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 impaired1.
According to the U. S. Centers for Disease Control and Prevention, approximately 5 percent of people with diabetes have the type 1 form of 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 activity1.
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) consumption1.
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 day1.
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 old1.
The Medtronic MiniMed 670G System includes SmartGuard HCL technology, which can be programmed to automatically adjust delivery of basal insulin based on Continuous Glucose Monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The Medtronic MiniMed 670G system consists of the following devices: MiniMed 670G insulin pump, the Guardian Link (3) transmitter, the Guardian Sensor (3), One-Press Sorter, and the Contour NEXT Link 2.4 glucose meter. The system requires a prescription from your physician. The Guardian Sensor glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home blood glucose monitor and not on values provided by the Guardian Sensor2.
The Medtronic MiniMed 670G has been reported to be entering the market in the spring of 20172, 3. The Medtronic website2 states that customers who want to be first in line to receive the new system can check out the Medtronic Priority Pathway Program. Anyone who purchases a MiniMed 630G system between August 11, 2016 and when we ship the MiniMed 670G system will be eligible to upgrade to the new system for $299. It appears the “all-in” costs for the unit itself is expected to be $799 because users signing up for their existing $500 Med 630G system will get the new technology then for a $299 upgrade fee3.
Readers of this blog are highly encouraged to read and review the links/references section below to gain further understanding into this FDA approval. Additionally, interested parties and healthcare practitioners should contact the manufacturer with any additional questions they may have about Medtronic’s Priority Pathway Program at 1-800-238-7111.