FDA Approves New Options for Managing Diabetes Following Strong Push from Senator Collins

Washington, D.C. – U.S. Senator Susan Collins, the Chairman of the Aging Committee and the founder and co-chair of the Senate Diabetes Caucus, applauded the U.S. Food and Drug Administration’s (FDA) approval of two advances in diabetes technologies that will help millions of Americans suffering from diabetes better manage the disease. 

 

Specifically, the FDA approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older and expanded the approval of theMiniMed 670G hybrid closed looped system (artificial pancreas) to include individuals from ages 7 to 13 with Type 1 diabetes (T1D).  The Eversense CGM is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose that can be worn for up to 90 days.

 

“These powerful tools will improve the safety of Americans with diabetes and help them to successfully manage the disease,” said Senator Collins.  “I am so pleased that our advocacy has spurred this change in policy that will help change our country’s future with regard to diabetes.  I will continue to work to ensure that the millions of Americans living with diabetes have access to these life-saving devices.”

 

More than 30 million Americans – 9.4 percent of the population – suffer from diabetes. About five percent of all diabetes cases are Type 1. T1D, sometimes referred to as juvenile diabetes, usually starts in childhood or adolescence and renders individuals insulin-dependent for life. Individuals with T1D must be injected daily with insulin (often multiple times) - or receive routine infusions of insulin to survive.

 

The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure.  After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days.  The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia).  The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (e.g., smart phone or tablet) that is running a device-specific mobile app.

 

The MiniMed 670G hybrid closed looped system works by measuring glucose levels in the body every five minutes and automatically adjusting insulin delivery by either administering or withholding insulin.  The system includes: a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump strapped to the body, and an infusion patch connected to the pump with a catheter that delivers insulin.  While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate consumption at mealtime.

 

As the founder and co-chair of the Senate Diabetes Caucus, Senator Collins has worked to increase awareness of the threats posed by diabetes, invest in research, and improve access to treatment options.   Senators Collins and Jeanne Shaheen (D-NH) successfully pushed the Centers for Medicare and Medicaid Services to provide coverage for CGMs and support the use of smartphone apps in conjunction with these devices.

 

Last year, Senator Collins questioned Dr. Jeffrey Shuren, director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health, about the status of the artificial pancreas for children under the age of 14.