Omnipod DASH Security

from Business Wire

Insulet’s Omnipod DASH™ Insulin Management System Receives ISO 27001 Certification for Information Security

The Only Insulin Pump to Receive Both ISO 27001 and DTSec Certifications

Insulet Corporation (NASDAQ: PODD) (Insulet), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced it has received ISO (International Standards Organization) 27001 certification of its Omnipod DASH™ System. ISO 27001 certification is the international standard for best practice in an information security management system globally. Insulet also recently announced that the Company received the DTSec (Diabetes Technology Society’s) Cybersecurity Standard for Connected Diabetes Device Security certification for the Omnipod DASH System. Insulet is the only insulin pump company to receive both certifications.

ISO 27001 is an internationally recognized standard for information security best practice that adheres to the highest international data security standards. DTSec leverages ISO/IEC 15408 to provide a framework for risk-based, multi-stakeholder definition of security requirements. The Omnipod DASH System, Insulet’s next-generation platform, was designed to be the foundation for the Company’s future innovation. With the ISO 27001 and DTSec certifications, the Omnipod DASH System is now globally recognized for incorporating the highest standards for information and cyber security and safety, including secure data transfer between the Pod and the personal diabetes manager (PDM), as well as secure cloud storage.

“This is part of a large-scale organizational commitment to ensure the highest-level of cyber security of our Omnipod DASH System and to provide information security our Podders can trust,” said Dr. Aiman Abdel-Malek, Executive Vice President and Chief Technology Officer. “We are committed to remaining at the forefront of best-in-class standards to secure patients’ safety and privacy. Our compliance with these internationally recognized standards sets us apart from others in the global insulin pump market and provides our users with further peace of mind that they can rely on a highly safe and secure product to manage their diabetes.”

Insulet’s Omnipod DASH System received FDA clearance in June 2018 and is currently in limited market commercial release. The Company expects to fully launch the product commercially in early 2019.

---

Try a free no obligation demo of the Omnipod today!

Contour Next One App

The Contour Diabetes app now integrates with Apple Health. Once you enabled the feature, data from the Contour app will be available in the Blood Glucose area of your iOS Health app.

Available in the iTunes app store here - Also available for Android

This is the meter that Omnipod users will be receiving when the DASH PDM is released sometime in the first quarter of 2019. Arden is using it now and we are finding the accuracy to be terrific!

---

Bolus Breakdown: Waffle Edition

Insulin is about timing and amount…

Listeners of my podcast hear me say all of the time that type 1 diabetes is about understanding how insulin works in you. With that understanding you can make good decisions about the timing of your insulin and how much you use. You need the right amount of insulin… at the right time. The goal is to create a tug of war between the insulin and carbs/body functions that neither side can win. You want both sides to pull in their respective directions, get tired and stop at the same time. When you create that battle properly the blood glucose can end where it began, creating stability.

If that makes sense, check out this plate full of waffles and chicken and then read on.

View fullsize

The day we are discussing was a school day. Arden had an appointment at 10:45 am that I picked her up for at 10 am. She texted me around 9:30 to say that she was hungry so I made a warm bagel with butter and brought it to school.

Use the graph below to help you visualize and follow the events. The graph has a low threshold of 70 and a high of 130.

10 am - Bolused for bagel on the way to the car. There was no opportunity to prebolus because of the situation so instead we overbolused.

10:50 am - Overbolus overpowered the bagel. She needed the large upfront infusion to squash the spike. Because the timing of the insulin was off, a low was not unexpected. Drank a small juice box in exam room to rebalance carbs with insulin.

11:55 am - Small bolus to stop creeping rise from juice.

12:17 pm - Decided to get lunch but not sure where or what - doubled basal insulin for an hour. Did this in part for lunch and in part because I didn’t think the previous bolus was having the effect I hoped for.

12:37 pm - Arrived at restaurant, talk of waffles began. Small bolus in parking lot to get BG drifting down. Bump and nudge.

View fullsize

Click to enlarge

12:45 pm - Order placed. Handmade chips as an appetizer, Waffles and chicken for lunch. Bolus 9.15 units extend. 5.50 in now and the rest over an hour. — Funny aside: 9.15 may seem random and it is. That’s just the number that it landed on when I took my finger off of the button. I was shooting for 9ish.

1:15 pm - Chips are obliterated (so good) and waffles (with real syrup) arrive. Cancel extended bolus (I saw the Dexcom line on 3 hr view beginning to curl up), immediately bolused the 2 units from 12:51 pm extended bolus that had not yet delivered.

Now we eat, laugh and talk. The main topic… is the guy two tables over being too friendly with the woman he’s eating with? He had a wedding ring but she didn't. Anyway, he was trying too hard and her smile looked forced. I digress.

1:34 pm - Dexcom line again looks to me like it’s about to break up. I like to say that we stop the arrows with small amounts of insulin to stop large amounts from being needed later. I wasn’t sure about this bolus but I like to err on the side of bold so we threw in a little over a unit for good measure.

Result: Good fun, a crazy carby Friday lunch and BGs that sat around 100 all afternoon. The gentle rise you see around 4 pm has been happening for a few weeks, I don’t think it had anything to do with he lunch. We bolused and stopped it.

Synopsis: Trying to count carbs for this (honestly for most things) is a fools errand. I mean, where would you even begin? Here’s what I did. I trusted that what I knew was going to happen, was going to happen. Meaning: I assumed (based on history) that Arden would eat 2/3 of the waffles and maybe two chicken fingers with honey mustard. I knew the restaurant didn’t have low carb syrup. I knew that in the past this has taken around 14 units of insulin. I knew how long insulin takes to work in Ardens body. I knew that I needed to give that insulin a head start over the carbs. I wanted to create momentum for the insulin (think about the tug of war) that the carbs couldn’t overwhelm. Why? So that when all of those chips, syrup and waffle batter began to “pull”, the insulin had a chance to hold those carbs in place. Not wanting to get the insulin too far ahead of the carbs, we bolused in stages to keep the power of the insulin up without overdoing it. Why? Because you aren’t just balancing the insulin, you are also balancing the carbs - like adding ballast to either side of a scale to keep it from tipping too far in one directions.

TOO much work! That’s what youre thinking, right? “This is too much” or “ I can’t do this”…. you can and many, many people do. Arden’s A1c has been between 5.2 and 6.2 for five years. She has no food restrictions and is an active and healthy 14 year old. What you see here represents fleeting moments of thought. And while this isn’t easy to describe in writing (mainly because it feels laborious when spelled out) it is easy to talk about and that’s why I hope you try listening to the Juicebox Podcast. All of this can be second nature in less time than you think. One day you’ll look at a plate and think, “that’s 14 units”.

I haven’t counted a carb in many, many years and it is wonderful!

On the Juicebox Podcast I talk about everything you read here and so much more. The show is 100% free and available on every podcast app and at JuiceboxPodcast.com. You’ll hear conversations with people just like you, industry professionals, the latest tech news, and even some famous folks living with diabetes. If you’re most interested in insulin management a good place to start is with episodes #4 Texting Diabetes #11 Bold With insulin, #29 Fear of insulin, #37, Jenny Smith, #44 Diabetes Rollercoaster, #62 Unfounded Fear, #100 Revisiting Bold, #105 All About A1c, #121 Insulin, Insulin, Insulin and #193 Live from the JDRF SW Ohio. But if you just want to jump in, go for it!

If all of this is a little hard to believe, I understand. Actually, how could any of this make sense when all you’ve been told is to count carbs, inject, wait… BG got high? “That’s just diabetes”. All I can tell you is that my daughter has had type 1 for 12 years and with a few simple concepts that I’ve honed over those years we, with relative ease, keep her A1c where I described. Diabetes doesn’t have to be like those people told you. This can be diabetes. What do you have to lose?

If you’d like to use the same tools that Arden uses to obtain these results please consider using these links to learn more. Its easy to get started with the Dexcom CGM and the Omnipod tubeless insulin pump today. Dexcom and Omnipod are sponsors of the Juicebox Podcast. Thank you for your support!

---

I am not a medical professional, nothing here is advice. A disclaimer is here if you’d like to read it.

Omnipod announces iPhone control

Omnipod announces iPhone control and interoperability!

There are so many things that we use everyday and couldn’t imagine living without. Air conditioners, a car and indoor plumbing to name a few. These one-time innovations are now technologies that we take for granted as they make our lives better.

“We are thrilled to announce that following remarkable work from our technical and cyber security teams and productive meetings with the FDA we now plan to launch Omnipod Horizon and future generations of Omnipod DASH with personal smartphone control. ”

— Shacey Petrovic, President, Chief Operating Officer at Insulet Corporation

Years from now as an app is automatically keeping your BGs in range, November 2018 will be long forgotten. But for today…. we are watching as diabetes management is about to take a generational leap forward. These quotes from Omnipod’s COO are quite simply the most inspirational words that I’ve read since Arden’s diagnosis fourteen years ago. So hold on just a little longer because one day soon we are all going to celebrate by sleeping through the night. I’m talking about that nodding off at 9PM and not waking up until morning sleep. I mean the kind of sleep where you wake up the next day and can’t be sure how long you’ve been out. You feel me? We are going to SLEEP and then get up feeling rested and go on to live easier and more carefree lives. The technology is so close, we are all so close… this is happening!

View fullsize

“Omnipod DASH was always designed to be interoperable and we’re thrilled to support this initiative by enabling the simplicity of Omnipod to work with other algorithms and CGMs. As a first step in our support of interoperability we are pleased to share that Insulet is the first pump partner for Tidepool’s Loop program.

Together we are developing an interoperable automated insulin delivery system that allows Omnipod Dash to be controlled by the Tidepool Loop algorithm from an iPhone. This partnership is additive to our internal Omnipod Horizon program and offers a potential faster route to market. An automated insulin deliver system with iPhone control for our Podders and a terrific way for us to support the DIY diabetes community.” - Shacey Petrovic

View fullsize

We're thrilled to be collaborating with Insulet to incorporate Omnipod DASH into Tidepool Loop. This is only the beginning. We invite people looking to stay in the loop about Tidepool Loop to signup for updates at https://tidepool.org/loop. - Christopher Snider, Tidepool

My recent interview with Tidepool’s Christopher Snider

---

Omnipod + Fiasp is cleared in Europe

press release

Omnipod® Insulin Management System Now Available for Use in Europe with Fiasp® Fast-Acting Insulin

LONDON--(BUSINESS WIRE)--Oct. 2, 2018-- Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that Novo Nordisk’s Fiasp® (Fast-Acting Insulin Aspart) has been tested and found safe for use in Insulet’s Omnipod System in Europe. Fiasp® is a new-generation, ultra fast-acting insulin developed by Novo Nordisk that enters the bloodstream two times faster, compared to NovoRapid®, so it more closely matches a healthy body’s insulin response to a meal, thereby improving glycemic control. Insulet will showcase its Omnipod System during the European Association for the Study of Diabetes (EASD) annual meeting at the Messe Berlin Exhibition Halls in Berlin, Germany taking place 1st October to 5thOctober 2018.

This is the first European conference presence for Insulet since the Company assumed direct operations of its Omnipod System product line in Europe. At its booth (#3.P05), the Company will highlight the history of its innovation, from the current Omnipod System to its Omnipod Horizon™ Automated Glucose Control System currently in development. Insulet will also feature the Pod Challenge – an opportunity for attendees to wear a sample Pod to experience the freedom it allows patients.

“Our European team is thrilled for this opportunity to engage with leading regional healthcare practitioners and advocacy groups to showcase the unique benefits of our Omnipod System,” said DJ Cass, General Manager, Insulet Europe. “The addition of Fiasp for use with the Omnipod System provides another option for both patients and prescribers to support their diabetes management needs. EASD is an important venue for direct contact with the diabetes community across Europe so they can see firsthand how our innovative product will help make diabetes a smaller part of their patients’ lives.”

“It is encouraging to see that Fiasp keeps expanding its reach, potentially benefiting more people in need of it via the Insulet Omnipod System,” said Stephen Gough, Global Chief Medical Officer of Novo Nordisk. “With its ultra-fast acting profile, Fiasp has brought a new option for adults living with diabetes who require insulin to manage their post-meal spikes, and I am confident that they will find in Fiasp and the Omnipod System good allies to best manage their diabetes.”

Learn more about Omnipod today

---