DOSE SAFETY INC — Department of Health and Human Services SBIR Phase II: 200

Description

DESCRIPTION provided by applicant The objective of this project is to demonstrate that the Dose Safety Controller DSC improves the health and lives of persons with Type diabetes T D that have become unaware of hypoglycemia This research aims to show that an artificial pancreas AP device using the DSC will safely andamp effectively control blood glucose for T D patients with hypoglycemic unawareness restore awareness of hypoglycemia andamp cognitive performance after weeks and maintain awareness at months and improve the quality of life andamp emotional symptoms to the end of the study This is accomplished through studies conducted at three locations a in a hospital clinical research center CRC b in a guarded outpatient setting and c in an unguarded outpatient setting at home Five study scenarios will be used a hour CRC study using the DSC with constant medical andamp engineering monitoring with controlled food andamp exercise followed for weeks without use of the DSC on self care to establish statistical control closely monitored for days in a hotel using the DS followed for days of guarded study at home using the DSC followed for the remainder of months in an unguarded outpatient setting at home using the DCS Through this progression it is expected that the DSC will automatically keep the participantandapos s blood glucose level within near normal range which is expected to restore the participantandapos s awareness of the onset of hypoglycemia Restoration of hormone response to low blood glucose will be tested using the hypoglycemia unawareness assessment HUA prior to use of the DSC at weeks end of study at the end of the guarded study at home study and at months end of study Patient Reported Outcomes and Cognitive Function will be assessed at the same times It is expected that improved glucose control provided by the DSC will be reflected in increased awareness of the onset of hypoglycemia The ultimate business goal of Dose Safety is the incorporation of the DSC software in a commercialized AP device These studies could validate the use of an AP by a specific group of patients which could lead to acceptance by the medical field and insurance companies of its use by those who have lost their awareness of hypoglycemia It is expected that the successful completion of these studies will validate the use of the DSC software in subsequent pivotal trials of a prototype commercial AP device PUBLIC HEALTH RELEVANCE Successful completion of this study could produce a fully automated closed loop commercially available and mobile artificial pancreas AP controller that is safe and effective for use by persons with diabetes who have Impaired Awareness of Hypoglycemia IAH The Dose Safety AP Controller DSC will be tested in a progression of clinical studies beginning with a hour study in a hospital Clinical Research Center and ending with a month outpatient study at home The resulting software program will be offered to diabetes medical device manufactures as a choice for an AP control algorithm for those with diabetes who have IAH