It was a big news day yesterday for FDA approval of diabetes devices.
The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.
Read yesterday’s full news release here.
I’m excited about this announcement for two reasons. First, this approval was received about six months before it was expected. I’m used to news coming later than predictions, not sooner. This is at least the second time the FDA has impressed me. The first time is when it approved the DexCom Share Receiver much sooner than expected. I’m optimistic that this is indicative of a great trend with the FDA.
Secondly, it’s another great step closer to a fully closed loop artificial pancreas system.
The 670G is a hybrid closed loop system. It will monitor glucose levels and adjust basal insulin to keep blood sugar as close to 120 as possible. Using this pump will still require carb counting, manually initiating meal boluses and corrections, and manually adjusting basal insulin to compensate for activity. This system is mono-hormonal: it uses only insulin, no glucagon. To me, the greatest benefit of this system may be for managing overnight basals.
For more information about this exciting announcement, here are some articles I found useful:
Updated 10/1/2016 to include this link to Diabetes Mine article describing what this pump is and what it is not. NEWSFLASH: FDA Approves First-Ever Pre-Artificial Pancreas from Medtronic!
diaTribe: Abbott’s FreeStyle Libre Pro AND Medtronic’s MiniMed 670G Get FDA Approval
diaTribe: Medtronic MiniMed 670G Trial Results: 44% Reduction in Hypoglycemia, 0.5% A1c Improvement
A Sweet Life: How the Medtronic 670G Artificial Pancreas Works: FAQ
Heath Day: FDA Approves 1st ‘Artificial Pancreas’ for Type 1 Diabetes
and also a lively discussion over at TuDiabetes.
Another option for managing continuous glucose data is now available in the United States. Abbott’s Freestyle Libre Pro has been FDA approved. This is the Pro version – not the consumer version. This will allow medical professionals to work with their patients to get and analyze data and make therapy decisions. The consumer version has been submitted to the FDA for approval. Hopefully it won’t take too long.
There are some specific differences of the Libre system, including the consumer version, to other CGMs currently available.
– It requires no calibration.
– Information is not displayed continuously. In the consumer version, you scan the reader device over the sensor at your discretion to get a reading. Fingersticks are eliminated.
-The cost is significantly less, thereby making it available to a consumer group to which the more expensive products are out of reach.
Click here for the complete press release.
Visit Abbott’s website for more information.
Caleb was diagnosed with type 1 at the age of three. He’s currently thirteen. There have been many struggles over the years, and managing diabetes at school is among the biggest. It is inherently complex, and it requires intense attention as it is ever-evolving with new participants each and every year.
Our range of experiences has been extreme. We’ve had remarkably helpful, caring and interested people offering to do whatever it took to keep Caleb safe, and we’ve had to take legal action resulting in staff members being removed because they were not able or willing to keep Caleb out of danger.
Caleb is currently in eighth grade. Diabetes has become such a small part of his school day, I’m not sure we did much of anything to prepare for it this year. This is a monumental difference to the documents and instructions and meetings and supplies that I coordinated when he was in preschool and early elementary school. It’s also a significant change from where we were just a couple of years ago when he started middle school.
I remember looking for these types of stories when Caleb was little, and not finding them. I wanted to know what it would be like. I needed to know whether we would be living this way for the rest of our lives. Although I knew Caleb would mature and become more autonomous, I couldn’t picture what that would be.
Now I know.
It’s a young man. He’s capable and responsible. He carries a bag with him wherever he goes without reminder because it’s become so natural to do so. He’s focused on his schoolwork and his friends and is excited about his varied after school activities. Diabetes is still there, but it’s so much less of a monster than it once was.
As parents, we teach and prepare our children to care for themselves. Just like Caleb has learned to dress himself, make his own meals, do his schoolwork independently, and countless other things I take for granted, so too has he learned to manage his diabetes independently.
Full transcript on Seeking Alpha.
In Insulet’s earnings call for the fourth quarter of 2015 yesterday, positive financial results with several performance records were heralded, and strong growth is expected for 2016.
– We were reminded of the divestiture of Neighborhood Diabetes to Liberty Medical to allow for focus on OmniPod and Drug Delivery (think using the Pod for cancer drugs) products.
– They are working with Eli Lilly to gain approval for use of concentrated insulins which would effectively increase (double or more) the capacity of the Pods for users with higher insulin needs. This is expected to hit the market in the next two to three years.
– Digital Insulet is the term used for all things mobile and artificial pancreas. In the first half of 2016, they expect to launch their first app which will allow for product ordering and accessing training tools. Further, quoting directing from the transcript:
In addition, later this year we will submit a 510(k) for our Bluetooth PDM and mobile app that will display key real-time data on a customer’s mobile device, including CGM integration with Dexcom’s G5 sensor. In fact, this will enable CGM integration in a manner that ensures that our users will always have the latest and greatest CGM sensor with the latest and greatest OmniPod.
-Insulet has entered into a licensing agreement with Mode AGC for an Artificial Pancreas algorithm. Clinical trials are expected later this year.
There was much discussion about the robust market opportunities in both type 1 and type 2 markets and why OmniPod is believed by management to be a superior choice for insulin delivery, as well as big improvements in customer retention and customer service. I will leave it to you to read those details in the full transcript.
For the full transcript, please go to Seeking Alpha.
Dexcom had an encouraging earnings call yesterday from both a historical financial perspective as well its prospective outlook. In addition to record-breaking financial results for 2015, I found the following noteworthy:
- A new G5 receiver and insertion device are expected for the second half of this year. Not mentioned on this call, but heard from a key exec from an interview conducted on Discuss Diabetes – the insertion device is expected to be MUCH simplified, and with automation will eliminate hand shake at insertion and reduce pain.
- Gen 6 will require 1 calibration per day, an advanced algorithm and be labeled for 10 day sensor use. Gen 6 IDE will be submitted in the next two weeks and there will be more information on the next investor call.
- Dexcom expects an FDA approved insulin dosing claim during the later half of 2016. G5 in Europe is currently thus approved – fingersticks are not required for dosing decisions; 2 daily calibrations are required.
- G5 Android app is expected for later this year; Follow app is already available on Android.
- A note in the financial overview that struck me references a charge recorded in Q4 relating to a potential increase in warranty expense for an issue with the speaker on the receiver. We’ve had two receivers whose audible alerts completely stopped and had to be replaced.
We also note that we recorded a charge in Q4 relating to a potential increase in warranty expense resulting from an important customer notification we have issued related to the speaker component in our hand-held receiver.
- The Life Sciences Google partnership is now the Life Sciences Verify partnership and is moving forward according to plan.
There’s lots more in the transcript including discussion of pump partners, international expansion plans, and a more detailed financial review. Find it at Seeking Alpha.
For at least a couple of years, I felt like we settled. The peaks and valleys of diabetes were smoother, less frequent, easier to handle. Nights provided the best interrupted sleep I’ve ever had. Years of experience and technological advances were paying off. It felt good and it felt earned.
These last few months have been a bit more rocky. High blood sugars reaching points I haven’t seen for years out of the blue for no explainable reason. Historically reliable corrective approaches having no effect whatsoever. Nine years of experience coupled with a subject who is exponentially more mature and capable have made these loops bearable, but no less surprising and bewildering.
Dance competition season is approaching. To me this means costume making. Caleb competes in jazz, lyrical and his favorite, tap. The depth of options for costuming for males is as minimal as it can get. I work with Caleb’s dance director to design his costumes to coordinate and complement his teammates’, and sew them myself.
In sorting through the options for Caleb, I asked him to try on a pair of pants from last year’s annual dance recital – just seven months ago. My immediate reaction was a mixture of amusement and relief. The pants weren’t merely short, they looked as though they were intentionally made to be of capri length. I knew Caleb seemed taller, even thinner, but the inches of flesh that appeared under his hem was astounding.
I don’t know that growth is the reason for the blood sugars we’ve been seeing. Knowing that most everything else is about the same, it certainly is a viable option in my mind, making the means to the end all seem okay.
Caleb joined me on the most recent edition of DSMA Live: ‘Rents, only this version wasn’t live. In our first prerecorded show, Caleb and I talk about his diabetes tools and how his role in his care has changed over the nine years with which he’s been living with type 1 diabetes.
I hope you enjoy the show, and thanks for listening!
You can listen here.
The first Diabetes Podcast Week kicks off on February 1. I will be taking part as cohost of DSMA Live: ‘Rents.
Since August of 2012, Bennet Dunlap and I have been hosting ‘Rents, interviewing fellow bloggers, medical professionals, diabetes device executives, people living with and caring for people with diabetes, to name just a few. We’ve covered topics from Nightscout, The Artificial Pancreas, Spare a Rose and so much more. We’ll be airing our 75th episode live on February 1.
Our DPodcastWeek show will feature fellow Podcaster, Christopher Snider, and we’ll be talking about Diabetes Secrets. He hope you’ll join us live at 1PM EST, when we’ll be happy to accept your calls.
Please check out all the participants of DPodcastWeek and consider supporting the Spare a Rose Campaign. Buy one or two less roses (or skip them altogether) and donate that money to Life for Child and bring life saving insulin to children in need. For more information, please visit IDF, or listen to our podcast with Kerri Sparling mentioned above. Donations will be accepted started on February 1, when DPodcastWeek kicks off!
For a complete listing of all DSMA Live: ‘Rents episodes, please subscribe on iTunes!
…I don’t have it.
I’ve been working hard towards learning it though experience for nearly nine years, or 3,200 trials and lots more errors. I’ve searched and asked many questions regarding it, but no clear direction has been discovered.
Overnight care is the final ugly beast of diabetes that wedges itself between Caleb and his full autonomy. There are other things that he doesn’t do – he hasn’t changed a Dexcom sensor by himself, he doesn’t call customer service when there are issues, he doesn’t manage basal program or sensitivity adjustments independently – but these are things I know he can learn and don’t present imminent danger. This overnight thing is different.
Sleepovers and extended field trips – these include periods of sleeping. Caleb is on the ball when he is awake. When he is asleep, well, he’s asleep and does it for numerous hours at a time. Diabetes works in 2 or 3 hour cycles. Sleeping in increments of 2 or 3 hours or even 4 hours is not healthy. I haven’t been able to balance these opposing needs after more than 3,000 attempts.
This is not to say that every night for the past nine years I’ve been up actively managing his blood sugar every 2 or 3 hours. Particularly with the use of Dexcom G4 Platinum, there have been a number of nights when I wake to just check the CGM number and go back to sleep until morning. But there has not been a single night that I have slept through uninterrupted. Over the past year I was lured into a feeling of safety because it was more the norm than exception that I could just do that eyeball thing at 1 or 2 am and all would be well. These past couple of months have rattled me back into the fear of how ugly overnights can be – highs that don’t correct and lows that won’t rise.
This isn’t new. It’s not pleasant, but I can handle it – or handle it well enough.
I don’t know the best way to prepare Caleb for these nights. The ones after long days of varying levels of activity that show up in overnight lows to an extent you cannot reasonably predict. The ones after uncommon and fatty foods are consumed in quantities that vary from the usual routine that release seemingly never-ending gushers of glucose into his bloodstream.
We’ve been able to normalize so many things. Special trips are the hardest to deal with and present the biggest danger because there are so many variables, yet are the times when he should be able to stretch his wings and leap and fly and learn from his mistakes.
It’s the fear of the magnitude of the mistake that has me on edge.
How do you manage overnights?
This is not new, although it’s new to me. As soon as I saw Meri post about it, I got this set up on my phone and Caleb’s phone.
Caleb has just about every form of medical ID there is. Caleb is not consistently compliant with wearing any of them. I know – it’s important. I can’t think of many times when he is not with people who are acutely aware of the fact that he is T1D, but there are times where the awareness is more general, and there’s the fact that he has the peanut allergy thing as well, not to mention if we crash and are all unconscious. He’s aging as a middle schooler; high school is just around the corner. He’ll continue to become more and more independent, so he’s got to become more compliant…
Caleb’s phone is with him always. The iOS health app allows for you to set up an emergency medical ID page that is accessible even if your phone is locked (there is the option to disallow) and first responders are becoming more and more aware of this. In addition to checking for bracelets and necklaces, they are checking phones.
Setting this up allows for you to be detailed about medical conditions and treatment – things that don’t always fit very well on a jewelry charm – and the ability to directly call emergency contacts listed.
For more information and instruction check here and here, and also note the mention of weighing the risk of privacy.