Table 2. Outcome measures of the FCL treatment period and the control period.

Outcome measure	FCL treatment period	Control period	p-value
* Daytime was defined as 06:00−24:00, ** Nighttime was defined as 24:00−06:00. Data are expressed as the median (IQR). TIR was the primary endpoint, tested at a significance threshold of α = 0.05. TITR, TBR, TAR, and median glucose were the key secondary endpoints, evaluated using a Bonferroni-adjusted significance threshold of α = 0.0125. All other metrics were considered exploratory and are reported with nominal p-values. Statistically significant results after correction for multiple comparisons are indicated in bold. n = 15.
Time in range (TIR; 3.9−10 mmol/L)	74.9% (73.1%−81.0%)	61.3% (53.7%−68.2%)	< 0.001
Daytime*	68.1% (65.1%−75.0%)	57.7% (52.3%−64.9%)	0.002
Nighttime**	95.0% (93.0%−96.2%)	74.7% (61.4%−82.5%)	< 0.001
Time in tight range (TITR; 3.9−7.8 mmol/L)	54.3% (50.7%−58.7%)	39.8% (33.4%−45.1%)	0.001
Daytime	44.9% (42.4%−49.8%)	36.7% (31.6%−42.2%)	0.012
Nighttime	79.0% (74.6%−81.5%)	52.8% (42.0%−56.2%)	< 0.001
Time below range (TBR; < 3.9 mmol/L)	0.8% (0.4%−1.7%)	2.1% (0.9%−3.3%)	0.022
Daytime	0.9% (0.4%−2.0%)	2.2% (1.1%−4.0%)	0.015
Nighttime	0.5% (0.1%−0.9%)	1.2% (0.0%−1.8%)	0.208
Time below range (TBR; < 3.9 mmol/L)	0.8% (0.4%−1.7%)	2.1% (0.9%−3.3%)	0.022
Daytime	0.9% (0.4%−2.0%)	2.2% (1.1%−4.0%)	0.015
Nighttime	0.5% (0.1%−0.9%)	1.2% (0.0%−1.8%)	0.303
Time below range level 2 (TBR2; < 3.0 mmol/L)	0.0% (0.0%−0.2%)	0.3% (0.1%−1.0%)	0.048
Daytime	0.1% (0.0%−0.2%)	0.3% (0.1%−0.9%)	0.048
Nighttime	0.0% (0.0%−0.0%)	0.2% (0.0%−0.4%)	0.139
Time above range (TAR; > 10.0 mmol/L)	24.5% (17.5%−25.9%)	36.2% (26.8%−45.0%)	0.001
Daytime	31.3% (23.3%−33.3%)	41.4% (32.6%−45.1%)	0.004
Nighttime	4.3% (2.9%−5.5%)	24.0% (13.1%−37.2%)	< 0.001
Time above range Level 1 (TAR1; 10.0−13.9 mmol/L)	16.7% (15.1%−19.7%)	22.8% (21.8%−27.2%)	0.001
Daytime	21.8% (19.7%−25.5%)	24.7% (22.8%−29.0%)	0.035
Nighttime	3.5% (2.5%−5.0%)	17.1% (11.5%−21.0%)	< 0.001
Time above range Level 2 (TAR2; > 13.9 mmol/L)	4.7% (3.1%−7.8%)	10.5% (7.0%−15.9%)	0.001
Daytime	6.1% (4.2%−10.2%)	13.1% (9.1%−17.3%)	0.001
Nighttime	0.0% (0.0%−1.1%)	2.7% (1.6%−8.6%)	0.001
Median blood glucose concentration (mmol/L)	7.4 (7.2%−7.7%)	8.5 (8.0%−9.6%)	0.001
Daytime	8.1 (7.6%−8.3%)	9.2 (8.3%−9.4%)	0.004
Nighttime	6.5 (6.4%−6.7%)	7.7 (7.5%−8.4%)	< 0.001
Glycemic variability
Standard deviation (SD; mmol/L)	2.9 (2.7%−3.2%)	3.2 (3.1%−4.0%)	0.001
Coefficient of variation (CV)	35.7% (32.9%−39.0%)	38.8% (34.5%−41.6%)	0.121
Interquartile range (IQR; mmol/L)	3.7 (3.2%−3.9%)	4.8 (4.3%−5.5%)	< 0.001
Daily insulin use (units)	57.3 (52.6%−68.7%)	46.6 (37.4%−55.3%)	< 0.001
Daily glucagon use (mg)	0.55 (0.37%−0.65%)	−