Trials / Withdrawn
WithdrawnNCT02646878
A Feasibility Study to Evaluate the Performance of the Harmony 1 Sensors in Adults and Pediatrics
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Medtronic MiniMed, Inc. · Industry
- Sex
- All
- Age
- 14 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to demonstrate the performance of the Harmony 1 Sensor in subjects age 14 - 75 years.
Detailed description
The study is a multi-center, prospective single-sample correlational design without controls.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Harmony 1 Sensor | Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2016-01-06
- Last updated
- 2017-11-20
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02646878. Inclusion in this directory is not an endorsement.