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Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System

NCT03602963 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2020-02-17

No results posted yet for this study

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

  • Type 1 Diabetes Mellitus

Interventions

DEVICE

Dexcom G5 Mobile CGM system

The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated

Sponsors & Collaborators

  • Jessa Hospital

    lead OTHER

Principal Investigators

  • Guy Massa, MD, PhD · Jessa Hospital

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2018-12-31
Completion
2019-03-30
FDA Device
Yes

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03602963 on ClinicalTrials.gov