Upon my nightly adventures of surfing the World Wide Web I came across this article on the Popular Science website announcing the FDA’s approval of the Medtronic MiniMed 530G Insulin pump, praisingly dubbed the first artificial pancreas. The Medtronic device was officially approved by the FDA on September 26, 2013 through the Premarket Approval (PMA) pathway. According to the FDA Approval Letter the MiniMed 530G 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 Diabetes mellitus in persons, sixteen 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 530G System can be programmed to automatically suspend delivery of Insulin when the sensor glucose value falls below a predefined threshold value.
Diabetes mellitus, commonly known as Diabetes, is a group of metabolic disease states in which a person experiences high levels of blood sugar. If left untreated, Diabetes can result in serious long term complications such as cardiovascular disease and chronic renal failure. Insulin is a hormone normally produced by the pancreas that plays an important role in regulating blood sugar levels. Insulin lowers blood sugars by triggering the body to remove excess glucose from the blood and store it as glycogen. However, for patients with Diabetes (primarily Type 1 patients and in some cases those with Type 2) they are unable to produce Insulin and thus lose the ability to regulate their blood sugar level. Insulin pumps counteract this Insulin deficiency by pumping doses of Insulin into the patient’s body, allowing the patient to lower his or her blood sugar. The caveat of current Insulin pumps is that they continue to deliver dosages of Insulin even after blood sugar levels have been brought down to normal levels, thus causing blood sugar levels to potentially reach dangerous low levels and cause loss of consciousness. Currently, patients with Insulin pumps prevent such low levels of blood sugar from occurring by regularly consuming foods that will raise blood sugar levels back to normal. However, this risk of blood sugar dropping to dangerously low levels becomes more severe when considering that it could occur when Insulin pump users are asleep.
What makes the Medtronic MiniMed 530G unique from other Insulin pumps available in the market is that the device is able to detect hypoglycemia (low blood sugar levels) episodes. Upon detection of a hypoglycemia episode the Insulin monitor sounds an alarm to warn the patient that their blood sugar levels are too low. If the patient does not respond or is not capable of responding due to being asleep for example, the MiniMed 530G automatically shuts off administration of Insulin dosages, thus preventing the patient from reaching dangerously low blood sugar levels.
We can expect the MiniMed530G to be available for use in the near future in the US. An important consideration to note is that the MiniMed 530G Insulin pump has been only approved for prescription use for patients 16 years or older. With Type 1 Diabetes, also known as juvenile Diabetes, being associated with primarily young adults, teenagers, and children, we can anticipate that Medtronic is planning to begin studies of the device with children to expand their intended patient population.
The approval of this device is exciting as it offers a device for Diabetes patients that greatly improves their quality of life but also because it hopefully marks the beginning of a wave of artificial organ type devices being approved for use in the US in the future!
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