Final FDA Artificial Pancreas Guidance a Milestone for People with Type 1 Diabetes


The FDA’s final artificial pancreas guidance adopts
JDRFs recommendations, providing a clear path toward
improving lives by moving the transformative
technology into the hands of millions with type 1 diabetes


William Sorensen, 212-479-7558;


New York, NY, November 13, 2012-Breakthrough T1D 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 Breakthrough T1D’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.

Breakthrough T1D first proposed draft guidance to the FDA in March 2011, after convening an expert panel of clinician researchers to assess the best ways to measure safety and effectiveness of artificial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. Breakthrough T1D then led an extensive scientific and patient advocacy campaign to encourage the FDA to adopt its recommendations. Breakthrough T1D provided extensive comments on the FDA’s draft guidance, released in December 2011.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 Breakthrough T1D 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 Breakthrough T1D. ”Breakthrough T1D 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. Breakthrough T1D will continue to work with the FDA to ensure the appropriate degree of regulation for artificial pancreas systems as we gain more experience with them.


About an Artificial Pancreas

An artificial pancreas is an external system of devices and software that people with type 1 diabetes (T1D) could use to replace their body’s lost ability to automatically control their blood sugar level around the clock. A basic artificial pancreas system would work by connecting a continuous glucose monitor (CGM) with an insulin pump using sophisticated computer software to automatically deliver the right amount of insulin at the right time. One of Breakthrough T1D’s research priorities is the development of artificial pancreas systems. Breakthrough T1D-funded studies have already shown the significant value of prototype artificial pancreas systems in better managing a person’s T1D.

About Breakthrough T1D

Breakthrough T1D is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, Breakthrough T1D is now the largest charitable supporter of T1D research. The goal of Breakthrough T1D research is to improve the lives of all people affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. Breakthrough T1D collaborates with a wide spectrum of partners who share this goal.

Since its founding in 1970, Breakthrough T1D has awarded more than $1.6 billion to diabetes research. Past Breakthrough T1D efforts have helped to significantly advance the care of people with this disease, and have expanded the critical scientific understanding of T1D. Breakthrough T1D will not rest until T1D is fully conquered. More than 80 percent of Breakthrough T1D’s expenditures directly support research and research-related education.