NCT04113694

Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 291 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).

Detailed description

This study is a multi-center, non-randomized, prospective single arm study with Type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at least every 174 hours. The time of infusion set insertion will be taken from Daily Log. Subjects can expect to participate for approximately 12-16 weeks.

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Extended Infusion Set	Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.

Timeline

• Start date: 2019-10-14
• Primary completion: 2020-11-05
• Completion: 2020-11-05
• First posted: 2019-10-03
• Last updated: 2021-10-01
• Results posted: 2021-10-01

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated device study