JDRF today called the Food and Drug Administration’s (FDA) final artificial pancreas guidance a milestone in advancing better treatments for people with type 1 diabetes (T1D)-one of JDRF’s key goals.
The final FDA guidance issued Friday provides, for the first time, researchers and industry with a clear and reasonable roadmap of the FDA’s expectations for conducting human studies of artificial pancreas systems, and for their approval for marketing to people with diabetes.
JDRF first proposed draft guidance to the FDA in March 2011, after convening an expert panel of clinician researchers to assess the best ways to measure safety and effectiveness of artificial pancreas systems. JDRF then led an extensive scientific and patient advocacy campaign to encourage the FDA to adopt its recommendations. JDRF provided extensive comments on the FDA’s draft guidance, released in December 2011. The FDA’s final guidance incorporates nearly all of the recommendations made by JDRF and the clinical community.
“This FDA guidance is an important milestone in improving lives of people with type 1 diabetes,” said Jeffrey Brewer, president and CEO of JDRF. “JDRF commends the FDA for its scientific leadership in the area of artificial pancreas systems, which have the potential to be the most revolutionary advance in treating type 1 diabetes since the discovery of insulin. Until we can cure this disease, we have an obligation to reduce the daily burden of managing it and enable people with the disease to live healthier lives.”
Today’s technologies for managing T1D leave millions exposed to substantial risks of blood sugar levels that are either too high or too low, despite their best efforts to maintain tight control of their diabetes. These extreme blood sugar levels can have serious consequences. High blood sugar levels (hyperglycemia) can cause long-term complications including heart disease, blindness, and stroke, and low blood sugar levels (hypoglycemia) can be life-threatening.
The FDA’s final guidance allows for a range of scientifically valid study designs, allowing flexibility that will encourage innovation in technologies for people with T1D while ensuring thorough evaluation of such systems before they can be prescribed by doctors. For example, the guidance recognizes “time in range” as a potential endpoint to use in artificial pancreas studies, as well as other measures of glucose control. It allows sponsors the ability to propose statistical measures of efficacy tailored for their systems, and accepts the use of continuous glucose monitoring (CGM) data in evaluating artificial pancreas systems.
For more information contact: William Sorensen, JDRF, 212-479-7558; email@example.com