With five times the population and ten times the cases of diabetes, what goes on in the US is often of interest, sometimes leading to impact in the UK too, eventually. Here is a recent round up of some interesting news items from over the waters.
JDRF’s Chair of the International Board of Directors, Ellen Leake has commented, “There really is no one who can represent the needs of the T1D community more passionately, drive our research toward a cure more strategically, and represent us with greater regard than Aaron.”
Kowalski, himself a Type 1 diabetic, brings to this important role a track record of leading initiatives and forging partnerships that are providing new life-changing treatment options and expanded access to help people with T1D stay healthy until there is a cure.
His vision of less burdensome and safer lives for people with T1D, combined with strategic leadership, drove JDRF’s transformative Artificial Pancreas (AP) Project, which has led to availability of multiple AP systems, as well as widespread coverage for components of such systems, such as continuous glucose monitors.
He also is a leader of the PEAK initiative, providing for the first time guidelines to help people with T1D exercise safely and has been a champion for groundbreaking beta cell and immunological research to cure and prevent Type 1 diabetes.
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A bipartisan group of lawmakers has introduced legislation seeking to bring down the cost of certain biologic drugs, such as insulin, by making it easier for drug makers to get generic versions of those drugs approved by the Food and Drug Administration.
The legislation is being led by U.S. Representatives Diana DeGette (Democrat, Colorado) and Tom Reed (Republican, New York), who serve as the co-chairs of the Congressional Diabetes Caucus. If approved this would make permanent a new FDA policy that was put in place in December to help speed up the time it takes for generic forms of certain drugs, known as biosimilars, to get approved and made available to consumers.
Insulin belongs to a class of complex drugs known as biologics, which are exponentially more difficult for drug makers to manufacturer than non-biologics (such as aspirin).
Says DeGette, “We know that one of the best ways to reduce the cost of insulin is to increase competition. Despite insulin being available for nearly 100 years now, there are still only three companies that manufacture the drug here in the U.S. and only one generic version of the drug available to consumers.”
Meanwhile, Korean medtech company EOFlow* has won breakthrough status from the FDA for its closed-loop automated insulin delivery system.
The EOPancreas system features a wearable patch pump, continuous glucose monitoring sensor and a closed-loop blood glucose control algorithm.
In 2016 Medtronic won breakthrough status from the FDA for its investigational closed-loop insulin delivery system, making it the first to gain FDA approval for a hybrid closed-loop insulin delivery system.
In the US state of Minnesota Medtronic has an agreement with Blue Cross & Blue Shield (BCBS) on an outcomes-based program for its diabetes patients*.
The plan gives BCBS Minnesota members access to Medtronic’s Guardian Connect continuous glucose monitor with payments pegged to how long patients spend in a targeted blood glucose range.
The deal also includes access to the company’s Inner Circle patient engagement program, which aims to improve outcomes for people by using Guardian Connect and Medtronic’s MiniMed 670G pump.
Suzanne Winter, Medtronic’s Americas Region VP for diabetes, commented, “With this new agreement, we’re excited to show how an innovative partnership between a health plan and a medical device company can work together to improve diabetes care.
“Making our Guardian Connect system more easily available to members of Blue Cross & Blue Shield of Minnesota will provide people with diabetes with the tools to help them achieve their best possible outcomes, so they can focus on living their life without constantly worrying about their glucose levels.”
BCBS interim CMO Dr. Mark Steffen added, “This partnership is great example of how we are working together to improve health. Through this value-based program, we are creating a better experience for our members by making it easier to access CGM technology from Medtronic, lowering the cost of care, and ultimately helping people better manage diabetes – a win for everyone.
Chicago-based Xeris Pharmaceuticals has started a Phase II trial of its ready-to-use liquid glucagon for people with Type 1 diabetes and expects to report top-line data from the study in the second half of 2019.
The trial will assess the company’s room-temperature stable liquid glucagon, called XeriSol and which has to be injected using its XeriJect pen. It will be trialled as a pre-treatment to prevent exercise-induced hypoglycaemia on a group of people who use insulin pumps.
Xeris’ solutions should mean a reduced injection volume and comes ready-made (no need to reconstitute), does not need to be kept in the fridge and should be overall less fuss and bother than currently available solutions.
In October 2018, Xeris announced that the FDA accepted the company’s new drug application its ready-to-use liquid glucagon rescue pen device, and the agency should make a decision about the Xeris product within the coming few months.
News items and features like this appear in the Desang Diabetes Magazine, our free-to-receive digital journal (see below). We cover diabetes news, diabetes management equipment (diabetes ‘kit’ such as insulin pumps and continuous glucose monitoring equipment) and news about food suitable for a diabetic diet including a regular Making Carbs Count column. We just need your email address to subscribe you (it’s free, and you can easily unsubscribe should you wish to).