Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System
NCT03959423 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288
Last updated 2025-01-14
Summary
This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.
Conditions
- Type 1 Diabetes Mellitus
Interventions
- DEVICE
-
AHCL insulin pump system
670G 4.0 system with GS3; 780G system with G4S (continued access phase);
Sponsors & Collaborators
-
Medtronic Diabetes
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 7 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-07-24
- Primary Completion
- 2021-03-17
- Completion
- 2023-10-27
- FDA Device
- Yes
Countries
- United States
Study Locations
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