治験レーダー

Percentage of time in target ranges

3.9-10.0 mmol/L \[70-180 mg/dL\]

14 weeks

Percentage of time in hypoglycemic range

\<3.9 mmol/L \[70 mg/dL\] and \<3.0 mmol/L \[54 mg/dL\]

14 weeks

Percentage of time in hyperglycemic range

\>10,0 mmol/L \[180 mg/dL\] and \>13,9 mmol/L \[250 mg/dL\]

14 weeks

Percentage of time in tight range

3.9 mmol/L-7.8 mmol/l \[70 mg/dL - 140 mg/dL\]

14 weeks

Changes in glycemic variability

Expressed as the coefficient of variation

14 weeks

Icidence of severe hypoglycaemia

Requiring third-party assistance to treat

14 weeks

Changes in glycated haemoglobin (HbA1c)

Differences between HbA1c values in the initial period and after follow-up

14 weeks

Hypoglycemia Attitudes and Behavior Scale (HABS)

This validated questionnaire contains in total 14 questions that highlights two critical dimensions of hypoglycemia related concerns (anxiety and avoidance) and one positive dimension (confidence). 14 items use Likert scales from 1 to 5, total score from 14 to 70, the higher total score means worse outcome.

14 weeks

Diabetec distress as assessed by validated questionnaire

The DDS17 yields a total diabetes distress score plus 4 subscale scores, each addressing a different kind of distress - Emotional Burden, Physician Distress, Regimen Distress, Interpersonal Distress. Scores in total and each subscales range between 1-21, higher scores denote higher distress.

14 weeks

The 5-item World Health Organization well-being index as assessed by validated questionnaire

This questionnaire contains in total 5 questions. Scores in total range between 0-25, higher scores denote higher quality of life.

14 weeks