Trials / Completed
CompletedNCT03369899
FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
Effectiveness and Safety Study of the FreeStyle Libre Flash Glucose Monitoring System in Pediatric Populations
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 72 (actual)
- Sponsor
- Abbott Diabetes Care · Industry
- Sex
- All
- Age
- 4 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study is a non-randomized, single-arm, multi-center study that is designed to evaluate the safety and effectiveness of the FreeStyle Libre Flash Glucose Monitoring Systems in pediatric populations.
Detailed description
Up to 100 subjects will be enrolled at up to six (6) clinical research sites in the United States. Subjects will wear two Sensors. Each Sensor will have a paired Reader that will be given to the subject. All Readers will be masked during the study (i.e. subjects will not be able to view glucose results obtained from the Sensor on the Reader screen). Subjects will be asked to perform at least 4 capillary Blood Glucose (BG) tests per day using the primary Reader. Interstitial glucose readings from each Sensor will be obtained with the corresponding Readers immediately following each BG test. Subjects will be instructed to report any problems with the device. Subjects will make two (2) to five (5) scheduled visits to the clinical study site, including the Enrollment/Screening Visit (Visit 1). Based on the subjects age and weight, subjects will have up to two (2) in-clinic visits during which intravenous blood draws and Yellow Springs Instrument (YSI) reference testing will occur.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | FreeStyle Libre Flash Glucose Monitoring System | Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes. |
Timeline
- Start date
- 2017-12-11
- Primary completion
- 2018-05-23
- Completion
- 2018-05-23
- First posted
- 2017-12-12
- Last updated
- 2018-07-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03369899. Inclusion in this directory is not an endorsement.