The study examined the potency and consistency of active insulin in products available across the United States
JDRF, the American Diabetes Association (ADA), and The Leona M. and Harry B. Helmsley Charitable Trust, announced the results of a study examining the consistency and potency of insulin purchased at U.S. retail pharmacies. The study, led by University of Florida researcher Timothy Garrett and published today in Diabetes Care, found all human and analog insulins measured contained the expected quantity of active insulin.
Insulin is a life-saving drug for people with diabetes that can be dangerous and potentially fatal when incorrectly dosed. Variation in insulin activity or insufficient insulin activity would pose significant challenges and safety risks for people with diabetes attempting to manage their blood glucose levels.
“During such an unprecedented time it's more important than ever for people with T1D to feel safe. This study reaffirms our confidence in the safety and effectiveness of insulin products,” said Aaron Kowalski, Ph.D., president and CEO of JDRF. “As JDRF, our partners, and the type 1 diabetes community pursue cures and support the development of better insulins, we must also work together to make these safe and effective insulin products affordable and accessible to everyone who needs them.”
“People living with type 1 diabetes make a life or death decision each time they decide how much insulin to dose, which happens many times a day. Having confidence in insulin quality is paramount,” said David Panzirer, a Trustee at the Helmsley Charitable Trust, and a parent of two children with type 1 diabetes. “Helmsley is committed to easing the burden of living with type 1 diabetes, and this study brings welcomed good news to our community and should alleviate any lingering concern around the quality of our insulin supply.”
In April 2018, JDRF, ADA, and Helmsley issued a request for proposals (RFP) to study insulin potency and consistency, which was prompted by a small study published in 2017 that found variation in the level of active insulin in products available commercially in the United States. Notably, this 2017 study did not use a research method approved by the U.S. Pharmacopeia (USP) and was inconsistent with data from previous regulatory audits. To research the issue further, JDRF, ADA, and Helmsley supported a team that devised an unbiased, well-powered, and independent assessment of insulin products from major manufacturers using approved USP methods.
This single year of research will be expanded during a second study phase to measure any potential seasonal variations in reported insulin activity.
USP and the U.S. Food and Drug Administration require insulin vials and cartridges to contain 100 U/mL (± 5 U/mL).
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,About JDRF
JDRF is the leading global organization funding type 1 diabetes (T1D) research. Our mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.2 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our six international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D. For more information, please visit jdrf.org or follow us on Twitter: @JDRF
About the American Diabetes Association
Every day more than 4,000 people are newly diagnosed with diabetes in America. More than 122 million Americans have diabetes or prediabetes and are striving to manage their lives while living with the disease. The American Diabetes Association (ADA) is the nation’s leading voluntary health organization fighting to bend the curve on the diabetes epidemic and help people living with diabetes thrive. For nearly 80 years the ADA has been driving discovery and research to treat, manage and prevent diabetes, while working relentlessly for a cure. We help people with diabetes thrive by fighting for their rights and developing programs, advocacy and education designed to improve their quality of life. Diabetes has brought us together. What we do next will make us Connected for Life. To learn more or to get involved, visit us at diabetes.org or call 1-800-DIABETES (1-800-342-2383). Join the fight with us on Facebook (American Diabetes Association), Twitter (@AmDiabetesAssn) and Instagram (@AmDiabetesAssn).
About the Helmsley Charitable Trust
The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional efforts in the U.S. and around the world in health and select place-based initiatives. Since beginning active grantmaking in 2008, Helmsley has committed more than $2.5 billion for a wide range of charitable purposes. The Helmsley Type 1 Diabetes Program is the one of the largest private foundation funders of T1D in the nation focused on understanding the disease, developing better treatments, and improving care and access. For more information on Helmsley and its programs, visit helmsleytrust.org.
