This is a feasibility study of an artificial pancreas (AP) system with our previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system.
This is a feasibility study of an artificial pancreas (AP) system with our previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTraisl.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system. The system will be evaluated on 2-3 subjects per site (n=6-9 subjects) for 2 weeks at 3 different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic, Rochester, MN). Basal rates will be adjusted in a run-to-run manner by study physicians prior to the closed-loop phase for a maximum of 3 weeks. Subjects will then complete 2 weeks at home use of the Zone-MPC/HMS system using the DIAs platform for a closed-loop feasibility trial. The purpose of this pilot study is to establish that safe day-and-night use of the Zone-MPC/HMS system integrated into the DiAs is achievable in the home environment, to analyze and learn to improve upon the run-to- run optimization process, and to collect efficacy data to inform a future larger study.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump
The devices that will be used in the Closed-Loop Control System include the following components: DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)
William Sansum Diabetes Center
Santa Barbara, California, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Virginia
Charlottesville, Virginia, United States
Safety and efficacy of the system, as assessed by the composite outcome of time in range for glucose levels of 70-180 mg/dL and time < 70 mg/dL.
The primary endpoint for this pilot study will be to determine the safety and efficacy of the system, as assessed by the composite outcome of time in range for glucose levels of 70-180 mg/dL and time \< 70 mg/dL, comparing between sensor-augmented pump use (open loop care) (week 1) to closed-loop care (final week), so as to determine the feasibility of eventual long-term use of the system.
Time frame: 1 Week
Time in range for glucose 80-140 mg/dL
Time in range for glucose 80-140 mg/dL at all times unless described otherwise.
Time frame: 1 Week
Time in range for glucose during the nocturnal period
Time in range for glucose 70-180 mg/dL during the nocturnal period.
Time frame: 1 week
Time in Range Postprandial
Time in range for glucose 70-180 mg/dL postprandial, for 5 hours following all meals
Time frame: 1 Week
Markers of hypo- and hyperglycemia
Markers of hypo- and hyperglycemia.
Time frame: 1 Week
Insulin Doses Given
Change in insulin doses given between the open and closed-loop phases of the study.
Time frame: 1 Week
Treatments for hypoglycemia
Treatments for hypoglycemia between the open and closed-loop phases of the study.
Time frame: 1 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of alerts given by the HMS to prevent hypoglycemia
Number of alerts given by the HMS to prevent hypoglycemia during closed-Loop control.
Time frame: 2 Weeks
Outside interventions needed
Outside interventions needed to aid with treatment during closed-Loop control.
Time frame: 2 Weeks
Failure analysis of the devices/connectivity issues that may occur.
Failure analysis of the devices/connectivity issues that may occur during closed-Loop control.
Time frame: 2 Weeks