The United States drug authorities (FDA) have raided the way for the approval of a new device to treat type 1 diabetes, which are in the development phase.Specifically, the FDA has published a guide with flexible recommendations to design and test this system that meets the requirements to guarantee its effectiveness and safety.
This document provides researchers and manufacturers flexibility when choosing the end of the study with this device, the number of patients to be analyzed and the duration of clinical trials.It also recommends developing a phase III clinical study, so that the works can be carried out in an ambulatory environment "as soon as possible."
The promoters of the device also have the opportunity to show that the system provides glycemic control, as well as standard therapies, or demonstrate that it offers better glycemic control when compared to other therapies.
According to the director of the Devices and Radiological Health Center of the FDA, Jeffrey Shuren, the FDA is "focused on improving the process for the study and approval of artificial pancreas systems and has developed this guide to provide maximum flexibility to manufacturerswho seek to facilitate this device to American patients. "
"We understand how this device could change the lives of millions of Americans with diabetes and we want their safety and effectiveness to provide patients to provide confidence in which the device works," he says.
Type 1 diabetes is a serious chronic disease, in which the pancreas produces little or no insulin, a hormone necessary for the proper control of glucose levels (sugar) that a blood patient has.
People with type 1 diabetes should control their blood sugar using a glucose meter during the day, calculating how much insulin they need to reduce these levels and administer the necessary dose with a syringe or an insulin pump that distributes it in the subcutaneous tissue.
An artificial pancreas does not require a synthetic tissue or organ.Instead, it combines two medical devices -an insulin pump and a continuous glucose control monitor (CGM), which receives information about glucose levels from a sensor located under the patient's skin.
The pump and monitor work together, controlling glucose levels in the patient and automatically pumping the appropriate dose of insulin, determined through a computer algorithm.
As long as there is no healdisease.
Last June, the FDA published a guide that recognized the agency's expectations on non -clinical tests and clinical trials with the first generation of artificial pancreatic systems, called 'Low Glucose suspend system'.
It is a system that helps eliminate or reduce the severity of the dangerous fall of blood glucose temporarily suspending the administration of insulin when glucose levels approach the lowest levels.
