The purpose of this study is to use closed-loop systems with the algorithms designed by the University of Virginia and by the Instituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) to determine the infusion of insulin in a prolonged period of time in patients with type 1 diabetes mellitus (T1DM).
Aims: 1. To test University of Virginia closed-loop algorithm with meal announcement for 36 hours at our facilities. 2. To test the ability of the closed-loopInstituto Tecnologico de Buenos Aires (ITBA)/ Universidad Nacional de La Plata (UNLP)/ Universidad Nacional de Quilmes (UNQ) algorithm without meal announcement to maintain glucose control for 2 periods of 12 hours In both cases, the adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.
System connectivity
Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time.
Time frame: 36 hours
Technical fail rate
Time frame: 36 hours
Percentage of time in glycaemia between 70-180 mg/dl
Time frame: 36 hours
Percentage of time in glycaemia between 181-250 mg/dl
Time frame: 36 hours
Percentage of time in hypoglycaemia defined as <70 mg/dl
Time frame: 36 hours
Percentage of time in hyperglycaemia defined as >180 mg/dl
Time frame: 36 hours
Number of all hypoglycaemic events (syntomatic and non syntomatic)
Time frame: 36 hours
Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial
Time frame: 36 hours
Meal composition's effect in the efficacy of the system to control glycaemia
Time frame: 36 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.