NCT05224258

Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®

Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp® (Insulin Aspart Injection)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 7 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.

Detailed description

This global study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed 780G system using Fiasp insulin as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long. A total of up to 250 subjects with insulin-requiring type 1 diabetes age 7-80 will be enrolled at up to 25 investigational centers across the United States, Canada, and Australia in order to have 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (7-17 years of age), up to 125 in the adult age group (18 years or older)

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	MiniMed 780G System	780G System used with Insulin Fiasp® (Insulin Aspart Injection)

Timeline

• Start date: 2022-03-17
• Primary completion: 2024-06-21
• Completion: 2024-06-21
• First posted: 2022-02-04
• Last updated: 2025-06-22
• Results posted: 2025-06-22

Locations

18 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated device study