Tab A in Slot B - Interoperability.

Raise your hand if you have built something from IKEA.

OK so that is all of us.

We eventually get a table or chair together because it was designed to go together.

How awesome would it be if our health information was designed to go together? Or at least that subset of health information that is our diabetes information? That was the topic of conversation at the Diabetes Mine Innovation Summit and was the driving point behind my fantasy device post.

A recent post at MobiHealthNews.com takes this to the broader case of EHR under the title, Interoperability holds the key to EHR, mobile health success. They quote Chuck Parker of Continua saying;

Studies of connected health show that when patients incorporate mHealth into their lives — at home, work, and on the go — they recognize the relationship between their health behaviors and experience of health and are consequently better able to self-manage.

and 

The fact is, unless personal health devices work together with minimal effort, patients are unlikely to stick with mHealth tools, and the momentous opportunity for connected health will be lost.

Will EHR's need to become interoperable drive diabetes devices to do the same? Who knows. Tab A will only fit slot B if it is designed to do so.

Lets get back to that future. (Cheesy way to tie image the in.) 

MDUFA III - The Summer Sequel

Hollywood is all about summer block busters. Often these are remakes or spinoffs. So Batman Rises again, Spiderman get a new look and there are More Men are in Black. A less well know franchise just inked a renewal. Even more surprising is the group who produced it - Congress. It is called MDUFA III. It is a sequel. 

You may not be very familiar with MDUFA. I mistakenly call it Mustafa or Medusa regularly. It isn’t a Lion King or a monster of myth with snakes for hair. MDUFA is DC speak for Medical Device User Fee Amendment is part of the regulations that fund and manage the FDA. Some wags may content that means it is a scary monarchical monster but is isn’t.

If you live with a chronic condition that is managed with medical devices you should probably know a little about MDUFA. It started in 2002. (1) It allows for industry to pay fees that fund the FDA. These fees help pay for the review of medical devices. These fees were a means of preventing a backlog of device and drug approvals by funding FDA staff to review applications. 

The review that was just signed into law also creates performance goals for the FDA review process with outside third party review of the FDA’s pre-market approval (PMA) process, meeting these goals. The goal are: 

• For submissions received in FY 2013, FDA will issue a MDUFA decision for 91% of 510(k) submissions within 90 FDA Days.
• For submissions received in FY 2014, FDA will issue a MDUFA decision for 93% of 510(k) submissions within 90 FDA Days.
• For submissions received in FY 2015 through FY 2017, FDA 

To put that into a diabetes perspective the International Organization for Standardization (ISO) 15197 standard that specifies that, for a blood glucose level of below 75 mg/dl, the monitor reading must be within 15 mg/dl of the reference reading and, for readings of 75 mg/dl or higher, the monitor reading must be within 20% of the reference reading in 95% of tests. (2) So starting in October 2012 the FDA will ave tighter response time goals that our meters have accuracy goal. Yes I know that is a bogus comparison but what matters is there are goals to turn around device applications. Those goals get tighter with time. 

I will concede that MDUFA is not as exciting as a summer action movie and it may take longer to read the entire legislation than a film takes to watch. That said I am happy to see this action taken by Congress before the summer is over and election year politicking get in the way of progress. 

Notes:

(1)  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/ucm109105.htm

(2) International Organization for Standardization. In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. 2010. Mar 20, ISO 15197:2003. http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=26309 Accessed.

Anyone have a Dummies Guide to @ANTPlus

Or maybe a not so dumb but new to it patients guide to how ANT+ may impact the diabetes space?

The headline reads:

ANT+ Expands Established ULP Wireless Ecosystem to Further Support Mobile Platforms and Augment Unique Use Cases in Sport, Fitness and Health

and down in the text it has this bullet: 

• Dexcom Continuous Glucose Monitoring (CGM): showing real-time glucose information at a glance. ANT+ technology will be incorporated into future products to enable connectivity with personal electronic devices.

Anyone up on this? 'Cause I aint and I would like to be. Here's why in case you forgot:

http://www.ydmv.net/2012/02/dexcom-acquires-sweet-spot-is-dewy-on.html

Dexcom and Tandem Announce CGM Development.

From the News Wire:

SAN DIEGO--(BUSINESS WIRE)-- DexCom, Inc. (NASDAQ:DXCM - News), a leader in continuous glucose monitoring systems, announced today that it has entered into a Development and Commercialization Agreement with Tandem Diabetes Care, Inc. to integrate a future generation of DexCom’s continuous glucose monitoring (CGM) technology with Tandem’s t:slim™ Insulin Delivery System, the first ever touch-screen insulin pump.

Under the terms of the Agreement, Tandem will pay DexCom a technology license fee of $3 million, reimburse DexCom’s development, clinical and regulatory expenses, and upon commercialization of the combined system, Tandem will pay DexCom a royalty of $100 for each CGM-enabled insulin pump sold. 

more here

So that is Animas, Omni Pod, Roche and Tandem all working with Dexcom to integrate DGM into their pumps. I think the Animas agreement is exclusive outside the US (see this post). So all the agreements are nice and all, I hope that we see some products in the marketplace.

#TwoBits on People and Devices

Two great recommendations from around the DOC in case you missed them over the weekend (or maybe 3 from 4). While they are not intended to be variations on a theme I can't help but eeing them that way. Yes they talk about Dexcoms but I see the theme as commentary on supporting the people with diabetes in our lives without being a pain in the ass about it. Not the easiest thing to do, particularly for a parent, but equally true of a partner or co-worker (or even a waiter* but then going there would make this three bits.)

Abby has a piece on SixUntilMe about her first day on the job as an RN, a low during orientation and a new coworkers calmly asking “Are you OK.” A spectacular piece. I particularly love the way she speaks of those three words.

“If you have diabetes, you know why this made me feel so comfortable. There was no stress from her side conveyed to me. She didn't freak out and ask someone for juice. At no point did she have a worried look on her face. She just knew.”

I highly recomend that we parents out here diabetes land read this and think about ways of talking with our kids about diabetes in ways that are: comfortable, not stressed, no freak out, skip the worried look and simply let them know we are there for them.

It ain’t easy. It is a great goal. I'll try. I'll slip up. I'll try again.

Christopher and Dayle write at A Consequence of Hypoglycemia writes about how they would improve the Dexcom CGM. Since I am out there advocating that people talk about what they want from gadgets you may think I like this because Christopher and Dayle write about what they want from their respective gadgets in this post.

OK I do like that, what makes this great is that the gadget are put info the context of how those devices effect the people they care about. They speak of time sensitive alarm volumes and custom alarms, kinda like selecting a ring tone on your phone. What is magic is they do that in consideration of the person next to them. Towards the end Dayle offers up the great idea of the Dexcom having a buddy system with other devices. Devices that play nice, what a concept. It is even more impressive when it is in the context of the devices supporting their loved ones as well as themselves. The idea that customizing devises so that people interact more comfortably, with less stress, fewer freak outs and simply dealing with the diabetes on the 'Are you OK' level seams so simple. In that it is revolutionary.

Great stuff.



*We can leave the waiter out of the equation but Kerri piece is so reminiscent of most of our dinners out with diabetes that I have to smile. Somehow dinner out is a particularly hard time to just ask "Are you OK?"

Of Fantasy Diabetes Devices, Sheldon & Dewy

Victoria’s Secrets holiday runway special has past, football is winding down so maybe we need some new fantasy league to talk about. How about insulin pumps? 

I had a fascinating conversation with Greg from Medtronic at CWD’s Friends For Life last summer on the topic of what would be my fantasy pump. A plausible device, that is one based on current technology, insulins etc.. I would say that a full artificial pancreas is beyond that scope but only a little. 

Yes it takes a particular lack of a real life to have fascinating conversations about fantasy pumps. You can call me Sheldon if you must. It turns out for me the fantasy isn’t a pump, and so the talk expanded out to a fantasy diabetes management system. Greg asked if I thought FDA would approve my fantasy devices. I allowed as how they  probably wouldn’t but industry would probably wouldn't make it either.

Meet DEWY, he's a winner. 

I think the tools available to manage diabetes are fairly good. I think there is a significant opportunity for better diabetes care through breaking down the technological towers of Babble that separate devices from each other and our lives. My fantasy device would be a common collection point for diabetes information in a way that would facilitate managing lives with diabetes not just adjusting parts of those lives. 

Our meters, pumps, CGMs need to talk together and work through a common Diabetes User Interface. A D.U.I. 

WAIT! We can’t call it D.U.I.! That’s been used. 

How about DEWY for ah.. um.. er.. Diabetes Equipment Works for You.   

Dewy’s job is to listen for information from devices and lives. Then to integrate that into a possible responses. Dewy should work for us, patients, in our lives. Dewy should try to accommodate our individual life styles not define them. 

Dewy should help out with the basics. If we are low or high Dewy needs the wizard logic already in pumps to help calculate corrections or carbs based on our particular insulin and carb sensitivity. Dewy should have access to food databases with the ability to create a meal list in a way that approaches the ease of use of making play lists in iTunes. Drop and drag foods into a meal, easily adjust quantities of food in a meal, calculate carbs and even make note of fat, fiber and protein. Parents will want to be able to store these 'cause kids eat the same meal over and over again, by choice. Dewy should be able to help adjust boluses based on all of that but like any good friend of a diabetic not be too pushy about it. 

Dewy could even help out tracking trends. He could gently mention times of the day that he sees spikes. He could pay attention to our post workout BGs and see if there are trends worthy of note. Along the same lines Dewy could even try to pay attention to two hour post meal BGs and make suggestions about I:C rates. He could look for between bolus times when basals are responsible for what happening with BG and point out trends. 

Dewy would scream bloody murder if he ever sees serious overnight lows. He would turn off basals and wake up everyone and anyone we say with phone calls and text messages and keep at it until we tell him it is OK. That is just the kinda guy Dewy is.

Some folks like patch pumps, some traditional pumps and some folks like shots. To accommodate those life styles choices Dewy should be independent of device manufacturers. That is Dewy should be able to accommodate what ever meter, pump or cgm an individual chooses. Dewy should be smart and tag along with us patients where  we do our living, so he will need to reside on the smart phone or device of our choice. 

Dewy isn’t an artificial pancreas, not that he wouldn't be willing to work with one. An AP tries to be a pancreas. AP wouldn't care what you ate or if you worked out. Dewy being a really good diabetes assistant would, if we wanted him to, track what we eat or how our workouts impact our lives. 

Dewy would talk wirelessly to devices; pumps, meters, CGMs. He would do this securely and let us know if he is in touch or lost connection to devices. He would be the universal remote to the show that is our diabetes lives. When we change to a device that woks better in our life, Dewy could cope. He would have simple friendly ways to enter shots, exercise, and daily, weekly and monthly cycles. He would let us invent variables of our own because, well, our diabetes many vary. 

Until there are artificial pancreases, smart insulins, encapsulated implantable functioning beta cells and the cure that reverses the autoimmune glitch that causes type 1 diabetes families will need to manage diabetes. Managing diabetes will requires multiple devices to measure and adjust blood glucose but wouldn’t be cool if they all played nice? 

Well that’s my crazed fantasy pump. This got me wondering what others would see as a fantasy diabetes device? What is yours?


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