I definitely understand where you are coming from. But, I just was quoting the wording that my insurance company used in their documents. They also had this listed below. So I guess the FDA uses this phrasing too? I’m not sure. Well unless the person who put the document together with my insurance company misquoted the FDA.
“According to the U.S. Food and Drug Administration (FDA), an artificial pancreas is a medical device that links a glucose monitor to an insulin infusion pump and the pump automatically reduces and increases subcutaneous insulin delivery according to measured subcutaneous glucose levels using a control algorithm. Because control algorithms can vary significantly, there are a variety of artificial pancreas device systems currently under development. These systems span a wide range of designs from a low-glucose suspend (LGS) device systems to the more complex bihormonal control-to-target systems. A 2016 horizon scan review identified 18 automated “closed-loop ” or semi-automated systems under development worldwide.
FDA has described 3 main categories of artificial pancreas device systems: threshold suspend device, control-to-range, and control-to-target systems. With threshold suspend device systems, also called LGS systems, the delivery of insulin is suspended for a set time when 2 glucose levels are below a specified low level indicating hypoglycemia. With control-to-range systems, the patient sets his or her own insulin dosing within a specified range, but the artificial pancreas device system takes over if glucose levels outside that range (higher or lower). Patients using this type of system still need to check blood glucose levels and administer insulin as needed. With control-to-target systems, the device aims to maintain glucose levels near a target level (e.g., 100 mg/dL). Control-to-target systems are automated and do not require user participation except to calibrate the continuous glucose monitoring system. Several device subtypes are being developed: those that deliver insulin-only, bihormonal systems, and hybrid systems.
To date, 3 artificial pancreas device systems have been approved by FDA. Two are threshold suspend devices. The other includes a threshold suspend feature and a semiautomatic adjustment of basal insulin levels. The third device uses a combination of control-to-range and control-to- target strategies.”