Trials / Completed
CompletedNCT03966911
Performance Evaluation of an Advanced Algorithm With CGM in Adults, Adolescents, and Pediatrics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 335 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 2 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Detailed description
The study is a multi-center, prospective, single-sample correlational design without controls. The purpose of this study is to demonstrate the performance of the Guardian™ Sensor (3) with an advanced algorithm in subjects age 2 - 80 years, for the span of 170 hours (7 days).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter | Continuous Glucose Monitoring and frequent sample testing |
Timeline
- Start date
- 2019-06-14
- Primary completion
- 2020-05-13
- Completion
- 2020-05-13
- First posted
- 2019-05-29
- Last updated
- 2021-06-07
- Results posted
- 2021-06-07
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03966911. Inclusion in this directory is not an endorsement.