New test better predicts which babies will develop type 1 diabetes
from Science Daily, August 7, 2020 - University of Exeter
Scientists at seven international sites have followed 7,798 children at high risk of developing type 1 diabetes from birth, over nine years, in The Environmental Determinants of Diabetes in the Young (TEDDY) Study. The TEDDY Study is a large international study funded primarily by the US National Institutes of Health and U.S. Centers for Disease Control, as well as by the charity JDRF.
In research published in Nature Medicine, scientists at the University of Exeter and the Pacific Northwest Research Institute in Seattle used the TEDDY data to develop a method of combining multiple factors that could influence whether a child is likely to develop type 1 diabetes. The combined risk score approach incorporates genetics, clinical factors such as family history of diabetes, and their count of islet autoantibodies -- biomarkers known to be implicated in type 1 diabetes.
The research team found that the new combined approach dramatically improved prediction of which children would develop type 1 diabetes, potentially allowing better diabetes risk counselling of families. Most importantly, the new approach doubled the efficiency of programmes to screen newborns to prevent the potentially deadly condition of ketoacidosis, a consequence of type 1 diabetes in which insulin deficiency causes the blood to become too acidic. Identifying which children are at highest risk will also benefit clinical trials on drugs that are showing promise in preventing the condition.
Dr Lauric Ferrat at the University of Exeter Medical School, said: "At the moment, 40 per cent of children who are diagnosed with type 1 diabetes have the severe complication of ketoacidosis. For the very young this is life-threatening, resulting in long intensive hospitalizations and in some cases even paralysis or death. Using our new combined approach to identify which babies will develop diabetes can prevent these tragedies, and ensure children are on the right treatment pathway earlier in life, meaning better health."
Professor William Hagopian of the Pacific Northwest Research Institute, said: "We're really excited by these findings. They suggest that the routine heel prick testing of babies done at birth, could go a long way towards preventing early sickness as well as predicting which children will get type 1 diabetes years later. We're now putting this to the test in a trial in Washington State. We hope it will ultimately be used internationally to identify the condition as early as possible, and to power efforts to prevent the disease."
Researchers believe the combined approach can also be rolled out to predict the onset of other diseases with a strong genetic component that are identifiable in childhood, such as celiac disease.
Sanjoy Dutta, JDRF Vice President of Research, said:" We know that while genetics have a strong correlation as a risk factor for family members to develop T1D, most newly diagnosed individuals do not have a known family history. JDRF has been exploring the non-genetic, environmental risk factors that trigger T1D to help develop treatments to forestall or prevent disease onset."
Complete info is available at Science Daily
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.
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!
Omnipod® Horizon™ System Significantly Improves Glycemic Control in Patients with Type 1 Diabetes
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.”
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.”
Amazon, Berkshire Hathaway and JP Morgan Chase join forces to tackle employees’ health-care costs
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