A randomized, double-blinded, single center, parallel design pediatric study, on 45 subjects with type 1 diabetes (T1D), aged six to 15 (inclusive) years, measuring sensor time in glucose values within range 3.9 - 10 mmol/l (70 - 180 mg/dl) achieved using the FreeStyle Libre Flash Glucose Monitoring System (FGM - intervention, Abbott Diabetes Care, California, USA) versus Self-Monitoring Blood Glucose (SMBG - control). Study duration will be two weeks per subject and two weeks overall, it will take place at youth summer camp for children with T1D. Main inclusion criteria include age of six to 15 (inclusive) years, clinical diagnosis of T1D for at least six months, at least three months of current use of insulin pump therapy, HbA1c between 6.3 and 10 % (both inclusive), no other chronic medical conditions (beside treated hypothyroidism and celiac disease) and no current medications (other than insulin) (detailed list of inclusion and exclusion criteria list can be found at section 6). The objectives of this clinical investigation is: 1\. to evaluate the efficacy of glucose control using the FreeStyle Libre FGM in children with T1D during two weeks of summer camp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Insulin dosing based on FreeStyle Libre FGM system that is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus.
Insulin dosing based on SMBG
Medical Faculty - University of Ljubljana
Ljubljana, Slovenia
Time within 3.9 and 10 mmol/l
between-group difference (FGM versus SMBG) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during two weeks of diabetes summer camp based on sensor glucose readings
Time frame: Two weeks
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