NCT04196140

Pivotal Omnipod Horizon™ Automated Glucose Control System

Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (actual)
• Sponsor: Insulet Corporation · Industry
• Sex: All
• Age: 6 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and an optional 12-month extension phase.

Detailed description

The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. Subjects will undergo a 14-day outpatient, standard therapy phase (Phase 1 or ST) during which sensor and insulin data will be collected. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. This will be followed by a 94-day (13-week) hybrid closed-loop phase (Phase 2), conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 12 months (Phase 3). During the hybrid closed-loop phase, there will be supervised exercise challenges. A subset of subjects will participate in 5-days of supervised Meal and Exercise challenges. A subset of subjects will participate in 3-days of supervised HypoProtect Exercise challenges where comparisons were made between exercising in Automated Mode vs initiating HypoProtect 60 minutes prior to exercise vs initiating HypoProtect 30 minutes prior to exercise. The hybrid closed-loop phase will begin on Study Day 1.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Omnipod Horizon™ Automated Glucose Control System	The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery

Timeline

• Start date: 2019-12-30
• Primary completion: 2020-07-10
• Completion: 2022-04-20
• First posted: 2019-12-12
• Last updated: 2025-04-03
• Results posted: 2024-05-14

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study