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

Study Overview
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Brief Summary
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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. Patient satisfaction will be evaluated using a questionnaire that will be completed after the Dexcom G5 sensor has been worn for 1 month. 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.

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

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Device: Dexcom G5 Mobile CGM system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 1 diabetes mellitus Treated by insulin injections Exclusion Criteria: Other types of diabetes Treated with insulin pump

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexcom G5 mobile CGM system<br>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. | Device: Dexcom G5 Mobile CGM system<br>* The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Diabetes Mellitus, Glucose sensor, Accuracy, Usability