Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G5 Mobile CGM system | Device | The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated |
|
| 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 |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Children with type 1 diabetes mellitus treated with insulin injections
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guy Massa, MD, PhD | Jessa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Hasselt | Limburg | B3500 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 month |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |