Table 3.

Safety Outcomes

	During 670G Arm (N=112)	During AHCL Arm (N=112)
Any Reportable Adverse Event a
Number of Events	7	6
Participants with ≥ 1 Event	7 (6·2%)	6 (5·3%)
Specific Events – # Participants [# Events]
Severe Hypoglycemia b	0 [0]	1 [1]
Diabetic Ketoacidosis	0 [0]	0 [0]
Other Serious Adverse Events c	2 [2]	0 [0]
Hyperglycemia or Ketosis Related to Insulin Pump Problem (without diabetic ketoacidosis)	3 [3]	2 [2]
Hyperglycemia or Ketosis Events not Related to Insulin Pump Problem (without diabetic ketoacidosis)	1 [1]	0 [0]
Other Reportable Events Related to Study Device d	1 [1]	2 [2]
Other Reportable Events Not Related to Study Device e	0 [0]	1 [1]

^aReportable adverse events included serious adverse events, adverse device effects, an adverse event occurring in association with study procedure, an adverse event which led to the discontinuation of a study device for two or more hours, hypoglycemia meeting the definition of severe hypoglycemia, and diabetic ketoacidosis

^bThe severe hypoglycemia event in the AHCL arm occurred in a 14 year old participant who forgot to give a manual bolus for dinner bolus but then gave the bolus about an hour after dinner. This was followed by another bolus for a late night snack about one to two hours later. The closed loop system functioned as intended and it is presumed that the event occurred due to the amount of insulin onboard from the boluses.

^cHospitalizations due to suicidal tendencies and due to ruptured appendix.

^dSkin reaction at infusion site (1) and skin reaction around the continuous glucose monitor sensor site (2).

^eGastroenteritis