Person Testing Blood Sugar Level with Test Strips / First Automated Insulin Delivery Device Approved for Type One Diabetes Patients
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The device automatically monitors glucose levels and provides appropriate insulin doses

September 29, 2016

The Food and Drug Administration (FDA) has approved an automated delivery device meant to automatically adjust insulin levels for use by patients with type 1 diabetes.

Medtronic's MiniMed 670G hybrid closed looped system is meant to automatically monitor a user's glucose levels and automatically provide the appropriate basal insulin dose in people who are at least 14 years old and who have type 1 diabetes.

Normally the human pancreas provides a low, continuous rate of insulin, which is known as basal or background insulin. Patients who have diabetes suffer from their bodies' impaired ability to produce or respond to insulin.

"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 device is often referred to as an "artificial pancreas" and is meant to adjust a patient's insulin levels automatically, with little to no input from the patient. The device measures those levels every five minutes and then either administers or withholds insulin as appropriate. It includes a sensor attached to the patient's body under the skin that measures levels of glucose; an insulin pump that straps to the body; and an infusion patch that connects to the pump with a catheter that delivers insulin. Although it automatically adjusts the patient's levels of insulin, the patient does need to manually request doses to counter carbohydrates when he or she eats a meal.

The U.S. Centers for Disease Control and Prevention estimates that roughly five percent of people who have diabetes have type 1 specifically. Also known as juvenile diabetes, the condition is usually diagnosed in children and young adults. Patients must constantly monitor their levels of glucose throughout the day and must inject themselves with insulin using a syringe, an insulin pen, or insulin pump in order to avoid hyperglycemia (too high glucose levels). They must also follow a healthy eating plan and engage in 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."

To approve the device, the FDA examined data gathered in a clinical trial of the device including 123 participants who had type 1. During the initial two weeks of the trial, the device's closed loop was not used. Then, for the following three months, participants used it as often as possible. The trial indicated that the device may be used safely by type 1 diabetes patients 14 years old and older. There were no serious adverse events, diabetic ketoacidosis, or severe hypoglycemia reported during the trial.

The risks run by patients using the system include hypoglycemia, hyperglycemia, and skin irritation or redness around the site of the infusion patch. This version of the device may not be safely used by children six years old or younger, nor by patients who require less than eight units of insulin a day.

As part of the approval, the agency is requiring a post-market study in order to gain a better understanding of how it works in the real world. Medtronic is currently conducting clinical students to evaluate the device's safety and efficacy in children seven to 13 years old who have diabetes.

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