Trials / Completed
CompletedNCT02897557
Insulet Artificial Pancreas Early Feasibility Study
A Prospective Early Feasibility Study to Assess the Performance of the Insulet Artificial Pancreas (AP) System Using the OmniPod® Insulin Management System and the Dexcom G4® Share™ AP System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 59 (actual)
- Sponsor
- Insulet Corporation · Industry
- Sex
- All
- Age
- 6 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The purpose is to perform an early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the OmniPod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Insulet Artificial Pancreas (AP) System |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2017-02-01
- Completion
- 2017-03-01
- First posted
- 2016-09-13
- Last updated
- 2021-04-09
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02897557. Inclusion in this directory is not an endorsement.