20
Participants
Start Date
March 31, 2014
Primary Completion Date
July 31, 2015
Study Completion Date
October 31, 2015
Closed-loop insulin infusion system
"Each subject will undergo two Open-loop and two Closed-loop meal tests, each one at 1-2 week intervals, thus completing the 4 experiments in about 6 weeks. The day of the experiment, a standard mixed meal test containing 60 g of carbohydrates (CHO), will be administered. On two occasions, patients will receive in a randomized order the standard insulin bolus based on the individual insulin to CHO ratio (First arm, Open-loop study). On the other two occasions they will receive a Sliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration, based on subcutaneous continuous glucose monitoring (Second arm, Closed-loop study). Commercial insulin infusion systems and continuous glucose monitoring devices will be used."
Open-loop insulin infusion system
Standard subcutaneous insulin infusion based on the individual insulin to carbohydrate ratio. Commercial insulin infusion systems and continuous glucose monitoring devices will be used.
Hospital Clínico Universitario de Valencia, Valencia
Hospital Clínic i Universitari de Barcelona, Barcelona
Hospital Clinic of Barcelona
OTHER
Universitat Politècnica de València
OTHER
Universitat de Girona
OTHER
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER