Pivotal Omnipod Horizon™ Automated Glucose Control System
Public ClinicalTrials.gov record NCT04196140. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT04196140
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 240 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 30, 2019 (Actual)
- Primary completion
- Jul 10, 2020 (Actual)
- Completion
- Apr 20, 2022 (Actual)
- Last update posted
- Apr 3, 2025
2019 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94305 | — |
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | — |
| University of Colorado Denver | Denver | Colorado | 80045 | — |
| Yale University | New Haven | Connecticut | 06511 | — |
| Atlanta Diabetes | Atlanta | Georgia | 30318 | — |
| East Coast Institute for Research | Macon | Georgia | 31210 | — |
| Northwestern University | Evanston | Illinois | 60208 | — |
| Iowa Diabetes | West Des Moines | Iowa | 50265 | — |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | — |
| International Diabetes Center | Saint Louis Park | Minnesota | 55416 | — |
| Mount Sinai | New York | New York | 10029 | — |
| SUNY Syracuse | Syracuse | New York | 13244 | — |
| University Hospitals Cleveland | Cleveland | Ohio | 44106 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Virginia | Charlottesville | Virginia | 22904 | — |
| University of Washington | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04196140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 3, 2025 · Synced Oct 16, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04196140 live on ClinicalTrials.gov.