Trials / Completed
CompletedNCT03602963
Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System
A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 10 (actual)
- Sponsor
- Jessa Hospital · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
1. The accuracy of the sensors (Dexcom G5 vs FreeStyle Libre Flash glucose monitoring) will be evaluated by simultaneous wearing of the 2 sensors during 2 weeks. During these 2 weeks the patients will do at least four capillary blood glucose measurements to compare with the sensor results. 2. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month. 3. The data recorded by the FreeStyle Libre Flash glucose monitoring system (average glucose,% above target, % within target, % under target, amount of hypoglycemia) in the month prior to the 2 weeks of double sensor wear will be compared to the same data recorded by the Dexcom G5 mobile CGM system during the first month of use.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dexcom G5 Mobile CGM system | The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated |
Timeline
- Start date
- 2018-07-09
- Primary completion
- 2018-12-31
- Completion
- 2019-03-30
- First posted
- 2018-07-27
- Last updated
- 2020-02-17
Locations
1 site across 1 country: Belgium
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03602963. Inclusion in this directory is not an endorsement.