FDA approves first “artificial pancreas” for type 1 diabetes.

The U.S. Food and Drug Administration 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.

FDA Approves MiniMed 670G System – World’s First Hybrid Closed Loop System | Medtronic Diabetes, Between the Lines

How does it work?

The Medtronic MiniMed 670G System consists of a continuous glucose monitor (CGM) that measures the user’s glucose levels for up to seven days, an insulin pump that delivers insulin to the user, and a glucose meter used to calibrate the CGM.

The MiniMed 670G System is able to decrease or stop insulin delivery when it detects the user’s glucose is low, or increase the insulin delivery when the system detects the user’s glucose levels are high with no input from the user. The glucose sensor contains a wire that is inserted under the skin on the abdomen and measures glucose values in the tissue fluid. The glucose values are wirelessly sent to the insulin pump, and displayed along with glucose trend information, alerts, and alarms on the pump screen. The insulin pump delivers a prescribed dosage of insulin through an infusion set. The insulin pump can automatically adjust the delivery of insulin using a mathematical equation, or algorithm that incorporates information from the CGM.

The system has two modes; Manual Mode and Auto Mode. While in Manual Mode, the system can be programmed by the user to deliver basal insulin at a preprogrammed constant rate. The system will automatically suspend delivery of insulin if the sensor glucose value falls below or is predicted to fall below a predetermined threshold. The system will also automatically resume delivery of insulin once sensor glucose values rise above or are predicted to rise above a predetermined threshold. While in Auto Mode, the system can automatically adjust basal insulin by continuously increasing, decreasing, or suspending delivery of insulin based on CGM values (different from Manual Mode where basal insulin is delivered at a constant rate). Although Auto Mode can automatically adjust basal insulin delivery without input from the user, the user must still manually deliver insulin therapy during meals.

New Guardian Sensor

The system uses new Guardian Sensor 3, our most advanced and accurate glucose sensor. The sensor offers seven-day continuous wear and incorporates diagnostic technology that continuously monitors how the sensor is doing, resulting in a CGM system trusted to power the hybrid closed loop system. It is also the first and only sensor approved by the FDA to control a hybrid closed loop system.

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.”

SAFETY INFORMATION

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.

IMPORTANT SAFETY INFORMATION

The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of Type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The 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 Serter, and the Contour NEXT Link 2.4 glucose meter. The system requires a prescription.

The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick 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 Sensor (3).

WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode.

The MiniMed 670G system is not approved for use in pregnant women and patients with impaired kidney function.

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.