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Pivotal Omnipod Horizon™ Automated Glucose Control System

NCT04196140 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2025-04-03

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Omnipod Horizon™ Automated Glucose Control System

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

Sponsors & Collaborators

  • Insulet Corporation

    lead INDUSTRY

Principal Investigators

  • Bruce Buckingham, MD · Stanford University

  • Sue Brown, MD · University of Virginia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2020-07-10
Completion
2022-04-20
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04196140 on ClinicalTrials.gov