The objective of this project is to demonstrate that the Dose Safety Controller (DSC) improves the health and lives of persons with Type-1 diabetes (T1D) that have become unaware of hypoglycemia.
This research aims to show that an artificial pancreas (AP) device using the DSC will 1) safely &effectively control blood glucose for T1D patients with hypoglycemic unawareness, 2) restore awareness of hypoglycemia &cognitive performance after 3 weeks and maintain awareness at 3 months and 3) improve the quality of life &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: 1) a 24-hour CRC study using the DSC with constant medical &engineering monitoring with controlled food &exercise, 2) followed for 3 weeks without use of the DSC on self-care to establish statistical control, 3) closely monitored for 3 days in a hotel using the DS, 4) followed for 18 days of guarded study at home using the DSC, 5) followed for the remainder of 3 months in an unguarded outpatient setting at home using the DCS. Through this progression it is expected that the DSC will automatically keep the participant's blood glucose level within near normal range, which is expected to restore the participant'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 3 weeks (end of study 2) at the end of the guarded study at home (study 4) and at 3 months (end of study 5). 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.
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 24-hour study in a hospital Clinical Research Center and ending with a 3-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.