Table 1.

Endpoints

Primary endpoints
HbA1c (%)	Difference in HbA1c at week 26 adjusted for baseline
Secondary endpoints
CGM metrics* (whole, night (00:00–06:00), daytime (06:00–00:00))	The difference in CGM profiles listed below collected via Ipro2 in week 12–14 and week 24–26 adjusted for baseline (week 0–2)
TIR (%)	Range 3.9–10.0 mmol/L (70–180 mg/dL)
TIT (%)	Range 3.9–7.8 mmol/L (70–140 mg/dL)
TBR (%)	<3.9 mmol/L (70 mg/dL); <3.0 mmol/L (54 mg/dL)
TAR (%)	>10 mmol/L (180 mg/dL); >13.9 mmol/L (250 mg/dL)
Mean blood glucose (mmol/L)
Estimated A1c (%)
SD
CV
MAGE
HBGI
LBGI
MODD
Number of hypoglycaemia events
Percentage of HbA1c value in target (%)	The difference in the percentage of HbA1 in range (<7%) tested at week 14 and 26 adjusted for baseline
Frequency of using FGM (times/day)†	Time frame: 24 weeks (from week 2 to week 26)
Frequency of using SMBG (times/day)	Time frame: 24 weeks (from week 2 to week 26)
Total of daily insulin dose (IU/kg/day)	The difference in insulin dose collected at week 14 and 26 adjusted for baseline
Questionnaires	The difference in scores of respective questionnaires collected at week 14 and 26 adjusted for baseline
DDS
HFS
EQ-5D-5L

*CGM metrics analysed here are calculated with the sensor data from Ipro2.

†The frequency of using FGM is calculated with the recordings derived from the FGM system.

CGM, continuous glucose monitoring; CV, coefficient of variation; DDS, Diabetes Distress Scale; EQ-5D-5L, European Quality of Life Scale; FGM, flash glucose monitoring; HBGI, high blood glucose index; HFS, Hypoglycemia Fear Scale; LBGI, low blood glucose index; MAGE, mean amplitude of glucose excursion; MODD, mean of daily differences; SMBG, self-monitoring of blood glucose; TAR, time above range; TBR, time below range; TIR, time spent in range; TIT, time spent in target.