Trials / Withdrawn
WithdrawnNCT02456922
A Performance Evaluation 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- Withdrawn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
- 2 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 2 - 75 years
Detailed description
This study is a multi-center, randomized, prospective single-sample correlational design without controls. A total of up to 310 previously-diagnosed type 1 or 2 diabetes subjects will be enrolled in order to have 160 subjects complete frequent sample testing at up to 17 centers. Subjects will wear Harmony 1 sensors used with the Guardian Mobile application.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Harmony 1 Sensor | Use of Harmony 1 Sensor over 10 days in arm and abdomen and used with the Guardian Mobile App in subjects aged 2-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year. |
Timeline
- Start date
- 2018-07-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2015-05-29
- Last updated
- 2020-09-29
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02456922. Inclusion in this directory is not an endorsement.