Documented clinical and demographic variables included sex, age at onset of diabetes, and age and duration of diabetes at each contact. A migratory background was assigned if the patient or at least one parent was born outside of Germany.5 Body weight standard deviation score (SDS), height SDS, and body mass index (BMI) SDS were based on the German Health Interview and Examination Survey for Children and Adolescents (KiGGs) reference [8 (link)].
HbA1c values were mathematically standardized to the reference range of 4.05–6.05% (IFCC 20.8–42.6 mmol/L) of the Diabetes Control and Complications Trial applying the multiple of the mean method in order to correct for different laboratory methods [5 (link), 9 (link)]. Corrected HbA1c values were deducted from time in range (TiR) data as described previously [10 (link)]. Laboratory-measured HbA1c values and those estimated from CGM data were integrated into a combined glucose indicator (CGI) expressed in “%”, in analogy to HbA1c values as described before [5 (link)]. Acute complications—DKA and hypoglycemia—were also documented as outcomes. DKA was defined as presence of metabolic acidosis with a pH below 7.3 and/or bicarbonate levels below 15 mmol/L. Severe hypoglycemia was defined as an episode when the affected patient required assistance, hypoglycemic coma as loss of consciousness or seizure [11 (link)].
HbA1c values were mathematically standardized to the reference range of 4.05–6.05% (IFCC 20.8–42.6 mmol/L) of the Diabetes Control and Complications Trial applying the multiple of the mean method in order to correct for different laboratory methods [5 (link), 9 (link)]. Corrected HbA1c values were deducted from time in range (TiR) data as described previously [10 (link)]. Laboratory-measured HbA1c values and those estimated from CGM data were integrated into a combined glucose indicator (CGI) expressed in “%”, in analogy to HbA1c values as described before [5 (link)]. Acute complications—DKA and hypoglycemia—were also documented as outcomes. DKA was defined as presence of metabolic acidosis with a pH below 7.3 and/or bicarbonate levels below 15 mmol/L. Severe hypoglycemia was defined as an episode when the affected patient required assistance, hypoglycemic coma as loss of consciousness or seizure [11 (link)].
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