Trials / Completed
CompletedNCT04320069
Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study
Evaluating the Safety and Effectiveness of the Omnipod Horizon™ CGM-informed Bolus Calculator in Patients With Type 1 Diabetes
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 25 (actual)
- Sponsor
- Insulet Corporation · Industry
- Sex
- All
- Age
- 2 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Subjects will use the Omnipod Horizon™ System in Manual Mode in an outpatient setting for 14-days. Subjects will be trained to use the Manual Mode feature of the Omnipod Horizon™ System including how to use the bolus calculator using manual entry of blood glucose values or by using the CGM-informed bolus calculator.
Detailed description
The study schedule consists of two outpatient phases: 1. 7 days of Omnipod Horizon™ use in Manual Mode without a connected CGM using manual entry of BG values to deliver boluses (Phase 1) followed by; 2. 7 days of Omnipod Horizon™ use in Manual Mode with a connected CGM using the CGM-informed bolus calculator to deliver boluses (Phase 2) Following subject screening, system training and enrollment, subjects will commence the first 7-day Manual Mode phase of the study. Subjects will be trained to use the Manual Mode feature of the system including how to use the bolus calculator using manual entry of BG values or by using the CGM-informed bolus calculator. After completion of the first 7 days of the Manual Mode phase using the Omnipod Horizon™ without a connected CGM, subjects will transition to the next 7 days of the Manual Mode phase using the system with a connected CGM using the CGM-informed bolus calculator to deliver boluses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Omnipod Horizon™ Automated Glucose Control System | Omnipod Horizon™ Automated Glucose Control System use in Manual Mode |
Timeline
- Start date
- 2020-06-09
- Primary completion
- 2020-09-29
- Completion
- 2020-09-29
- First posted
- 2020-03-24
- Last updated
- 2023-11-13
- Results posted
- 2023-11-13
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04320069. Inclusion in this directory is not an endorsement.