The aim of the investigator's study is to compare real-time continuous glucose monitoring (rt-CGM) and flash glucose monitoring (FGM) in adult patients with Type 1 Diabetes (T1D) in real life practice during 24 weeks of follow-up.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
187
rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
3rd Department of Internal Medicine, 1st Faculty of Medicine, Charles University
Prague, Czechia
Changes in glycated haemoglobin (HbA1c)
Differences between HbA1c values in the Run in period and after 12 month of follow-up and differences of HbA1c between groups.
Time frame: Up to 13 months
Percentage of time in hypoglycemic ranges
\<3.9 mmol/L \[70 mg/dl\] and \<3.0 mmol/L \[54 mg/dl\]
Time frame: Up to 13 months
Percentage of time in target ranges
3.9-10.0 mmol/L \[70-180 mg/dl\]
Time frame: Up to 13 months
Percentage of time in hyperglycemic ranges
\>10.0 mmol/L \[180 mg/dl\] and \>13.9 mmol/L \[250 mg/dl\]
Time frame: Up to 13 months
Changes in glycemic variability
Expressed as the standard deviation
Time frame: Up to 13 months
Mean sensor glucose concentration
Measured by rtCGM or FGM
Time frame: Up to 13 months
Incidence of severe hypoglycaemia
Requiring third-party assistance to treat
Time frame: Up to 13 months
Incidence of severe ketoacidosis
Requiring hospitalization
Time frame: Up to 13 months
Incidence of skin reaction, infection or hematoma at the site of insertion of the sensor
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Skin reaction, infection or hematoma reported by patients
Time frame: Up to 13 months