E10
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Patients aged 12 to 18 years suffering from Diabetes mellitus type 1 • Intensified conventional therapy (ICT) or continuous subcutaneous insulin infusion (CSII) • Diabetes training by the team of “Kinderkrankenhaus Amsterdamer Straße” • Flash glucose monitoring (FGM) or continuous glucose monitoring (CGM) • Sufficient knowledge of the German language • Normal intelligence • Compliant • Signed informed consent
Exclusion criteria
Exclusion criteria: • Diabetes < 6 months • Learning disability • Competitive sports or more than 60 min of physical exercise per day • Psychiatric comorbidity. Medically treated ADHS patients can participate • Lack of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time in range (%) The time in range, i.e. the percentage time of the blood glucose value in the target range 70 and 180mg/dl, represents the primary outcome . The "continuous glucose monitoring" or "flash glucose monitoring" provide the possibility of graphic processing of the blood glucose values. At baseline, after three, six and twelve months a period of two weeks is considered. A prerequisite is that the sensor must have been worn at least 70-80% of the time during this period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life and fitness are defined as secondary outcomes. The quality of life of the patients and their parents is determined by means of standardized questionnaires at baseline, as well as after three, six and twelve months. The patients´ fitness is assessed at baseline, as well as after three, six and twelve months using a shuttle-run test. | — |
Countries
Germany
Contacts
Kinderkrankenhaus Amsterdamer StraßeKliniken der Stadt Köln gGmbH