The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes. This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
FreeStyle Libre, 4 weeks
Standard blood glucose monitoring with glucose meters
Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok
Bialystok, Poland
Department of Metabolic Diseases, Jagiellonian University Medical College
Krakow, Poland
Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
Poznan, Poland
Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice
Zabrze, Poland
Hypoglycemia Fear Survey II
Change in HFS II score from baseline to day 28
Time frame: Baseline and day 28
TBR <70 mg/dL
Difference in time \<70 mg/dL between intervention and control group assessed in days 14 to 28
Time frame: Baseline and days 14 to 28
TIR
Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28
Time frame: Baseline and days 14 to 28
TBR <54 mg/dL
Difference in TBR \<54 mg/dL between intervention and control group assessed in days 14 to 28
Time frame: Baseline and days 14 to 28
TAR >180 mg/dl
Difference in TAR \>180 mg/dL between intervention and control group assessed in days 14 to 28
Time frame: Baseline and days 14 to 28
TAR >250 mg/dl
Difference in TAR \>250 mg/dL between intervention and control group assessed in days 14 to 28
Time frame: Baseline and days 14 to 28
DKA
Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group
Time frame: Baseline to day 28
Severe hypoglycemia
Difference in number of severe hypoglycemia episodes between intervention and control group
Time frame: Baseline to day 28
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DDS
Change in DDS score from baseline to day 28
Time frame: Baseline and day 28
DTSQ
Change in DTSQ score from baseline to day 28
Time frame: Baseline and day 28
HFS II - Worry subscale
Change in HFS II - worry subscale from baseline to day 28
Time frame: Baseline and day 28
HFS II - Behaviour subscale
Change in HFS II - behaviour subscale from baseline to day 28
Time frame: Baseline and day 28