December 25, 2012
December 20, 2012
Lipstick Art on Coco - Natalie Irish
Funny bit on Conan last night about lipstick art with Natalie Irish. Funny all by itself but there is a T1D connection as Natalie - the artist has a bionic pancreas. Delightfully silly and cool art too.
http://teamcoco.com/video/lipstick-artist-natalie-irish-works-entirely-with-lips
http://teamcoco.com/video/lipstick-artist-natalie-irish-unveils-her-conan-portrait
More about Natalie's work.
www.natalieirish.com
Enjoy.
December 18, 2012
A Parent's Prayer
This is a blog about parenting. In this post I offer a short parent’s prayer. I shared this prayer last night on DSMALive Parents Talk. My thanks to Cherise and Lorraine for helping me find these words:
I wrote a letter to a friend years ago. He and I differ on some trivial things, like politics. Still I know, respect and love what is at his core. We are both proud fathers, husbands, sons and brothers. We share the love of family, humor, neighbor, community and country.
In retrospect why I wrote this letter is insignificant in light of the tragedy in Connecticut. Still I think there is a key truth in it. I hear this truth coming from parents who lost a child last friday. In their grief they struggle to be true to the unconditional embracing love that defined their children's lives. I think we need to start the process of responding to the Newtown massacre with the assumption of good in those with who we may differ.
With that I offer this letter; Bad things happen to good people.
Father above, we feel a small sample of your infinite parental love with the children we have been blessed to raise, to care for and to love. We pray for a similar measure of your wisdom and grace to guide us as we react to the horror that has happened in Newtown. We pray that your love be felt by parents and the community in Connecticut and by all who struggle with shock and grief.
I wrote a letter to a friend years ago. He and I differ on some trivial things, like politics. Still I know, respect and love what is at his core. We are both proud fathers, husbands, sons and brothers. We share the love of family, humor, neighbor, community and country.
In retrospect why I wrote this letter is insignificant in light of the tragedy in Connecticut. Still I think there is a key truth in it. I hear this truth coming from parents who lost a child last friday. In their grief they struggle to be true to the unconditional embracing love that defined their children's lives. I think we need to start the process of responding to the Newtown massacre with the assumption of good in those with who we may differ.
With that I offer this letter; Bad things happen to good people.
December 14, 2012
OmniPod 2.0 Approved.
This just in:
Insulet's (PODD) Next-Gen OmniPod Receives FDA 510(k) Clearance
http://www.streetinsider.com/related.php?id=7949280&type=pr
Press Release:
BEDFORD, MA -- (Marketwire) -- 12/14/12 -- Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation OmniPod Insulin Management System. The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features. In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager (PDM) that also features a series of enhancements.
"The OmniPod revolutionized insulin delivery with its tubeless and wireless design when it was introduced in 2005 and today, the next-generation OmniPod raises the bar for insulin pump therapy again," said Duane DeSisto, President and Chief Executive Officer of Insulet. "We are thrilled to have received FDA approval and it is my hope that our new Omnipod insulin pump will continue to make living with diabetes easier for our customers across the United States."
"When technology can make diabetes management easier for my patients, they have better clinical outcomes," said Steve Edelman, MD, Clinical Professor of Medicine at the University of California at San Diego and founder of Taking Control of Your Diabetes (TCOYD), a not-for-profit organization with the goal of teaching and motivating patients in diabetes self-care. "As an OmniPod wearer myself, I love its ease of use and no tubing! Now with its smaller and sleeker design, it will make it even easier for more people to take control of their diabetes."
"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production," said Mr. DeSisto. "We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition."
Customers are encouraged to keep informed via http://www.MyOmniPod.com/NewOmniPod where the Company will publish its latest information about the exact timing and availability of the new OmniPod System, including details on how current users will be converted. Additionally, current users will receive direct notification from the Company when the conversion process is commencing.
While performing its launch preparation initiatives, Insulet continues to collaborate closely with healthcare providers and patients so they can enjoy the many benefits of the current OmniPod today.
About the OmniPod Insulin Management System The OmniPod Insulin Management System is the world's first tubeless insulin pump. The OmniPod offers people living with insulin-requiring diabetes all the benefits of insulin pump therapy, with freedom and ease. The tubing-free OmniPod insulin pump has just two easy-to-use parts: the discreet, waterproof Pod, which automatically inserts and can be worn on many parts of the body to hold and deliver insulin; and the Personal Diabetes Manager (PDM), a hand-held device that wirelessly programs the Pod, calculates suggested doses and has a built-in blood glucose meter. For more information on the OmniPod insulin pump, please visit: http://www.myomnipod.com.
Forward-Looking Statement This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and of Section 21E of the Securities Exchange Act of 1934 concerning Insulet's expectations, anticipations, intentions, beliefs or strategies regarding the future, including those related to its planned expansion of sales of the next generation OmniPod System in the U.S. and abroad, product demand, the market acceptance of our next generation OmniPod System, regulatory matters and financial performance. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the Company's dependence on the OmniPod System; Insulet's ability to increase customer orders and manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform legislation; potential supply problems or price fluctuations with sole source or other third-party suppliers on which Insulet is dependent; international business risks; Insulet's inability to obtain adequate coverage or reimbursement from third-party payors for the OmniPod System and potential adverse changes in reimbursement rates or policies relating to the OmniPod; potential adverse effects resulting from competition with competitors; technological innovations adversely affecting the Company's business; potential termination of Insulet's license to incorporate a blood glucose meter into the OmniPod System; conflicts with the intellectual property of third parties, including claims that Insulet's current or future products infringe the proprietary rights of others; adverse regulatory or legal actions relating to the OmniPod System; failure of Insulet's contract manufacturers or component suppliers to comply with FDA's quality system regulations; product liability lawsuits that may be brought against Insulet; reduced retention rates; unfavorable results of clinical studies relating to the OmniPod System or the products of Insulet's competitors; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to Insulet's products; the expansion, or attempted expansion, into foreign markets; the concentration of substantially all of Insulet's manufacturing capacity at a single location in China and substantially all of Insulet's inventory at a single location in Massachusetts; Insulet's ability to attract and retain key personnel; Insulet's ability to manage its growth; intense competition among distributors of diabetes supplies impairing Insulet's business; failure to retain key supplier and payor partners; the expansion of Insulet's distribution network; and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 28, 2012 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.
About Insulet Corporation Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a revolutionary and easy-to-use tubeless insulin pump that features just two parts and fully-automated cannula insertion. Insulet's subsidiary, Neighborhood Diabetes, is a leading distributor for diabetes products and supplies, delivered through a high touch customer service model. Founded in 2000, Insulet Corporation is based in Bedford, Mass.
Contact:
Stephanie Marks for Insulet Corporation
ir@insulet.com
877-PODD-IR1 (877-763-3471)
Erich Sandoval for Insulet Corporation
pr@insulet.com
917-497-2867
Source: Insulet Corporation
Insulet's (PODD) Next-Gen OmniPod Receives FDA 510(k) Clearance
http://www.streetinsider.com/related.php?id=7949280&type=pr
Press Release:
BEDFORD, MA -- (Marketwire) -- 12/14/12 -- Insulet Corporation (NASDAQ: PODD), the leader in tubeless insulin pump technology, today announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the next-generation OmniPod Insulin Management System. The new OmniPod insulin pump is more than one-third smaller and one-quarter lighter than the original model, while maintaining the same 200-unit insulin reservoir capacity and easy-to-use features. In addition to the smaller, lighter Pod, the new OmniPod System includes an updated Personal Diabetes Manager (PDM) that also features a series of enhancements.
"The OmniPod revolutionized insulin delivery with its tubeless and wireless design when it was introduced in 2005 and today, the next-generation OmniPod raises the bar for insulin pump therapy again," said Duane DeSisto, President and Chief Executive Officer of Insulet. "We are thrilled to have received FDA approval and it is my hope that our new Omnipod insulin pump will continue to make living with diabetes easier for our customers across the United States."
"When technology can make diabetes management easier for my patients, they have better clinical outcomes," said Steve Edelman, MD, Clinical Professor of Medicine at the University of California at San Diego and founder of Taking Control of Your Diabetes (TCOYD), a not-for-profit organization with the goal of teaching and motivating patients in diabetes self-care. "As an OmniPod wearer myself, I love its ease of use and no tubing! Now with its smaller and sleeker design, it will make it even easier for more people to take control of their diabetes."
"Preparations are underway to launch the new OmniPod, including training of healthcare professionals and transitioning the rest of our manufacturing production," said Mr. DeSisto. "We expect that these initiatives will take approximately two to three months to complete and anticipate our first shipments in the U.S. to occur in late Q1 2013. Like the System itself, converting our current OmniPod users to the new system has been designed to be extremely easy as to ensure a seamless transition."
Customers are encouraged to keep informed via http://www.MyOmniPod.com/NewOmniPod where the Company will publish its latest information about the exact timing and availability of the new OmniPod System, including details on how current users will be converted. Additionally, current users will receive direct notification from the Company when the conversion process is commencing.
While performing its launch preparation initiatives, Insulet continues to collaborate closely with healthcare providers and patients so they can enjoy the many benefits of the current OmniPod today.
About the OmniPod Insulin Management System The OmniPod Insulin Management System is the world's first tubeless insulin pump. The OmniPod offers people living with insulin-requiring diabetes all the benefits of insulin pump therapy, with freedom and ease. The tubing-free OmniPod insulin pump has just two easy-to-use parts: the discreet, waterproof Pod, which automatically inserts and can be worn on many parts of the body to hold and deliver insulin; and the Personal Diabetes Manager (PDM), a hand-held device that wirelessly programs the Pod, calculates suggested doses and has a built-in blood glucose meter. For more information on the OmniPod insulin pump, please visit: http://www.myomnipod.com.
Forward-Looking Statement This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and of Section 21E of the Securities Exchange Act of 1934 concerning Insulet's expectations, anticipations, intentions, beliefs or strategies regarding the future, including those related to its planned expansion of sales of the next generation OmniPod System in the U.S. and abroad, product demand, the market acceptance of our next generation OmniPod System, regulatory matters and financial performance. These forward-looking statements are based on its current expectations and beliefs concerning future developments and their potential effects on Insulet. There can be no assurance that future developments affecting Insulet will be those that it has anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond its control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with the Company's dependence on the OmniPod System; Insulet's ability to increase customer orders and manufacturing volumes; adverse changes in general economic conditions; impact of healthcare reform legislation; potential supply problems or price fluctuations with sole source or other third-party suppliers on which Insulet is dependent; international business risks; Insulet's inability to obtain adequate coverage or reimbursement from third-party payors for the OmniPod System and potential adverse changes in reimbursement rates or policies relating to the OmniPod; potential adverse effects resulting from competition with competitors; technological innovations adversely affecting the Company's business; potential termination of Insulet's license to incorporate a blood glucose meter into the OmniPod System; conflicts with the intellectual property of third parties, including claims that Insulet's current or future products infringe the proprietary rights of others; adverse regulatory or legal actions relating to the OmniPod System; failure of Insulet's contract manufacturers or component suppliers to comply with FDA's quality system regulations; product liability lawsuits that may be brought against Insulet; reduced retention rates; unfavorable results of clinical studies relating to the OmniPod System or the products of Insulet's competitors; potential future publication of articles or announcement of positions by physician associations or other organizations that are unfavorable to Insulet's products; the expansion, or attempted expansion, into foreign markets; the concentration of substantially all of Insulet's manufacturing capacity at a single location in China and substantially all of Insulet's inventory at a single location in Massachusetts; Insulet's ability to attract and retain key personnel; Insulet's ability to manage its growth; intense competition among distributors of diabetes supplies impairing Insulet's business; failure to retain key supplier and payor partners; the expansion of Insulet's distribution network; and other risks and uncertainties described in its Annual Report on Form 10-K, which was filed with the Securities and Exchange Commission on February 28, 2012 in the section entitled "Risk Factors," and in its other filings from time to time with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of its assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. Insulet undertakes no obligation to publicly update or revise any forward-looking statements.
About Insulet Corporation Insulet Corporation (NASDAQ: PODD) is an innovative medical device company dedicated to making the lives of people with diabetes easier. Through its OmniPod Insulin Management System, Insulet seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The OmniPod is a revolutionary and easy-to-use tubeless insulin pump that features just two parts and fully-automated cannula insertion. Insulet's subsidiary, Neighborhood Diabetes, is a leading distributor for diabetes products and supplies, delivered through a high touch customer service model. Founded in 2000, Insulet Corporation is based in Bedford, Mass.
Contact:
Stephanie Marks for Insulet Corporation
ir@insulet.com
877-PODD-IR1 (877-763-3471)
Erich Sandoval for Insulet Corporation
pr@insulet.com
917-497-2867
Source: Insulet Corporation
December 13, 2012
12 Day of Christmas #DSMA Style
#DSMA chat is a blast. Every Wednesday evening at 9:00 pm eastern time the diabetes online community holds a little group chat. If you don't know about it you should, go here: http://diabetessocmed.com.
Last night we did the twelve days of Christmas, Diabetes Style. With much love the the Diabetes Online Community (DOC) and particular thanks to #DSMA Here are mine (with the exception of day 6 which I swiped from someone far more clever than I.)
If you, like I consider DSMA something that helps people woith diabetes, donating a dollar or twelve to support it and other DCAF programs.
On the first day of Christmas Diabetes gave to me:
A Cartridge from the DOC
On the second day of Christmas Diabetes gave to me:
Two blunt lancets and
A Cartridge from the DOC
On the third day of Christmas Diabetes gave to me:
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the forth day of Christmas Diabetes gave to me:
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the forth day of Christmas Diabetes gave to me:
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the fifth day of Christmas Diabetes gave to me:
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Sixth day of Christmas Diabetes gave to me:
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Seventh day of Christmas Diabetes gave to me:
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Eighth day of Christmas Diabetes gave to me:
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Ninth day of Christmas Diabetes gave to me:
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Tenth day of Christmas Diabetes gave to me:
Ten Hoop a Leaping (through)
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Eleventh day of Christmas Diabetes gave to me:
Eleven Boluses a Bolusing
Ten Hoop a Leaping (through)
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Eleventh day of Christmas DSMA gave to me:
Twelve Tweets a Tweeting,
Eleven Boluses a Bolusing
Ten Hoop a Leaping (through)
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
Last night we did the twelve days of Christmas, Diabetes Style. With much love the the Diabetes Online Community (DOC) and particular thanks to #DSMA Here are mine (with the exception of day 6 which I swiped from someone far more clever than I.)
If you, like I consider DSMA something that helps people woith diabetes, donating a dollar or twelve to support it and other DCAF programs.
On the first day of Christmas Diabetes gave to me:
A Cartridge from the DOC
On the second day of Christmas Diabetes gave to me:
Two blunt lancets and
A Cartridge from the DOC
On the third day of Christmas Diabetes gave to me:
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the forth day of Christmas Diabetes gave to me:
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the forth day of Christmas Diabetes gave to me:
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the fifth day of Christmas Diabetes gave to me:
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Sixth day of Christmas Diabetes gave to me:
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Seventh day of Christmas Diabetes gave to me:
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Eighth day of Christmas Diabetes gave to me:
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Ninth day of Christmas Diabetes gave to me:
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Tenth day of Christmas Diabetes gave to me:
Ten Hoop a Leaping (through)
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Eleventh day of Christmas Diabetes gave to me:
Eleven Boluses a Bolusing
Ten Hoop a Leaping (through)
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
On the Eleventh day of Christmas DSMA gave to me:
Twelve Tweets a Tweeting,
Eleven Boluses a Bolusing
Ten Hoop a Leaping (through)
Nine Insurers a Dancing (around a simple question)
Eight Finger sticks a Milking
Dexcom 7 a Sensing
Six bills for paying.
FIVE GLUCO TABS!
Four calls to insurance
Three French Fries (damn carb counting),
Two blunt lancets and
A Cartridge from the DOC
December 7, 2012
Diabetes, 2012, new places ‘and more’
My 2012 relationship with diabetes was about it moving to new places. Those brought new emotional challenges and more. Our T1D son move on to college and his diabetes challenges moved with him. The younger moved on to high school. Both are settling into to new places and dragging along their diabetes. These have new stresses. In the larger diabetes community I also see a desire to move, from talking about diabetes to taking actions.
Having a child move to college requires a different level of trust and confidence. Fortunately we have had ongoing coaching to work to that from the day of diagnosis. I think we have tried to prepare for diabetes moving out but it is still a new source of stress. We trust him and still we worry. Txt messages help.
Moving into high school is a big step, maybe bigger than college in terms of finding how to fit in with others. Naturally diabetes doesn’t make stepping into high school any easier. Seriously does diabetes make anything easier? No. So why should high school be different? Diabetes is the Lord High King of making someone feel different. Not helpful in an environment where feeling different is already an issue. The good news is she choose to play ice hockey. Hockey has proven to be a wonderful thing, new, fun and physically demanding. It is still early in the season but the preliminary results are it does wonders for appetite, engaging with other, fun and even stabilizing sugars. Yay hockey!
The DOC has talked a lot and I am excited by efforts to move from talking about diabetes to doing stuff about it. That doing takes on a host of different meanings. It can be as simple as one on one conversations to help someone else become more confident and empowered. It can be making video, web sites, holding local support meetings and more. The and more is very exciting. In my case part of the ‘and more’ has been starting DSMALive ‘Rents with my good friends Lorrain and Cherise.
I look forward to more and new ‘and more’ in 2013. Like my friend Mike I will focus on doing something.
How about you?
November 27, 2012
Patient to Patient Support, A Heavily Footnoted Post
Diabetes is a chronic condition that requires significant ongoing self management by patients. Self management includes monitoring of blood sugar levels, staying with medication regimes prescribed by health professionals and lifestyle changes. Patients often struggle with all of it. Peer to peer support can help patients face the ongoing challenges of diabetes management. Research demonstrates that patient better follow medication recommendations improves with internet follow up. This follow up support can be provided through social media. Diabetes peer to peer support is something that could and maybe should be recommend by health professionals to patients to support self effective management.
Before being recommended by physicians peer to peer support need to be trustworthy. Lay person patient advocates involved with peer support need to practice to ethical standards that specifically focus on emotional support while deferring treatment and medical advice to professionals. I think it is worth noting that a lot of the Diabetes Online Community is already there.
It is not me making up the value of peer to peer connections. Studies demonstrate that technology based communications can improve all types of diabetes compliance. These studies have examined people with diabetes from a variety of age ranges, economic backgrounds and nations. Patients who have received internet support have better health outcomes, typically measure by HbA1c. Studies also show improved patient quality of life measures.
Research matters so brief overview of key points form a few studies follows. Bandura (2004) observes, “The field of health is changing from a disease model to a health model.” It is no longer enough to treat the sick, health he writes, “is heavily influenced by lifestyle habits” and “health promotion should begin with goals not means.” To me that can be seen to say the goal is living better with diabetes and maybe the doctor’s office is only part of the way to get to better.
In Pumpers, Skypers, Surfers, & Texters: Technology to Improve the Managemnt of Diabetes in Teenagers Harris, Hood and Mulvaney observe that, “the goal of this technology is to support health behaviors and implement changes in strategy in a way that is more integrated into the everyday lives of patients and even in the context in which behaviors occur in “real time.””
The goals of change can start in consultation with healthcare providers but must happen in individual’s lives. These changes can be difficult. The internet can be a means of peer support for change if it connects with real empathy and support for making change.
Even with significant advancements in the tools used to provide self care in recent decades, “the daily management of diabetes can be overwhelming,” say Bond, Burr, Wold and Feldt (2010.) A twelve-month study showed that diabetes support delivered through an internet-based program significantly improved behaviors in lower literacy populations improved as much as other participants. This reenforces the importance of followup as part of the cycle of care (Kol et al. 2012.)
In Patient Week 2011: How Health 2.0 can improve patient compliance, Lui observes that patient opinion leaders in various levels of social media can inspire better compliance. Lui advocates for interaction of pharmaceutical firms, professionals and social media to improve patient compliance citing a Roche event that brought representatives of social media, the American Diabetes Association (ADA) and the American Association of Diabetes Educators (AADE) together in a social media summit. (Having been at that very event I would add that developing cooperative action between those participants is critical and often missing at social media summits.) Hawn (2009) suggest that, “new media tools like weblogs, instant messaging, video, chat and social networks are reengineering,” health. In part Hawn suggest this is happening as a transition from one-to-one communications to a many-to-many dialog that values inter-patient dialog. This improves “the experience of those either receiving or delivering it.” Hawn identifies value not only to those in need of support but to those patients who provide it.
I think this is significant. Providing others with support has health value. In a peer to peer environment it is accountability to peers that drives healthy behaviors. The peer pressure that parents worry will lead teens astray can be a tool to keep those same parents, if they are living with diabetes, on track. They just need the right peers. The goal is to find peers who help sustain change to healthy behaviors. Some would see sustaining change to healthy behaviors as compliance. That word however often is felt to carry a significant amount of paternalistic judgment that is often counter productive to the very ends it seeks.
A legitimate concern of health professionals is that social media may cause patients to seek alternative treatment options online. Studies suggest this is not the case. Fox (2011) says, “The bottom line is that the internet does not replace health professionals.” Like Fox, other research shows patients turn to the internet for emotional support. Toljamo and Hentinen (2001) found that patients struggling with diabetes had “no difficulties with insulin treatment, but had more problems with other aspects of self care.” They go on to say that changing long held lifestyle behaviors is complex and that emotional support for lifestyle issues “might be a motivating factor in improving adherence to health recommendations.” Glasgow et al. (1999) had similar findings saying, “Support from one’s healthcare team was most strongly related to following recommended diabetes care guidelines, whereas use of community resources especially ‘personal support’ and family resources were more related to lifestyle behaviors” Piette (2008) says, “One promising approach to enhancing diabetes self-management support is to increase mutual support among patients facing similar behavioral challenges.”
So to me it seems that there is ample cause to think that peer to peer support on the internet or in real life can have be a positive force to help people live better with diabetes. Better is an ongoing goal. As we move into the world of the Affordable Care Act I think that peer to peer connections can play an effective role in both better and affordable care.
Before being recommended by physicians peer to peer support need to be trustworthy. Lay person patient advocates involved with peer support need to practice to ethical standards that specifically focus on emotional support while deferring treatment and medical advice to professionals. I think it is worth noting that a lot of the Diabetes Online Community is already there.
It is not me making up the value of peer to peer connections. Studies demonstrate that technology based communications can improve all types of diabetes compliance. These studies have examined people with diabetes from a variety of age ranges, economic backgrounds and nations. Patients who have received internet support have better health outcomes, typically measure by HbA1c. Studies also show improved patient quality of life measures.
Research matters so brief overview of key points form a few studies follows. Bandura (2004) observes, “The field of health is changing from a disease model to a health model.” It is no longer enough to treat the sick, health he writes, “is heavily influenced by lifestyle habits” and “health promotion should begin with goals not means.” To me that can be seen to say the goal is living better with diabetes and maybe the doctor’s office is only part of the way to get to better.
In Pumpers, Skypers, Surfers, & Texters: Technology to Improve the Managemnt of Diabetes in Teenagers Harris, Hood and Mulvaney observe that, “the goal of this technology is to support health behaviors and implement changes in strategy in a way that is more integrated into the everyday lives of patients and even in the context in which behaviors occur in “real time.””
The goals of change can start in consultation with healthcare providers but must happen in individual’s lives. These changes can be difficult. The internet can be a means of peer support for change if it connects with real empathy and support for making change.
From: The Book of Better
Life with diabetes can't be perfect. Make it Better
by Chuck Eichten
Even with significant advancements in the tools used to provide self care in recent decades, “the daily management of diabetes can be overwhelming,” say Bond, Burr, Wold and Feldt (2010.) A twelve-month study showed that diabetes support delivered through an internet-based program significantly improved behaviors in lower literacy populations improved as much as other participants. This reenforces the importance of followup as part of the cycle of care (Kol et al. 2012.)
In Patient Week 2011: How Health 2.0 can improve patient compliance, Lui observes that patient opinion leaders in various levels of social media can inspire better compliance. Lui advocates for interaction of pharmaceutical firms, professionals and social media to improve patient compliance citing a Roche event that brought representatives of social media, the American Diabetes Association (ADA) and the American Association of Diabetes Educators (AADE) together in a social media summit. (Having been at that very event I would add that developing cooperative action between those participants is critical and often missing at social media summits.) Hawn (2009) suggest that, “new media tools like weblogs, instant messaging, video, chat and social networks are reengineering,” health. In part Hawn suggest this is happening as a transition from one-to-one communications to a many-to-many dialog that values inter-patient dialog. This improves “the experience of those either receiving or delivering it.” Hawn identifies value not only to those in need of support but to those patients who provide it.
I think this is significant. Providing others with support has health value. In a peer to peer environment it is accountability to peers that drives healthy behaviors. The peer pressure that parents worry will lead teens astray can be a tool to keep those same parents, if they are living with diabetes, on track. They just need the right peers. The goal is to find peers who help sustain change to healthy behaviors. Some would see sustaining change to healthy behaviors as compliance. That word however often is felt to carry a significant amount of paternalistic judgment that is often counter productive to the very ends it seeks.
A legitimate concern of health professionals is that social media may cause patients to seek alternative treatment options online. Studies suggest this is not the case. Fox (2011) says, “The bottom line is that the internet does not replace health professionals.” Like Fox, other research shows patients turn to the internet for emotional support. Toljamo and Hentinen (2001) found that patients struggling with diabetes had “no difficulties with insulin treatment, but had more problems with other aspects of self care.” They go on to say that changing long held lifestyle behaviors is complex and that emotional support for lifestyle issues “might be a motivating factor in improving adherence to health recommendations.” Glasgow et al. (1999) had similar findings saying, “Support from one’s healthcare team was most strongly related to following recommended diabetes care guidelines, whereas use of community resources especially ‘personal support’ and family resources were more related to lifestyle behaviors” Piette (2008) says, “One promising approach to enhancing diabetes self-management support is to increase mutual support among patients facing similar behavioral challenges.”
So to me it seems that there is ample cause to think that peer to peer support on the internet or in real life can have be a positive force to help people live better with diabetes. Better is an ongoing goal. As we move into the world of the Affordable Care Act I think that peer to peer connections can play an effective role in both better and affordable care.
Bandura, A. "Health Promotion by Social Cognitive Means." Health Education & Behavior 31.2 (2004): 143-64. Print.
Bond, G. E., R. L. Burr, F. M. Wolf, and K. Feldt. "The Effects of a Web-Based Intervention on Psychosocial Well-Being Among Adults Aged 60 and Older With Diabetes: A Randomized Trial." The Diabetes Educator 36.3 (2010): 446-56. Print.
Fox, Susan. "Medicine 2.0: Peer-to-peer Healthcare." Www.pewinternet.org/. 18 Sept. 2011. Web. 10 Apr. 2012. .
Glasgow, Russell E., Manuel Barrera, H. Garth Mckay, and Shawn M. Boles. "Social Support, Self-Management, and Quality of Life Among Participants in an Internet-Based Diabetes Support Program: A Multi-Dimensional Investigation." CyberPsychology & Behavior 2.4 (1999): 271-81. Print.
Harris, M., K. Hood, and S. Mulvaney. "Pumpers, Skypers, Surfers, & Texters: Technology to Improve the Management of Diabetes in Teenagers." Diabetes, Obesity and Metabolism (2012). Print.
Hawn, C. "Take Two Aspirin And Tweet Me In The Morning: How Twitter, Facebook, And Other Social Media Are Reshaping Health Care." Health Affairs 28.2 (2009): 361-68. Print.
Koh, Howard, Donald Berwick, Carolyn Clancy, Cynthia Baur, Cindy Brach, Linda Harris, and Eileen Zerhusen7. "New Federal Policy Initiatives To Boost Health Literacy Can Help The Nation Move Beyond The Cycle Of Costly ‘Crisis Care’." Health Affairs 31.2 (2012). Print.
Liu, Kim. "Patients’ Week 2011: How Health 2.0 Can Improve Patient Compliance." Www.eyeforpharma.com. 20 Sept. 2011. Web. 10 Apr. 2012. .
Piette, JD, C. Richardson, and M. Heisler. "Veterans Affairs Research on Health Information Technologies for Diabetes Self-management Support." J Diabetes Sci Technol 2.1 (2008): 15-23. Print.
Toljamo, Maisa, and Maija Hentinen. "Adherence to Self-care and Social Support." Journal of Clinical Nursing 10.5 (2001): 618-27. Print.
November 20, 2012
A Few Science Bits Stem Cels & Nano Particles.
Here's some fun reading for you Science Guys:
New nanoparticle halts multiple sclerosis, now being tested in Type 1 diabetes and asthma
In a breakthrough for nanotechnology and multiple sclerosis, a biodegradable nanoparticle turns out to be the perfect vehicle to stealthily deliver an antigen that tricks the immune system into stopping its attack on myelin and halt a model of relapsing remitting multiple sclerosis (MS) in mice, according to new Northwestern Medicine research.
Type 1 Diabetes Stem Cell Breakthrough Moves Toward Cure
In a breakthrough that signifies a move toward a cure for type 1 diabetes, researchers in Australia have identified stem cells in the pancreas that can be turned into insulin-producing cells. The finding promises to bring closer the day when people with type 1 diabetes will be able to produce their own insulin in their own regenerated insulin-producing pancreatic cells.
NUI Galway to lead €6m research project into stem cell therapy for diabetes
Could a particular type of adult stem cell offer a useful therapy for diabetes? An EU-funded project being led by NUI Galway hopes to find out. http://www.irishtimes.com/newspaper/finance/2012/1119/1224326783026.htmlBatman, Super Heroes and the Diabetes Mine Innovation Summit.
I had the privilege of joining with a number of industry, patient and regulatory participants at the Diabetes Mine Innovation Summit in Palo Alto last week. By number of participants, I mean a hundred or more. Our focus was the low percentage of diabetes patients who download information from their devices, the lack of interoperability of that data and how living with diabetes could be improved by addressing both.
Patient voices shared in video express the reason for the gathering clearly:
Linda Johnson of JDRF outlined some of the research initiatives they are funding. Alberto Guiterriez of the FDA shared a presentation on how they have made changes and are working more collaboratively with constituencies. Bruce Buckingham rose to share his experience that the agency has been successful in that transformation. He was joined by members of the Dexcom team who reinforced the FDA message of collaborative effort. These presentations set the stage for the conversations of innovations that can come to people with diabetes more rapidly and from a diversity of sources.
Patients are one of those source. If you haven’t seen Jana Beck’s presentation to the at the NY Quantified Self meetings have a look. Her work is an outstanding example of how data can be collected and used. I sought out this video after conversations with her at the summit.
from Steven Dean on Vimeo.
I had the privilege of providing a closing patient's response to the day’s presentations and panel discussions. I am not sure what I actually said but this is a rough approximation based on my notes:
Hello. I am Bennet Dunlap I have type two diabetes and two teens who have lived with type one for 8 and 9 years respectively. This morning Steve from TCOYD asked if I was a patient and I instinctively said, No. He encouraged me to take cafe of my diabetes. I think in reflection I said no, as a function of the intensity of effort required for my care verses my kids. Raise you hand if you have any experience with the intensity of teenage attitude.
I manage my diabetes with a plate half covered with greens and a new puppy that needs a lot of walks. My kids test, correct, carb count and infuse all day, every day. I am not an endocrinologist or general practitioner but my wife and I are primary care givers. We manage care in the 8,700 plus hours a year that they are not with a physician.
The summit participants had a great conversation about the 90% of patients who don’t download data. Steve said that part of that was the B.S. spaghetti bowl of wires and cables needed. (I had a sign for that.)
I feel compelled to touch base on a different 90%. Diabetes care, some say is 90% emotional and 10% or technical. In one panel discussion one of the Saras talked about her emotional responses to service, to the lift she gets form someone knowing she is a name not a number. That is one of a myriad of examples.
As a parent and a 8,700 hour a year, times two kids, primary care giver I want information to help me interact with our teens and I want it to help minimize attitude opportunities. Let me give you an example of how that can work. The good folks at Medtronic gave me a trial run on mySentry. That is a small screen that connects signals from the pump on my daughters belt to a bat-signal amplifier that beams the signal to the bat-cave screen downstairs. Somehow in all this I became Alfred the butler. I intentionally used all this batman language to move talk of the devices from seriously solemn to silly and so approachable.
I could look at that bat-screen and choose times of good bg to interact. To go to my daughter and say, “Hey good work look at this graph. What ever you did was great! What was it?” The technology facilitated non attitude producing, positive feedback to help the 90% of diabetes care that is emotional. That is the sweet spot.
Here is another example. Last week I had the opportunity to give a patient comment the FDA panel considering a new basal insulin. That process seemed detached from the reality of hypos. A representative of the Endocrine Society stood up and spoke about hypos and patient fear. Fear. There is a real diabetes emotion. He said that some patients intentionally run high blood sugars and poorer control out of fear of lows. For parents the fear is often focused nocturnal hypos because they kill a kids, every few weeks. The sad news spreads through social media, reinforcing the fear. This fear is a part of the emotions of diabetes care where a where technical innovation such as low glucose suspend and artificial pancreas that JDRF and the FDA spoke can start to help. Information technology super heroes are needed to make them.
This morning the point was made that to improve the use of data, the process has to be made fun. I would maybe say rewarding is close enough to fun. Not fun as in a game. Not points adding up to gift cards, not commerce but emotionally rewarding. This group can create the means of connecting to patients to peers to make sure each success, no matter how small, has a chance to shine. I suggest that is where the reward can be found.
People with diabetes are their own primary care givers. Peer to peer patient support can the reward that drives behavior 8,700 hours a year. If the group at the Diabetes Mine Summit can create tools to make those connections simple, peers will make them rewarding.
If you do, you are Super Heroes in my eyes.
November 14, 2012
November 13, 2012
The Spanish Inquisition, Children With Diabetes and Surgery.
File this in the I wish I had know this better before folder. In my case that folder is a file cabinet but what the heck.
I didn't spend a ton of time thinking that the kids may need surgery. Health, active kids seem to have a myriad of issues most of which involved looking forward to school, sports, a camp, a play or some other interest. Typically we didn't think about them needing surgery.
Spending a few minutes thinking about it is would have been a solid idea. I am reminded of this by a great article with some useful links that I just read. I wish I had read it years ago: Pamela Wilson's, Surgery and Children with Diabetes.
Our experience has been that even routine dental surgery can wreck havoc on diabetes balance. One of the issues was steroids. They were routinely prescribed for recovery. They totally screw up Blood Glucose (BG) balance. How routine? Well so routine that even when we have had a agreed not to have them given to the kids, the post dental surgery process handed them out as a matter of course. The result was a festival of whacky BG that left the poor kid feeling a lot worse. His recovery to get back into the swing of things was significantly impared.
If Monty Python has taught us anything it is that Nobody expects the Spanish Inquisition!
Not a lot of people expect appendicitis either. Should you happen to have a case of appendicitis and choose not to turn over BG management to the hospital, who in our case were going to change insulins and use a "sliding scale" they couldn't or maybe wouldn't define, you can expect the equivalent of the inquisition. Without the comfy chair.
I think the dental experience helped us anticipate the issues with the appendicitis. So maybe that file cabinet of things we learned the hard way payed off.
So here is today's YDMV school of hard knocks top tip: Next time you are at the endo have a conversation about, steroids, going off your regular insulin program and other emergencies medicine treatments. Prepare to advocate for your best interest when what is least expected happens.
UPDATE: A friend of the blog sent this link about insulin and hospitalization:
http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf
Related YDMV posts:
Speaking Up for Yourself with Health Professionals.
Not that I was planning to be here
Of the ER, the Web and Perfection
The Boy's Oratorical
I didn't spend a ton of time thinking that the kids may need surgery. Health, active kids seem to have a myriad of issues most of which involved looking forward to school, sports, a camp, a play or some other interest. Typically we didn't think about them needing surgery.
Spending a few minutes thinking about it is would have been a solid idea. I am reminded of this by a great article with some useful links that I just read. I wish I had read it years ago: Pamela Wilson's, Surgery and Children with Diabetes.
Our experience has been that even routine dental surgery can wreck havoc on diabetes balance. One of the issues was steroids. They were routinely prescribed for recovery. They totally screw up Blood Glucose (BG) balance. How routine? Well so routine that even when we have had a agreed not to have them given to the kids, the post dental surgery process handed them out as a matter of course. The result was a festival of whacky BG that left the poor kid feeling a lot worse. His recovery to get back into the swing of things was significantly impared.
If Monty Python has taught us anything it is that Nobody expects the Spanish Inquisition!
Not a lot of people expect appendicitis either. Should you happen to have a case of appendicitis and choose not to turn over BG management to the hospital, who in our case were going to change insulins and use a "sliding scale" they couldn't or maybe wouldn't define, you can expect the equivalent of the inquisition. Without the comfy chair.
I think the dental experience helped us anticipate the issues with the appendicitis. So maybe that file cabinet of things we learned the hard way payed off.
So here is today's YDMV school of hard knocks top tip: Next time you are at the endo have a conversation about, steroids, going off your regular insulin program and other emergencies medicine treatments. Prepare to advocate for your best interest when what is least expected happens.
UPDATE: A friend of the blog sent this link about insulin and hospitalization:
http://www.ashp.org/s_ashp/docs/files/Safe_Use_of_Insulin.pdf
Related YDMV posts:
Speaking Up for Yourself with Health Professionals.
Not that I was planning to be here
Of the ER, the Web and Perfection
The Boy's Oratorical
November 12, 2012
Doing The Right Thing. J&J Donates a Million Strips.
It is often all too easy to be skeptical. To balance that I think it is useful to appreciate people who do the right thing. Sometimes that is easy too.
Today for example the folks at J&J diabetes announced that they will donate one million strips to the International Diabetes Federation's (IDF) Life for a Child program.
From the press release:
Yes. Industry is for profit. They need to be profitable to keep doing the right thing. I include in doing the right thing selling testing supplies and developing better tools. I don't have a problem with the system. That is their job. I hope they are successful and keep doing it for a long time. I am also thrilled to see them sharing from that success with people who can't buy supplies.
I lift my glass and toast the team at J&J today. Cheers.
P.S. Don't think this means you get any slack if one of my kids' pumps breaks.
Today for example the folks at J&J diabetes announced that they will donate one million strips to the International Diabetes Federation's (IDF) Life for a Child program.
From the press release:
"This donation will enable up to 1,300 young people with diabetes in these seven countries to monitor their blood glucose at least twice daily for about a year. Many of these children have never had access to a meter before – so this will be a tremendous support to them."I think there are a lot of people in industry that do the right thing. I think they do it because it is the right thing to do. The right thing can be teaching at a camp, joining a walk and it even be donating a million strips. I think we in social media have a responsibility to recognize these when we see them. Particularly if we maybe critical at other times.PR Newswire (http://s.tt/1t5Do) - Dr. Graham Ogle, General Manager of Life for a Child.
Yes. Industry is for profit. They need to be profitable to keep doing the right thing. I include in doing the right thing selling testing supplies and developing better tools. I don't have a problem with the system. That is their job. I hope they are successful and keep doing it for a long time. I am also thrilled to see them sharing from that success with people who can't buy supplies.
I lift my glass and toast the team at J&J today. Cheers.
P.S. Don't think this means you get any slack if one of my kids' pumps breaks.
November 10, 2012
Patient Voices
At a blogger event with a drug company one conversation turned to why they were engaging with diabetes people rather than patients from one of their other lines of business. The company folks replied it was because the diabetes online community (aka DOC) is significantly more active than the online patient communities of the conditions they serve.
Yay us! Right?
I had the chance to see another side of patient engagement this week. The FDA had an advisory committee considering a potential new basal insulin. There was a part of the meeting where 'we the people' could speak. Thanks to a little help with gas money from the Diabetes Advocates I drove down and spoke as a dad of T1d teens.
Comments about the DOC, like the one I started with, could make one think patients have more influence than maybe we do really do. Patients were not a significant voice in the FDA meeting room.
The majority of the committee discussion I heard was not about diabetes outcomes but about potential cardio vascular signals that may, or may not, be a potential risk. The talk around hypos and the possibility of reducing them seemed to me to be detached from the idea of hypos as a material health issue. In fairness I did not hear all the presentations.
A few physicians spoke in the public comment forum. God bless them. They were patient advocates. A doctor from the Endocrine society spoke very clearly to the fear of hypos as a barrier to good care. I found it particularly significant that he was talking about the role emotions play in the process of care, specifically the fear. Next time we complain that the care community doesn’t get the emotional side, I want to remember who spoke up to the FDA about the impact of the fear of hypos.
Hypos matter. The conversation about night time lows should be about the impact they have on how patients self manage, the fear of them and the complications of nocturnal hypos - including dead in bed. Sadly a big part of the conversation was about what time frame counts as a nocturnal hypo; 10 p.m. to 6 a.m., 12 a.m. to 6 a.m., or 12 a.m. to 8 a.m..
While I found the time of a nocturnal hypos conversation inane for the most part this meeting was a serious science event. I freely admit it was a little intimidating to speak as a layperson, particularly following four very articulate physicians. However if we the DOC don’t show up to speak for patients who will?
We need better care options. Innovative insulins even incrementally innovative insulins are an area of better options. We would benefit form longer non-peaking basal insulin, faster bolus insulin and the holy grail of injectables glucose responsive insulins. So we need to be our own advocates making our case for benefits of better tools.
I felt there was a distinct under current in the conversation that there are perfectly serviceable insulins on the market now, so the process can hold possible innovations to a higher standard with more and longer trials without any adverse affect.
No.
Delaying or preventing access to better tools is an unfortunate outcome. These CV tests will cost more and so be barriers to new insulins making it into the butter compartments of people with diabetes. I am not sure Banting and Best could have had done CV studies. (Nor do I think there process is a model for modern safety and efficacy.)
Let me be clear. I am not advocating neglecting other safety issues such as CV risk. I am suggesting that we as patient community need to be part of the off line conversations that determine the medications and tools that are options for us to explore with our physicians. We need to be there to voice the value of better diabetes care. Maybe even introduce into the process a definition of better that not only looks at A1C but one that considers stability of glucose levels. That can include fewer or no night time hypos.
I am not saying there was no conversation about balancing better diabetes care with risks. I am saying from my perspective the value of better care appeared to be trivialized at times. In fairness I may be over stating my views. (Raise you hand if you think I ever over state my views - ok, that is everyone who has ever read anything I ever have written.) The committee did recommend the insulin subject to ongoing CV consideration 8 to 4. Clearly the 8 felt there was benefits that were significant even with possible risks.
Still I think patient voices are needed to help balance the benefit side of consideration. We could even help the good doctor from the endo society make the case that the emotional parts of diabetes care are significant. I have been kicking myself the past two days for letting emotion breaks into my voice when I spoke about doing night time blood tests. In retrospect maybe that was a good thing. Maybe I helped him make his point. He did reach out and shake my hand as I retuned to my seat.
If we are not part of the process who will be our voice? How can we consistently do that?
Yay us! Right?
I had the chance to see another side of patient engagement this week. The FDA had an advisory committee considering a potential new basal insulin. There was a part of the meeting where 'we the people' could speak. Thanks to a little help with gas money from the Diabetes Advocates I drove down and spoke as a dad of T1d teens.
Comments about the DOC, like the one I started with, could make one think patients have more influence than maybe we do really do. Patients were not a significant voice in the FDA meeting room.
The majority of the committee discussion I heard was not about diabetes outcomes but about potential cardio vascular signals that may, or may not, be a potential risk. The talk around hypos and the possibility of reducing them seemed to me to be detached from the idea of hypos as a material health issue. In fairness I did not hear all the presentations.
A few physicians spoke in the public comment forum. God bless them. They were patient advocates. A doctor from the Endocrine society spoke very clearly to the fear of hypos as a barrier to good care. I found it particularly significant that he was talking about the role emotions play in the process of care, specifically the fear. Next time we complain that the care community doesn’t get the emotional side, I want to remember who spoke up to the FDA about the impact of the fear of hypos.
Hypos matter. The conversation about night time lows should be about the impact they have on how patients self manage, the fear of them and the complications of nocturnal hypos - including dead in bed. Sadly a big part of the conversation was about what time frame counts as a nocturnal hypo; 10 p.m. to 6 a.m., 12 a.m. to 6 a.m., or 12 a.m. to 8 a.m..
While I found the time of a nocturnal hypos conversation inane for the most part this meeting was a serious science event. I freely admit it was a little intimidating to speak as a layperson, particularly following four very articulate physicians. However if we the DOC don’t show up to speak for patients who will?
We need better care options. Innovative insulins even incrementally innovative insulins are an area of better options. We would benefit form longer non-peaking basal insulin, faster bolus insulin and the holy grail of injectables glucose responsive insulins. So we need to be our own advocates making our case for benefits of better tools.
I felt there was a distinct under current in the conversation that there are perfectly serviceable insulins on the market now, so the process can hold possible innovations to a higher standard with more and longer trials without any adverse affect.
No.
Delaying or preventing access to better tools is an unfortunate outcome. These CV tests will cost more and so be barriers to new insulins making it into the butter compartments of people with diabetes. I am not sure Banting and Best could have had done CV studies. (Nor do I think there process is a model for modern safety and efficacy.)
Let me be clear. I am not advocating neglecting other safety issues such as CV risk. I am suggesting that we as patient community need to be part of the off line conversations that determine the medications and tools that are options for us to explore with our physicians. We need to be there to voice the value of better diabetes care. Maybe even introduce into the process a definition of better that not only looks at A1C but one that considers stability of glucose levels. That can include fewer or no night time hypos.
I am not saying there was no conversation about balancing better diabetes care with risks. I am saying from my perspective the value of better care appeared to be trivialized at times. In fairness I may be over stating my views. (Raise you hand if you think I ever over state my views - ok, that is everyone who has ever read anything I ever have written.) The committee did recommend the insulin subject to ongoing CV consideration 8 to 4. Clearly the 8 felt there was benefits that were significant even with possible risks.
Still I think patient voices are needed to help balance the benefit side of consideration. We could even help the good doctor from the endo society make the case that the emotional parts of diabetes care are significant. I have been kicking myself the past two days for letting emotion breaks into my voice when I spoke about doing night time blood tests. In retrospect maybe that was a good thing. Maybe I helped him make his point. He did reach out and shake my hand as I retuned to my seat.
If we are not part of the process who will be our voice? How can we consistently do that?
November 7, 2012
FDA Endocrinologic and Metabolic Drugs Advisory Committee
On November 8, 2012, the FDA Endocrinologic and Metabolic Drugs Advisory Committee will discuss the safety and efficacy of new drug applications (NDAs) 203313, insulin degludec/insulin aspart [rDNA origin] injection and 203314, insulin degludec [rDNA origin] injection, manufactured by Novo Nordisk Inc. The proposed indication (use) for these applications is for the treatment of Type 1 and Type 2 diabetes mellitus.
There was an invitation for public comment. I applied, was accepted to comment and will be offering the following:
I added a little and have tried to include it here in red as best as I can remember it and my notes. I am 100% confident I goofed some of tit up but I think I got out the gist of it.
I added a little and have tried to include it here in red as best as I can remember it and my notes. I am 100% confident I goofed some of tit up but I think I got out the gist of it.
My name is Bennet Dunlap. Following three doctors is a little intimidating. I am not a physician, I am a parent of two teens with Type 1 Diabetes, I am a frequent and maybe even respected diabetes social media writer, and am a member of Diabetes Advocates an association of e-patients who helped with gas money to be here. I have no relationship with the drug sponsor.
Social media is often critical of the pace of advancements coming to market and the FDA. In that context I would like to thank the FDA and this committee and each of the individuals serving here for efficiently considering new insulin alternatives for people with diabetes. Diabetes care varies from individual to individual. Most people with diabetes who use insulin to managed their blood sugar need basal insulin. While many people are successful with the insulin products on the market, others are not as fortunate and so may benefit from wider alternatives.
I regularly tell people online that your diabetes may vary. Just as different people respond to fast acting insulin analogs in unique ways, it is likely that patients, with their physicians, will discover that different basal insulins suit patients’ particular needs in individual ways. I applaud a systematic review of additional insulin options.
I hope that the committee maintains and sharpens an ongoing institutional expertise in evaluating new insulin products. Today’s basal insulin candidates are likely to be followed by even more innovative products, specifically the glucose responsive insulins that are in development. These have the potential to revolutionize diabetes self management. I trust that the experience gained in evaluating basal now insulins can serve to inform consideration of these other insulins when they get to the review process. I hope that you look beyond A1C as a measure of control to include glucose variability in your consideration of insulins.
I appreciate the comments of the representative of the Endocrine Society on hypoglycemia. This morning's conversation on hypos at one point suggested that since night time data is hard to get that daytime results could be an indication of night time. As a parent of type 1 kids I feel a need to state the obvious, nigt and day are as different as... well.. night and day. Parents fear night time hypos because that is what has killed a number of kids this year.
I realize this is not a pediatric application. Type 1 diabetes often presents in young children. My kids were 7 and 9 at diagnosis. I have many friends who’s children were much younger. Because of children’s size, activity patterns, growth patterns, variable appetites and communication skills parents often struggle to manage diabetes in children. The expeditious and judicious review of innovative products for pediatric use will be greatly appreciated by all parents of children with diabetes and our care teams.
I realize this is not a pediatric application. Type 1 diabetes often presents in young children. My kids were 7 and 9 at diagnosis. I have many friends who’s children were much younger. Because of children’s size, activity patterns, growth patterns, variable appetites and communication skills parents often struggle to manage diabetes in children. The expeditious and judicious review of innovative products for pediatric use will be greatly appreciated by all parents of children with diabetes and our care teams.
Thank you for safe and effective tools to help people live with diabetes.
Serviceable Hot Caffeinated Beverage, Puppies, and Coffee Super Tanker Spills.
I forgot how to make coffee. It isn’t that hard but I still messed it up.
Except I missed the desk. The hot (and it was seriously hot) serviceable beverage sloshed all over the desk, my keyboard, both legs and floor. BP would be proud of this spill.
I got the paint brush from the dog. (Earlier he had a syringe - where did that come from? Oh wait kids with diabetes have been leaving diabetes stuff all over the house for years - Right.) Slopped up most of the mess with paper towels tossed them in the trash under the desk and went off to change into dry jeans.
When I came back to the computer, I found the mutt happily chewing the paper towels drenched in spilled serviceable no longer hot caffeinated beverage under the desk. Great now do I have a caffeinated puppy? and doesn’t caffein work to loosen the “business” end of the digestive tract? So I guess I will be outside in the cold more this morning too.
If there is a moral here it is print the map to the FDA meeting out in the evening while you are waiting for the speeches late into election night morning. Also don’t attempt to work with heavy machinery like a pre Bloomburg NYC Big Gulp Sized coffee super tanker until you are fully up to speed from the serviceable hot caffeinated beverage. Which is a catch 22 if I ever heard one. Finally if the puppy isn't doing "Business" check the bedroom floors because he now understands stairs.
I think I need a cup of coffee.
November 5, 2012
DSMALive Rents Tonight: Joyce Lee
Our Guest will be Joyce Lee of Glu Research:
More about this episode of DSMALive:
http://dsmalive.com/2012/11/05/1338/
November 4, 2012
Diabetes Deaths Fall 61% Among Youths
That is the headline at medpage Today.
I would say:
Families Empowered to be More Successful with Diabetes
This news story is that mortality from diabetes in the US has declined significantly since the late 1960s. In this case I am more a glass partially full kind of guy so I want to talk about success not mortality. I also think I am we hold these truths to be self evident kind of guy'cause diabetes care tools and education have improved a lot since the late 60s. None the less a little formal study is a good thing.
The real questions are:
How do we keep making progress?
What is next big advance, the next DCCT?
Were the improvements since the late '60s the results of picking the low hanging fruit of diabetes care making them next series of advancements incrementally more difficult?
What is our role as patients and advocates in making next steps a reality?
My two cents is to reduce diabetes death in youth - Continue to Empower Families.
I would say:
Families Empowered to be More Successful with Diabetes
This news story is that mortality from diabetes in the US has declined significantly since the late 1960s. In this case I am more a glass partially full kind of guy so I want to talk about success not mortality. I also think I am we hold these truths to be self evident kind of guy'cause diabetes care tools and education have improved a lot since the late 60s. None the less a little formal study is a good thing.
The real questions are:
How do we keep making progress?
What is next big advance, the next DCCT?
Were the improvements since the late '60s the results of picking the low hanging fruit of diabetes care making them next series of advancements incrementally more difficult?
What is our role as patients and advocates in making next steps a reality?
My two cents is to reduce diabetes death in youth - Continue to Empower Families.
October 29, 2012
October 24, 2012
New Technique for Finding Test Strips on the Floor
Fact of diabetes life: Used strips find the floor.
Puppy fact: They chew everything.
Skippy chews anything on the floor. His crate, my chair, his toys, the other dog, my feet and has a real skill at funding used test strips. I think he is less likely however to choke on a rawhide the size if his head.
- Posted using BlogPress from my iPhone
October 23, 2012
Wanted: Patients Voice in Diabetes and Emotional well Being
A few days ago I wrote about research were patients were not seen as a stakeholder in research. There were some good comments and I encourage you to go read them. If researcher are part of the problem so at times maybe are patients. I think at times we don't participate as much as we should (arguably because we don't see the results as being to our benefit or even accessible.) We need to step up when we can. Here is place we can.
Here is how to share your voice:
- Join Glu www.myglu.org (if you haven’t already.)
- Scroll down to the bottom on the home page, in the glu u section click October’s Survey.
- Look over the terms and agree as appropriate, this is being run by real researchers so yes there is a real consent process. (I think that approachable research is a good thing). Enter you password so they know it's officially OK with you.
- There are a number of questions each has its own page. A few of pages is a little cumbersome yes but it is a good start and an important topic.
- Participate, spread the word and help make it better.
Full disclosure. I was part of a group that offered views on how to start this process and communicate it to the DOC. I would love to see it succeed not because I had a tiny part in getting the ball rolling but because I think patients voices need to be a bigger part of the research process. Here is a chance to do that. Lets all help make the effort a success so they keep doing it.
Why not parents? As I said this is being done by real researchers with review boards and all that that involves. Doing research with kids, even parents sharing information about their kids is anther level of dotting I(s) and crossing T(s). It should be. Kids deserve to be protected with a little extra diligence. In the mean time parents of T1D kids share this with friends in the adult T1D community OK?
Thanks.
October 22, 2012
Do we need a FDA Office of Mobile?
Here is a section of the piece:
But a bill set to be introduced in the U.S. House of Representatives later this month aims to smooth the agency’s evaluation process. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would establish a special Office of Mobile Health at the FDA to provide recommendations on mobile health app issues. It would also create a mobile health developer support program at the Department of Health and Human Services to help app developers make sure they are operating within privacy regulations, including the federal law HIPAA that sets privacy standards.
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," Rep. Mike Honda, D-Calif., who is introducing the bill, said in a statement. “Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space.”
I have written about mobile and diabetes apps a few times ok maybe more than a few.... As Gold's article notes The FDA is expected to issue guidance on mobile soon.
I think that diabetes care offers some unique challenges for the regulation of apps. The FDA appears to be interested in taking thing one step at a time or more precisely single mobile devices at a time. The FDA draft guidance said, “The FDA plans to address in a separate issuance mobile medical app intended to analyze, process, or interpret medical device data (electronically collected or manually entered) from more than one medical device.”
Diabetes is managed by patients with multiple devices, meters, cgms, pumps, and logs of food, working out and other life activities. To be meaningful diabetes mobile apps will need to deal with more than one device. To me that is more relevant than the structure of the regulatory office.
(edited to add) I would suggest that we keep an eye open to closed loop A.P. and to get there maybe a good step is an open loop app where users are involved in the process but supported by an app that integrates information from multiple devices.
ADA Discrimination Twitter Chat
Twitter Chat on Diabetes and Discrimination – Wednesday, Oct. 24
On Wednesday, Oct. 24, from 1 to 2 p.m. ET, the American Diabetes Association will hold a special Twitter chat on diabetes, discrimination and how to get help. Tweeting from the Association’s handle (@AmDiabetesAssn) will be special guest Katie Hathaway, Managing Director for Legal Advocacy, who will answer questions from the audience.
To participate, just log on to Twitter, follow @AmDiabetesAssn and search for #DiabetesRights. Those who do not have Twitter accounts can also follow along by visiting Twitter.com and searching for #DiabetesRights.
To participate, just log on to Twitter, follow @AmDiabetesAssn and search for #DiabetesRights. Those who do not have Twitter accounts can also follow along by visiting Twitter.com and searching for #DiabetesRights.
http://www.diabetes.org/living-with-diabetes/know-your-rights/discrimination/