplier qualification. The design changes included an increase of the needle tunnel height and base from 0.034" to 0.036" and 0.030" and 0.031", respectively. These changes were intended to reduce the probability of a user having difficulty with removing the needle after sensor insertion. Further, the connector ledge of the senor base was increased from 0.007" to 0.011" to reduce relative rotational motion between the sensor base connector and GST transmitter. Phillips Plastics was also qualified as a new supplier for the glucose sensor bases in this supplement. The qualification included modifications including modifications to the needle guard core pin, a manufacturing tooling device. This device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring devices. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.
June 1, 2009
From the News Wire: FDA PMA Updates
The FDA updated the PMA database today with April approvals. Not exactly exciting stuff but what the heck someone may find it interesting.
Graduation
Crazy weekend.
Lots of running around. Kelley graduated from high school and will be off to NYU's film and telivision program in the fall.
Mrs. YDMV did a huge job of organizing events for the graduates in the evening. Key in that was a lock in at the school gym. A good proactive measure to keep the party safe and the kids had a great time. Nice work Dear, Love Ya Mean It.
Delaney wore a very nice dress she swiped from Kelley’s closet to wear to graduation. So one is graduating and getting ready to move to the next step in life and the “little one” serves notice she isn’t so little.
Delaney has her pump burred under the dress. So naturally she needed a little boost from the pump mid ceremony and the dress was NOT pump compatible. Yes Kerri, I see we need to be on the dress with a pump pocket band wagon.
One of the other graduates moms came up at cook out commented about Delaney getting up. She smiled and pulled out her pump. She had spotted the set on Delaney’s her arm.
Nice to have someone understand. It’s a small world after all.
In that Disney frame of mind. Kelley wanted to go see Pixar's Up as a graduation present. She is a HUGE Pixar fan and as a film geek she should be. It was outstanding. Go see it. Take your little ones even if they are big.
Lots of running around. Kelley graduated from high school and will be off to NYU's film and telivision program in the fall.
Mrs. YDMV did a huge job of organizing events for the graduates in the evening. Key in that was a lock in at the school gym. A good proactive measure to keep the party safe and the kids had a great time. Nice work Dear, Love Ya Mean It.
Delaney wore a very nice dress she swiped from Kelley’s closet to wear to graduation. So one is graduating and getting ready to move to the next step in life and the “little one” serves notice she isn’t so little.
Delaney has her pump burred under the dress. So naturally she needed a little boost from the pump mid ceremony and the dress was NOT pump compatible. Yes Kerri, I see we need to be on the dress with a pump pocket band wagon.
One of the other graduates moms came up at cook out commented about Delaney getting up. She smiled and pulled out her pump. She had spotted the set on Delaney’s her arm.
Nice to have someone understand. It’s a small world after all.
In that Disney frame of mind. Kelley wanted to go see Pixar's Up as a graduation present. She is a HUGE Pixar fan and as a film geek she should be. It was outstanding. Go see it. Take your little ones even if they are big.
May 28, 2009
From The News Wire: CGMs Work
Science Daily is reporting a JDRF study of CGM use by people with good control. The conclusion: CGMs help maintain control and limit hypos. Film at 11:00
ScienceDaily (May 27, 2009) — People with type 1 diabetes who have already
been successful in achieving recommended blood sugar goals can further benefit
from using continuous glucose monitoring (CGM) devices, according to results of
a major multi-center clinical trial by the Juvenile Diabetes Research
Foundation.
According to the JDRF study, using CGM devices enables people who have
achieved excellent control (with HbA1c levels below 7 percent) to continue to
tightly manage their diabetes while cutting down on the frequency of low blood
sugars, called hypoglycemia.
May 26, 2009
IPhone 3.0 and Life Scan Behind the Scenes
I still get a fair number of hits from iPhone 3.0 diabetes searches. If you missed the edit after the edit on the original iPhone post here at YDMV, this is the back story:
The Ap at the the 3.o show "was of a prototype application that LifeScan created specifically for the event to show what medical devices can do when connected with iPhone 3.0. Detmers stressed that the demo was not meant to represent a fully-defined commercial product that is imminent. Apple asked LifeScan just a few weeks ago to create a prototype for the event and LifeScan was all too happy to participate, but a product like the one shown is not on the verge of a commercial launch."
http://mobihealthnews.com/973/interview-lifescan-on-iphone-30/
update Sept 21 2010 Sanofi/WaveSense announce iBGStar
The Ap at the the 3.o show "was of a prototype application that LifeScan created specifically for the event to show what medical devices can do when connected with iPhone 3.0. Detmers stressed that the demo was not meant to represent a fully-defined commercial product that is imminent. Apple asked LifeScan just a few weeks ago to create a prototype for the event and LifeScan was all too happy to participate, but a product like the one shown is not on the verge of a commercial launch."
http://mobihealthnews.com/973/interview-lifescan-on-iphone-30/
update Sept 21 2010 Sanofi/WaveSense announce iBGStar
Tell Your Type 1 Daughter
She can aim high. Like at the high court. Ap is reporting that the President has nominated federal appeals judge Sonia Sotomayor for the Supreme Court. She has been type 1 since age 8.
Our good friend Amy at Diabetes Mine wrote that there was reporting that her diabetes would lessen her chances at a nomination. It good to see that the diabetes didn't stop her.
There is a message for your daughters. She wasn't stopped by her diabetes. Help you kids reach for their dreams.
Our good friend Amy at Diabetes Mine wrote that there was reporting that her diabetes would lessen her chances at a nomination. It good to see that the diabetes didn't stop her.
There is a message for your daughters. She wasn't stopped by her diabetes. Help you kids reach for their dreams.
May 25, 2009
Your Advocates Should Vary
When I say Your Diabetes May Vary I mean of course it will. The only constant with diabetes is nothing is constant. Well almost nothing.
I find it fascinating that the Professional Diabetes Advocacy organizations are remarkably constant. From the emails I receive from them it appears that diabetes to them is one thing and on thing only - Stem Cells.
Both ADA and JDRF fill my in box with emails urging Stem Cell Advocacy. They want me to understand, as the ADA put it that, “It is critical for NIH to hear from as many members of the public as possible letting both the Administration and Congress know that diabetes advocates strongly support the expansion of stem cell research.” Their bolding, not mine.
Here is the deal. I personally am in favor of stem cell research. I am Christian too. I don’t see a conflict between those two. Others do and I try to be as respectful of their convictions as I would want them to be of mine. For me being respectful while differing is part of that “Do unto other…” bit Christianity teaches.
Where the respect starts to break down is with the image of individual diabetes advocates that these organizations project by their focus on stem cell advocacy. I don’t like the idea that type 1 advocacy is de facto stem cell advocacy. As I see it, there are a number of challenges in a family living with type 1. Many if not most are more pressing day to day than stem cells.
I want to be seen as an advocate for the totality of type 1's challenges and not be defined, by others, to a single issue around diabetes, even if it is one of the many I support. I think it would be ideal if those Professional Diabetes Associations would equally reflect the variety of challenges diabetes puts in our lives.
So here are some random thought on where they can do that.
School problems are a day to day reality for many families of children with diabetes. When the schools relationship goes bad, “Critical” is an understatement of its importance. If little Johnny is facing issues with his diabetes care at school, nobody at home gives a hoot about stem cells.
Crystal Jackson at ADA is the National Queen of Diabetes at School issues. After meeting her at Friends for Life a few years ago, I honestly feel an upgrade to Empress of the Universe is in order. Wouldn’t it be great if ADA emailed as much about how to advocate for support safe schools and with the same urgency, polish and organizational attention that stem cell advocacy gets?
Our friends at JDRF invest huge money, as in tens of millions, with for profit companies, trying to move research from the laboratory to peoples lives. They call the program Industry Discovery and Development Partnerships or IDDP. They have a section of their web page about IDDP but it isn’t always kept up to date. I have made a number of passes at learning and sharing more about the program and how it is doing.
In my experience, JDRF shares little about IDDP deals beyond an initial press release. Once I called the PR person whose name was on a particular press release. I wanted to know if a big pharma acquisition of rights of to a process JDRF had an IDDP 'partnership' deal on, triggered a repayment to JDRF of IDDP funds.
‘Good question,’ the PR person said, ‘I don’t know. Can I get back to you?’
The return call never happened. What ever the outcome in that case (and I would think it could it be a success story to share) JDRF certainly doesn't feel the need to share about IDDP like they do with stem cell lobbying.
JDRF is acting as an investment banker / venture capitalist in the diabetes space. I am OK with that. I think those of us who walk would see investing like this, in trials of discoveries, as the JDRF mission.
Sadly that investment banker roll seems to include the lack of transparency that the financial industry is now infamous for. The message apparently is, “Trust us - there are smart real people working on this.” That sounds a lot like Congress’s rational for not regulating derivatives in the close of the ‘90s to me - we all know how well that turned out. Maybe a little more being open with details about IDDP along with the stem cell emails would help all of us see how JDRF gets that type 1 diabetes isn’t a Johnny one note deal. At least it would be something new to read.
Care to step up to a mundane but real every day issue Professional Diabetes Advocates? A number of families with diabetes are concerned that mail order houses (required by insurance) like CVS/Caremark handle insulin in a manner that appears to us to be outside the FDA approved labeling. Specifically that they ship it warm. Want to help insure insulin is shipped cool?
It is not sexy at all. Not taking sides in the big political picture. It's just our insulin - in a hot delivery truck. Don't worry Professional Diabetes Advocates I won't be surprised if it is not your priority. You’re probably working on another critical stem cell email - looking forward to it, honest.
Your Diabetes May Vary. So should your Advocates.
I find it fascinating that the Professional Diabetes Advocacy organizations are remarkably constant. From the emails I receive from them it appears that diabetes to them is one thing and on thing only - Stem Cells.
Both ADA and JDRF fill my in box with emails urging Stem Cell Advocacy. They want me to understand, as the ADA put it that, “It is critical for NIH to hear from as many members of the public as possible letting both the Administration and Congress know that diabetes advocates strongly support the expansion of stem cell research.” Their bolding, not mine.
Here is the deal. I personally am in favor of stem cell research. I am Christian too. I don’t see a conflict between those two. Others do and I try to be as respectful of their convictions as I would want them to be of mine. For me being respectful while differing is part of that “Do unto other…” bit Christianity teaches.
Where the respect starts to break down is with the image of individual diabetes advocates that these organizations project by their focus on stem cell advocacy. I don’t like the idea that type 1 advocacy is de facto stem cell advocacy. As I see it, there are a number of challenges in a family living with type 1. Many if not most are more pressing day to day than stem cells.
I want to be seen as an advocate for the totality of type 1's challenges and not be defined, by others, to a single issue around diabetes, even if it is one of the many I support. I think it would be ideal if those Professional Diabetes Associations would equally reflect the variety of challenges diabetes puts in our lives.
So here are some random thought on where they can do that.
School problems are a day to day reality for many families of children with diabetes. When the schools relationship goes bad, “Critical” is an understatement of its importance. If little Johnny is facing issues with his diabetes care at school, nobody at home gives a hoot about stem cells.
Crystal Jackson at ADA is the National Queen of Diabetes at School issues. After meeting her at Friends for Life a few years ago, I honestly feel an upgrade to Empress of the Universe is in order. Wouldn’t it be great if ADA emailed as much about how to advocate for support safe schools and with the same urgency, polish and organizational attention that stem cell advocacy gets?
Our friends at JDRF invest huge money, as in tens of millions, with for profit companies, trying to move research from the laboratory to peoples lives. They call the program Industry Discovery and Development Partnerships or IDDP. They have a section of their web page about IDDP but it isn’t always kept up to date. I have made a number of passes at learning and sharing more about the program and how it is doing.
In my experience, JDRF shares little about IDDP deals beyond an initial press release. Once I called the PR person whose name was on a particular press release. I wanted to know if a big pharma acquisition of rights of to a process JDRF had an IDDP 'partnership' deal on, triggered a repayment to JDRF of IDDP funds.
‘Good question,’ the PR person said, ‘I don’t know. Can I get back to you?’
The return call never happened. What ever the outcome in that case (and I would think it could it be a success story to share) JDRF certainly doesn't feel the need to share about IDDP like they do with stem cell lobbying.
JDRF is acting as an investment banker / venture capitalist in the diabetes space. I am OK with that. I think those of us who walk would see investing like this, in trials of discoveries, as the JDRF mission.
Sadly that investment banker roll seems to include the lack of transparency that the financial industry is now infamous for. The message apparently is, “Trust us - there are smart real people working on this.” That sounds a lot like Congress’s rational for not regulating derivatives in the close of the ‘90s to me - we all know how well that turned out. Maybe a little more being open with details about IDDP along with the stem cell emails would help all of us see how JDRF gets that type 1 diabetes isn’t a Johnny one note deal. At least it would be something new to read.
Care to step up to a mundane but real every day issue Professional Diabetes Advocates? A number of families with diabetes are concerned that mail order houses (required by insurance) like CVS/Caremark handle insulin in a manner that appears to us to be outside the FDA approved labeling. Specifically that they ship it warm. Want to help insure insulin is shipped cool?
It is not sexy at all. Not taking sides in the big political picture. It's just our insulin - in a hot delivery truck. Don't worry Professional Diabetes Advocates I won't be surprised if it is not your priority. You’re probably working on another critical stem cell email - looking forward to it, honest.
Your Diabetes May Vary. So should your Advocates.
May 23, 2009
From the News Wire: Navigator Complaint Handling & FDA
FDANesw.com ran a short bit abbout the Navigator, the FDA and customer complaints. FDANews wants a subscription for more and I don't have the coin for their reports so I can only see the teaser. It looks to me like it relates to isolated incidents. Alert CWD readers will have seen the Navigator community talking amongst themselves on supply and customer service issues. So I am not so sure this ranks as actual news to the people most effected, Navigator users.
From FDANews.com
From FDANews.com
Abbott Diabetes Care Gets 483 for Complaint Procedures
An FDA investigator cited Abbott Diabetes Care for complaint handling and employee training in a Form 483 that included three observations.
The company received the Form 483 in March after an inspection of its facility in Alameda, Calif., for operations related to the FreeStyle Navigator continuous glucose monitoring system.
Staff did not complete training for complaint procedures or device failure investigations, and the company did not appropriately evaluate a complaint to determine if a medical device report was needed. The complaint came from a customer “who was using the Navigator and was in pain and wanted to return the system,” the form says.
May 20, 2009
From The News Wire: Mini Med Teaser
Medtronic, Inc. F4Q09 (Qtr End 04/24/09) Earnings Call Transcript
SeekingAlpha.com
The interesting part is the coming attractions bit. I bolded it for you.
SeekingAlpha.com
The interesting part is the coming attractions bit. I bolded it for you.
In Diabetes, strong double digit performance on a constant currency basis this quarter was driven by the continued success of Continuous Glucose Monitoring and solid insulin pump sales. We continue to have success as the only company with a proprietary Continuous Glucose Monitor Sensor Augmented Pump on the market. At this point, we have a three year lead on the competition. We are also the only company with the iPro, a unique professional CGM tool, and with our Diabetes CareLink therapy management software, we offer the most integrated diabetes data management system on the market.
We continue to execute on our significant new product pipeline, including making strong progress in blazing the trail to a closed loop system so stay tuned for an update on this program at our upcoming Investor Meeting on June 2nd.
As another sign of our increasing business development efforts, later today we will announce details of a strategic marketing collaboration with Eli Lilly, which combines our delivery and glucose sensing leadership with the insulin expertise of Lilly, a recognized leader in diabetes treatment, research, and education.
May 17, 2009
Sorry but there is just no other way to put it..
At the dinner table:
“Why is there a set on ‘Lanes’ arm?” Kelley.
“She is wearing them there now,” Me.
“Why?”
“Better absorption than her butt.”
Looking at her arm, “That is Bad Ass!” Kelley. Then with a little mock contrition, “Sorry but there is just no other way to put it.”
“No problem. Anytime you can describe your 5th grade little sister as Bad Ass, I think you should.”
“Oh and that’s 45 carbs.”
I love family dinner.
“Why is there a set on ‘Lanes’ arm?” Kelley.
“She is wearing them there now,” Me.
“Why?”
“Better absorption than her butt.”
Looking at her arm, “That is Bad Ass!” Kelley. Then with a little mock contrition, “Sorry but there is just no other way to put it.”
“No problem. Anytime you can describe your 5th grade little sister as Bad Ass, I think you should.”
“Oh and that’s 45 carbs.”
I love family dinner.
Sometime life is just funny.
I am reading my Diabetes Daily email when what to my wondering eyes should appear but this: (I dare you to read line 2 & 3 and not laugh.)
Recent Diabetes News
* Cyloset Approved for Type 2 Diabetes (discuss)
* Vibrate Yourself to a Leaner You (discuss)
* Diabetes Often Affects Women's Sex Life (discuss)
* Is Sugar-Free Ice Cream Healthier? (discuss)
* 70 Years with Type 1 Diabetes (discuss)
* NY Doctor Offers Flat-Rate for Uninsured (discuss)
* Read more in the News & Interesting Links forum
Recent Diabetes News
* Cyloset Approved for Type 2 Diabetes (discuss)
* Vibrate Yourself to a Leaner You (discuss)
* Diabetes Often Affects Women's Sex Life (discuss)
* Is Sugar-Free Ice Cream Healthier? (discuss)
* 70 Years with Type 1 Diabetes (discuss)
* NY Doctor Offers Flat-Rate for Uninsured (discuss)
* Read more in the News & Interesting Links forum
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