Diabetes Clinical Trial
Official title:
Real-Time Continuous Glucose Monitoring (RT-CGM) in Patients With Type 1 Diabetes at High Risk for Low Glucose Values Using Multiple Daily Injections (MDI) in Germany (HYPODE-STUDY)
Demonstrate that usage of RT-CGM (Real time continuous glucose monitoring) reduces the frequency of low CGM-recorded glucose events in patients using MDI (Multiple daily injections) that are at risk for hypoglycemic events.
In a randomized controlled trial the primary hypothesis is tested if the usage of RT-CGM in
the intervention group (CGM group) reduces the frequency of glucose values <55 mg/dl in
patients with hypoglycemia problems (hypoglycemia unawareness or documented previous severe
hypoglycemia) significantly more than in the control group receiving usual care (without
CGM).
Secondary is tested if patients in the CGM group showed a significantly more favorable change
in the below defined secondary endpoint than patients in the control group after 26 weeks
follow up.
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