Type 1 Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Child, Glucose sensor, Accuracy, Usability
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.
Interventions
DEVICEDexcom G5 Mobile CGM system
The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated
Sponsors
Jessa Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus * Treated by insulin injections
Exclusion criteria
* Other types of diabetes * Treated with insulin pump
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium
Outcome results
None listed