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Arden's Day Blog

Arden's Day is a type I diabetes care giver blog written by author Scott Benner. Scott has been a stay-at-home dad since 2000, he is the author of the award winning parenting memoir, 'Life Is Short, Laundry Is Eternal'. Arden's Day is an honest and transparent look at life with diabetes - since 2007.

type I diabetes, parent of type I child, diabetes Blog, OmniPod, DexCom, insulin pump, CGM, continuous glucose monitor, Arden, Arden's Day, Scott Benner, JDRF, diabetes, juvenile diabetes, daddy blog, blog, stay at home parent, DOC, twitter, Facebook, @ardensday, 504 plan, Life Is Short, Laundry Is Eternal, Dexcom SHARE, 生命是短暂的,洗衣是永恒的, Shēngmìng shì duǎnzàn de, xǐyī shì yǒnghéng de

On This day, January 11 1922: Insulin Was First Used to Treat Diabetes

Scott Benner

On Jan. 11, 1922 fourteen-year-old Leonard Thompson was injected with a pancreatic extract prepared by Dr. Frederick Banting, and medical student, Charles Best.

from TheStar.com:

Although his blood sugars went down a little, there was not a lot of change following Thompson’s initial injection, according to the University of Toronto’s heritage website.

But biochemist Bert Collip, who had been working with Banting and Best in a lab provided by the university’s head physiologist, Prof. J.J.R.. Macleod, developed a method to refine the extract and daily injections of this extract started Jan. 23. Improvement was immediate and remarkable. The boy’s blood sugar levels dropped to normal levels (Thompson would live another 13 years with daily injections of insulin, before dying of tuberculosis.)

It was not a cure but it was a monumental breakthrough in treatment for what had been an untreatable disease.

In March, 1922 a paper describing the case of Leonard Thompson, and six other patients the Banting and Best team treated with the refined extract, was published in the Canadian Medical Association Journal. It was the first official announcement of an extract developed to alleviate the symptoms of diabetes.

A message of hope to sufferers from diabetes goes out authentically today from the medical research laboratories of the University of Toronto. The modesty of medical men and scientific investigators of the genuine brand attempts to minimize the results obtained. The harm of exaggeration and the injustice to both parents and research men in awakening false and premature hopes before the extracts can possibly be manufactured cannot be over-emphasized. But the fact remains that one of the most important discoveries in modern medical research has been made at the university here. It is not a cure for diabetes, its authors state. Within six months, however, their discovery will be used on a large scale, they hope, to prolong life quite considerably at least. There will be no secrecy, as from the beginning. The medical profession will know all the facts.
— The Toronto Daily Star - March 22, 1922 Edition

The Toronto Daily Star broke the news a day before other outlets. The March 22, 1922 bold all-capital headline ran eight columns on the front page: “Toronto doctors on track of diabetes cure.” A subhead stated: “Discovery made at University of Toronto will be means of prolonging life considerably — F.G. Banting and C.H. Best pushed experiments all last summer.”

The Star referred to the Alliston-born Banting — who had won the Military Cross in 1916 for bravery in World War I — as being “strangely slow in speech” and “unassuming” but he also had “the reputation of coming across with the punch at the critical moment.”

click to enlarge

Two months later, on May 22, 1922, Prof. Macleod delivered a paper on the U of T team’s findings to the American Association of Medical Physicists in Washington, D.C. and got a standing ovation. Macleod used the term “insulin” to describe the extract. According to the Canadian Encyclopedia, “in the eyes of most of the world,” this was considered the announcement of insulin.

The next year, on Oct. 26, 1923, the first Nobel prize awarded to Canadians was given to Banting and Macleod.

But the reaction of Banting and Macleod to the prize revealed a little of the testy relationship that had existed in the background between the two men.

According to an account on the website scienceheroes.com (similar to other published reports) Banting was furious that he was sharing the award with Macleod, not Best, and at first swore he “wouldn’t accept the award.” But friends persuaded him that it wouldn’t be smart to refuse the first Nobel for a Canadian (he remains the youngest Nobel Laureate in Physiology/Medicine). Instead, Banting announced he would split his share of the $40,000 monetary prize with Best.

read the story in it’s entirety at TheStar.com


Juicebox Podcast in Diabetes Forecast Magazine!

Scott Benner

Diabetes podcasts in the spotlight!

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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

Scott Benner

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.


Omnipod DASH Security

Scott Benner

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

Scott Benner

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

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!