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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Enrollment
141
Gemeinschaftspraxis Dres. Klausmann
Aschaffenburg, Germany
m&i-Fachklinik Bad Heilbrunn
Bad Heilbrunn, Germany
Forschungsinstitut Diabetes-Akademie Bad Mergentheim (FIDAM)
Bad Mergentheim, Germany
Change in the total number of low glucose events (<55 mg/dl), between baseline and outcome phase (week 22-26) in CGM group and control group (change = subtracting number of follow up events from number of baseline events
Time frame: For each subject, the experimental phase has an expected duration of up to 7 months
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