The primary purpose of this study is the evaluate an Artificial Pancreas during 2 months in home setting in Type 1 Diabetic patients
During this study, we propose to assess an Artificial Pancreas in a group of Type 1 diabetic patients who will participate in two study periods of two-month duration with an insulin pump and a Continuous Glucose Monitoring (CGM) device. During one of these periods, called HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day. During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times. Overall, an increase of time spent in range when using artificial pancreas in the hybrid period should be observed with a reduction of both hypo and hyperglycemia episodes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
CHU Montpellier
Montpellier, France
University of Padova
Padova, Italy
University of Amsterdam
Amsterdam, Netherlands
Percent time spent in target range (3.9-10.0 mmol/L or 70-180 mg/dL) during each study period
Time frame: during 2 months-hybrid period and during 2 months-open period
Low Blood Glucose Index (LBGI)
Time frame: for each period of 2 month (hybrid period and open period)
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