Boston, MA 10/15/2014 (wallstreetpr) – On Tuesday, Medtronic, Inc. (NYSE:MDT) announced that it has initiated a pivotal study for the treatment of diabetes with its breakthrough technology, called the Predictive Low Glucose Management (PLGM).
Medtronic posted an article in its newsroom that informed that Medtronic, Inc. (NYSE:MDT) has enrolled the first set of patients in its investigational device exemption (IDE) research on the PLGM technology. The step is a significant advancement towards developing an artificial pancreas in the U.S.
Chief Objectives
According to the announcement, the trial aims at evaluating the safety of Medtronic, Inc. (NYSE:MDT)’s next-generation integrated insulin pump with its continuous glucose monitoring (CGM) system. The CGM system is s designed as to inhibit insulin delivery automatically when a predefined level of glucose is predicted to attain the lowest limit of tolerance. This is done using a sensor that measures the glucose levels. As the desired limit is reached, the system again automatically resumes delivery of insulin. Medtronic seeks to help diabetic patients to manage the problems related to the traditional insulin therapies for hypoglycemia and hyperglycemia. The two conditions, respectively, cause low and high sugar levels in diabetic patients’ blood.
The primary aim of this study is to assess the safety of the PLGM work-flow pattern using the new sensor. It will also evaluate the system’s capability to prevent hypoglycemia, which occurs quite commonly and is a major concern in the management of the disease. The condition of hypoglycemia poses a threat of causing unresponsiveness and confusion. In extreme cases, hypoglycemia an also result into death of the patient.
Medtronic, Inc. (NYSE:MDT)’s study will evaluate the efficacy of the system on as many as 84 patients, who are enrolled at around eight facilities across the U.S. The study deploys a fourth-generation sensor along with latest intelligent sensor diagnostic equipment. The new diagnostics are 80% smaller as compared to the Enlite sensor that is currently used in the country. In addition, the study also uses a new MiniMed design of insulin pump.
