Table 2.
Adverse events (AEs): total, continuous glucose monitor (CGM), and insulin pumps/infusion sets
| Total, n (%) | CGM, n (%) | Pump/infusion set, n (%) | |
|---|---|---|---|
| Device user | |||
| Yes | 549 (100) | 170 (35.0) | 276 (62.4) |
| AEs | |||
| Yes | 75 (13.7) | 24 (14.1) | 35 (12.7) |
| Number of AEs/past 12 months | |||
| 0–1 | 26 (34.7) | 8 (33.3) | 14 (40.0) |
| 2–3 | 27 (36.0) | 9 (37.5) | 13 (37.1) |
| 4+ | 22 (29.3) | 7 (29.2) | 8 (22.9) |
| Cause of AE* | |||
| Device error | 41 (54.7) | 20 (83.3) | 12 (34.3) |
| User error | 19 (25.3) | 5 (20.8) | 9 (25.7) |
| Health problem experienced† | |||
| Hypoglycemia | 36 (48.0) | 18 (75.0) | 4 (11.4) |
| Hyperglycemia | 37 (49.3) | 7 (29.2) | 25 (71.4) |
| Infection | 7 (9.3) | 2 (8.3) | 4 (11.4) |
| Diabetic ketoacidosis | 9 (12.0) | 0 (0) | 8 (22.9) |
| Needed help to manage AE | |||
| Yes | 36 (48.0) | 12 (50.0) | 17 (48.6) |
| Reported adverse event | |||
| Yes | 40 (53.3) | 9 (37.5) | 26 (74.3) |
| Event reported to* | |||
| Healthcare provider | 24 (32.0) | 8 (33.3) | 12 (34.3) |
| Manufacturer | 21 (28.0) | 6 (25.0) | 14 (40.0) |
*Continuous glucose monitor.
†Multiple responses allowed.