Many, many thanks | He’s back on US soil

fullsizeoutput_21117So much has happened since my last blog post which was a call (cry) for help. I was set on a path that took up every spare moment of my attention to prepare for Caleb’s trip. He has returned, and I’m relieved to say that diabetes actually cooperated!

Before I get to the details of what we did, I need to thank the many people who made it happen:

Alicia, who gave me the direction and pushed me off the starting line, encouraging me every step of the way.

Melinda, Jacquie, Linda, Meri, Karen, Gina, Alicia again and my other friend, Alicia, who were so very generous in sharing supplies and/or pointing me in the direction of where to get them.

For so many others – Liz, Nancy, Kim, Scott, Mike, Donna, Kay, Lisa, Michelle, Isabelle, Laura, Laura, Bill, Jennifer, Cara, Chasiti, Sarah, Brandi, Bridget, Deanne, Anne, Christine, Emily, Mariana, Eddie, Michel, Jen, Natalie and Bennet – who were extremely kind and gracious when I contacted them asking them for help, or who reached out to me offering it.

Melissa, Cliff, Pete, Kate, Katie, Hristina, Scott, Tim, Terry, Dragan, Tia, Jeremy and Jeremy and so many others on Gitter and Facebook who provide feedback, guidance, direction in times of desperation, and who have selflessly committed so much time, energy and knowhow to create learn and/or continuously improve technology and freely share it and their knowledge with others!

My dear amici, Marco and Chiara.

Dana and Scott, for starting this revolution.

Ben West and others behind the #wearenotwaiting movement.

Nate Racklyeft for creating Loop, with what looks like some significant inspiration, support and assistance from Pete Schwamb who continues to support and update Loop with tremendous improvements.

Since Caleb was diagnosed, I have used his older brother, Colin (who does not have diabetes) as my guide – if I would let Colin do it, I will let Caleb do it and make diabetes work into whatever “it” is. Taking a trip to Europe at the age of 14 for 12 days with no one trained in his care (or that he even knew) was not something I imagined coming up as a possibility. I’m not sure I could have made it work without all the people mentioned above.

Thank you for allowing me to keep this commitment to Caleb. This community is made up of the most determined, caring and selfless people I have ever met in my life. Mille grazie!!

Advertisements

#Insulet Announces Plans for #OmniPod Dash and Horizon #APS

On Wednesday, Insulet held an Investor Day conference. The presentation and webcast are available here.

I focused on the discussion of new products. The next generation PDM and Pod, otherwise known as Dash, are planned for launch in 2017. The PDM will be a locked down Android device. This means it will not have cellular capability. The presenter explained that one of the top requests of users is to be able to use their phone as their medical device, however he FDA is not quite ready for this, therefore it’s a locked down device for now.

There will be a secondary display patient app. This will allow the patient to view all the statistics – IOB, last bolus, etc, on their phone, but they will need the PDM to dose any insulin. The data will push to an Insulet cloud, and there will be a follow app available for caregivers.

Although I did not hear it specifically stated. I am presuming the secondary display and follow apps will be available for both Apple and Android as the current My OmniPod app is.  The current My OmniPod app has helpful tips, videos and the ability to reorder product, but no treatment functionality or display.

It looks like the integrated meter is lost in the Dash based upon the diagram.

screen-shot-2016-11-16-at-1-54-58-pm

The Horizon Artificial Pancreas was also announced. This will be a hybrid closed loop. As stated in the presentation, nighttime will be closed loop, daytime will be hybrid closed loop. This means bolusing is still required.

screen-shot-2016-11-16-at-1-56-27-pm

The timing of launch of the Horizon AP on the slide shows late 2019, however, in the presentation late 2018 was also mentioned.

screen-shot-2016-11-16-at-1-56-41-pm

The executive team at Insulet has completely turned over in the last few years. Plans for the next generation OmniPod have also changed and appear to be a very intentional first step toward the Horizon AP system. Listening to the presentation, I definitely got the sense of excitement and commitment to advance technologically in relevant ways based upon customers needs and wants. I am impressed and encouraged.

Dash For Halloween
Dash for Halloween

Even so, the 2019 launch, or nearly three year wait for a product that will do what the Minimed 670G will do in the spring of 2017 is a bit disappointing, albeit not unexpected. Can those of use who value the tubelessness freedom that OmniPod provides hold off for the mental freedom the hybrid artificial pancreas will give?

________

I couldn’t resist throwing in this shot of Caleb in 2006 when he dressed up as Dash, his most favorite super hero at the time. Who would have guessed he might be using an insulin delivery system of the same name one day.

Medtronic’s MiniMed 670G FDA Approved

screen-shot-2016-09-29-at-1-00-51-pmIt 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.

 

 

 

 

Freestyle Libre Pro FDA Approved

screen-shot-2016-09-28-at-11-59-57-amAnother 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.

 

 

I Used to Wonder | from preschool to 8th grade

fullsizeoutput_14ec6Caleb 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.

Investor Bit | Insulet Q4 2015 Call

Screen Shot 2016-02-26 at 9.03.10 AMFull 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.

Investor Bit | Dexcom Q4 2015 Call

Screen Shot 2016-02-24 at 10.30.31 AMFor 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:

  1. 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.
  2. 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.
  3. 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.
  4. G5 Android app is expected for later this year; Follow app is already available on Android.
  5. 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.

  6. 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.

 

 

 

 

Clamdiggers

IMG_9526For 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.

Podcasting with Caleb

IMG_4458.jpgCaleb 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.