About Lorraine

Mom of Colin, Caleb & Lila. Caleb was diagnosed T1D in January 2007 at the age of 3. Thank you for sharing this journey with us.

Why we chose to #Loop | #WeAreNotWaiting #DIYAP

fullsizeoutput_22433Caleb and I were in the lobby of his dance studio and he started jumping up and down – not for dance but because he has just received an email announcing his acceptance to the Global Leadership program to which he applied. Up until that moment, I was pretty certain I had nothing to worry about, expecting he would not be awarded the scholarship. Not that I don’t have confidence is his abilities, I just assumed it was a competitive program (which it was) and a long shot (apparently not).

As Caleb is celebrating, I really want to be happy for him, but I’m overwhelmed with dread. I’m responsible for Caleb’s care overnight. I prioritize his need to sleep as a growing young man, and take any measures necessary to keep him safe with as little disturbance to his rest as possible. He’s been on sleepovers and overnight field trips, and although he’s gotten through them, they’ve been complicated. We were just in Italy for a family trip last summer and with irregular eating patterns, carb intense meals, and walking seven miles a day, diabetes management worked out reasonably well, but took a lot of extra attention, creative extended boluses, temp basals, and corrections overnight to keep him safe. All of which I did.

Caleb knows what to do in the waking hours of the day, and if he has any questions, I’m usually accessible to trouble-shoot, but overnights and vacations are my responsibility. He’s fourteen – vacation should be a vacation, not extra work and stress. He’s not immune to the anxiety that the variables of traveling bring, I just do my best to soften the burden as much as possible.

I couldn’t grasp how we were going to get him prepared to do it all within the next five months. All I could think of were the overnights – him exhausted after a long, active day, with carbohydrates releasing into his bloodstream willy nilly, an artificial process crudely, manually, and non-scientifically slapping insulin at him, with aftereffects of varying levels of activity unpredictably lowering his blood sugar – to me, it was somewhat horrifying.

I heard it over and over again – “He’ll be fine!” Yes, he’s a bright young man and very responsible about his diabetes – he’s never forgotten to bolus for a meal, for example – but that isn’t useful when you’re in a deep sleep, unresponsive to alarms blaring directly into your ear, and your blood sugar is 70 with a rapid drop alarm. I know the term “dead in bed,” and I can’t ignore it.

My goal for Caleb’s blood sugar on this trip was not optimal care. My goal was no need for emergency intervention: no severe hypoglycemia resulting in unconsciousness and no hypoglycemia resulting in vomiting. Okay, something a little tighter than that, but really, if that’s what it ended up being, it would have been fine. I just wanted Caleb to be safe.

We decided to try Loop because overwhelmingly what I read about a hybrid closed loop system was the safety and assurance it provided overnight and how users were able to sleep like never before.

Simplistically, this is what Loop does:

An app on Caleb’s phone performs a bit of magic. It communicates with his pump through a little computer (see the pic above) via bluetooth. The app connects with Dexcom, assesses his current blood sugar level, the direction of his blood sugar, the amount of carbohydrates he has on board and the amount of insulin he has on board predicts what his future blood sugar will be. Based upon those predictions and the defined target bg range, the Loop app will calculate a need for insulin dosing, either higher, lower or the same and change Caleb’s basal insulin to administer any adjustments. This evaluation is done every five minutes, and his basal is adjusted every five minutes. Caleb does nothing while the app, dexcom and his pump do the work.

If Loop predicts a low blood sugar three or four hours in the future, basal will be reduced or shut off. If Loop predicts a high blood sugar, basal is raised.

We’ve managed Caleb’s blood sugar manually in a similar, albeit much broader way – played with basal to address rising and dropping bgs that weren’t what we expected. We’ve used SuperBolus techniques, again, using basal to deal with the peaks and valleys of certain foods, like breakfast cereal. But what we’ve achieved manually doesn’t compare to what is attained by recalculating future bg and adjusting dosing every five minutes. My hope was that Loop could be the watchdog over Caleb while he slept, when I couldn’t be there, softening out the Dexcom line and keeping him safe.

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Traveling to Another Country Alone as a Teen #Loop

fullsizeoutput_22356I wasted no time from the day Caleb learned he was awarded a scholarship to tour Italy for 12 days. He would be traveling with strangers – nineteen other students from all over the country who were also awarded scholarships, as well as the touring company’s staff and chaperones. The clock was counting down and I had a little more than five months to get ready.

This is something for which I never imagined I would need to prepare. For years I had been focused on the event of leaving for college as the ultimate deadline to pass over complete responsibility to Caleb for his diabetes care. This trip accelerated that timeline by four years.

We had already changed insulins and seen the elimination of some erratic results.

Other key strategies employed:

– use of a travel scale

– an increased use and therefore knowledge of carb factors

– use of an instragram account to post pictures of meals and get opinions on carb counts

– using Dexcom G5 CGM, ensuring transmitter was not about to expire and a nice new fresh one was inserted at the beginning of this adventure

– reinstating Nightscout

– teaching Caleb to insert Dexcom by himself

– acquiring a powerful battery charger

– ensuring we had an international data plan, and

– deploying Loop

All of the above were important and useful, but Loop was the most impactful change we made. In response to my call for help, Alicia shared her experiences with OpenAPS and Loop and pointed me in the right direction to find out more. I’d been actively following DIY APS as Dana graciously shared her experiences and knowhow with the world. It all seemed overly technical and complicated, and Caleb wanted nothing to do with tubing, so I remained a spectator up until this point.

Understanding the benefits that a hybrid closed loop system provided, Caleb became open to tubing. Relatively quickly, I was able to secure the supplies I needed and we got started. The learning curve was steep, and we faltered many times. But the payoff was big: a system helping me look over Caleb on another continent even when he slept.

 

 

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After more than six years, back to Novolog

Novolog Apidra

Caleb started using Apidra when he was seven years old after about four years of pumping Novolog.

I noticed immediate change in Caleb’s blood glucose control with Apidra. There was less of a need to prebolus. Seemingly never ending insulin tails were eliminated. We could safely be more aggressive with corrections and get him into range quicker. Post meal spikes were fewer and much easier to manage when they did occur.

It was so effective for Caleb that we were willing to change his Pod every two days rather than three. In our estimation, that was better than dealing with the peaks and valleys of Novolog.

We did that for a period of time, but when the smaller Pods came out, Apidra was working more reliably and we were able to go back to changing Pods every three days. Yay!

Then, after a fairly solid year of reasonably predictable blood sugars, things became unreasonably unpredictable. This started an analysis phase: hormones, food content, site location, age of insulin, etc. etc. We had gotten into a groove of constant reaction and fairly regular changing of Pods early for lack of any other explanation.

Given our history with Apidra, I was reluctant to concede that the insulin was the issue. It didn’t make sense after the evolution of working great, gradually becoming weak but consistently at the 48 hour mark, resolving that issue with the new smaller Pods and cruising along successfully for years after that.

After months of analysis, I had to consider it was Apidra and I asked for a vial of Novolog.

I braced myself for significant dosing changes in basal and IC ratios. I prepared Caleb for spikes after meals and long after effects from boluses. I expected the reverse of what we experienced when we switched to Apidra.

None of that happened.

There were slight changes in dosing – immaterial when you consider we are continuously adjusting basals and ratios for growth, activity, seasons of the year, etc.

Most surprising was no noticeable change in post meal rises in blood sugar and absolutely no noticeable change in the tail of insulin. <—This one shocked me.

He’s been using Novolog for about 7 months now – this was the first step in planning for his trip to Italy. It was a needed step regardless of his travels, but the urgency to tighten things up pushed me to seriously consider that Apidra might just not be working for us anymore. I’m glad Apidra helped us through some of Caleb’s younger years, and happy that he has options to address his changing needs.

 

 

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!!

Call for help! He’s traveling abroad. Alone.

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Well, not alone. He will be traveling to Italy with a group of scholars for an educational tour and leadership summit in Milan. By alone, I mean: without me.

We have a few months to prepare. I plan to simulate the experience at home as best I can. This will include Italian cuisine, varying levels of exertion, and the most challenging aspect: independent overnight care. This is the only area where Caleb is usually not involved. I prefer he sleep and let me do the number crunching.

Since Caleb was diagnosed with type 1 diabetes, I’ve been committed to not letting diabetes drive decisions about what he does. Having an older son has helped. We let Colin travel to Prague last year with his school jazz band. So when Caleb showed an overflowing enthusiasm about applying for a scholarship for a Global Summit to Europe, I knew I could not discourage it.

The fact that Caleb himself was not letting the thought of managing his diabetes alone in another county deter him is a significant progression in his self confidence.

So here we are. On Friday he received the news that he was awarded the scholarship. After initial shock, I’m in planning mode and am asking you for advice and suggestions.
fullsizeoutput_148cdWe traveled as a family to Italy last summer. Blood sugars worked out pretty well as far as vacations go. Lots of increased basals overnight and extended bolus’ to deal with pastas, pizzas and gelatos. Temp basals to deal with daytime activity of walking seven miles a day in August heat resulted in no traumatic events. So I have an idea of what to do. Caleb does as well, but I was the one making the lion’s share of those decisions, so he needs to hone these skills.

The biggest issue is that Caleb just does not wake up at night. I hear Dexcom’s urgent low alert from his phone on the other side of the house and it wakes me up. It’s next to his head and he doesn’t stir. Given the complexity of activity and food, I think it will be necessary for Caleb to check at some point each night. But he has to wake up.

Here are some of my current considerations:

  • I’d like to try a split basal regimen – half long acting insulin, half pump basal insulin. The reasoning behind this is I found that the margin of error was more forgiving when Caleb was on injection therapy. The longer action of NPH he was using seemed to soak things up like a sponge, whereas all fast acting requires a more laser precise dosing amount. This, however, was 10 years ago, when he was 4 and newly diagnosed.
  • For months, I’ve been trying to figure out if we can get a #DIYPS project going . Caleb is an OmniPod user, and we have no current access to a compatible pump for this project. I’ve gone through the websites and forums, and am simply having trouble figuring this all out. However, given the reality of this now, I’m going to give it another go. I am welcoming of any help, aka: handholding, anyone is willing to offer. This seems like the ideal scenario for Caleb, and a commercial option won’t be available in time for his trip.
  • I will definitely make sure he has international cell service and am interested to know if anyone has experience with “following” Dexcom internationally.
  • New Dexcom inserter?! I’ve been watching for this – I thought it might be available by now. This will make one thing easier. Anyone with any info?
  • I am always open to new fast acting carb ideas, particularly those that can travel in the heat.

Thank you for any input, suggestions, shared experiences and ideas!

 

 

 

 

#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.

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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.

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

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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.