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NCT04196140 · ClinicalTrials.gov registry record · NA

Pivotal Omnipod Horizon™ Automated Glucose Control System

A NA study, sponsored by Insulet Corporation.

Completed
Registry status
NA
Development phase
240
Enrollment target

NCT04196140: Completed NA study, sponsored by Insulet Corporation.

NCT04196140 is a NA study that has completed, run by Insulet Corporation. The registered enrollment target is 240 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04196140, a NA study, has completed, sponsored by Insulet Corporation.

COMPLETED
Registry status
NA
Development phase
240 participants
Enrollment target

Study 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.

Primary Outcome

Measure of serious device-related adverse events

Interventions

  • DEVICE Omnipod Horizon™ Automated Glucose Control System

Trial Details

FieldValue
Enrollment Target 240 participants
Start Date 2019-12-30
Est. Completion 2022-04-20
Phase NA
Insulet Corporation

16 total trials

What the finished NCT04196140 record still lists

NCT04196140 is an interventional study that assigns participants to a tested intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 1 intervention - of which Omnipod Horizon™ Automated Glucose Control System is the first listed.

NCT04196140 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04196140 about?

NCT04196140 is a clinical study titled "Pivotal Omnipod Horizon™ Automated Glucose Control System". 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.

What is the current status of trial NCT04196140?

This trial is currently completed. It is a NA study. The enrollment target is 240 participants. The study started on 2019-12-30. Estimated completion is 2022-04-20.

What interventions are being tested in trial NCT04196140?

The interventions under investigation include: Omnipod Horizon™ Automated Glucose Control System (DEVICE).

Who is sponsoring clinical trial NCT04196140?

This trial is sponsored by Insulet Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04196140's enrollment target sits among peer trials

240 440th of 2000 higher than 1,542 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04196140, the US trial registry maintained by the National Library of Medicine. NCT04196140 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.