Table 3.

Hypoglycemia Events and Other Safety Endpoints

	Baseline-Month 3			Months 3-6			Months 6-12			Months 12-24			Total
	Control, N = 31a	CSII, N = 28a	Basal Insulin, N = 26a	Control, N = 27a	CSII, N = 23a	Basal Insulin, N = 19a	Control, N = 27a	CSII, N = 22a	Basal Insulin, N = 19a	Control, N = 24a	CSII, N = 22a	Basal Insulin, N = 16a	Control, N = 31a	CSII, N = 28a	Basal Insulin, N = 26a
Hypoglycemia events (total)	0 (0.0%)	2 (7.1%)	2 (7.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (7.1%)	2 (7.7%)
Symptomatic	0 (0.0%)	1 (3.6%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (3.6%)	0 (0.0%)
BG 41-60 mg/dL	0 (0.0%)	2 (7.1%)	2 (7.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (7.1%)	2 (7.7%)
BG < 40 mg/dL	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
Death	0 (0.0%)	0 (0.0%)	2 (7.7%)	0 (0.0%)	1 (4.3%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (4.2%)	1 (4.5%)	0 (0.0%)	1 (3.2%)	2 (7.1%)	2 (7.7%)
Rejection episode	2 (6.5%)	1(3.6%)	2 (7.7%)	0 (0.0%)	0 (0.0%)	1 (5.3%)	2 (7.4%)	0 (0.0%)	0 (0.0%)	2 (8.3%)	0 (0.0%)	1 (6.3%)	4 (12.9%)	1 (3.6%)	4 (15.4%)
Graft loss	2 (6.5%)	3 (10.7%)	2 (7.7%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (3.7%)	0 (0.0%)	0 (0.0%)	1 (4.2%)	0 (0.0%)	0 (0.0%)	4 (12.9%)	3 (10.7%)	2 (7.7%)
Hospitalization	4 (12.9%)	4 (14.3%)	6 (23.1%)	5 (18.5%)	3 (13.0%)	6 (31.6%)	6 (22.2%)	3 (13.6%)	3 (15.8%)	5 (20.8%)	6 (27.3%)	4 (25.0%)	10 (32.3%)	12 (42.9%)	12 (46.2%)

Notes: Total refers to number of patients within the study population from baseline to 24 months. Number of hypoglycemia events is equivalent to number of patients with hypoglycemia events.

Abbreviations: CSII, continuous subcutaneous insulin infusion group; BG, blood glucose.

^an (%).