NCT03959423

Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 7 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.

Detailed description

The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting. The main objective in conducting this research is to collect data from patients who use the AHCL system at home, at work, at school and everywhere else. Subjects will use 670G 4.0 system with Guardian Sensor 3 (GS3) during study period, and will be allowed to participate in continued access phase, and use 670G 4.0 system with GS3 and 780G system with Guardian 4 Sensor (G4S).

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	AHCL insulin pump system	670G 4.0 system with GS3; 780G system with G4S (continued access phase);

Timeline

• Start date: 2019-07-24
• Primary completion: 2021-03-17
• Completion: 2023-10-27
• First posted: 2019-05-22
• Last updated: 2025-01-14
• Results posted: 2022-04-08

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study