DIABETEStalkfest

Linking Diabetics Coast 2 Coast

*** (08:51):Welcome to JDRF CGM Chat with Aaron Kowalski , Dr. Aaron Kowalski !

jon says (09:01):Welcome everybody to tonights chat with Aaron Kowalski!

jon says (09:02):Let's get started

gina says to (09:02):Ok everyone here we go

jon says (09:02):Aaron, can you give us a brief description of what you do?

Dr. Aaron Kowalski says to (09:03):Hi Everyone - thanks again to Gina for having me back on!

gina says to (09:03):Thank you!

Dr. Aaron Kowalski says to (09:03):So - I'm one of the scientists on staff at JDRF - I head up our Metabolic Control funding

- which includes the JDRF Artificial Pancreas Project

sstrumello says to (09:04):Has JDRF named a new CEO yet?

Dr. Aaron Kowalski says to (09:04):I also oversee our hypoglycemia funding and other metabolic reserarch

Dr. Aaron Kowalski says to (09:04):No new CEO yet. The process is ongoing.

jon says (09:06):what exactly is metabolic control?

pattyk says to (09:06):we have coverage for our 9 year old son for the cgm but took almost a year of appeals > Do you think

this study will make it easier for others to get coverage?

Dr. Aaron Kowalski says to (09:07):This is the research that includes glycemic control but also some of the mechanisms that

lead to the development of type1 aside from autoimmunity

BillRuss says to (09:07):What can we do to get Medicare coverage for DGM?

Dr. Aaron Kowalski says to (09:07):We think the CGM study results will help with insurance coverage.

BillRuss says to (09:07):I mean CGM

Dr. Aaron Kowalski says to (09:08):They say that CGM works and well! Better A1c with no increase in hypo

beanboy says to (09:08):Where will we go with CGM for better accuracy? More development with interstitial fluid reading or

reading a different fluid altogether?

beanboy says to (09:08):in terms of future development

MelissaBL says to (09:08):Is there something specific folks should be stating in their appeals after a preliminary denial?

sstrumello says to (09:08):Why is it that JDRF has funded the major trials on CGMS. The last time I checked, one

manufacturer (Medtronic Minimed) was a $4 billion/year company. It seems to me they should be funding this stuff, not our

charitable foundations.

Dr. Aaron Kowalski says to (09:08):The results in the younger age groups suggest that the CGM works but there are barriers

we need to address to make the devices easier to use for more people

mick says to sixuntilme (09:08):The study included 3 different devices, any differences in accuracy or correlation.

pattyk says to (09:09):I think that will be good...I would like to also see proper education for the people who use the

cgm...there is a learning curve. My son has been using it for 19 months now with a marked a1c decrease without alot of

hypos..but it takes time to learn how to

Dr. Aaron Kowalski says to (09:09):I don't know that the accuracy is the main thing any more. The devices can certainly get

more accurate, but with these devices now people do better - I've used one for more than two years now and couldn't live

without it.

Dr. Aaron Kowalski says to (09:10):What i think we really need is smaller, easier to use and AUTOMATION - hence our focus on

closed loop

beanboy says to (09:10):doesn't closed loop REQUIRE better accuracy? without the 20 minute delay?

Dr. Aaron Kowalski says to (09:11):We didn't compare devices in the study - each person chose their device with their

physician

sixuntilme says to (09:11):I'm hoping this study will help push my insurance appeal through - but is this particular study

geared towards adults only?

gina says to (09:11):Why do people still continue to get denials of the CGM still being experimental and investigational?

AndyRozman says to (09:11):beanboy: and better sensors

Dr. Aaron Kowalski says to (09:11):I think we can close the loop with today's devices - we've funded research in people that

shows that this is the case. What we really need to define is what the precise definition of a closed-loop is.

gina says to (09:12):when is has been proven to be affective

gina says to (09:12):it has

millyyates says to (09:12):How do you use the CGMS to improve pump ettings retrospectively and what is your A1C.

Dr. Aaron Kowalski says to (09:12):I don't know it will be "beta cell-like" but it could bring automation that reduces most

high and low sugars

beanboy says to (09:12):Very interested. With today's technology...that's what you said?

pattyk says to (09:12):that is a huge misconception..it is a algorhythm and if you calibrate properly the numbers are not

too far off unless you have arrows(moving fast) I just checked my son the cgm says 134 and his fingerstick was 136..that is

the way it usually is for us

Dr. Aaron Kowalski says to (09:13):Most of the benefit i see from cgm is the predicitive nature of the device - seeing the

trends and proactively addressing issues before they become big problems

mick says to (09:13):How do we "close the loop" without having IV insulin infusion or sensing?

gina says to (09:13):patty when i was using the cgm that is how it was for me as well.

Dr. Aaron Kowalski says to (09:13):My last A1c was in the mid 6's.

pattyk says to (09:14):that is where the education comes in Gina..I think alot of people are not taught properly how to use

it and calibration and stable sensor are the key

gina says to (09:14):i agree.

Dr. Aaron Kowalski says to (09:14):We don't need iv infusing or sensing - again, we can't let perfection be the enemy of the

good in artificial pancreas. With sophisticated algorithms we could significantly reduce hyper and hypoglycemia and ease some

of the burden - not a beta cell but much

beanboy says to (09:14):I have my CGM range from 10 points to 150+ points off (reading 350 instead of 200)...I think the

accuracy varies a lot, regardless of proper calibration

Dr. Aaron Kowalski says to (09:14):better than today with open loop

pattyk says to (09:14):my sons a1c is 6.8 right now and we don't see alot of hypos. I am able to keep him flat at 100

through the night because of the cgm

Lloyd says to (09:15):I think there are many people who would benifit from cgm on a part time basis, for adjusting basal on

a pump, but might not have a full time need.

gina says to (09:15):aaron can you tell us a little about the JDRF clinical trials

Dr. Aaron Kowalski says to (09:15):To beanboy- remember that there are errors in the system and their is the normal

physiologic difference - the numbers SHOULDN'T always match.

mick says to (09:15):I guess my question is whether "closed loop" is a misnomer. If the patient still has to calculate carb

and decide on insulin doses, the loop is "open" so to speak.

Dr. Aaron Kowalski says to (09:16):To gina: we're funding the CGM trial that was just published in the NEJM - that is still

going, as it will end after everyone has gone 12 months

pattyk says to (09:16):and they don't always but about 95% of the time...we insert our cgm vastly different than the way mm

tells you to but it works

Dr. Aaron Kowalski says to (09:16):We are also funding 7 closed loop sites

Lloyd says to (09:16):How about "semi-automatic" for a description?

MelissaBL says to (09:16):I like that, Lloyd.

gina says to (09:16):can people still get into those trials?

mick says to (09:16):better

Dr. Aaron Kowalski says to (09:17):To mick - the idea is to make it as automated as possible given the nature of today's

sensors. That said you're correct -
it will be at first a semi-closed loop

beanboy says to (09:17):On the whole 'is an IV necessary' question: have you found moving from insulins like humalog to

faster acting ones like apidra is helpful in 'closing the gap/loop' or not necessary due to the advanced algorithm approach?

Dr. Aaron Kowalski says to (09:17):the trials are recruiting people on a limited basis, as they are mostly pilot studies

right now

mick says to (09:18):thank you

MelissaBL says to (09:18):but even "fast-acting" insulins are slower than naturally produced insulins

Dr. Aaron Kowalski says to (09:18):BUT - I think this is going to scale up quickly and you'll be very excited by the results

- THIS CAN BE DONE!

AndyRozman says to (09:18):aaron: but it will never be totally closed loop.. since you need to either enter CH or enter food

(best case scenario)

mick says to (09:18):insulins are tooooo slow in general.

Dr. Aaron Kowalski says to (09:19):To andyrozman - it will really depend on the target bg number. To get to a target for

someone without diabetes it will be tough

Dr. Aaron Kowalski says to (09:19):But - we can get close soon and there are some tricks - for example one of our sites is

doing insulin and glucagon - dual pump

Dr. Aaron Kowalski says to (09:19):Or insulin and symlin - which could be interesting

gina says to (09:20):doesnt symlin make people sick

AndyRozman says to (09:20):mhm. yes that could work...

Dr. Aaron Kowalski says to (09:20):I'm trying to keep up!!:P

mick says to (09:20):Those sound like great studies

Dr. Aaron Kowalski says to (09:20):Symlin has issues now for some people, but I think if was dosed in a much more

sophisticated manner - such as this - we may be able to do much better

millyyates says to (09:21):Medtronic took out patents on a closed loop system in 2003. Why don't they get on with releasing

anything that helps even if it is semi-closed. Why isn't this just seen as another pump algorithm add on or upgrade. Like

bolus on board or bolus wizard?

mick says to (09:21):Are you giving it as a continous infusion or bolus or both?

Dr. Aaron Kowalski says to (09:21):Milly - there are a number of obstacles that the JDRF is aiming to address

jon says (09:22):Let's give the Dr. a minute to catch up on all the questions. If your question is missed, you can send it

to Gina or myself as a private message and we will make sure it gets answered.

Dr. Aaron Kowalski says to (09:22):Regulatory - reimbursement - further clinical testing -

sstrumello says to (09:22):Aaron, beyond the closed loop system, you mention that your role is metabolic Control funding.

Are you pursuing any other possibilities? For example, a company called SmartCells, Inc. in Beverly, Massachusetts is in

pre=clinical trials for a type of insu

sstrumello says to (09:22):insulin that would essentially self-regulate, meaning the insulin would only go to work when

blood glucose levels are elevated above a certain level. This would (theoretically) lead to an elimination of testing,

hypoglycemia and radically simplify managem

Dr. Aaron Kowalski says to (09:23):Will there be a closed-loop without JDRF - yest at some point - but we want to see it

happen SOONER- accelerate by leveraging the strenghts of each consituency

Dr. Aaron Kowalski says to (09:23):We are funding Smartcells - very interesting and exciting - like a micro-artificial

pancreas - I will be there this week!

sstrumello says to (09:24):Excellent, to date, they have been funded with venture capital and some NIH grants!

gina says to (09:25):MelissaBL asked: Can you ask Aaron how the companies who produce the CGMSs have
cooperated or have benefitted from the JDRF's study?

Dr. Aaron Kowalski says to (09:25):I really want to see them make it (obviously)! We have another great scientist working

with me - Marlon Pragnell - who will be working on this too

Dr. Aaron Kowalski says to (09:26):To Melissa - we funded this independently because the insurance companies saw that as

being critical

Dr. Aaron Kowalski says to (09:26):However, we needed help from the companies, for example the Navigator wasn't yet FDA

approved when we started

Dr. Aaron Kowalski says to (09:26):And we used the DexCom SEVEN before it was out on the market

mdavis says to (09:27):regarding Melissa's question, don't companies like Medtronic already donate considerably to jdrf?

sstrumello says to (09:27):Excellent question, considering they stand to profit from JDRF's investments in trials!

Dr. Aaron Kowalski says to (09:28):We do receive some donations from companies, but they are small overall and the vast

majority of the money JDRF raises comes from volunteers - thanks to all of you!

Dr. Aaron Kowalski says to (09:28):Regarding the companies - its important to realize that we rely on them to deliver good

products - if they do its a win win - the JDRF can't manufacture an artificial pancreas

daddy says to (09:29):why not?

mdavis says to (09:30):i think you stumped him with that whopper

Dr. Aaron Kowalski says to (09:30):we're just not set up to do that - that is a massive undertaking and ultimately we are

trying to fill gaps that will lead to acceleration of better solutions for people with diabetes

MelissaBL says to (09:30):True. We need them to develop the product. But I would like to see them make their products

(read: sensors) less cost-prohibitive for those who will choose to go it alone without coverage. The JDRF researches, the

company develops, and we're still broke

sstrumello says to (09:31):I get the sense that the companies are looking for someone else to pay for the research so they

can make even more money, rather than funding trials themselves.

MelissaBL says to (09:31):Thanks, Scott. You say it better.

dwendel says to (09:31):I think once there is a reliable, easy to use and finacially feasable CGMS an artificial pancreas or

closed loop system will be possible.

Dr. Aaron Kowalski says to (09:31):Melissa - we've said all along that we want a competitive markert that supports more

solutions for folks and we hope that will lead to less cost as well

mdavis says to (09:31):yeah but... why not nail the AP and taking control of it start to finish is the best way to get it

done. JDRF invests in companies now (drug companies so far) so why not set up a company to nail the AP?

AndyRozman says to (09:32):MellisaBL: That would be real goal.... CGMS and all their equipment is not covered in my country

and it won't be soon..

mick says to (09:32):I don't think medtronic needs any finanacial support :)

tmana says to (09:32):I think there are some federal regulations against non-profits like JDRF from doing any actual

large-scale manufacturing and marketing

diabeticidol94 says to (09:32):me either

mdavis says to (09:32):...but they overpaid for minimed :D

Dr. Aaron Kowalski says to (09:32):mdavis - we looked at that as an option - but with lots of very smart people thinking

about it decided that our best return on investment was to support the field

sstrumello says to (09:33):medtronic DOESN'T need support, but if some nonprofit pays for the trials, its like corporate

charity

Dr. Aaron Kowalski says to (09:33):and allow for us to do what we do best - de-risk the process and fill gaps and take

advantage of the infrastructure that was in place

dwendel says to (09:33):To a certain extent why would any company want to cure diabetes? Profit wise it does not make

sense!!

MelissaBL says to (09:34):good point, Aaron.

mdavis says to (09:34):maybe more disclosure from JDRF and the CGM companies including intellectual property that's flying

around the space would be a good first step.

diabeticidol94 says to (09:34):absoulity scott

Dr. Aaron Kowalski says to (09:35):mdavis - any ip that is developed with JDRF funding will be available under non-exclusive

licensing

daddy says to (09:35):what about open sourcing the algorithms that were devceloped w/ donated money given to JDRF? shouldn't

that be 'owned' by the community?

diabeticidol94 says to (09:35):AARON are you going to be talking at dri in nyc?

daddy says to (09:35):what is the license cost?

mdavis says to (09:36):ah. that is a good plan

annie keys says to (09:36):If you want to look at 'it' like that, 'why would any of them want to find a cure?', then that

would go for cancer and asthma and even the flu. I don't think the companies feel that way.

Dr. Aaron Kowalski says to (09:37):We are working under ip stuctures that pre-exist at many universities and have worked

very hard - with expert lawyers who donated time - to set up the most fair system to move the field forward

daddy says to (09:37):sure, sun has expert lawyers that help w/ thier open source ;). So how much does a license cost?

AndyRozman says to (09:38):annie: companies don't feel at all, their owners even less

Dr. Aaron Kowalski says to (09:38):ANnie - that is a common misconception. I've worked with (but never at) many of these

companies and most are run by dedicated folks often with a personal connection

Dr. Aaron Kowalski says to (09:38):If they don't drive towards a cure it can be sure their competitors will and they can't

take that risk

sstrumello says to (09:39):What are the remaining obstacles before CGMS becomes more widely covered ... say at the point

where insulin pumps are now fairly routinely covered?

Dr. Aaron Kowalski says to (09:39):Daddy - we haven't gotten to cost yet - we are fuding development at multiple sites and

its still at the research stage

diabeticizme says to (09:39):great question scott

MelissaBL says to (09:40):What does the JDRF need - specifically your department - in terms of community support?

Dr. Aaron Kowalski says to (09:40):Mello - I think the trial results will help a ton

daddy says to (09:40):so there is no license agreemnt yet; but there will be once the research is final, is that right?

will there be a page on jdrf.org w/ license detials?

Dr. Aaron Kowalski says to (09:40):Any we need to address more payer issues as well as issues in the dr.s offices too. I see

these as the two major issues

annie keys says to (09:41):Aaron, I think you misstook somebody elses' answer for what I said. I do NOT think the companies

fail to find a cure because it would mean less profits.(F)

Dr. Aaron Kowalski says to (09:41):Daddy - feel free to email me offline and I can go over the license stuff

daddy says to (09:41):ok thanks

dwendel says to (09:42):Personally as someone who uses CGM and is very into gadgets and technology using CGM is frustrating

and has a very large learning curve. I think for insurance companies to fully embrace it needs to be easier to use and more

reliable, even though

millyyates says to (09:42):Aaron you mentioned early about things moving quickly. Please elaborate.

dwendel says to (09:42):I totally hooked on it and don't use it for up to the minute reults.

gina says to (09:42):i think that anyone that wants a CGM needs to know upfront the work that it takes

Dr. Aaron Kowalski says to (09:42):There is a learning curve but for me - I always joke its all about getting "In an

interstitial fluid state of mind" - yes you can sing it

MelissaBL says to (09:43):LOL

diabeticizme says to (09:43):lol

dwendel says to (09:43):One reason I wear the sensors for 20 days is that getting them up and running is a serious pain

diabeticidol94 says to (09:43):thats my next step cgm. my brother loves his.

MelissaBL says to (09:43):You certainly have to treat the CGMS as a tool for trending rather than a thermostat.

Dr. Aaron Kowalski says to (09:43):If you want the numbers to always match, you'll get frustrated - but that's not what cgm

is all about

sstrumello says to (09:43):Is JDRF doing anything to bring more competition to the market? For example, Abbott has a system

which may (or may not have) been approved, and I think Johnson & Johnson also have something in the pipeline.

gina says to (09:43):i learned it really shows the trends

annie keys says to (09:43):I referred to getting used to my insulin pump as being assimilated into the Borg--remember Star

Trek?

AndyRozman says to (09:43):dwendel: which one's? which CGM do you have

dwendel says to (09:43):Medtronic

dwendel says to (09:43):I love it

dwendel says to (09:44):most of the time my numbers are in sink

Dr. Aaron Kowalski says to (09:44):Mello - we want multiple companies to succeed here - better products, more options,lowe

cost

AndyRozman says to (09:44):and your sensor lasts for 20 days?

diabeticizme says to (09:44):lowe cost is a plus:)

jon says (09:44):Aaron, what can we as individuals do to help you get funding?

dwendel says to (09:44):I think 25 is the longest I have stretched it before the number get crazy

diabeticidol94 says to (09:44):yeah! most defenitely

sstrumello says to (09:44):experience has proven that more competition = better products and lower prices

mdavis says to (09:44):I'm concerned that the commercial opportunity isn't yet great enough and how long will Medtronic,

Dexcom and Abbott keep slugging away at this if they lose money year after year

dwendel says to (09:45):It is all about recharging and keeping your sensor from moving around

Dr. Aaron Kowalski says to (09:45):The JDRF relies on folks like you to do the research - to be advocates (THANKS GINA - A

SUPER ADVOCATE FOR PEOPLE WITH DIABETES) etc...

beanboy says to (09:45):So we have the technology and algorithms so all you need now is time to perfect? You just sound

like you have almost everything you need. Before this chat tonight I thought the hardware itself was years away.

diabeticidol94 says to (09:45):get out there and raise money for jdrf walk like i did this past weekend over one thousand

dollars more coming in

MelissaBL says to (09:46):So the denial campaign raising awareness? The JDRF is pro our complaining? :)

AndyRozman says to (09:46):dwendel: that is great news for me. I plan on getting on pump soon, and I will choose paradigm,

but I wasn't sure if I should buy CGMS stuff too, because sensors are so expensive

mdavis says to (09:46):it is for my little brother - he doesn't like to wear his

Dr. Aaron Kowalski says to (09:46):mdavis - this is one of the huge challenges for us - we need these companies to succeed

and to invest in the next generation of products - that's why JDRF is taking a multi-pronged approach here

gina says to (09:46):thanks Aaron, i help everyone get covered, everyone but me ! i just cant seem to get the CGM

dwendel says to (09:46):Medtronic is very good about replacing them as well. You just need to call them when you have

problems

diabeticizme says to (09:46):your not alone gina

MelissaBL says to (09:46):But Gina, if you'd been approved at first try, would you have caused this online advocacy storm?

mdavis says to (09:46):ok but who is going to fund the gap when they say they are done losing money on this (if that were to

happen) prior to broad reimbursement?

gina says to (09:47):i am grateful of all the people i have helped in the past couple of months they have given me great

tips

MelissaBL says to (09:47):Anyone approved owes it to you in a way.

dwendel says to (09:47):I am more than happy to tudor anyone in CGM!!!

Dr. Aaron Kowalski says to (09:47):Quick diet coke sip - I know folks can appreciate that!

diabeticidol94 says to (09:47):yeah my brothers pump died at 300am he had new one by 900am next day. thank god

diabeticizme says to (09:47):lol where's the paypal link..hahaha

diabeticizme says to (09:48):you are a blessing Gina:) you've done so much

Dr. Aaron Kowalski says to (09:48):Thanks for all that Gina has done here -JDRF also has info about cgm coverage (we've been

linking sites) and need your help to keep pushing here!

dwendel says to (09:48):Insurance companies-Optimum Choice is what you need if you are diabetic!!

annie keys says to (09:48):My pump went whacko on me---Medtronic replaced it within 24 hours.

beanboy says to (09:48):Just a FYI on the 20 day wearing of CGM sensors... I hear 6 days a LOT more than people wearing

their sensors upwards of 10. I wouldn't count on 15 day wear times...I think that is more of the exception than the norm

gina says to (09:48):check out my CGM site

gina says to (09:48):www.cgm-antidenial.ning.com

dwendel says to (09:48):Yes 15 is average

gina says to (09:48):i have all the info from the jdrf on there

dwendel says to (09:48):my last one was 20 plus

gina says to (09:48):the petition you can sign

gina says to (09:48):insurance companies that have covered

MelissaBL says to (09:48):I don't think the companies producing the cgms will give up. It's a necessary next step toward

whatever else is to come. They can't skip it.

dwendel says to (09:49):recharging the transmiter is key

gina says to (09:49):we have over 2200 signatures on the cgm anti denial petition

dwendel says to (09:49):very true Melissa

diabeticizme says to (09:49):true melissa

gina says to (09:49):melissa yes

Dr. Aaron Kowalski says to (09:49):Melissa - I dont think that they will give up either - but like everyone here - time is

of the essence -

dwendel says to (09:49):The first company that has a closed loop system will make bank!!

MelissaBL says to (09:49):They all want to be first to perfect that closed loop or the artificial pancreas. They know they

have to streamline this cgm
technology.

diabeticidol94 says to (09:50):how long were you on pump before you started cgm?

gina says to (09:50):aaron have you done any studies on women that want to get pregnant or are pregnant wearing the CGM?

Dr. Aaron Kowalski says to (09:50):we need better solutions sooner. That is what the JDRF APP is all about - my family has

been doing this a long time - 30+
years for my brother - almost 25 for me

dwendel says to (09:50):That is why we are the guinea pigs!!

MelissaBL says to (09:50):good question, gina. i'll be a guinea pig!

gina says to (09:50):me too! lol

diabeticizme says to (09:50):me too:)

sixuntilme says to (09:50):G - I saw the article from Ireland that cited pregnant women.

beanboy says to (09:50):idol94: was that to everyone or just aaron?

gina says to (09:50):me too

Dr. Aaron Kowalski says to (09:50):Gina - we haven't - yet - I work closely with Dr. Jovanovic and we've talked about this -

I think it's a pressing need

sixuntilme says to (09:50):And count me in as one of those hopefuls, too.

gina says to (09:51):DR. J was on here not too long ago

diabeticidol94 says to (09:51):anyone looking to go on cgm

diabeticizme says to (09:51):i wish i had one during my first preg

MelissaBL says to (09:51):G, K, DizMe - I feel like we're all on some kind of baby team!

beanboy says to (09:51):I started pump and CGM the same day

Dr. Aaron Kowalski says to (09:51):And yes - there was just an article published this week that says cgm can add significant

value during pregnancy

gina says to (09:51):she told all of us how we need a1c of 6.5

annie keys says to (09:51):I've been an insulin dependent diabetic for 44 years. I'd love to be somebody's guinnea

pig---insurance is out of the question, I'm totally self pay for the last several years.


gina says to (09:51):and i have been on a quest for 6.5 lol

Dr. Aaron Kowalski says to (09:51):I'm sorry if I'm a little behind here - ask a question again if I missed it

sstrumello says to (09:51):http://www.bmj.com/cgi/content/full/337/sep25_2/a1680

diabeticidol94 says to (09:52):i am 5.4 and so is my brother on cgm . i am not yet on it

sstrumello says to (09:52):Sorry, British Medical Journal did a study on pregnant women at

http://www.bmj.com/cgi/content/full/337/sep25_2/a1680

MelissaBL says to (09:52):thx Scott

beanboy says to (09:52):aaron: You said you think the current hardware is good, and the algorithms are the key. So what are

we waiting on? More trials with current hardware + algorithms or newer hardware?

annie keys says to (09:52):I've been running A1C of 6.2

gina says to (09:52):annie thats great!

Dr. Aaron Kowalski says to (09:53):Beanboy - we are workign on more trials but the key has been working with the companies

to show them that this is feasible

Dr. Aaron Kowalski says to (09:53):A main obstacle was the regulatory pathway

annie keys says to (09:53)::)

MelissaBL says to (09:53):we need more diabetics in the FDA...

diabeticizme says to (09:53):i am at 6.3 trying to get back to 5.7...

MelissaBL says to (09:53)::)

diabeticizme says to (09:53)::)

tmana says to (09:53):Of course. The FDA keeps good meds off the market and bad meds overpriced and on the market

Dr. Aaron Kowalski says to (09:54):We've worked closesly with FDA over the past two years and they have been working hard

with us to provide more clarity

Dr. Aaron Kowalski says to (09:54):I think we are very close!

gina says to (09:54):i just got my a1c down from 8.3 - 7.4

tmana says to (09:54):IMHO We need to get rid of the FDA

gina says to (09:54):lowest i have been in about 5-6 yrs

MelissaBL says to (09:54):good for you, G

beanboy says to (09:54):When you are 'working with the companies' are you using humalog, apidra, or both

dwendel says to (09:54):My last was a 6.1 and I am expecting a mid 5 in a couple of weeks!!

gina says to (09:54):awesome dwendel

Dr. Aaron Kowalski says to (09:54):FDA is important - like everyone here, we want to be sure the devices we use are

effective and safe - that is critical to me

dwendel says to (09:54):thnx

diabeticidol94 says to (09:55):i think i am ready for sensor. been pumping sice feb any suggestions. pros or cons

daddy says to (09:55):so aaron what is the ETA on a study of 'free roaming' patients using a closed or semi-closed loop

system?

sstrumello says to (09:55):I agree that the FDA has relied too much on "surrogate endpoints" rather than the entire picture

... I think they are finally seeing the error of their ways!

mdavis says to (09:55):how is the night time accuracy going to affect closed loop (the person is sleeping)? If false high

and insulin corrects then we're in trouble

annie keys says to (09:55):Apidra did absolutley nothing to control my daily BG. Works great for food--but did nothing for

me as a control insulin. I take the Apidra for food--when I can get it. Apidra cost nearly $300 per bottle with no

insurance.

dwendel says to (09:55):I will get there because I virtually cut out all bread, pasta, rice and potato. I cut down about

10-12 units of insulin a day.

Dr. Aaron Kowalski says to (09:55):But - it should be pointed out that people with diabetes aren't doing great now - many

lows - every day! And with an A1c of 7 you're spending on average about 9+ hours a day above 180

Dr. Aaron Kowalski says to (09:55):we can do much better!

diabeticizme says to (09:56):yes we can :)

gina says to (09:56):thanks for pointing that out aaron lol

gina says to (09:56):jk

MelissaBL says to (09:56):I just came up from low #6 today...somebody needs to fiddle with her basals...

Dr. Aaron Kowalski says to (09:56):mdavis - great question about overnight. Its interesting that in our studies we can peg a

bg every time

gina says to (09:56):the lows at the gym are what get me most

Dr. Aaron Kowalski says to (09:56):But - again we need to be sure that we dont ever cause a problem

gina says to (09:57):when i was on the cgm for a week i felt so much more confident

diabeticidol94 says to (09:57):well i am already5.4 how much more can i except

gina says to (09:57):because it would alarm and i could check my BS and see if i was plummeting

jon says (09:57):We only have a couple of minutes left. Did everybody get their questions answered?

mdavis says to (09:57):thanks Aaron

diabeticizme says to (09:57):good job dbidol

annie keys says to (09:57):I've learned a lot. Thanks.

dwendel says to (09:57):diabeticidol94 Very nice!!

Dr. Aaron Kowalski says to (09:57):Interesting - about the lower a1cs

sstrumello says to (09:57):I think increased glycemic stability is a key, and again, the FDA's reliance on reduced HbA1c

rather than the quality of the HbA1c is the reason

fletcher says to (09:57):thanks Aaron !!!

diabeticidol94 says to (09:57):aaron are you going to be at dri in nyc

MelissaBL says to (09:57):Thank you for all you do, Aaron. And thank your team at JDRF.

diabeticizme says to (09:57):I did and learned a heck of a lot, thanks gina

Dr. Aaron Kowalski says to (09:58): We have another part of our study that looks at folks starting at a1c below 7

gina says to (09:58):your welcome!

diabeticizme says to (09:58):Thank Aaron keep up the good work

gina says to (09:58):what about 7.4 lol

millyyates says to (09:58):Many thanks to you for doing what you do!!!!

sstrumello says to (09:58):Thanks for joining us this evening, Aaron ... as always, its been very informative!

Dr. Aaron Kowalski says to (09:58):I'll keep you posted

AndyRozman says to dwendel (09:58):thanks aaron... i learned quite a few things...

Dr. Aaron Kowalski says to (09:58):THANKS FOR ALL THAT ALL OF YOU DO!

diabeticidol94 says to (09:58):thanks aaron for all you do for jdrf

daddy says to (09:58):thx aaron - no ETA on free roaming patients?

gina says to (09:58):Aaron you need to sign the petition lol

gina says to (09:58):the cgm petition

Dr. Aaron Kowalski says to (09:58):Free roaming -

Dr. Aaron Kowalski says to (09:59):I hope next year

MelissaBL says to (09:59):sounds like free range

MelissaBL says to (09:59)::)

dwendel says to (09:59):only 3 ft

gina says to (09:59):http://www.ipetitions.com/petition/CGMSdenial/

daddy says to (09:59):yeah, free roaming is just regular folks 'out in the wild'

daddy says to (09:59):thanks aaaron

mdavis says to (09:59):no hormones at least no insulin

diabeticidol94 says to (09:59):<:o)

Lori says to (09:59):Thanks for letting me sit in Gina. Take care! Check out our site in November:

www.DiabeticLivingOnline.com. Thanks everyone.

Dr. Aaron Kowalski says to (09:59):Mdavis - good one - I like that !

jon says (09:59):Thank you Aaron for taking the time to chat with us tonight!

gina says to (09:59):thanks aaron i hope next time you chat i will be covered for my CGM!

diabeticidol94 says to (10:00):me too

jon says (10:00):The transcript will be available to view tomorrow on the past transcripts page

Dr. Aaron Kowalski says to (10:00):Thanks Gina !!! Talk to you soon. I can stay on for a few more minutes if anyone has a

last question or two

mdavis says to (10:00):what other hypoglycemia research do you look at

mdavis says to (10:00):you said this at the top

sstrumello says to (10:00):Thanks Aaron, Gina, and Jon ... another great program!

jon says (10:00):Thanks everybody for coming, we had a great turnout!

gina says to (10:00):thanks scott

MelissaBL says to (10:00):I wanted to know if you had any suggestions for people making their appeals.

diabeticidol94 says to (10:01):Anyone attending dri in nyc in october

Dr. Aaron Kowalski says to (10:01):Melissa - i hate to say it, but persistence

annie keys says to (10:01):Does anybody know of any programs to assist with cost for pump supplies? Totally self pay is a

real bear.

Dr. Aaron Kowalski says to (10:01):Plus - the new evidence should help

dwendel says to (10:01):Thanks everyone I will see you on Tudiabetes as that is where I recognize most of you from!!

tmana says to (10:01):I'm close enough, but (1) have other plans for that day and (2) it seems to be one of those "only T1s

allowed" deals

Dr. Aaron Kowalski says to (10:02):I heard just today of an appeal that was accepted based upon the recent publication

tmana says to (10:02)::)

MelissaBL says to (10:02):that's great

diabeticidol94 says to (10:02):(Tp) take care dwendel

dwendel says to (10:02):thanks

diabeticizme says to (10:02):c-ya dwendel

lore says to (10:02):hi all i was late coming in here....i wil read the transcript later

tmana says to (10:02):do you think things will speed up if you and the manufacturers look at providing devices for clinical

diagnostic use rather than therapeutic use?

millyyates says to (10:02):Surely the study won't help children?

diabeticidol94 says to (10:03):why not

MelissaBL says to (10:03):I've used two diagnostic

tmana says to (10:03):Study is based on less percent time used by children, and less drop in A1c (possibly for that reason)

millyyates says to (10:04):It doesn't say it reduces A1c.

tmana says to (10:04):I'd like to see it added into things like these Sleep For Live places... along with continuous BP

measurement and continuous body temperature measurement

lore says to (10:04):is anyone in the nwest per chance?

Dr. Aaron Kowalski says to (10:04):The paper doesn't show an a1c drop in kids

Dr. Aaron Kowalski says to (10:05):BUT - we presented at the EASD meeting that the kids who used it saw similar a1c

reduction to adults!

Dr. Aaron Kowalski says to (10:05):We will publish this soon

tmana says to (10:05):Lots of new stuff came out of the EASD meeting :)

MelissaBL says to (10:05):easd?

tmana says to (10:05):European Association for the Study of Diabetes, IIRC

MelissaBL says to (10:06):thx

tmana says to (10:06):The abstracts are available online, no cost

tmana says to (10:06):http://www.easd.org/

millyyates says to (10:06):Aaron

millyyates says to (10:07):Aaron how do you adjust your rates and settings or do you now rely on CGMS to do continual

corrections?

diabeticizme says to (10:07):i have to go thanks again

diabeticidol94 says to (10:08):niters8-)

sixuntilme says to (10:08):Thanks for all of the information!

Dr. Aaron Kowalski says to (10:08):Milly - I have to say (and I can't recommend this - I'm a scientist not a physician) that

I do most of my dosing etc... with my cgm numbers

Dr. Aaron Kowalski says to (10:08):Any my a1c is bettter with fewer lows

diabeticidol94 says to (10:09):how long you been diabetic?

Dr. Aaron Kowalski says to (10:09):Coming up on 24 years

millyyates says to (10:09):That's what I have found when using cgms

diabeticidol94 says to (10:10):wow! AMAZING ! me since 94 brother since early 70s

lore says to (10:10):sigh its been just under a year for me

diabeticidol94 says to (10:11):whats your aic aaron and do you have any complications?

Dr. Aaron Kowalski says to (10:11):My brother was diagnosed at age 3 in 1977 - I was 13 in 1984.

Dr. Aaron Kowalski says to (10:12):A1c in the mid 6's and knock on wood no complicaitons - literally just at the eye doc

today and was pleased to get a clean report

gina says to (10:12):awesome

tmana says to (10:12)::)

diabeticidol94 says to (10:12):i was 25 blood sugar 1064 brother was 24 months slipped into coma.

gina says to (10:12):i just had my check up a coupleof weeks ago

tmana says to (10:12):sheesh, d-idol

diabeticidol94 says to (10:13):great job aaron

millyyates says to (10:13):That is so fantastic. Over the years what has been your highest A1c and for what oeriod?

diabeticidol94 says to (10:13):my brother is truely my hero and insperation for me! now pumping

Dr. Aaron Kowalski says to (10:14):Sounds strange but I feel lucky that I was born at a time where we had more options than

those foks with t1 in the past

tmana says to (10:14):I certainly understand, Aaron.

gina says to (10:14):i feel the same

Dr. Aaron Kowalski says to (10:14):And that I survived college with diabetes! I certainly didn't always have a great a1c -

particularly back then

landileigh says to (10:15):i just got my pump!

lore says to (10:15):lat year has been the year from hell..but life is getting better..now that i seem to be stable

diabeticidol94 says to (10:15):yes! this is truely a blessing i feel same ay. we come along way since ringing out old urine

diapers

Dr. Aaron Kowalski says to (10:15):The research that we're funding at JDRF gives me much hope for the future!

tmana says to (10:15):I remember my great-grandmother having shots (I think geriatric T2), and my grandmother (other side of

family) having a very strict diet

Dr. Aaron Kowalski says to (10:15):We're not there yet, but the future is bright!

diabeticidol94 says to (10:15):YEAH! FOR JDRF ALL THE WAY

tmana says to (10:15):I wish sometimes that we could get the OCD-like attention to our care across to our parents and

grandparents

tmana says to (10:16):for their care

diabeticidol94 says to (10:16):There are many challenges to face . And a few bumps along the way but we will get to our

goal. And that will truely be a dream come true

landileigh says to (10:17):I only wish it was for me. I'm an other, whose only cure will be a Double.

Dr. Aaron Kowalski says to (10:17):Thanks again GIna - it's time for me to log off everyone. Thanks for all of your passion

- we're going to get there. I look forward to coming on again soon.

Dr. Aaron Kowalski says to (10:17):Good night everyone!

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Sorry I was not able to attend this discussion, but other things got in the way. I am 70 and have had T1 since age 12. I have been pumping for 13 years, and have used a Dexcom Seven for 14 months. My Hba1c's run from 5.5 to 6.3. When I was at 5.5 my Endo pleaded with me to let them 'float' up to 6.0 to 6.4, to avoid the dangers inherent in lows. I love my CGM for the trending and realtime data, and wish everyone could have one. BC/BS Federal pays about 80% of my costs.
While I agree that learning to manage the CGMs is important, the important thing I did not see mentioned is the issue of fingerstick accuracy ( or nonaccuracy), and the mindset change necessary to 'accept' CGMs' data. Once you get past that hurdle it is easier to utilize the CGMs.
thanks, Gary Taylor

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Sorry to hear you missed the chat. Hopefully we can get Dr. Kowalski back again soon. His chat's are always so informative.

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yah i miss him.. wen hi will came back? i have lots of question to ask.. for my sis.. tnx


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