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
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target group | Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enlite sensor communicating with Minimed 640G pump | Device | Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Enlite sensor | The accuracy of the sensors (flash vs enlite glucose monitoring) will be evaluated with a standardized breakfast test. Patients receive a standardized breakfast. The usual insulin bolus will be administered at breakfast. After breakfast, a venous blood sample is taken for 2 hours every 15 minutes to determine the blood sugar. At the same time, the glucose value shown by the sensors will be noted. A comparison of the blood glucose value with the data recorded by the sensor can evaluate the accuracy of the sensor and also estimate the lag-time between the sensor glucose and the venous glucose. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Usability of Enlite sensor | Patient satisfaction will be evaluated using a questionnaire that will be completed after the Enlite sensor has been worn for 1 month. | 1 month |
| skin reactions wih Enlite sensor |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Guy Massa, MD, PhD | Jessa Hospital, hasselt, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jessa Hospital | Hasselt | 3500 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
blood samples
The development of skin reactions will be checked by a short questionnaire, supplemented with a picture of possible skin phenomena.
| 1 month |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |