Role of automated insulin delivery in managing insulin-treated outpatients with type 2 diabetes: A systematic review and meta-analysis

Table 4 Comparison of the safety outcomes in the automated insulin delivery vs the control arms

Outcome variables	Type of the randomized trial	Number of study reports	No. of participants with outcome/participants analyzed		Pooled effect size, risk ratio (95%CI)	P value	I2 (%)
			Automated insulin delivery arm	Control arm
Number of SAEs	All	4	24/234	15/229	1.58 (0.85-2.93)	0.15	0
	Crossover	2	6/52	3/51	1.92 (0.50-7.37)	0.34	0
	Parallel-group	2	18/182	12/178	1.50 (0.74-3.01)	0.26	0
Number of participants with SAEs	All	4	24/234	15/229	1.58 (0.85-2.93)	0.15	0
	Crossover	2	6/52	3/51	1.92 (0.50-7.37)	0.34	0
	Parallel-group	2	18/182	12/178	1.50 (0.74-3.01)	0.26	0
Number of SAEs (study-related)	All	3	6/208	3/203	1.85 (0.54-6.40)	0.33	0
	Crossover	1	1/26	0/25	2.89 (0.12-67.75)	0.51	N/A
	Parallel-group	2	5/182	3/178	1.71 (0.44-6.58)	0.44	0
Number of SAEs (not study-related)	All	5	41/449	20/333	1.37 (0.81-2.33)	0.24	0
	Crossover	2	6/52	4/51	1.47 (0.44-4.91)	0.53	0
	Parallel-group	3	35/397	16/282	1.44 (0.67-3.06)	0.35	29
Number of severe hypoglycemia events	All	4	2/281	0/170	2.10 (0.22-19.81)	0.52	0
	Crossover	2	1/52	0/51	3.00 (0.13-70.42)	0.50	N/A
	Parallel-group	2	1/229	0/119	1.46 (0.06-35.50)	0.82	N/A
Number of participants with severe hypoglycemic events	All	5	2/449	1/333	1.13 (0.18-7.10)	0.90	0
	Crossover	2	1/52	0/51	3.00 (0.13-70.42)	0.50	N/A
	Parallel-group	3	1/397	1/282	0.69 (0.07-6.57)	0.74	0
Number of non-SAEs	All	3	66/267	22/155	1.67 (1.07-2.63)	0.02	0
	Crossover	2	10/52	7/51	1.33 (0.54-3.28)	0.53	0
	Parallel-group	1	56/215	15/104	1.81 (1.07-3.04)	0.03	N/A
Number of participants with non-SAEs	All	4	154/435	120/318	1.08 (0.92-1.26)	0.35	0
	Crossover	2	9/52	7/51	1.22 (0.49-3.04)	0.67	0
	Parallel-group	2	145/383	113/267	1.07 (0.92-1.26)	0.38	0
Number of device deficiencies	All	4	53/281	3/170	9.13 (2.17-38.37)	0.003	0
	Crossover	2	11/52	1/51	6.90 (1.29-36.78)	0.02	0
	Parallel-group	2	42/229	2/119	19.93 (1.22-326.34)	0.04	N/A
Number of participants with device deficiencies	All	4	31/281	3/170	5.70 (2.11-15.36)	0.0006	0
	Crossover	2	10/52	1/51	6.49 (1.21-34.74)	0.03	0
	Parallel-group	2	21/229	2/119	5.31 (1.55-18.16)	0.008	0

N/A: Not applicable; SAEs: Severe adverse events.