Thursday, September 29, 2016

FDA approved 1st hybrid closed loop system- Artificial Pancreas Device System

(Source: FDA)
There have been tremendous strides made in the research and development of an Artificial Pancreas Device System. On September 28, 2016, the FDA approved the first hybrid closed loop system, the Medtronic's MiniMed 670G System, intended to automatically monitor blood sugar and adjust basal insulin doses in people with type 1 diabetes.

(Source: FDA- Medtronic Information
)
What is it? The Medtronic MiniMed 670G System is the first FDA approved hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user’s glucose reading.

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.

What will it accomplish? People with diabetes can use the glucose information from the CGM to help determine patterns in their glucose levels. The MiniMed 670G System can alert users when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels. People with diabetes can use the insulin delivered from the pump to help keep their glucose levels at a safe level. The 670G System provides additional diabetes management assistance by automatically adjusting basal insulin delivery based on changes in glucose levels. When used along with a blood glucose meter to obtain a more accurate reading of actual glucose levels, a continuous glucose monitoring and insulin pump system can also help people with diabetes make long-term adjustments to their treatment plan to keep glucose levels in a safe range.

When should it not be used? The MiniMed 670G System should not be used in:

-People who require less than a total insulin dose of 8 units per day because the device requires a minimum of 8 units per day to operate safely
-Children under 7 years of age because most children under the age of 7 require less than 8 units of insulin per day.
-The FDA has not reviewed data to support the safety and effectiveness of the device in children ages 7-14 as these studies are ongoing.

Anyone unable or unwilling to:
--Perform a minimum of four blood glucose tests per day.
--Maintain contact with their healthcare professional.
--Carry the Medical Emergency Card provided with the system when traveling. The Medical Emergency Card provides critical information about airport security systems, and pump usage on an airplane.

People whose vision or hearing does not allow recognition of pump signals and alarms. Patients should always remove their pump, sensor, transmitter, and meter before entering a room that has x-ray, MRI, diathermy, or CT scan equipment. The magnetic fields and radiation in the immediate vicinity of this equipment can make the devices nonfunctional or damage the part of the pump that regulates insulin delivery, possibly resulting in over delivery and severe hypoglycemia.

Patients should not expose their pump to a magnet, such as pump cases that have a magnetic clasp.

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