This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. Specifically, the investigators will test zone model predictive control AP that will be enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios (CR).
This clinical trial is a study to assess the performance of an automated glucose control system (Artificial Pancreas, AP) device in home settings for subjects with type 1 diabetes. Specifically, the investigators will test zone model predictive control AP that will be enhanced by run-to-run optimizations of basal rates (BR) and insulin to carbohydrate ratios (CR). This protocol builds on the investigators previously validated Zone-MPC and Health Monitoring System (HMS) algorithms (ClinicalTrials.gov: NCT01929798) integrated into the Diabetes Assistant (DiAs) system (ClinicalTrials.gov: NCT02463682). The same AP system used in NCT02463682 will now be used with algorithmic adjustment of CR's prior to closed-loop initiation, and continued BR and CR algorithmic optimization during closed-loop use for a longer duration. The system will be evaluated on up to 12 subjects per site (n=36 subjects) for 15 weeks at 3 different sites (William Sansum Diabetes Center, University of Virginia, and Mayo Clinic, Rochester, MN).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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 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
Change in Hemoglobin A1c (HbA1c) (%) from baseline (week 2) to end of week 15 (end of study), with A1c measured at weeks 7 and 11 as well for repeated measures.
The primary endpoint is change in HbA1c from baseline (end of week 2) to end of week 15 (end of study). HbA1c will be measured at weeks 7 and 11 as well following each adaptation period, so the overall design of the study includes 4 repeated measures and a baseline-end of study contrast.
Time frame: 13 Weeks
Time within the target range for glucose 70-180 mg/dl overall
Time within the target range for glucose 70-180 mg/dl overall, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.
Time frame: 1 week
Time within the tight target range for glucose 80-140 mg/dl overnight
Time within the tight target range for glucose 80-140 mg/dl overnight, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.
Time frame: 1 week
Time within the target range for glucose 70-150 mg/dl postprandial within 5 hours following meals
Time within the target range for glucose 70-150 mg/dl postprandial within 5 hours following meals, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.
Time frame: 1 week
Markers of hypo- and hyperglycemia
Markers of hypo- and hyperglycemia, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use. These markers include LBGI (Low blood glucose index) and HBGI (High blood glucose index.
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Time frame: 1 week
Insulin Doses Given
Change in insulin doses given, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.
Time frame: 1 week
Treatments for hypoglycemia
Treatments for hypoglycemia between the open and closed-loop phases of the study, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.
Time frame: 1 week
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: 12 weeks
Outside interventions needed.
Outside interventions needed to aid with treatment during closed-Loop control.
Time frame: 12 weeks
Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).
Failure analysis of the devices/connectivity issues that may occur during closed-Loop control. This includes number of CGM communication losses with 3 or more missed points, and number of times the entire system required a restart
Time frame: 12 weeks
Time with glucose ≤ 70 mg/dL, overall
Time with glucose ≤ 70 mg/dL, compared between sensor-augmented pump use (open loop care, week 2) and adapted closed-loop control (final week of each month) to determine the feasibility of long-term system use.
Time frame: 1 week