Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe for Ambulatory Patients With Type 1 Diabetes

CompletadoClinicalTrials.gov

ID: NCT04793165Tipo: INTERVENTIONALInicio: 8 de mar de 2021Fin estimado: 8 de abr de 2021

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Patient has been diagnosed with T1DM at least two years ago and has been using an insulin pump and a CGM for at least 6 months prior to the trial first visit
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

Criterios de exclusión

Patient has been hospitalized for diabetic ketoacidosis in the last 12 months
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

Intervenciones

device

Non-hybrid closed-loop system with ARG algorithm

To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting

Ubicaciones

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Patrocinadores

PrincipalHospital Italiano de Buenos Aires

ColaboradorInstituto Tecnológico de Buenos Aires

ColaboradorUniversidad Nacional de La Plata

ColaboradorFundación Nuria/Cellex

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