The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system. The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps.
Montpellier University Hospital
Montpellier, France
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl): * in the basal or late postprandial period * in the early postprandial period (first 4 hours). All analyses will be done by using the YSI blood glucose measurements unless otherwise noted.
Time frame: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Mean and standard deviation blood glucose
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Time frame: For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Time frame: during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
Percentage of time spent in hyperglycemia
* Percentage of time spent in hyperglycemia with blood glucose \>10 mmol/l (180 mg/dl) in the early postprandial period * and Percentage of time spent in hyperglycemia\>8mmol/l (144 mg/dl) in the basal or late postprandial period All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days
Time frame: in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal)
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