FDA: The U.S. Food and Drug Administration today approved Medtronic’s
MiniMed 670G hybrid closed looped system, the first FDA-approved device
that is intended to automatically monitor glucose (sugar) and provide
appropriate basal insulin doses in people 14 years of age and older with
type 1 diabetes.
The human pancreas naturally supplies a low, continuous rate of
insulin, known as basal or background insulin. In patients with
diabetes, the body’s ability to produce or respond to insulin is
impaired.
“The FDA is dedicated to making technologies available that can help
improve the quality of life for those with chronic diseases – especially
those that require day-to-day maintenance and ongoing attention,” said
Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and
Radiological Health. “This first-of-its-kind technology can provide
people with type 1 diabetes greater freedom to live their lives without
having to consistently and manually monitor baseline glucose levels and
administer insulin.”
The MiniMed 670G hybrid closed looped system, often referred to as an
“artificial pancreas,” is intended to adjust insulin levels with little
or no input from the user. It works by measuring glucose levels every
five minutes and automatically 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 (meal)
consumption.
According to the U. S. Centers for Disease Control and Prevention,
approximately 5 percent of people with diabetes have type 1 diabetes.
Also known as juvenile diabetes, type 1 diabetes is typically diagnosed
in children and young adults. Because the pancreas does not make insulin
in people with type 1 diabetes, patients have to consistently monitor
their glucose levels throughout the day and have insulin therapy through
injection with a syringe, an insulin pen or insulin pump to avoid
becoming hyperglycemic (high glucose levels). In addition, management of
type 1 diabetes includes following a healthy eating plan and physical
activity.
“As part of our commitment to improving diabetes care, the FDA worked
interactively with Medtronic from the earliest stages of development to
assist in making this technology available to people with type 1
diabetes as quickly as possible,” said Alberto Gutierrez, Ph.D.,
director of the Office of In Vitro Diagnostics and Radiological Health
in the FDA’s Center for Devices and Radiological Health. “We encourage
companies to work closely with the agency to ensure scientifically
sound, highly efficient clinical study designs, helping to expedite the
FDA’s evaluation and subsequent approval of novel devices that can make a
difference for patients.”
The FDA evaluated data from a clinical trial of the MiniMed 670G
hybrid closed looped system that included 123 participants with type 1
diabetes. The clinical trial included an initial two-week period where
the system’s hybrid closed loop was not used followed by a three-month
study during which trial participants used the system’s hybrid closed
loop feature as frequently as possible. This clinical trial showed that
the device is safe for use in people 14 years of age and older with type
1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA) or
severe hypoglycemia (low glucose levels) were reported during the study.
Risks associated with use of the system may include hypoglycemia,
hyperglycemia, as well as skin irritation or redness around the device’s
infusion patch. This version of this device is unsafe for use in
children 6 years of age or younger and in patients who require less than
eight units of insulin per day.
As part of this approval, the FDA is requiring a post-market study to
better understand how the device performs in real-world settings. While
the device is being approved today for use in people 14 years of age
and older with type 1 diabetes, Medtronic is currently performing
clinical studies to evaluate the safety and effectiveness of the device
in diabetic children 7-13 years old.
The MiniMed 670G hybrid closed looped system is manufactured by Medtronic, headquartered in Dublin, Ireland.
The FDA, an agency within the U.S. Department of Health and Human
Services, promotes and protects the public health by, among other
things, assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human use,
and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating tobacco
products.