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| Name | Class |
|---|---|
| Instituto Tecnológico de Buenos Aires | OTHER |
| Universidad Nacional de La Plata | OTHER |
| Universidad Nacional de Quilmes | UNKNOWN |
| University of Virginia |
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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:
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UVa and ITBA/UNLP algorithm arm | Experimental | To control glycaemia in T1DM patients through UVa and ITBA/UNLP algorithm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| System connectivity | Adequate operation of the system will be considered verified if the system works properly at least 80% of the total connection time. | 36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Technical fail rate | 36 hours | |
| Percentage of time in glycaemia between 70-180 mg/dl | 36 hours | |
| Percentage of time in glycaemia between 181-250 mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldo H Belloso, MD | Hospital Italiano de Buenos Aires | Study Director |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER |
| Fundación Nuria/Cellex | UNKNOWN |
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| 36 hours |
| Percentage of time in hypoglycaemia defined as <70 mg/dl | 36 hours |
| Percentage of time in hyperglycaemia defined as >180 mg/dl | 36 hours |
| Number of all hypoglycaemic events (syntomatic and non syntomatic) | 36 hours |
| Comparison of glycaemic profiles during the trial with glycaemic profiles in the days before the trial | 36 hours |
| Meal composition's effect in the efficacy of the system to control glycaemia | 36 hours |