Comparison Between Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System and the FreeStyle Libre Flash Glucose Monitoring System
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03602963|
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 31, 2018
- 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.
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes Mellitus||Device: Dexcom G5 Mobile CGM system|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||A Comparative Study on the Accuracy and Usability Between the Dexcom G5 Mobile CGM System and the FreeStyle Flash Glucose Monitoring System|
|Actual Study Start Date :||July 9, 2018|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||March 30, 2019|
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.
Device: Dexcom G5 Mobile CGM system
The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated
- Accuracy of the Dexcom G5 mobile continuous glucose monitoring (CGM) system by comparison of sensor glucose measurements with capillary blood glucose determinations [ Time Frame: 2 weeks ]Comparison of sensor glucose measurements will be compared with capillary blood glucose measurements at least 4 times a day
- Patients' and parents' satisfaction with the Dexcom G5 mobile CGM system will be evaluated by a standardized questionnaire [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602963
|Contact: Guy G Massa, MD, PhDfirstname.lastname@example.org|
|Contact: Renate Zeevaert, MD, PhDemail@example.com|
|Hasselt, Limburg, Belgium, B3500|
|Contact: Guy G Massa, MD, PhD +3211309866 firstname.lastname@example.org|
|Contact: Renate Zeevaert, MD, PhD email@example.com|
|Principal Investigator:||Guy Massa, MD, PhD||Jessa Hospital|