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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

Filtering by Tag: In the News

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!

Omnipod® Horizon™ System Significantly Improves Glycemic Control in Patients with Type 1 Diabetes

Scott Benner

Good news for the future from Omnipod!

BILLERICA, Mass.--(BUSINESS WIRE)--Jun. 24, 2018-- Insulet Corporation (NASDAQ:PODD) (Insulet or the Company), the leader in tubeless insulin pump technology with its Omnipod® Insulin Management System (Omnipod System), today announced that positive results from the most recent clinical trial of the Omnipod® Horizon™ Automated Glucose Control System (Omnipod Horizon System) were presented during the American Diabetes Association (ADA) 78th Scientific Sessions in Orlando.

The study demonstrated that the Omnipod Horizon System performed well and was safe for over five days of use in adults, adolescents, and children with type 1 diabetes.

In the era of personalized medicine, Insulet is committed to bringing our innovative technology to the global diabetes community and our clinical data give us confidence that the Omnipod Horizon System will be a significant advancement in diabetes management.
— Dr. Trang Ly, Senior Vice President and Medical Director

The study was conducted in a supervised hotel setting under free-living conditions with unrestricted meals and moderate-intensity exercise and included patients who use multiple daily injections or traditional tubed insulin pumps as their standard therapy. Study participants spent significantly less time in hypoglycemia, more time in the target glucose range and had better overnight glycemic control compared to their standard therapy. The investigational device includes features that allowed study participants to customize their diabetes management by adjusting their target blood glucose levels and insulin delivery.

“We recognize that everyone’s treatment needs are different, and the Omnipod Horizon System provides individualized diabetes management to address real world challenges,” said Dr. Jennifer L. Sherr, MD, PhD, of Yale University School of Medicine. “One of the important features is the ability for users to tailor the system for exercise and high fat meals to maintain good glycemic control.”

During the study, glucose control was maintained in the target range (70 to 180 mg/dL) between 69% and 79% of the time overall, and between 74% and 85% of the time during the overnight period, across all age groups. Hypoglycemia was very low overnight, ranging from 0.7% and 1.3% of the time, across age groups.

“In the era of personalized medicine, Insulet is committed to bringing our innovative technology to the global diabetes community and our clinical data give us confidence that the Omnipod Horizon System will be a significant advancement in diabetes management,” said Dr. Trang Ly, Senior Vice President and Medical Director. “We are very pleased that for the second consecutive year, Omnipod Horizon System research was highlighted in the official ADA Press Program based upon its overall excellence in furthering research and advancing treatment for people with diabetes.”

The rest of the article is here


Amazon, Berkshire Hathaway and JP Morgan Chase join forces to tackle employees’ health-care costs

Scott Benner

By Carolyn Y. Johnson January 30 at 8:31 AM - Washington Post

Three major employers, Amazon, Berkshire Hathaway and JP Morgan Chase, announced Tuesday they were  partnering to create an independent company aimed at reining in health- care costs for their employees.

The independent company would be jointly led by executives from all three companies and would be focused on technology that could increase transparency and simplify health care, according to the joint announcement. It will be free from the need to deliver a profit.

"The ballooning costs of healthcare act as a hungry tapeworm on the American economy. Our group does not come to this problem with answers. But we also do not accept it as inevitable," Warren Buffett, Berkshire Hathaway chairman said in a statement.

Few details were available about the new initiative, described as in the initial planning stages. The announcement comes amid anticipation that Amazon could disrupt health care as it has in other industries -- sending tremors through companies that make and supply prescription drugs.

“The healthcare system is complex, and we enter into this challenge open-eyed about the degree of difficulty,” Jeffrey P. Bezos, Amazon founder said in a statement. “Hard as it might be, reducing healthcare’s burden on the economy while improving outcomes for employees and their families would be worth the effort. Success is going to require talented experts, a beginner’s mind, and a long-term orientation.”

the original article can be found here


US NEWS: Emergency Services Crews Often Unprepared for Diabetic Crises

Scott Benner

By Serena Gordon
HealthDay Reporter

FRIDAY, Jan. 26, 2018 (HealthDay News) -- If you call 911, you expect to get the medical services you need.

But new research suggests that when it comes to severe low blood sugar episodes in people with diabetes, first responders might not be able to administer a potentially lifesaving medication called glucagon.

Glucagon is an injectable medication that prompts the liver to release stored glucose. This quickly raises blood sugar.

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But paramedics can give the injections, said Dr. Craig Manifold, medical director of the National Association of Emergency Medical Technicians. That's because paramedics get between 750 and 1,500 hours of education compared to about 100 to 150 hours of training for EMTs.

Low blood sugar levels (hypoglycemia) generally occur in people with type 1 or type 2 diabetes taking insulin or other blood sugar-lowering medications. Researchers said more than 100,000 serious hypoglycemia episodes occur each year.

Gabbay noted even U.S. Supreme Court justices aren't immune to this problem. Earlier this month, Justice Sonia Sotomayor, who has type 1 diabetes, had to call emergency services for help with serious low blood sugar.

You can read the rest of the article here