This clinical trial is a feasibility study to assess the performance of an Artificial Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with type 1 diabetes. The device is a closed-loop between a DexCom™ SEVEN® PLUS (DexCom™ Corp, San Diego, CA) continuous glucose monitor (CGM) and a OneTouch® Ping® Glucose Monitoring System (Animas Corp, Westchester, PA) subcutaneous insulin delivery pump (CSII). The AP device is controlled by a zone-Model Predictive Control (zone-MPC) algorithm augmented by a safety algorithm named the Health Monitoring System (HMS). The clinical study will include 12 to 20 adults subjects aged 21 to 65 years old.
The study consists of an evaluation of the Artificial Pancreas device during a 24-hour closed-loop in a clinic environment (Sansum Diabetes Research Institute, Santa Barbara, CA). The 24-hour period includes: * 2 unannounced meals (evening dinner and breakfast); * 1 period of 30 minutes of exercise at 50% of the predicted heart rate reserve (HRR) preceded with a snack and followed by a snack 3 hours later (on Day 2); * complete night from 12:00 am to 7:00 am; The subject will arrive at approximately 4:00 pm to the CRC (clinical research center), the closed-loop will be initiated at approximately 4:30 pm that same day and continued until 4:30 pm the next day. A physician will be monitoring the patient with the artificial Pancreas (AP) device at all time. The proposed study will evaluate the performance of the AP device in predicting the fall and rise of glucose values and in regulating insulin delivery to mitigate extreme blood glucose variations during the following challenges: * following unannounced meals, * during a nocturnal period, and * during a period of active exercise. The goal is to demonstrate that the AP device is able to maintain the subject blood glucose within a safe range at all times. One of the objectives of the study will be to measure the percent of time spent in the following zones: * \[80-140\] mg/dL at all times unless described otherwise * \[80-140\] mg/dL during the nocturnal period * \[70-180\] mg/dL postprandial, for 5 hours following the unannounced meals * \[70-150\] mg/dL during and for 3 hours following exercise It is anticipated that following the planned challenges, glucose value might increase temporarily beyond those ranges. These excursions will be reviewed and analyzed (value and duration) and the study will determine how the AP device mitigates those excursions and maintains glucose levels within a safe and acceptable range. The clinical study will also review any event that occur during the course of the 24-hour closed-loop: hypoglycemic events, hyperglycemic events, outside intervention, other Adverse Event, Serious Adverse Events, Unanticipated Adverse Device Effect, and device complaints for the commercial devices used. The safety of the patient will remain the primary goal. The goal of the AP device is to operate without outside intervention even when challenged by meals or exercise unless the outside intervention is requested by the Health Monitoring System (HMS).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
12
The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.
The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.
The CGM, which is an approved device (P050012), measures interstitial glucose.
The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.
The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.
Sansum Diabetes Research Institute
Santa Barbara, California, United States
% of time within zone [80-140] mg/dL except 5 hours post-prandial and during exercise and 3 hours post-exercise
Measures ability of AP device to maintain glucose level within a safe zone and to return to save zone following unannounced meals and exercises.
Time frame: 24 hours
% of time within zone [80-140] mg/dL during night between 12:00 am and 7:00 am
Measures ability of AP device to maintain glucose level with a safe zone during the night and prevent hypoglycemia
Time frame: 24 hours
% of time within zone [70-180] mg/dL 5 hours after unannounced evening meal, and breakfast
Measures ability of AP device to react to small meal and to prevent glucose level from dangerous excursions.
Time frame: 24 hours
% of time within zone [70-150] mg/dL during the 30 min exercise
Measures ability of AP device to maintain safe glucose level during 30 minutes of non-strenuous exercise
Time frame: 24 hours
% of time within zone [70-150] mg/dL during the 3 hours following exercise
Measures ability of AP device to address exercise and to prevent glucose level from dangerous excursions
Time frame: 24 hours
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