To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.
Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner. Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase. Trial population A total of 30 subjects with type 1 diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
Standard boluses for all meals
Tartu University Hospital
Tartu, Estonia
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.
Time frame: 14 days
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (\<3,9 mmol/L)
Time frame: 14 days
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (\>10.0 mmol/L)
Time frame: 14 days
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