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| Name | Class |
|---|---|
| Instituto Tecnológico de Buenos Aires | OTHER |
| Universidad Nacional de La Plata | OTHER |
| Fundación Nuria/Cellex | UNKNOWN |
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This is a pilot, interventional clinical trial to assess the effectiveness and safety of artificial pancreas (AP) using the ARG algorithm closed-loop system in a monitored 3-day period outpatient study. Once the safety of the device has been validated in the open-loop first 3-day period (continuous subcutaneous insulin infusion (CSII) plus continuous glucose monitoring (CGM)) the investigators will move the study to the second 3-day closed-loop period, without carbohydrate (CHO) counting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-hybrid closed-loop system | Experimental | To compare two types of treatments: During the first 3 days: Previous or conventional, with CSII plus CGM in open loop. During the second 3 day period: AP with CSII plus CGM in a closed-loop system, through the ARG algorithm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-hybrid closed-loop system with ARG algorithm | Device | To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness and safety of AP treatment without CHO counting in an outpatient setting. | Percent of time in each range according to sensor glucose readings | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the percentage of time with glycemic levels from 70 to 180 mg/dl (time in range). | Percent of time in the target range of 70-180 mg/dl according to sensor glucose readings | 3 days |
| To determine, as a safety parameter, the percentage of time with glycemic levels less than 70 mg/dl. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis A Grosembacher, MD | Hospital Italiano de Buenos Aires | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29998754 | Background | Sanchez-Pena R, Colmegna P, Garelli F, De Battista H, Garcia-Violini D, Moscoso-Vasquez M, Rosales N, Fushimi E, Campos-Nanez E, Breton M, Beruto V, Scibona P, Rodriguez C, Giunta J, Simonovich V, Belloso WH, Chernavvsky D, Grosembacher L. Artificial Pancreas: Clinical Study in Latin America Without Premeal Insulin Boluses. J Diabetes Sci Technol. 2018 Sep;12(5):914-925. doi: 10.1177/1932296818786488. Epub 2018 Jul 12. | |
| 35549733 |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Percent of time in range of less than 70 mg/dl according to sensor glucose readings |
| 3 days |
| Derived |
| Garelli F, Fushimi E, Rosales N, Arambarri D, Mendoza L, Serafini MC, Moscoso-Vasquez M, Stasi M, Duette P, Garcia-Arabehety J, Giunta JN, De Battista H, Sanchez-Pena R, Grosembacher L. First Outpatient Clinical Trial of a Full Closed-Loop Artificial Pancreas System in South America. J Diabetes Sci Technol. 2023 Jul;17(4):1008-1015. doi: 10.1177/19322968221096162. Epub 2022 May 12. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |