Type 1 Diabetes Clinical Trial
Official title:
Use of Artificial Pancreas in Pediatric Patients. Feasibility , Safety and Efficacy Study of an Automatic Control of Blood Glucose 24/24 at a Diabetes Camp
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.
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