NCT04793165

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Hospital Italiano de Buenos Aires · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

• Type 1 Diabetes
• Autoimmune Diabetes

Interventions

Type	Name	Description
DEVICE	Non-hybrid closed-loop system with ARG algorithm	To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting

Timeline

• Start date: 2021-03-08
• Primary completion: 2021-03-14
• Completion: 2021-04-08
• First posted: 2021-03-11
• Last updated: 2021-07-30

Locations

1 site across 1 country: Argentina