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NCT03602963 Clinical Trial

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

Type 1 Diabetes Mellitus Clinical Trial

Official title:
A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03602963
Other study ID # JessaH_18.64/ped18.02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 9, 2018
Est. completion date March 30, 2019

Study information
Verified date July 2018
Source Jessa Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date March 30, 2019
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 6 Years to 18 Years
Eligibility Inclusion Criteria:

- Type 1 diabetes mellitus

- Treated by insulin injections

Exclusion Criteria:

- Other types of diabetes

- Treated with insulin pump

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Dexcom G5 Mobile CGM system
The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated

Locations
Country Name City State
Belgium Jessa Hospital Hasselt Limburg

Sponsors (1)
Lead Sponsor Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations Comparison of sensor glucose measurements will be compared with capillary blood glucose measurements at least 4 times a day 2 weeks
Secondary Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire after 1 month of sensor wear. Patients and parents will rate their experience with the Dexcom G5 mobile CGM system on a scale of 1 (strongly agree) to 5 (strongly disagree). There are three questions about sensor application (e.g. It is easy to put the sensor on) and eleven questions about the wearing of the sensor (e.g. The sensor doesn't disturb me for sporting). 1 month
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