. 2021 Mar 22;23(4):277–285. doi: 10.1089/dia.2020.0516

Table 1.

Continuous Glucose Monitor-Measured Glucose Metrics and Insulin Metrics

	Time	HCL	APEX	P
Primary outcome
Episodes of hypoglycemia^c	[17:00–19:00] day 1	1[0–1.7]	0 [0–1]	0.04^b
Exploratory outcomes
Episodes of hypoglycemia^c	Overall	1[1–3]	0 [0–1]	0.01^b
	[17:00–19:00] day 2	0 [0–0]	0 [0–0]	0.25^b
	[19:00–23:00]	0[0–1.7]	0 [0–0]	0.02^b
	Overnight	0 [0–0]	0 [0–0]	1^b
Mean BG (mg/dL)	Overall	136.9 (19.9)	141.9 (20.3)	0.03^a
	[17:00–19:00] day 1	125.0 (27.2)	140.3 (27.1)	0.02^a
	[17:00–19:00] day 2	130.4 (34.4)	152.6 (28.8)	0.007^a
	[19:00–23:00]	113.6 (23.2)	131.3 (33.3)	0.01^a
	Overnight	115.8 (10.9)	116.2 (9.0)	0.5^a
% time <54 mg/dL	Overall	0 [0–0.3]	0 [0–0]	0.06
	[17:00–19:00] day 1	0 [0–0]	0 [0–0]	0.5^b
	[17:00–19:00] day 2	0 [0–0]	0 [0–0]	1^b
	[19:00–23:00]	0 [0–2.0]	0 [0–0]	0.06^b
	Overnight	0 [0–0]	0 [0–0]	1^b
% time <70 mg/dL	Overall	1.3 [0.0–2.7]	0 [0–0.7]	0.02^b
	[17:00–19:00] day 1	0 [0–0]	0 [0–4.0]	0.5^b
	[17:00–19:00] day 2	0 [0–0]	0 [0–0]	0.1^b
	[19:00–23:00]	0 [0–10.2]	0 [0–0]	0.01^b
	Overnight	0 [0–0]	0 [0–0]	0.6^b
% time [70–180] mg/dL	Overall	81.0 (12.4)	81 (15.7)	0.5^a
	[17:00–19:00] day 1	96.0 [64.0–100]	84.0 [66.0–100]	0.31^b
	[17:00–19:00] day 2	92.0 [81.6–100]	100 [96.0–100]	0.2^b
	[19:00–23:00]	89.9 [87.8–100]	100 [90.8–100]	0.3^b
	Overnight	100 [100–100]	100 [100–100]	0.9^b
% time [70–140] mg/dL	Overall	62.0 (14.1)	58.4 (15.3)	0.08^a
	[17:00–19:00] day 1	68.0 [46.0–92.0]	48.0 [39.1–74.0]	0.08^b
	[17:00–19:00] day 2	55.6 [30.4–89.3]	3.2 [0.0–50.0]	0.02^b
	[19:00–23:00]	75.5 [51.0–88.8]	77.5 [30.6–93.0]	0.3^b
	Overnight	96.9 [85.0–100]	95.8 [77.3–100]	0.3^b
% time >180 mg/dL	Overall	16.6 (12.6)	18.5 (15.9)	0.1^a
	[17:00–19:00] day 1	0.0 [0.0–34.0]	12.0 [0.0–32.0]	0.8^b
	[17:00–19:00] day 2	0.0 [0.0–10.2]	0.0 [0.0–4.0]	0.4^b
	[19:00–23:00]	0 [0–5.1]	0 [0–5.1]	0.9^b
	Overnight	0 [0–0]	0 [0–0]	1^b
% time >250 mg/dL	Overall	0 [0–2.0]	0 [0–4.4]	0.8^b
	[17:00–19:00] day 1	0 [0–0]	0 [0–0]	1^b
	[17:00–19:00] day 2	0 [0–0]	0 [0–0]	1^b
	[19:00–23:00]	0 [0–0]	0 [0–0]	1^b
	Overnight	0 [0–0]	0 [0–0]	1^b
CV—glucose (%)	Overall	30.5 (6.1)	29.1 (6.3)	0.2^a
	[17:00–19:00] day 1	24.3 (8.9)	21.1 (12.6)	0.2^a
	[17:00–19:00] day 2	14.7 (9.2)	6.0 (3.5)	0.002^a
	[19:00–23:00]	22.0 (7.4)	17.2 (6.5)	0.02^a
	Overnight	11.8 (4.0)	15.1 (7.2)	0.04^a
SD—glucose (mg/dL)	Overall	42.0 (11.8)	42.0 (12.2)	0.5^a
	[17:00–19:00] day 1	30.8 (14.0)	29.5 (18.0)	0.4^a
	[17:00–19:00] day 2	18.4 (10.3)	8.8 (5.1)	0.002^a
	[19:00–23:00]	24.7 (8.7)	22.0 (8.7)	0.2^a
	Overnight	13.7 (5.2)	17.7 (9.3)	0.05^a
LBGI	Overall	0.6 [0.4–0.9]	0.3 [0.3–0.7]	0.04^b
	[17:00–19:00] day 1	0.9 [0.4–1.8]	0.5 [0.2–1.4]	0.07^b
	[17:00–19:00] day 2	0.3 [0.1–1.5]	0.0 [0.0–0.0]	0.002^b
	[19:00–23:00]	1.3 [0.5–2.9]	0.2 [0–1.9]	0.01^b
	Overnight	0.2 [0.1–0.5]	0.2 [0.1–0.7]	0.5^b
Infused insulin (U)	Overall	50.6 (18.2)	46.2 (13.0)	0.002^a
	[15:30–17:00] day 1	1.8 (0.7)	1.3 (0.9)	0.004^a
	[17:00–19:00] day 1	1.1 [0.8–1.5]	0.7 [0.2–2]	0.21
	[15:30–17:00] day 2	1.6 (1.0)	1.1 (0.8)	0.02^a
	[17:00–19:00] day 2	1.5 [0.6–2.4]	0.9 [0.6–2.5]	0.4
	[19:00–23:00]	9.3 (5.5)	8.2 (2.7)	0.12
	Overnight	6.9 (3.0)	6.1 (2.0)	0.05^a
Meal information
	Lunch (1st day)	Dinner (1st day)	Breakfast (2nd day)	Lunch (2nd day)
Carbohydrate content (g)	48 (5.5)	44 (15.8)	59 (25.4)	48 (5.5)
Meal estimation error (%)	2 [0–4.7]	0 [0–0]	6.5 [0–18.5]	2 [0–4.8]
System operation
Time in closed-loop (%)	HCL: 100 [96.7–100]		APEX: 100 [100–100]

Values are shown as mean (SD) for normally distributed samples and median [Q1–Q3] for non-normally distributed samples. Significance levels <0.05 are presented in bold font.

^{^a}

One-sided paired t-test.

^{^b}

Wilcoxon signed-rank test.

^{^c}

No severe hypoglycemia episodes occurred during the clinical trial.

APEX, treatment controller; BG, blood glucose; CV, coefficient of variation; HCL, hybrid closed-loop (baseline); SD, standard deviation.