At a glance
ClinicalIndex Comparison RecordN/ACompleted· 80 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.
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort
In Brief
A clinical study evaluating Omnipod Horizon™ Automated Glucose Control System for Type 1 Diabetes Mellitus. Completed, enrolled 80 participants across 10 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--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartSep 2020
Primary CompletionJan 2022
Study CompletionOct 2022
TodayJul 2026
First PostedJul 20, 2020
Enrollment StartSep 8, 2020
Primary CompletionJan 17, 2022
Study CompletionOct 12, 2022
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.0 years ago
Interventions
Omnipod Horizon™ Automated Glucose Control Systemdevice
The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.