Juicebox Podcast in Diabetes Forecast Magazine!

Diabetes podcasts in the spotlight!

A huge thanks to Diabetes Forecast Magazine for spending some ink on the podcasts dedicated to people living with type 1 diabetes. You can listen to my show below or follow the link to Diabetes Forecast to see the others highlighted.

Apple Podcasts - http://bit.ly/JBPAPod
Android - http://bit.ly/jbpandroid
Spotify - http://bit.ly/JBPspot
Google Play - http://bit.ly/JBPGoogplay
or JuiceboxPodcast.com

Check out the latest edition of Diabetes Forecast Magazine… on your newsstand now.

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Statement from FDA Commissioner on Insulin Pricing

The FDA has issued a statement intended to spur competition and lower prices. I’ve pulled out and included a few passages that are about insulin. You can read the entire statement as written here.

from FDA.gov

Statement from FDA Commissioner Scott Gottlieb, M.D., on new actions advancing the agency’s biosimilars policy framework.

“There are currently no approved insulin products that can be substituted at the pharmacy level. One reason is that it was hard to bring a substitutable generic insulin to the market under the conventional drug pathway. The biosimilar pathway should make this kind of competition more accessible. Once an interchangeable insulin product is approved and available on the market, it can then be substituted for the reference product at the pharmacy, potentially leading to increased access and significantly lower costs for patients.”

We’re going to be monitoring these markets. And we’ll be taking additional actions. We’re actively evaluating how we can make it easier for biosimilar manufacturers to use reference products from outside the U.S., where prices may be cheaper and reference products more accessible.

We’re also releasing today two critical guidance documents that describe how the agency plans to implement Congress’ direction that we transition certain biological products currently approved as drugs under the FD&C Act to be licensed as biologics under the PHSA.

Transitioning these drugs to the PHSA will let them to be treated as biologics under that law. And that means opening them up to competition through the biosimilars pathway. This includes insulin, which has been historically regulated as a drug and not a biologic.

Starting in March 2020, the approved marketing applications for the small subset of “biological products” such as insulin and human growth hormone – which for complex historical reasons were previously generally approved as drugs under section 505 of the FD&C Act – will be deemed to be biologics licenses under section 351 of the PHSA. Sponsors have known about this transition for a decade. They’ve had time to prepare.

“As a result, we’ve heard frequent reports of patients rationing insulin, and in some cases dying because they can’t afford the injections they need to survive. These tragic stories aren’t isolated occurrences. And they’re not acceptable for a drug that’s nearly a century old.”

Today, we’re laying out our policy on how these products will transition from the drug pathway to the biologics pathway, and in so doing, how we intend to use this new framework to promote competition. The two guidance documents we’re releasing today, one final and one draft, describe how the FDA intends to accomplish the transition of these products under the “Deemed to be a License” provision of the BPCI Act. The final guidance deals with “Interpretation of the ‘Deemed to be a License’ Provision of the Biologics Price Competition and Innovation Act of 2009,” finalizes the FDA’s draft guidance from 2016.

We’ve shaped these policies to implement the intent of Congress, and to make sure a few things happen. First, that the anti-evergreening provisions under the biosimilars legislation – meant to prevent sponsors from being able to game the exclusivity provisions to forestall biosimilar entry – will apply to these newly deemed products, including insulin.

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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.

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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!

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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.

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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.

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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!

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