Table 2—

Injection or infusion site problems and treatment-specific technical or mechanical problems reported by subjects

CSII (n = 51)
MDI (n = 54)
P
EventsSubjectsEventsSubjects
Injection and infusion site problems*
    Infection55 (10)00 (0)0.20
    Irritation/inflammation8536 (69)1510 (19)<0.01
    Bleeding/bruising5026 (50)18047 (87)<0.01
    Any site problem12242 (82)18848 (89)0.41
Technical and mechanical problems
    Device malfunction (infusion pump or insulin pen)2017 (33)97 (13)
    Improper or inadequate insulin delivery1010 (20)32 (4)
    Difficulty with pump setup or operation2515 (28)
    Concern about pen accuracy22 (4)
    Difficult to depress pen plunger54 (7)
    Difficult to see units on pen44 (7)
    Problem type not specified1614 (27)55 (9)
    Any technical or mechanical problem7239 (76)2822 (41)
  • Data are n (%). Events reported at time of routine study visits. All visits subsequent to treatment initiation are included. P values are for difference in numbers of subjects reporting problems.

  • *

    * P values were calculated for injection/infusion site problems only. Treatment specificity of technical and mechanical problems precluded direct comparison of groups.