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

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: Dexcom G5 Mobile CGM system

• Registration Number: NCT03602963
• Lead Sponsor: Jessa Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-05
• Study Start: 2018-07-09
• Study First Submitted QC: 2018-07-18
• Study First Posted: 2018-07-27
• Primary Completion: 2018-12-31
• Study Completion: 2019-03-30
• Last Update Submitted: 2020-02-14
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Type 1 diabetes mellitus
• Treated by insulin injections

Exclusion Criteria

• Other types of diabetes
• Treated with insulin pump

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexcom G5 mobile CGM system	Dexcom G5 Mobile CGM system	Children (6 to 18 years) with type 1 diabetes mellitus treated with insulin injections and wearing a FreeStyle Libre Flash glucose sensor that will switch to the Dexcom G5 mobile glucose monitoring system.

Primary Outcome Measures

Name	Time	Method
Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations	2 weeks	Comparison of sensor glucose measurements will be compared with capillary blood glucose measurements at least 4 times a day

Secondary Outcome Measures

Name	Time	Method
Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire	1 month	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).

Trial Locations

Locations (1)

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium