Total Number Of Adverse Events; Adverse Events Related To Study Device - Tandem t:slim X2 User Manual

DCLP5: Types of Adverse Events by Treatment Group (N=101)

Total Number of Adverse Events

Adverse Events Related to Study Device

Ketosis (Infusion Site Failure)
Abscess at Sensor Site (CGM Sensor)
Hyperglycemia (Defected Cartridge)
Adverse Effects Not Related to a Study Device
Hypoglycemia (User Error)
Ketosis (User Error)
Ketosis (Gastroenteritis)
Hyperglycemia (User Error)
Accidental Over-Delivery of Insulin (User Error)*
*One subject primed tubing while connected to body. This was a serious adverse event, requiring treatment in the emergency room for hypoglycemia prevention.
CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies
Number of Events
Control-IQ (n=78)
16
8
0
1
1
2
1
2
1
SAP (n=23)
3
0
2
0
0
1
0
0
0
295