1st FDA approval of semi-artificial pancreas (hybrid closed loop)
Gerti Tashko, MD
Your Comprehensive Endocrinologist | Board Certified in Lipidology, Hypertension, and Obesity
The 1st pump to deliver insulin automatically based on body needs during fasting state, as determined by glucose measurements every 5 minutes. Manual changes are needed to cover carbohydrate intake from meals. The semi-artificial pancreas is approved for patients with type 1 diabetes who are ≥14 years of age, require ≥8 units of insulin per day, and check home glucose ≥4x/day
GT
"The MiniMed 670G System should NOT be used in:
- People who require total insulin dose of <8 units/day, because the device requires a minimum of 8 units/day to operate safely
- Children <7 years of age because most children <7 yo require <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 4 blood glucose tests/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.
"The U.S. FDA today approved Medtronic’s MiniMed 670G HYBRIDclosed 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 MiniMed 670G hybrid closed looped system, often referred to as an “artificialpancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every 5 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% 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).
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 < 7 years of age and in patients who require < 8 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."
Medical Doctor, Internal Medicine-Endocrinology, Diabetes & Metabolism at Private Practice
8yWelcome, we were waiting it since the Biostator of Tom Clements in the early eighties. Julio V. Santiago should be quite interested if he were alive. Congratulations.