CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Omnipod Horizon™ Automated Glucose Control Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04196140
NCT04196140N/ACompleted

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

Insulet Corporation·interventional·Posted Dec 12, 2019·Updated Apr 3, 2025

In Brief

A clinical study evaluating Omnipod Horizon™ Automated Glucose Control System for Type 1 Diabetes Mellitus. Completed, enrolled 240 participants across 16 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedDec 12, 2019
Enrollment StartDec 30, 2019
Primary CompletionJul 10, 2020
Study CompletionApr 20, 2022
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.6 years ago

Interventions

Omnipod Horizon™ Automated Glucose Control Systemdevice

The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery