The FDA has just announced approval for the 1st all-in-one artificial pancreas, giving new hope for approximately 29 million type 1 diabetics (about 5% of the population) in the US, and eliminating the need for constant self-checking of Blood Sugar Levels throughout the day. and injections to compensate for fluctuations.
Instead, the device, known as the MiniMed 670G, includes a special sensor is designed to monitor a person’s Blood Sugar levels under the skin automatically, and administer insulin as needed via a “hybrid closed loop” system in which insulin is pumped into the body through an infusion patch with a catheter worn on the outside of the body.
While there have been other artificial pancreases available on the market fir a number of years, most systems incorporate three types of devices; a continuous glucose monitoring system, an insulin infusion pump, and a glucose meter. The CGM and pump are connected through a computer-controlled algorithm, which permits them to communicate with each other constantly. The MiniMed 670G is the first to combine a monitor and pump in the same machine.
According to Jeffrey Shoorin of the FDA, “the device measures blood sugar every five minutes, then responds by sending insulin into the body, or holding steady.” Meanwhile, diabetics can also manually request insulin to correspond with meals.
Diabetes is an autoimmune disease that causes the body to (mistakenly) attacks cells in the pancreas designed to produce the hormones insulin and glucagon, leaving them unable to properly absorb and process sugar. While insulin enables the body to use sugar (glucose) from carbohydrates for energy, glucagon triggers the liver into releasing stored glucose, which raises blood sugar levels.
High levels of glucose can result in reparable damage to minute blood vessels, which in turn can lead to blindness, heart disease, stroke and kidney failure. In some extreme cases, patients have also had to have their lower extremities (toes, feet or legs) amputated due to the problems with circulation caused by the disease.
Although the MiniMed 670G is currently to be used by type 1 diabetics over the age of 14, the manufacturers, Medrontic reports it is working on new trials to see if it can be adapted for juveniles 7-14 years of age. If possible, this could provide major relief to parents who worry about monitoring their children while they are away from home, whether at school, camp or simply visiting friends, etc.
“We are committed to preparing for commercial launch as quickly as possible,” stated Dr. Francine Kaufman, MD., chief medical officer of the Diabetes Group at Medtronic.
Although a clinical trial involving 123 patients showed that there were no major side effects connected to use of the monitor/pump device, the FDA did note that possible risks ”may include hypoglycemia, hyperglycemia, as well as skin irritation or redness around the device’s infusion patch.”
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