The FDA has given the go ahead signal for the world’s first Hybrid Closed Loop System for people with Type 1 Diabetes.
The FDA has given the thumbs up to the first artificial pancreas. This is a wonderful chapter in the fight against diabetes. It is basically a smartphone-sized gadget that autonomously sends insulin doses into the bloodstream and also takes readings of glucose levels.
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Thus it is a sort of two-in-one device. The approval by the FDA came as a pleasant surprise. It was supposed to come a year from now. Yet it came at the present moment which is a blessing for those suffering from the “sweet sickness” that is diabetes.
Those patients who have type 1 diabetes can just connect the device to their bodies. What this means is that they will not have to undergo the finger-pricking torture that was the routine method before this new page in diabetes opened up.
Termed the Medtronics MiniMed 670G system, it includes a sensor that can measure glucose levels by submerging itself beneath the skin. Also an insulin pump is hooked up right next to the body.
Finally, an infusion patch has a catheter next to it which gives the daily finetuned dosages of insulin to the patient.
“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.”
"With SmartGuard HCL, the ability to automate basal insulin dosing 24 hours a day is a much-anticipated advancement in the diabetes community for the profound impact it may have on managing diabetes - particularly for minimizing glucose variability and maximizing time in the target range," said Richard M. Bergenstal, M.D., principal investigator of the pivotal study and executive director of the Park Nicollet International Diabetes Center in Minneapolis.
"The data from the pivotal trial were compelling and I am confident that this therapy will be well-received by both the clinical and patient community."
"This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with this chronic disease," said Derek Rapp, president and CEO of JDRF, the leading global organization funding type 1 diabetes research.
"We are very encouraged by the speed in which this groundbreaking technology was approved by the FDA, and we are proud of the role JDRF played in achieving this exciting breakthrough. Medtronic and JDRF are committed to ensuring appropriate patient access to this therapy.
“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.”
Many other companies are busy working on devices of their own so as to facilitate diabetic paitients who otherwise have to go through a virtual hell everyday to keep their sugar levels in check.
One person who is a female is reported to have starting sobbing uncontrollably when she heard the news regarding this device, according to NBCNews.
Her son is currently examining it since he suffers from type 1 diabetes and is seeing how it works in case of his blood glucose. Her tears are proof of the miracles wrought by science and the scientific method. Where would we be without science.
The mother whose son had diabetes has said that in the past, she used to worry herself sick over her son’s health. Whether he was at basketball practice or going on a trek, she constantly remained apprehensive regarding his state.
Yet now she may rest her head knowing that he will hopefully be fine in the future. The concern this mother felt about her son was reaching alarming proportions. 5% of diabetics in America have type 1 diabetes. It is basically an auto-immune disease.
The body’s own tissues get destroyed by the devastating ailment. Some of these diabetics even enter a coma and die due to falling glucose levels. A simple mistake by these patients may land them in deep trouble. Now thanks to the artificial pancreas, these hassles will be a thing of the past.
"The FDA approval of the world's first hybrid closed loop system is a culmination of many years of hard work and close collaboration with the clinical and patient communities to generate the body of evidence needed to advance this technology for those living with diabetes," said Francine Kaufman, M.D., chief medical officer of the Diabetes Group at Medtronic.
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"We appreciate the unprecedented speed by which the agency approved our PMA submission to help bring this advanced insulin pump therapy so quickly to U.S. patients living with this challenging disease. We are committed to preparing for commercial launch as quickly as possible while ensuring we provide the most successful rollout of this novel therapy."