The Best Insulin Pump - The One You Use

I wrote about the best Insulin Pump a few years back. My view hasn't changed much, so, Summer Rerun. 

So here what I said in 2012

The question which is the 'best' insulin pump floats up in diabetes conversation regularly. Best is a natural but probably the wrong question.

The quality of pumps and their ability to perform the basic insulin delivery functions is so good that these days users and their care teams have the potential to define the device and vendor that most appropriately fits a person's unique lifestyle. That is a real wordy way of saying, ‘there is no best pump.’

Happily one size does not fit all.

People with diabetes have different needs because their diabetes varies. So don't look for the absolute best pump but to the device that best accommodates your individual lifestyle. This dude may love his backpack,  but it may not be your best choice. (And what is in the giant bottle on the bottom of that thing anyway?)

Design and feature matter. For example the patch, folks seem to have a love/hate relationship with the OmniPod. That is great. If you are drawn to the patch pump, no tubing, PDA driven approach -great. If like my kids. You think it is too big and uncomfortable and tube are okay a more traditional pump may be better in your life. There are a lot of criteria individuals can consider. Remotes are really great for little kids. Lock the pump down and have mom or dad operate it with a remote control. How much insulin do you use and how much does it hold. Is it a color a young girl is comfortable wearing 24/7.

CGM may matter. If CGM integration is mission critical only Medtronic has int on the market in the USA. Animas, Roche, OmniPod, and Tandem are in the on-deck circle with Dexcom. Remember that deck circle is a baseball term. There is no clock in baseball and Animas, and Omni pod have been next in the line up for years waiting to come to bat. Some of the fans in the stands are getting rowdy and jeering the Ump wanting to see them come to bat. Food databases are touted as a key feature. If they are to your look carefully at the implementation and ease of building realistic meals. Can you customize the food database to your needs.

Service matters. Check it out by calling the service in the middle of the visit by the sales team. Like everything else service varies. We have had great service from Animas other say they have had issues. Read up on TuDiabetes and CWD and keep in mind that when the device is as integral a part of life as an insulin pump, individual service expectations will be very high.

Sets matter. People talk about pump features, but the set and how it feels going in are where the rubber meets the road. -  Well, the insulin meets the subcutaneous tissue. Try on sets as part of the sales process. Sets plural, not set.

Instead of which is best maybe the question should be what features best adapt to my lifestyle. That the art and science of insulin pumping have progressed from that backpack size prototype, in the black and white pictures above, to diverse, miniature devices is great.

What is best is we get to choose based on our individual preference.


Related posts from the YDMV archives:
Why Pump
What would be Really Cool.

Updated with some grammar & spelling fixed 5/31/16. Sure there are still a ton of errors. My Writing May Vary

Of Automobiles and Insulin Delivery

I applaud the New York Times for caring to write about type 1 technology. I would encourage them to take a little more time to better understand the subject next time. I'll try to help. Since we are all Americans here, lets use a metaphor we all understand - cars. Fuel efficient small foreign cars, so maybe not something we all understand.

In the 1970s I drove a VW Beatle. It had been my mom’s. It would go anywhere, including places my friend Ric broke his jeep. One year for Christmas I got a hand full of Craftsman tools and rebuilt the engine and clutch. Bugs were easy enough to fix anyone with tools could do it.  

Coming home from college one weekend, I was cut off on a highway and skidded into a gas station sign. The car was totaled. I was nearly so too. The impact of my face cracked the steering wheel and popped the windshield out. The Glass flew across the service station and landed unbroken. I remember the gas station guys talking about seeing the glass fly and marveling that it didn’t break, from my semi conscious state waiting for the ambulance. 

I still like small cars. I have a Mini. It has a host of features my Bug lacked; anti lock breaks, a host of front and side air bags, crumple zone construction, good seat belts, power steering and much more.

I bring all this up to point out the value of current automotive technology verses 1970s technology. It would be easy to say that both the Beatle and the Mini do the same job. They get me from point A to point B in relatively the same mix of shifting, steering, breaking and being a little weary of bigger vehicles. In that context the newer car’s significantly higher cost could be seen an extravagance. 

Modern cars are significantly safer (even if they don’t go up Jeep trails like a Bug.) 

I think there is a parallel to diabetes technology. Modern diabetes technology looks like it is doing the same job as the 70s stuff. 

It isn’t.

Modern insulins allow a better if not perfect parallel of physiologic insulin. Pumps provide a better delivery system and allow delivery to be programed to daily rhythms. Continuous sensing can alert patients to changes and prevent dangerous lows and highs. 

Yes, this stuff cost more than 1970’s stuff. Cost isn’t the question, value is. Air bags are mandated because some cars are gonna crash. Antilock breaks, crumple zone construction, side impact doors, safe fuel systems etc all cost more. The value is in safer roads, lives saved. 

See where I am goin’ here? 

The story of technology is the value it brings. Computers cost more than pencils, ruled notebooks and movable type presses. The New York Times assembles the paper with computers, because they bring value. We drive safer cars for the value. People with type 1 diabetes can be more productive members of society due to the value of effective technology.

Sent via email to: Elisabeth Rosenthal NYT. (without the cool images, what can ya do.) 

ps. Neither my Bug of Mini looked the good but the colors are right. 

Dexcom, Magic Radars and Connectivity: Q4 Earnings Call

Dexcom’s Q4 / Full Year 2012 earnings call is up on their site. As usual it makes for interesting listening for those interested in sensor supported diabetes care. I may get stuff wrong so first hand (ear?) listening is available: Click here to listen to the webcast. (1 hour, 4 minutes.) 

Artist's Depiction
(OK not much of an artist)

The most interesting part of the call for me was Terry Gregg talking about Dexcom Share. Share was described as a docking station for a Dexcom receiver that could send information to “designated recipients.” Share would send that information to smart phones. Naturally I assume magic and 50's style radar stations are involved. At one point Dexcom suggest that Share may be the first class III device approved by the FDA to work with a smart phone. I wouldn't know. I do know the FDA mobile guidance is not light reading.

For parents this sounds something like mySentry. I perviously likened mySenty to the BatSignal. Share seem like it may be similar but with connections to more phones than the red BatPhone in commissioner Gordon's office. By that I mean cell phones not just the dedicated mySentry receiver.

The device springs from market research with parents and Dexcom said they hope to submit a filing for Share to the FDA in Q3 2013. In part, Terry said that Share is not getting up at 3:00 am to do a finger stick.  Share then would need pediatric approval of Dexcom sensing to thrive.

Dexcom reported they received an extension of their CE mark giving pediatric approval of the G4 system in Europe last week. Further they said they have filed a PMA supplement with the FDA for pediatric approval in the USA. That is a 180 day regulatory process. Optimist will note that the FDA has seen the G4, the adult G4 approval was less than 180 days, the FDA on pervious calls was reportedly is very interested in pediatric use. Pessimist will make comments about the FDA.

Regarding pump integration Dexcom expects that a PMA for the Animas integrated pump to be filed first quarter of 2013. In another part of the call they noted JnJ reports that in the parts of Europe where the CGM pump is on sale the demand is 30% than where it is not available. There is some detailed conversation about PMA, 510k and who files what is in the Q and A around 35:00 (+/-) mark. There was detailed conversation about pediatric integrated pump approvals in the last few minutes of the call which is another can of worms.

Tandem was reported to have agreed to move forward with G4 integration with their pump. Previously the G5 was reported to be the path for integration for Tandem and that the G4 was being studied. So apparently the study showed that integration was a good fit.

My editorializing here is the Animas sales and the Tandem study indicate what I think many people living with diabetes hold to be self evident; that an integrated CGM / pump product is more desirable and two separate devices.

Regarding the OmniPod, Dexcom cited Insulet releases that the OmniPod is moving to a relationship with an undisclosed CGM vendor to explore a single site combination Pod/CGM sensor. Dexcom’s G5 platform with mobile connectivity was cited as part of the reason that the OmniPod chose to go in a different direction with CGM. Also Dexcom is hoping to extend the time sensors can be worn. This would create a significant difference between pod like and sensor life span.

In Q and A approval for a ten day sensor approval was to said not to be a 2013 priority.

Dexcom also reported that Roche will not be moving forward with G4 integration with their pump. Costa and time to market were cited as reasons as was the G5 and mobile.


As I have written before I own shares in Dexcom, I still do and I have an obligation to disclose that.

Bernard Spots a New Insulin Pump Approval in FDA Docs: the Pearl

OK we d-geeks can be like bird spotters looking for prey in the thickets. So props to my pal Bernard who spotted what sure looks like FDA clearance for the Asante Pearl, a new insulin pump in the wild of the FDA's latest round of 510(k) announcements. 510(k) means something is substantially equivalent to some other approved device and this claims to be the equivalent of and Animas 1200 IR or a Disetronic D-TRONplus.

A screen grab off Asante's site shows Pearl looks like this:

I don't know much about it but this is what the company web site says:

The Pearl insulin pump is designed to make living every day with an insulin pump, easier. 

Filling a pump reservoir is an outdated process in today’s world. So we designed our insulin pump around a pre-filled insulin cartridge, a simple-to-use interface, a pump that primes itself as you assemble it, and occlusion detection designed to identify occlusions earlier. Not just fancier, but really, less work. 

The Pearl insulin pump has a durable controller and a replaceable pump body that, once assembled, functions as a "traditional" insulin pump. Just insert the prefilled cartridge into the replaceable pump body that simply clicks together with the controller, and off you go.
Half the work, half the time.

OK. There ya go.

Reservoirs are not on the top of my list of pump issues but Your Diabetes May Vary. I left a message for a PR guy and will pass on what I learn.

Kudos to Bernard for spotting the FDA announcement. 

t:slim in the Wild: Bill's New Insulin Pump

Friend of the DOC and Glu Community Guru Bill Woods has the earliest review of a t:slim pump in the wild I have seen. You can read about his first impressions here. While you are clicking about Like Glu on Facebook http://www.facebook.com/MyGlu

I like this I had to recycle it. 

A lot of other folks have written coming attractions pieces for this thing. Including:

Like Bill good friend Bernard Farrell is moving from a Cosmo to a t:slim. I haven't seen his review but here is one of his posts about the choosing pump at Diabetes Daily.
http://www.diabetesmine.com/2012/07/tandems-tslim-up-close-and-personal.html
http://www.ydmv.net/search?q=t%3Aslim

I think more options is good news. YDMV so pump choices do too. 

They're Here... Tandem T-Slim Shipping

Well not here as in our house but Tandem Pumps are shipping.

See: http://www.diabetesmine.com/wp-content/uploads/2011/11/tslim-pump-front.jpg

PODD Call re: Dexcom

In writing about yesterday's Dexcom earnings call I noted that they left Insulet (aka stock symbol PODD) out of the Dexcom/Pump integration conversation. Today PODD had their earnings call and at about the 12:00 minute mark spoke briefly about CGM. They said that they have had conversations with Dexcom about integrating the Gen 4 into the new OmniPod product and expect to “soon commence” work on integration. They say that the integrated device is expected to also use the LifeScan Verio strip.

OmniPod fans may want to listen to the call and break out their tea leaf reading skill. Management did speak to the FDA process and the new device. They have been working through details with the agency. I sounded to me like they are woking on some final interface issues, the entry of some information and training. I will be honest I am not particularly well versed in OmniPod. A cold war Kremlinologist or and an experienced Pod user may be able to gleam more out of what was said than I can.

The PODD call is online here: http://investor.insulet.com/events.cfm

YDMV

Important Patient Notification: Don't Become Unglued.

I just got a letter about my son's pump. In red caps it says: IMPORTANT PATIENT NOTIFICATION. I am sure there is another on the way about my daughter's pump too.

Animas wants me to know that the keys can wear and we should check to be sure that while the keys were built to last, some folks' buttons have worn out.  We should reach out to them there is any suspected issue with our pumps.

Thanks for the letter. No worries. We hold these truths to be self evident.

I think it says something significant about how much effort is involved in living with Type 1 Diabetes (T1D) if users wear out the buttons that deliver insulin on their insulin pumps. How many times do you need to bolus to wear out the keys? A crap load I am sure. Each bolus requires a bunch of other stuff too. checking BG, carb counting, considering IOB, activity, protean and fat intake and a partridge in a pear-tree. Okay the pear-tree was deliberately facetious but the rest is only part of the reality. 


But I get it. Pat attention to the devices too. We have had screens crack, button labels wear away, the rubber cover over the buttons come off, cases split and a bunch of other stuff I can't remember. These pumps are on the kids all the time. The pumps take a pounding. 


As if to prove that there is actual rage in a rage bolus we have a broken window upstairs where by son threw a meter that registered unexpectedly high results. I guess at times, all pump buttons get mashed with  a wee bit of emotion. 


Pumps are in use 24/7/365. They go into all kinds of hostile environments regularly. For example my teens' bedrooms, talk about jungles. For the most part the pumps are just fine. That occasionally something is a little off is inevitable. Maybe my kids don't mention it right away. 


I actually think that is great. It means the kids are living life and the pump is going along for the ride. Not - The kids are putting the pump first and avoiding normal kid activities to protect the stupid thing. That is how it should be. Life first, diabetes second. 

Part of our responsibility as users is to pay attention and if something looks funny or acts funny to call the manufacturer. That seems really obvious but somehow I suspect that a notice in the mail means that someone waited for a little funny to become flat out doesn't work. Maybe, from time to time I need to check in with the kids and be sure all is well. 

Animas has been great with us replacing worn and broken pumps. So have a host of other companies like meter manufacturers. I wrote about mySentry a few days ago. I didn't write that somehow it malfunctioned and their normal call process managed to have a new unit in my home at 10:00 am based on a 9:00 pm phone call the night before. (While I was on #DSMA) Great service from the companies happens because there are plans to do it and people who will make sure it happens. (Same for great DOC Twitter chats come to think of it.)

So when I see a letter like this about my son's pump, or the one we'll get tomorrow about my daughters, I see it as a a sign that industry goes to great lengths to support the devices my kids rely on. These firms understand how significant the effort is to try to live well with T1D. They compete, in part, with service.

T1D is stressful. Most of that has little to do with the devices and more to do with the emotions and variability of diabetes itself. So I don't become unglued by an "important patient notification." I see the letters as a sign that people have our back. It is good to know that.

Thanks for being there.

Thanks for the reminder.

Diabetes Pump & CGM Integrated on a Cocktail Napkin

I got into a rousing conversation about the possibility of over bolusing based on CGM information over drinks at FFL. To be specific we were talking about over bolusing or stacking insulin based on high BGs on a CGM screen. I started drawing on napkins at which point there may have been a case to be made that I over bolused beverages.

Someone pulled out their pump CGM combo and showed a little tick mark that indicated a bolus. Good start. However I think it would be great to see more. How about putting the insulin on board on the CGM trend line as an area chart. This would be a clear visual there is IOB. 

This IOB area would be linked to what ever the pump uses for IOB calculations. For simplicity imagine it runs off evenly over three hours. So when you bolus it puts a little triangle on you CGM screen. The peak is the total units bolused and it slopes down over three hours to zero. So if just after at 6:00 pm bolus for a quick dinner your CGM would show IOB reaching out beyond the current time.  Say something like this:

If you extended the bolus it would take a different shape. The point still is to make IOB clear on the integrated pump cgm screen. 

Say that bolus was part of an imaginary day that started off okay with overnight bouncing around 130. You pre-bolus a little for breakfast and manage to only spike a little to about 200 and work your way down. Dash for lunch try to pre bolus a little spike a little more but come down too much. - because what is a day without a low? Grab a juice to treat the low and pre bolus for dinner. At the time you pre bolus maybe you day’s cgm IOB looks like this: 

(BG scale on the left IOB on the right.)

Brilliance right? And it only took a few drinks. 

DOC has News of JnJ Insulin Patch Pump Acquisition

Kerri at SixUntilMe.com reports on a JnJ of acquisition of Calibra Medical. Who are they you ask? the DOC Bernard has the story. Who are they. Bernard has the story here.

There is an interesting exchange of info on Kerri's Facebook about it here: http://www.facebook.com/kerrisparling/posts/466578396688569?notif_t=close_friend_activity

Think of this as a wearable insulin pen more than a traditional pump and you are on the right track. 

LGS in USA?

Medtronic announced today that their Low Glucose Suspend pump is into the FDA for a PMA aka blessing. Good news and a step towards innovation in insulin pump care. 

FDA to Review World’s First Insulin Pump with Threshold Suspend – Another Significant Step Toward the Artificial PancreasMINNEAPOLIS – June 8, 2012 –In the next step toward the development of an artificial pancreas, Medtronic, Inc. (NYSE:MDT) today announced that it has filed the final module of its Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration for the MiniMed® 530G system featuring Threshold Suspend Automation. If approved by the FDA, the MiniMed® 530G system will be the only integrated insulin pump and continuous glucose monitor in the United States that automatically suspends insulin delivery if the sensor glucose value is equal to or below the low threshold value.

Read more about it here:

http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1339159198703&lang=en_US

The Best Pump

The question which is the 'best' insulin pump floats up in diabetes conversation regularly. Best is a natural but probably the wrong question.

The quality of pumps and their ability to perform the basic insulin delivery functions is so good that these days users and their care teams have the potential to define the device and vendor that most appropriately fits a person's unique lifestyle. That is a real wordy way of saying, ‘there is no best pump.’

Happily one size does not fit all.

People with diabetes have different needs because their diabetes varies. So don't look for the absolute best pump but to the device that best accommodates your individual lifestyle. This dude may love his backpack,  but it may not be your best choice. (And what is in the giant bottle on the bottom of that thing anyway?)

Design and feature matter. For example the patch, folks seem to have a love/hate relationship with the OmniPod. That is great. If you are drawn to the patch pump, no tubing, PDA driven approach -great. If like my kids. You think it is too big and uncomfortable and tube are okay a more traditional pump may be better in your life. There are a lot of criteria individuals can consider. Remotes are really great for little kids. Lock the pump down and have mom or dad operate it with a remote control. How much insulin do you use and how much does it hold. Is it a color a young girl is comfortable wearing 24/7.

CGM may matter. If CGM integration is mission critical only Medtronic has int on the market in the USA. Animas, Roche, OmniPod, and Tandem are in the on-deck circle with Dexcom. Remember that deck circle is a baseball term. There is no clock in baseball and Animas, and Omni pod have been next in the line up for years waiting to come to bat. Some of the fans in the stands are getting rowdy and jeering the Ump wanting to see them come to bat. Food databases are touted as a key feature. If they are to your look carefully at the implementation and ease of building realistic meals. Can you customize the food database to your needs.

Service matters. Check it out by calling the service in the middle of the visit by the sales team. Like everything else service varies. We have had great service from Animas other say they have had issues. Read up on TuDiabetes and CWD and keep in mind that when the device is as integral a part of life as an insulin pump, individual service expectations will be very high.

Sets matter. People talk about pump features, but the set and how it feels going in are where the rubber meets the road. -  Well, the insulin meets the subcutaneous tissue. Try on sets as part of the sales process. Sets plural, not set.

Instead of which is best maybe the question should be what features best adapt to my lifestyle. That the art and science of insulin pumping have progressed from that backpack size prototype, in the black and white pictures above, to diverse, miniature devices is great.

What is best is we get to choose based on our individual preference.


Related posts from the YDMV archives:
Why Pump
What would be Really Cool.

Updated with some grammar & spelling fixed 5/31/16. Sure there are still a ton of errors. My Writing May Vary

OmniPod and One Touch to Connect

From the News Wire:

Johnson & Johnson's market-leading LifeScan blood glucose monitor will be incorporated intothe remote controller for Insulet's next-generation OmniPod insulin pump.

The next generation of Insulet's (NSDQ:PODD) OmniPod insulin pump, which is awaiting 510(k) clearance from the FDA, will be compatible with the LifeScan blood glucose monitoring technology made by Johnson & Johnson (NYSE:JNJ).

The 2 companies inked a deal for LifeScan's OneTouch technology to be incorporated into a new personal diabetes manager that patients use to control the OmniPod. Insulet's chief commercial officer, Peter Devlin, told MassDevice.com that the company is targeting a mid-2013 commercial release.

More: http://www.massdevice.com/news/diabetes-insulet-inks-deal-with-jjs-lifesscan-next-gen-omnipod

How Good Was Animas Customer Service?

Hint: I’m writing thank you notes.

A milestone in our kids' school careers is the 8th grade play. All the kids participate in a a number of ways - acting, makeup, making props and other team building processes. Delaney was practicing acting yesterday. Her part calls for her to dramatically roll across stage or some such thing. As she did her pump slipped out and she dramatically rolled it was across more than the actual stage. Exit one cracked Ping pump screen, stage left.

Amimas has always been great about replacing pumps when life happens. Life, not accidents. Being a regular kid is no accident. It is the goal.*

Sometimes when life happens, pumps need to be replaced. That is a great thing! It means the T1D kid was more focused on being normal than being T1D with an inulin pump.

While replacing a pump sounds easy, it actually isn’t. Our friends in the device business have to keep track of everything to keep the regulators happy. They gotta know who has what device, made when, with what parts, by what factory and probably at what time and if that time was daylight savings time or not. That way, if anything ever goes wrong, with any of the parts, they know who they are gonna call. Dotting i-s and crossing t-s takes systematic processes, rules, records, people and time.

Aminas’s offices are about 45 minutes from my house. When I can, I drive down for replacements. It saves a night time without a pump. That Animas can, at times, make that happen is brilliant.

I know the names of two of the people who made that happen yesterday, Steve and Bill. They made magic because of who they are and because they could. All too often we ascribe the role of villain to the companies who make the tools we rely on. The truth is way more often they are the mild mannered alter egos of super heroes who are trying to live with in the rules. They get what we are trying to do, which in this case is let life happen. When they can, they slip into the spandex and become super heroes.

I think there is probably more than one Steve and Bill at Animas. I’m waiting on a return call to get last names so I can mail LY/MI pins with thank you cards. All in all if they are busy helping others with real emergencies I’m cool. Somehow if getting a name takes longer than getting a pump replaced that would be magic where it matters.

Got as story of Magic Service? I would love to hear about it as a post here or as a link here to your own blog post about a hero.

*More Your Diabetes May Vary ramblings about The Goal:
http://www.ydmv.net/2008/08/what-is-your-goal.html
http://www.ydmv.net/2008/03/newbie-advice-long-run.html

Tandem t:slim™ FDA Approval

From the News Wire:

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

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

Pump Hack II

From the news wire: Pump hacked by sniffing serial number.

http://www.cso.com.au/article/404909/lethal_medical_device_hack_taken_next_level

I get that hacking is seen as a noble endeavor, particularly by the practitioners. My gripe is that while there are significant computing shills involved the communications leave me cold.

Consider these headlines:


Lethal medical device hack taken to next level
Attacker sniffs insulin pump ID, delivers fatal dose

To me these articles project a cavalier attitude of, 'We play games with devices that keep people alive.'

There is an FDA process for reporting device flaws. That seems more useful and a nobel a channel of communications than general media. If reason for the hacks is to motivate change then the FDA is in a position to see that it happens.

Artificial Pancreas and Egg Baskets

A friends asked this about the artificial pancreas (AP):

I have noticed over the past few days a lot of interest in the Artificial Pancreas project, the FDA and an online petition.  

I know nothing of the project beyond the controversy it caused when the JDRF supported it and people felt that money was better spent on a cure rather than technology.  

From what I have seen, and again, I need to do a lot more research, this will be a tool-a more advanced pump if you will.  If this is correct, are we looking at a tool that will only be available to those that can afford it or will it be looked upon as similar to a pacemaker for a heart patient?  

In Canada, we are still fighting to have insulin pumps covered in all provinces for all ages.  Very few have coverage for CGM.  How will the masses therefore afford to have access to another device...unless this is something for the masses again like an artificial limb or pacemaker. 

Please feel free to email me direct if you can help me to better understand this rather than clog up the list.   I don't mind standing behind something if I feel it will make a real difference.  At the moment, I am just not sure I understand the planned way forward with this. 

This was my response: 

There are a number of approaches to AP. Some use just insulin others, I think a study at Boston University uses something to raise BG as well as provide insulin. If you get the chance, go to a JDRF technology meeting. The Capital Chapter ran a great one last year. You will see AP is part, but by no means all of the story of making living with diabetes better.

You are correct about the tools involved - CGM and pumps. There is wide appreciation that improvement is needed in both sensing and insulin delivery. Faster insulins and better pumps sets. The benefits of those would also improve care outside of AP. Faster insulin would be good for everyone, better sets and sensors would benefit those who use pumps and CGM without AP. 

AP then is an set of algorithms, or an application if you will, that manages BG with the pump as measured buy the sensor. It certainly will be costly to develop and more so to get approved, particularly as there are currently not guidelines to get it approved. (in part this relates to the recent conversations about Low Glucose Suspend (LGS) and apps.) In fact LGS is a stepping stone to AP in that it does one AP function, stopping additional insulin with low BG. 

You are correct in noting AP is concerning to some. It is worth noting that JDRF's investment in AP is small compared to to their other research initiatives. I don't have the current numbers percentage numbers. 

I think you are legitimately concerned about costs and reimbursement. My good friend Scott Strummello often expresses the same concern. I think that AP will need to demonstrate effectiveness before insurance will cover it. To do that it will need to be approved by the FDA and tested, to be approved it
needs to be invented and go through trials. That is a lot of steps. 

Glucose responsive insulin (GRI) would make AP mute. I think GRI may be even more distant down the same path of discovery and approval as AP. Still one could argue that GRI is a better solution than AP and that it should be the focus. Others can rightly point out neither is a cure or a sure bet. 

I believe that better is better and perfect should not be the enemy of good.
So I am all for advances in type 1 diabetes care that may fit into individual's life styles in a Your Diabetes May Vary kind of way. AP may work for some while GRI works better for others. I fairly sure none of it will make diabetes care easy but it may be less hard and that's better. 

I support a diversified approach to making life better. There is a fable about putting eggs in more than one basket that explains modern portfolio theory better than most finance professors. Any one approach to making diabetes life better may fail. Most pharma development projects start with promise but don't make it to the market. So to make life better for people with diabetes a lot of different approaches need to be tried. It is in that context that I think JDRF GRI x-prize like initiative is a good idea even after the support they have put into and the promise that is still expected from SmartCell's Smart Insulin that Merk bought. 

Let me know if this helped any. 

You can learn more at the JFDR AP website: http://www.artificialpancreasproject.com/

Share you support for the AP initiative at this online petition. 

Bennet 

prescient |ˈpreSH(ē)ənt, adjective

prescient |ˈpreSH(ē)ənt, ˈprē-|

adjective

having or showing knowledge of events before they take place: a prescient warning. 

It takes no prescience to guess my topic, sorry about that. I will learn a new tune, soon. There are times in life when tunes are prescient. Consider the Talking Heads Rock Movie, Stop Making Sense and insulin pump hacking. How can a 30 year old rock and roll album show knowledge of insulin pump hacking well before insulin pumps and hacking were commonly used terms? Read on my friends YDMV is going pop culture.


Jay “Pump Hack” Radcliffe wrote on Facebook that he thought this war was over.  Jay didn’t seem to expect that as the hack story lives on and in that others (a word that here means me) would continue to put forward the idea that there are other risks associated with insulin pumping that are as, or more, pressing than hacking. That is Life During Wartime Jay 


But I do not see myself as at War with Jay. In my first post on the issues I offered up the fact that I kinda hacked a pump way back when when we first started using them.  I hope I am all about the idea that pumps need to evolve and become better. Better should be prioritized in terms of advancements in improving lives and not simply be a function of what scare get the most press play. 


I do not see Jay as a Psycho Killer. On the contrary he brings up legitimate issues. Doing so, I think he is responsible to offer up suggestions on how to address the issues he found. I see him as anxious to do that. I do worry that the media attention given the hack story will suck all the oxygen out of the room and things like low glucose suspend, faster insulins, smart insulin and the glucose meter shuffle will choke for lack of attention. 


I think we would be Burning Down the House if hacking were to become the only or even primary concern around innovative diabetes care. So I speak up. I would hate to see the meter that has bolus wizards for the multiple daily injection community be kept off the market out of fear of hacking. I can’t see how the color screen on a remote is regulatory issues in any issue in any but the most minor way what so ever but it is available in Canada and not here. I look forward to seeing the Dexcom integration with Animas and Omnipod but both are in regulatory purgatory. LGS is a small first step towards automating insulin delivery and blood glucose sensing. All the laypeople in the world think that is what a pump does now but we know it does not.  Further delay keeping that innovation from the market may cost lives. 


Are the media Slippery People for publishing a compelling story without putting it into put into a wider context? No. Their job seem to me to be focusing on the next edition's Once in a Lifetime story that will sell banner advertising. For the mews media every day is Shark Week.


I fear an isolated and exaggerated risk myopia may be responsible for Burning Down the House of better diabetes care. So on second thought maybe we should focus on what really matters and Start Making Sense:


There is no war: Pumps communications should be secure. LGS matters. We all need to talk about risk in the context of life with diabetes.


Get Serious: Industry with the FCC and FDA need to figure out secure protocols for medical devices. Regulators should make these protocols easily approved as changes for device manufacturers to implement. This should be in the form of standards to spread the cost of the changes widely and efficiently. Each manufacturer should not be required to reinvent the secure communication wheel. Each consumer and insurer should not have to pay for new and different processes for each device. 


Remember Who’s Air It Is: Secure communications over the public radio spectrum should NOT be proprietary. That is no firm should have the proprietary advantage of excluding others from the spectrum's use for safe secure health care device communications. The air belongs to us all. 


Make it Work: The FDA should make it very clear how to implement secure communications and make it easy to get such communications approved into existing devices. 


Risk is not absolute: The lack of such security protocols should be balanced with the benefit of innovation. Advances such as LGS need to come to market while the FDA and FCC figure out what they will require.

Shouldn't Better Diabetes Devices Be BIGGER News?

Pump-hack-gate, yes I am officially going with the gating of the event to signify its significance, continues to get print and now more media attention for the congress members who wrote a letter about it.

Here is the thing that bugs me. Do these same folks have the same interest in keeping people with diabetes healthy? Do they invest a similar concern that Low Glucose Suspend is available in 40 countries around the world but not here in the USA where it was engineered?  Do they cover advances that can save the lives of kids with the same attention that they cover the very unique and isolated hacking of a pump.

No. It doesn't seem so.

I though I was used to the rest of the world not appreciating the real risks of type 1 diabetes. The food police and the ignorant are one thing. One ignorant person at a time. This wholesale stuff with media that are selling their banner ads with stories about what are very marginal risks would do well to learn what the real balancing acts of diabetes are and what the risk associated with them mean in daily life.

http://abcnews.go.com/Technology/wireStory?id=14344300

Congress & Pump Hacking, Who Didn't See This Coming

So it begins:

Aug 15, 2011: Eshoo, Markey Ask GAO to Study Safety, Reliability of Wireless Healthcare Tech
Senior Committee members Anna G. Eshoo (D-CA) and Edward J. Markey (D-MA) sent a letter to the Government Accountability Office (GAO) early this week calling on them to look into whether the new devices are "safe, reliable and secure. " The issue stems from a hack shown at the popular Las Vegas conference where researcher Jerome Radcliffe -- diagnosed with Diabetes 11 years ago -- demonstrated how he could tweak the dosage levels on his pump remotely.

Dear Congresswoman Eshoo and Congressman Markley

I read the press release about your letter concerning wireless health technology. I have a personal interest in insulin pumps. I am a social media writer and participant in the diabetes community online as I am the father of two teenage type 1 diabetics who lives depend on insulin pumps. I know that diabetes management is a balancing act. Insulin and activity balance with food to maintain blood sugar. It is never a perfect balance of risks but it is what families living with diabetes strive to manage.

I hope that in your efforts to publicize your letter you are aware of the relative risks involved with insulin pumping. The community of families living with type 1 diabetes has been shocked with the deaths of a number of adolescents in the past year form hypoglycemia, excessively low blood sugar. You may know the condition better as insulin shock and it can result even when people believe that have balanced all the inputs just right. 

Insulin absorption is affected by a number of variables. Physical activity can present diabetics with increased insulin efficiency as well as changes when in insulin impacts blood sugar. It is possible that healthy, active kids see blood sugars fall overnight as a result of daytime physical exertion. In those cases reducing or stoping the delivery of insulin, even normal amounts that have previously been fine, can help prevent dangerous low blood sugars.

The US Government has tightened regulation of insulin pumps to the point where innovations that are available around the world are not available for use here. Continuos glucose monitoring systems (CGM) integrated with pump systems are sold in Europe. These insulin pump systems are made by US companies. The more advanced systems can shut off insulin to people having a low glucose episode. This innovation, while made in the USA, is not available for sale here, yet it is available around the world. 

These devices have the potential to save lives. They give people living with diabetes in Europe more choices to consider with their physicians than we have in the US. Sadly the FDA does not even have guidelines for considering how to approve low glucose suspend.

Let me be clear. I am not suggesting that wireless security is unimportant. The devices should be secure. Device makers should be allowed to bring more secure devices to market without a significant regulatory delay.

I am urging you to reflect on the life saving capabilities of innovations like CGM integration and low glucose suspend with the security risk. To date there has been no reported case of any health impact from the possibility of hacking an insulin pump. Zero. 

There have been and continue to be tragic cases of severe hypoglycemia that cost young American lives. The particularly sad loss of adolescents with type 1 diabetes highlights  where LGS may have prevented the unfortunate loss of life. Unlike pump hacking, the lives of American children are been lost to hypoglycemia. Pump hacking, considered outside of the balance of risks facing insulin dependent diabetics, may increase the regulatory delay of life saving technology reaching American families.

The cumbersome FDA regulatory process for inulin pumps slows innovation to US families. Your letter uses the word proliferation. Typically politicians use the word with a negative context. We need a wider rapid adoption of life saving innovation to help keep American teens alive not the proliferation of government studies that prevent US patients from using the innovations of American companies to live healthy lives. 

How can you as senior members of the House Energy and Commerce Committee speed up not only the safety of devices but the availability of life saving tools?