This is a pilot, interventional clinical trial to assess the effectiveness and safety of artificial pancreas (AP) using the ARG algorithm closed-loop system in a monitored 3-day period outpatient study. Once the safety of the device has been validated in the open-loop first 3-day period (continuous subcutaneous insulin infusion (CSII) plus continuous glucose monitoring (CGM)) the investigators will move the study to the second 3-day closed-loop period, without carbohydrate (CHO) counting.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
5
To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting.
Percent of time in each range according to sensor glucose readings
Time frame: 3 days
To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range).
Percent of time in the target range of 70-180 mg/dl according to sensor glucose readings
Time frame: 3 days
To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl.
Percent of time in range of less than 70 mg/dl according to sensor glucose readings
Time frame: 3 days
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