Whether you are newly diagnosed or have been living with type 1 diabetes (T1D) for a long time, Breakthrough T1D is committed to improving the lives of all people affected by the disease. We aim to accelerate the progress of research to provide better treatments, prevention, and ultimately a cure for T1D. We hope that you will enjoy reading about two exciting areas of research that have the potential to bring us closer to our goal.

FDA Finalizes Guidance for Artificial Pancreas Systems

An artificial pancreas is an external system of devices and software that people with type 1 diabetes (T1D) could use to end the daily burden of managing blood-sugar levels and insulin doses. In T1D, the body’s immune system attacks and destroys insulin-producing cells in the pancreas. As a result, no insulin can be produced and the body loses its ability to control blood-sugar levels. An artificial pancreas system would mimic the biological function of the pancreas by connecting a continuous glucose monitor with an insulin pump and using sophisticated computer software to automatically deliver the right amount of insulin at the right time.

In a triumph for Breakthrough T1D and people with T1D, the U.S. Food and Drug Administration (FDA) has issued its final guidance on artificial pancreas systems, and has adopted nearly all of Breakthrough T1D’s recommendations. The final guidance provides 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Breakthrough T1D first proposed draft guidance to the FDA in March 2011, and then spearheaded an extensive scientific and patient-advocacy campaign to encourage the FDA to adopt its recommendations. The FDA’s final guidance also allows scientists to submit a range of clinical study designs and ensures thorough evaluation of the artificial pancreas systems before they can be prescribed by doctors. Breakthrough T1D supports the FDA’s final guidance and will continue to work with the agency to endorse the appropriate degree of regulation for this potentially life-changing device.

Combating Complications through Collaboration

People with type 1 diabetes (T1D) are at risk for developing complications from the disease. Diabetic nephropathy (kidney disease) is one of these complications, and it can be life threatening. In this form of kidney disease, kidney function declines, which can eventually lead to kidney failure. About 30 percent of people with T1D develop the condition.

The kidneys are made up of hundreds of thousands of tiny units called nephrons, which filter the blood and help remove waste from the body. But in people with T1D, the nephrons thicken and become scarred. In some cases, tight blood-sugar control can delay or prevent the onset of kidney complications, but T1D can still lead to kidney failure.

To investigate genetic components of the condition, the Breakthrough T1D Genetics of Diabetic Nephropathy Collaborative Research Initiative has been formed. This initiative brings together top scientists in the field to build on previous research and share their findings, in order to identify disease pathways and prevent and treat the condition. More than $7 million will be provided to the main institutions collaborating on the project: the Broad Institute of MIT and Harvard; Joslin Diabetes Center; the University of Toronto; and the University of Virginia.

This global collaboration of researchers and scientists has assembled samples from more than 20,000 subjects with T1D and kidney disease, and the process of determining each participant’s genetic makeup is under way. Data is expected to be available in late 2013.