Adverse Effects - Tandem t:slim X2 User Manual

CHAPTER 32 • Overview of Control-IQ Technology Clinical Studies

32.4 Adverse Effects

The following tables provide a full list of adverse events that occurred during the main part of the study for both DCLP3 and DCLP5
study groups.
DCLP3: Types of Adverse Events by Treatment Group (N=168)
Total Number of Adverse Events
Adverse Events Related to Study Device
Ketosis (Infusion Site Failure)
Hyperglycemia (Infusion Site Failure)
Hyperglycemia (Defected Cartridge)
Diabetic Ketoacidosis (Infusion Set Failure)
Adverse Effects Not Related to a Study Device
Hyperglycemia (User Error)
Hyperglycemia (Respiratory Infection)
Coronary Bypass Surgery
Otitis Externa
Concussion
294
Number of Events
Control-IQ (n=112)
13
3
4
1
1
3
0
1
1
1
SAP (n=56)
3
0
2
0
0
0
1
0
0
0