Omnipod 5 System Compared to Pump Therapy

Status Active, not recruiting

Clinical Trial Summary

Subject will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 90-day outpatient phase where subjects will either use the Omnipod 5 system or continue to use their personal insulin pump with the study provided continuous glucose monitoring system.

Clinical Trial Description

This is an outpatient study that consists of two phases, Phase 1 and Phase 2. There will be approximately 8 study visits conducted in person or via telehealth. Phase 1 is a 14-day period to collect baseline sensor and insulin data where subjects will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system. Phase 2 is a 90-day period where subjects will be randomized into one of two groups. One group will use the Omnipod 5 system and the other group will continue to use their personal insulin pump with the study continuous glucose monitoring system. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05409131
Study type	Interventional
Source	Insulet Corporation
Contact
Status	Active, not recruiting
Phase	N/A
Start date	July 7, 2022
Completion date	January 10, 2025

View Details

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