Tag Archives: Diabetes Technology

Because… Progress.

January is practically over, and you know what? It’s been a pretty good start to 2015.

Tandem has announced approval of their larger-capacity insulin pump.
The t:flex pump may not raise a lot of eyebrows, but it does provide something no pump has provided before: The ability to pack 480 units of insulin in the reservoir. I can’t name anyone off the top of my head who needs this right now, but I have been in support group discussions where People With Diabetes felt they couldn’t use an insulin pump because their daily insulin needs are higher, and they would have to change a set out too often, and it just wasn’t worth it to them to go through that. For many, this will solve that problem.

Not to be outdone, Medtronic obtained approval (outside of the USA) for their new 640g system.

This is the first system available to the public that will both suspend insulin delivery when a patient reaches a low point on their CGM, and resume insulin delivery when a patient’s CGM reading recovers. It also comes with additional hardware that looks to me like a PDM, and a seriously-needed upgrade to the CareLink software that, in images on Med-T’s website, look an awful lot like what you see with Dexcom’s downloads.

Speaking of Dexcom… The FDA announced approval of the Dexcom app software that allows CGM users to share their data with others in real time.

For people with hypo unawareness, sharing CGM readings with people close to you is life-changing, and potentially live-saving. Dexcom’s system will employ a new Dexcom Share receiver (the previous version was the Dexcom Cradle), and existing users will be able to upgrade at little or no cost. Of course, you and anyone you connect with (via the Dexcom Follow app) will have to have an iPhone or an iPad device to make this happen. But yay for the FDA allowing Dexcom to go through the de novo classification process, a regulatory pathway for low to moderate risk medical devices that are novel and not substantially equivalent to any legally marketed device, rather than making them go through the gauntlet of the full medical-device approval pathway.

I know, I know… all of these devices may have issues and fall short of what we are looking for from innovations in the diabetes device space. But who was talking about real-time CGM monitoring a year ago? Who was talking about pumps that suspended, then resumed insulin delivery based on CGM readings? Who was discussing larger pump capacities? Okay, well, people were talking about those things a year ago, but at least some of us didn’t expect any of these innovations to be rolled out to actual customers within a year’s time.

In the end, we can’t complain entirely that we don’t get everything we want right now, because… Progress. Things are moving forward, and I’m hoping that we’ll eventually reach a tipping point where the urge to both innovate and get those innovations to patients as soon as possible will cause device and drug makers to move at a pace that matches the rest of the world’s technological advancements.

Because… Necessary.
 
 
 

The Glu Real-World Research App is a finalist today.

Got anything on your plate today, say at 1:00 EDT in the USA? Are you a MyGlu member? If so, you might already know about this. If not, you probably want to log in and check this out.

I got a chance to chat by phone with Christine from T1D Exchange this week, and she filled me in on the details of a live streaming presentation being made today for (official title) Sanofi’s Partners in Patient Health and North America Research & Development Hub Innovation Challenge: Collaborate Innovate. T1D Exchange is a finalist for the $100,000 prize!

So… many of you are familiar with the T1D Exchange, an online database effort headquartered in Boston that gathers oodles of data from people with Type 1 diabetes. T1D Exchange also works with 73 clinics in the USA, covering 27,000 patients. In addition, part of T1D Exchange’s efforts is MyGlu, which is an “online community designed to accelerate research and amplify the collective voice of those living with T1D.” MyGlu has something approaching 10,000 members now, who share information and participate in data gathering in a huge way. To that end, they’ve been wanting to create an app (called the Glu Real-World Research App) that would make it easier for patients to participate in studies. Their presentation will be centered around that. In their own words:

”Our hope is to expand our already successful model to help mitigate the issues in R&D and accelerate progress for those living with T1D and, in the future, other disease groups.”

I was interested in the challenge, and what T1D Exchange and MyGlu hope to accomplish through all of this. So I asked some questions. Questions like:

How many competitors are you going up against on Friday?
There are four finalists that were selected from a large number of presentations. Since the finalists were announced, they’ve all been working with mentors assigned to help the teams develop their pitch in a clear, concise fashion designed to wow the judges. All of the teams will present via live streaming beginning Friday at 1:00 eastern time. The T1D Exchange presentation will be second. After that, from about 2:30 to 3:30, the judges will deliberate, and at 3:30 the winner will be announced.

Note: You can view the live streaming presentations at 1:00 today by going to www.collaborateinnovate.com. You can also follow @CollaboratePIPH on Twitter for updates throughout the course of the challenge.

What is the app about? What will it do?
The app will further T1D Exchange and MyGlu’s mission, connecting and supporting patients, and helping researchers and patients share information in a very easy way. Say, for instance, a researcher is doing a study that requires real-world responses from T1D patients that meet a certain criteria: pump users, CGM users, MDI patients, etc. Researchers would find those people from among those who’ve downloaded the Glu Real-World Research App and completed their profiles. This way, study organizers could more easily find study subjects, and potential study subjects could find researchers seeking the data these patients are uniquely qualified to deliver.

This is also a collaborative effort with others?
They’re partnering with MIT’s (Massachusetts Institute of Technology’s) H@acking Medicine in the design of this app, and they’re partnering with Joslin Diabetes Center in Boston. MIT obviously brings technical expertise to the table in areas such as rapid product design, lean start-up methodology, workflow re-engineering, novel data collection, big data analysis, and information publishing. And Joslin brings unparalleled knowledge and passion for researching diabetes and treating patients with diabetes.

You seem to have a pretty good idea of what you want. Let’s say you win. What happens next?
Should they win, they would immediately start sitting down with various stakeholders and subject matter experts to determine timelines and establish priorities. Then they’ll assign people to various aspects of the project, and keep track of specific milestones to make sure everything is going according to plan and budget.

Anything else you wish to tell us?
They’ve been wanting to develop an app like this for a long time. They’re thrilled to be a finalist for this award. They’re hoping everyone will watch!

Once again… You can watch the live streaming event at 1:00 EDT (US) today by going to www.collaborateinnovate.com, and you can follow the challenge via Twitter by following @CollaboratePIPH.

This is a wonderful opportunity to see what forward-thinkers in the diabetes world are working on. I hope you can make it! Don’t forget to share this with others.
 
 
 

What else do you want?

So GoogleX has announced their intent to develop, and find a manufacturing partner for, a glucose-sensing contact lens. Okay, great. Let’s hope their research comes up with something new and fantastic for People With Diabetes.

However, it’s not usually one device, but an entire system that matters, that helps us. In fact, I’d like it if GoogleX’s research results included several other ideas. You (and by You, I mean anyone developing new medical technology) can apply many of these notions to anything you might develop in the future. I’m including some other ideas here just because, you know, it’s my blog, and it’s Friday. Do you have ideas of your own? Feel free to get your own blog, or leave a comment below.

1. Accuracy, accuracy, accuracy. The data I’m getting from your device needs to accurately report what’s happening with my BGs, or it’s a non-starter with me. Period.

2. Can you make this technology work with the rest of my robot parts? Like, can it talk to my pump please? Regardless of the pump manufacturer? This also requires you to get on board, Asante, Medtronic, Tandem, Animas, et al. And FDA. Silos: Bad. Collaboration: Good. I believe the word we’re referencing here is “Interoperability”. See also “Open Platform”.

3. Ooh… Can we also have it upload data directly to our healthcare professionals? And can we force our healthcare professionals to actually read it and use it to help us get to meaningful outcomes? I’m not above using Pavlovian methods in pursuit of this goal. In fact, just thinking about this has me salivating like a dog.

4. Any chance you could get it to determine actual carb counts in literally everything? This is something else that would need to work in concert with another device. Look at a plate of food, blink your eye (or maybe wiggle your nose– whatever works), and have the carb count immediately display on your smart phone or Google Glass. You know, something like that might actually get me to invest in a smart phone.

5. While we’re at it, can you get any accompanying software associated with your product to work over multiple operating systems, including Windows, Apple, and all the rest? No excuses about how “we just wanted to get it to work on one system, and we’ll be working on the others soon”. Conformity: Bad. Diversity: Good.

6. While we’re still at it, can you make it affordable? Always? I mean, if you can help someone use their phone so they can see House of Cards or an adorable dog food commercial via their television set, and do it for 35 dollars, you should allow me to have access to my personal data without it costing me a fortune.

7. Can you get my insurance plan to cover it? This would eliminate the need for #6. Extra points for you if you can pull this off. Extra extra points if you can make it available to everyone who wants it. If we’re living with diabetes, we’re all equal, even if our insurance plans are not. No use getting excited over a new device if I can’t afford to get my hands on it. And I don’t need the guilt that comes with having access to something that someone else does not.

8. Can you use David Bowie’s Space Oddity in your marketing efforts for this product? No real reason, except I think it’s kind of a cool song with a great sound that lends itself to something futuristic. Even if it is nearly 45 years old. Side note: Maybe this isn’t the best choice here. Listening to it again, I realize it always reminds me of going low. That funky/weird guitar thing in the background is what’s playing in my mind during hypoglycemia. So, ummmm…. Never mind.

Those are my eight seven ideas. Feel free to add to the list by leaving the results of your brainstorming below. And please remember it’s Friday, so feel free to have fun with it too.
 
 
 

October DSMA Blog Carnival. What would you say?

One of the hot issues in the DOC these days is test strip accuracy. It’s exciting to see outside agencies beginning to take note. With that in mind, let’s revisit our September 4th chat “Test Strip Accuracy” and talk about . . .

What would your comment be on meter accuracy at the Diabetes Technology Society meeting?

Well, I could say a lot of things. But I’d really want to say the perfect thing, of course. To do that, I think I’d have to point out that while we have lots of technology at our disposal, not all of it is the best technology available.

Just like many things in life, Diabetes often comes in degrees and layers of differences. We all know this, and we reflect that in our choices of tools to help us manage our glucose. Sometimes, rules in other countries make something available or not available to us, and we’re stuck with what we have. Here in the USA, we sometimes encounter the same thing thanks to insurance guidelines and medicare.

What that means is we’re all using different meters with different strips, many of which aren’t nearly as accurate as they should be. As accurate as they need to be. So we need the Diabetes Technology Society to understand these simple things:

– Lives depend on the accuracy of our devices.  Let me repeat:  Lives depend on the accuracy of our devices

– Continued accuracy, or lack of it at current levels could cost lives

– The proliferation of diabetes technology does not automatically equate to improved quality of the devices we use

– Quality and accuracy of our diabetes devices always needs to improve.  Ninety-nine percent accuracy still won’t be good enough when our lives are at stake, and right now we’re a long, long way from ninety-nine percent

– Ongoing, continuous post-market inspection of meters and strips, and holding manufacturers responsible for shortcomings will be a huge leap forward in improving and saving the lives of People With Diabetes

That’s what I would tell them.

If you’re living with diabetes, or caring for someone with diabetes, you know the importance, the hard work, of maintaining glucose numbers within a range that helps us to continue leading meaningful lives. Shouldn’t we expect at least as much from the Diabetes Technology Society, the FDA, and the manufacturers of our devices?

This post is my October entry in the DSMA Blog Carnival. If you’d like to participate too, you can get all of the information at http://diabetescaf.org/2013/09/october-dsma-blog-carnival-3/
 
 
 

Pump Issues – Medtronic and Animas.

Just in case you didn’t know, or in case you’ve moved your e-mail or physical address and you didn’t get these, here are a couple of important notices from insulin pump makers Metronic and Animas.

– First, the Med-T notice, regarding possible loose drive support caps. The drive support cap holds the pump’s motor in place. If you have a Paradigm insulin pump, check the little disc portion on the bottom, just to the right of your light button– your down arrow. That’s the drive support cap. If that disc seems to be pushing out from the pump housing, Medtronic wants you to call them and arrange to send your pump back. Don’t worry, they’ll send you a new one.

Most important: Do not push on the drive support cap! There was an instance of someone pushing on the drive support cap, causing extra insulin to be delivered, which in turn caused severe hypoglycemia. By the way, I checked the drive support cap on my own Revel™ pump and everything is okay. Whew.

If your drive support cap is pushing out, call Medtronic customer support at 1-888-204-7616 and choose option 1. They’ll work with you to send the pump back so you can get a new one. In the notice I received, there was an additional note about making sure you don’t get your pump wet. But if you’ve had your Medtronic pump for any time at all, you already know you shouldn’t take it for a swim or put it in the wash or drop it in the toilet. Not that anyone would want to do that last thing, but you get where I’m going with this, yes?

Second, an all-out recall of certain Animas pumps. From the U.S. Food and Drug Administration:

Animas identified a component issue affecting Animas 2020 Infusion Insulin Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

“Loss of prime”
“Occlusion”
“No Cartridge detected”

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no longer deliver insulin and will generate a “Call Service Alarm.”

If this describes you and your pump, you should call the Animas Product Fulfillment Center at 877-280-2339 between the hours of 6 a.m. and 12 a.m. EDT so they can work out the details of shipping your free replacement pump. If you have technical questions, or if you want to report a concern, you should contact the Animas Customer Technical Support Center at 866-793-5253. For the full notice from the FDA, go to:
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm346650.htm

For many of us, these are our lifelines. Be safe everyone. If you have a Metronic or Animas pump, check your pump now, and if you need to, do something about it… now.
 
 
 

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