Category: Technology

It’s been more than ten years since Caleb began pumping. That’s more than 1,500 Pods, roughly estimating.

Caleb was four when we decided to use OmniPod. He didn’t have much say in the matter. Over the years, we’ve talked about other pumps. I thought he might be intrigued by the T Slim because of its slick touch screen. Not so. “Does it have a tube? Yes? No, thanks.” Simple as that.

Traveling on his own and wanting the benefit of closed loop technology that was only available with a tubed pump changed his perspective. Now that we have first hand experience with a tubed pump, I can provide a user comparison of it to a tubeless one.

– The process of changing a site and reservoir is much more involved than filling a Pod and inserting it. There are so many more steps. It’s not difficult – Caleb took over immediately and I don’t even remember what to do – but it’s definitely simpler with OmniPod.

– Being tethered takes some getting used to. Caleb adjusted quickly. Figuring out what to do with the tube with certain clothing, in particular a dress shirt and khakis, was a little perplexing. I sympathize with the ladies wearing dresses.

– This is probably no longer relevant with newer tubed pumps, but the screens and menus of the older model Medtronic pumps – just ugh.

– I now appreciate all the comments about failed Pods. This was never a problem for us. Yes, we had the occasional Pod error, but we didn’t know any differently. It’s what we experienced from the very beginning and we learned to be prepared for it – always carrying extra Pods, insulin and alcohol. No biggie. After using a tubed pump, which almost never errors (we did have a pump go kaput – not fun), I understand how someone switching to OmniPod would find these errors completely unacceptable. Screeching alarms after putting on a staticky winter coat is just not something you experience with a tubed pump. It’s much less risky to leave the house without a site/reservoir change. It’s not risk-free, but the risk is way lower based on our experience.

– Insulin waste. This is another thing I never thought was that big of a deal. The Pod needs a certain amount of insulin to activate. It stops working after 80 hours. Caleb uses less insulin in 80 hours than what is needed to fill a Pod, especially when he started and was using 2 units a day! Yes, I knew insulin was being wasted, and I wasn’t above extracting insulin from a Pod if it failed within the first 24 hours.  Caleb thinks it’s a hoot to see how low he can get his reservoir before changing it, even considering letting it go overnight with only 6 units left. Not much waste with a tubed pump.

– Remembering site changes is far easier with the Pod. You have no choice and the alert is relentless. There are times when I ask Caleb – when was your last site change? Silence indicates unknowing. I try to remember to update Nightscout with all his site, CGM and reservoir changes, but I don’t always. I don’t even know the longest time he’s gone with a single site, but it’s over the recommended three days.

– The integrated meter in OmniPod is no small deal. It’s just so convenient and one less thing to possibly forget. Caleb continued to use his PDM as his meter while pumping with Medtronic. It’s worthy to note that the integrated meter will go away with the Dash system.

– There is no comparison regarding the ease of use of OmniPod for sports and similar physical activities. Having to figure out what to do with a tubed pump is just a big pain in the tush. Caleb disconnected for a couple of dance competitions. That didn’t go too well for his bg. He wears it in a belt under his shirt for baseball. That’s less than ideal, for sure. He disconnects to swim – again, his body is not fond of missing any kind of basal insulin and trying to make up for it through microboluses is not something with which we’ve had success. Trying to protect it for paintball – we didn’t bother. He went OmniPod for that one.

– There are more placement options with OmniPod. I know people get creative with weaving their tubes from all spots on their body. It’s so much easier with OmniPod to rotate sites without worrying what to do with the tubing. Caleb sticks to abdomen and legs with Medtronic.

Caleb’s use of Medtronic was planned as temporary – we just wanted a way to help him get through his trip. It seems every time we talk about switching back, it’s deferred to the next site change. For us, OmniPod is the preferred pump choice, but it’s hard to leave the world of Looping once you’ve had a taste of it.

 

 

 

 

Both Insulet Corporation and Tandem Diabetes Care have created welcome programs for Animas and Roche customers to try their pumps at reduced costs. Roche announced the discontinuation of their insulin pump in the US earlier this year. Animas announced their exit last week.

 

Qualified customers can trial the OmniPod system at no cost at all for about a month (as long as ten Pods will last). More info here: Insulet offers no cost Welcome program to Animas and Roche users.

Tandem Diabetes Care offers the Touch Simpicity Today Pump Access Program:

For a limited time, eligible Animas pump users can use a Tandem insulin pump for the remainder of their Animas warranty, up to 24 months, for a one-time payment of $999. This amount can be credited to the purchase of a new Tandem pump and/or supplies at the end of their current pump warranty period.

More from Tandem Diabetes Care on Animas’ decision to exit the pump market here.

Animas is discontinuing production and sale of its insulin pumps. Current customers
to be referred to Medtronic.

Edit 10/10/17 Both Insulet and Tandem Diabetes Care have offers for Animas users. More information here.

Full release here. 

Animas Corporation, one of the Johnson & Johnson Diabetes Care Companies, today announced that it intends to discontinue the manufacturing and sale of Animas® Vibe® and OneTouch Ping® insulin pumps, close operations and exit the insulin pump business.

Animas has selected Medtronic plc (NYSE: MDT), a world leader in diabetes, as its partner-of-choice to facilitate a seamless transition for patients, caregivers and healthcare providers. Patients using an Animas insulin pump will be offered the option to transfer to a Medtronic pump.

Previously available in Europe and Canada, the Freestyle Libre Flash Glucose Monitoring System was approved by the FDA last week.

From the press release:

The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days.

You can read the full release here.

What distinguishes this system is that is requires no finger stick calibration. Dosing can be made of its blood glucose measurements. To get a reading, the user waves the handheld reader over the sensor worn on the body that has a wire inserted under the skin. The reader reports bg levels as well as directional arrows and an 8 hour trend history.

The Libre Pro version was previously available in the US, but that allowed for medical professionals only to access the data. The Libre Flash now gives the user full access to information and its immediate use.

For more:

Diabetesmine.com

A Sweet Life

Novo Nordisk released news last week that its faster-acting fast-acting insulin has been approved by the FDA. No need for US citizens to cross the border to Canada to get it anymore!

Here’s an excerpt from the press release:

Fiasp^® can be dosed at the beginning of a meal or within 20 minutes after starting a meal. Fiasp^® is a new formulation of NovoLog^®, in which the addition of niacinamide (vitamin B3) helps to increase the speed of the initial insulin absorption, resulting in an onset of appearance in the blood in approximately 2.5 minutes.² Fiasp^® will be available in a pre-filled delivery device FlexTouch^® pen and a 10 mL vial.¹

You can read the full release here.

For more on Fiasp, here are some great resources, including Tim Street’s blog, Diabettech.com, where he shares his personal experiences of using Fiasp (along with lots of great posts on OpenAPS and Loop).

Diabetesmine.com

A Sweet Life

Diabettech.com

SaveSave

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.

 

 

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:

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.