Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting
NCT ID: NCT04793165
Last Updated: 2021-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
5 participants
INTERVENTIONAL
2021-03-08
2021-04-08
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Non-hybrid closed-loop system
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.
Non-hybrid closed-loop system with ARG algorithm
To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
Interventions
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Non-hybrid closed-loop system with ARG algorithm
To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
Eligibility Criteria
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Inclusion Criteria
* Patient is \>18 and \<65 years
* Patient has HbA1c \< 10%
* Woman in premenopausal age agrees to use contraceptive methods
* Woman in premenopausal age has negative B-HCG in the tests performed in the trial
* Patient is trained in CHO counting
* Patient has signed informed consent and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled visits
Exclusion Criteria
* Patient has experienced severe hypoglycemia with loss of consciousness in the last 12 months
* Patient has a history of coronary disease or cardiac failure
* Patient with uncontrolled arterial hypertension
* Patient with a condition that makes the researcher believe that it might increase the chance of hypoglycemia
* Patient has symptoms compatible with active infectious disease
* Patient has Cystic Fibrosis
* Pregnant women, or women with the intention of getting pregnant; women breastfeeding
* Patient has been hospitalized for psychiatric treatment in the last 6 months.
* Patient with a diagnosis of adrenal disease
* Patient has abnormal laboratory values for liver function: transaminase \> 2x upper limit normal
* Patient has abnormal laboratory values for renal function: GFR \< 60 ml/min/1.73m2
* Patient has active gastroparesis
* Patient is under oncological treatment
* Patient has taken acetaminophen 72 hours previous to the study
18 Years
65 Years
ALL
No
Sponsors
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Instituto Tecnológico de Buenos Aires
OTHER
Universidad Nacional de La Plata
OTHER
Fundación Nuria/Cellex
UNKNOWN
Hospital Italiano de Buenos Aires
OTHER
Responsible Party
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Principal Investigators
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Luis A Grosembacher, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Italiano de Buenos Aires
Locations
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Hospital Italiano de Buenos Aires
Buenos Aires, , Argentina
Countries
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References
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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.
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.
Other Identifiers
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5302
Identifier Type: -
Identifier Source: org_study_id