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Is the Artificial Pancreas, Without Carbohydrate Counting, Efficient and Safe in an Outpatient Setting

NCT04793165 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-07-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Non-hybrid closed-loop system with ARG algorithm

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

Sponsors & Collaborators

  • Instituto Tecnológico de Buenos Aires

    collaborator OTHER

  • Universidad Nacional de La Plata

    collaborator OTHER

  • Fundación Nuria/Cellex

    collaborator UNKNOWN

  • Hospital Italiano de Buenos Aires

    lead OTHER

Principal Investigators

  • Luis A Grosembacher, MD · Hospital Italiano de Buenos Aires

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-08
Primary Completion
2021-03-14
Completion
2021-04-08

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04793165 on ClinicalTrials.gov