The purpose of this study is to determine safety, feasibility and efficacy (with respect to sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night closed-loop control in children and adolescents with type 1 diabetes.
The AP prototype is based on a Modular Model Predictive Control algorithm (MMPC) implemented on the Diabetes Assistant (DiAs) wearable platform. The study will be divided in two parts: the first part will serve as a 3 days pilot study and will be conducted in a hotel/residence near the hospital. The investigators will recruit 6/8 children (5-12 years) and/or 6/8 adolescents (12-18 years), with type 1 diabetes who have experience with insulin pump. DiAs will be used 72 continuous hours of day and night. If part 1 will be successfully, after about 2-3 months, the study will move to the second part (the main part), that will consist in cross-over randomized study that will be conducted in a camp setting. The participants will be randomly assigned to the treatment arm (Artificial Pancreas) or to the control arm (sensor-augmented insulin pump). Then the same patient will be assigned to the other arm. Each treatment will be applied 3 consecutive days. During the first period (days 1-3) patients will do the same activites and will have the same diet as in the second period (day s 5-7). The investigators will recruit 30/40 children (5-12 years) and/or 30/40 adolescents (12-18 years), affected by type 1 diabetes who have experience with insulin pump therapy. The study has the permission of the Ethics Committee reference and the permission for "clinical investigation with devices not CE marked" by the Health Ministry.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.
During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas
University of Padova
Padua, Italy
Percentage of Time Spent With Blood Glucose < 3.9 mmol/L (or 70 mg/dl)
percentage of time spent in hypoglicemia (\< 70 mg/dl or 3.9 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial Pancreas and SAP period
Time frame: 3 days
Percentage of Time Spent in Target Range (70-180 mg/dl or 3.9-10.0 mmol/L)
percentage of time spent in target range (70-180 mg/dl or 3.9-10.0 mmol/L) both during day and night. All analyses will include a comparison of the results in Artificial pancraes and SAP period
Time frame: 3 days
Percentage of Time Artificial Pancreas is Active
percentage of time that the system worked without any technical problem
Time frame: 3 days
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