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Clinical Care/Education/Nutrition

A Clinical Trial of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Older Adults With Type 2 Diabetes

  1. William H. Herman, MD, MPH1,
  2. Liza L. Ilag, MD, MS2,
  3. Susan L. Johnson, MD2,
  4. Catherine L. Martin, MS2,
  5. Joyce Sinding, MS3,
  6. Abdulaziz Al Harthi, MD2,
  7. Cynthia D. Plunkett, RNC2,
  8. Frankie B. LaPorte, MS4,
  9. Ray Burke, MA2,
  10. Morton B. Brown, PHD4,
  11. Jeffery B. Halter, MD2 and
  12. Philip Raskin, MD3
  1. 1Department of Internal Medicine and Epidemiology, University of Michigan Medical Center, Ann Arbor, Michigan
  2. 2Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, Michigan
  3. 3Department of Biomedical Research, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
  4. 4Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan
  1. Address correspondence and reprint requests to William H. Herman, MD, MPH, University of Michigan Health System, 1500 East Medical Center Dr., 3920 Taubman Center, Ann Arbor, MI 48109-0354. E-mail: wherman{at}umich.edu
Diabetes Care 2005 Jul; 28(7): 1568-1573. https://doi.org/10.2337/diacare.28.7.1568
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    Figure 1—

    Study recruitment and retention.

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    Figure 2—

    Mean A1C by treatment group and time. Data are means ± SD.

Tables

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  • Table 1—

    Characteristics of the study population

    CSIIMDI
    Subjects randomized (n)5354
    Age (years)66.6 ± 5.966.2 ± 4.5
    Sex (male)38 (72)24 (44)
    Race
        Caucasian43 (81)49 (91)
        Black4 (8)2 (4)
        Hispanic4 (8)2 (4)
        Other2 (4)1 (2)
    Duration of diabetes (years)16.9 ± 9.015.4 ± 8.9
    Prior diabetes treatment
        Insulin only30 (57)33 (61)
        Insulin and oral agent(s)23 (43)21 (39)
        Prior insulin treatment (years)8.1 ± 8.38.2 ± 7.7
    History of diabetes complications*
        Retinopathy20 (42)19 (36)
        Nephropathy9 (17)7 (13)
        Neuropathy37 (72)32 (59)
    History of cardiovascular complications*
        Hypertension38 (72)41 (76)
        Dyslipidemia31 (58)41 (76)
        Cigarette smoking (current)2 (4)3 (6)
        Angina/myocardial infarction/heart failure24 (45)17 (32)
    BMI (kg/m2)32.5 ± 5.831.8 ± 5.8
    A1C (%)8.4 ± 1.18.1 ± 1.2
    • Data are means ± SD or n (%).

    • *

      ↵* Self-reported.

  • 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 accuracy——22 (4)
        Difficult to depress pen plunger——54 (7)
        Difficult to see units on pen——44 (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.

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A Clinical Trial of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Older Adults With Type 2 Diabetes
William H. Herman, Liza L. Ilag, Susan L. Johnson, Catherine L. Martin, Joyce Sinding, Abdulaziz Al Harthi, Cynthia D. Plunkett, Frankie B. LaPorte, Ray Burke, Morton B. Brown, Jeffery B. Halter, Philip Raskin
Diabetes Care Jul 2005, 28 (7) 1568-1573; DOI: 10.2337/diacare.28.7.1568

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A Clinical Trial of Continuous Subcutaneous Insulin Infusion Versus Multiple Daily Injections in Older Adults With Type 2 Diabetes
William H. Herman, Liza L. Ilag, Susan L. Johnson, Catherine L. Martin, Joyce Sinding, Abdulaziz Al Harthi, Cynthia D. Plunkett, Frankie B. LaPorte, Ray Burke, Morton B. Brown, Jeffery B. Halter, Philip Raskin
Diabetes Care Jul 2005, 28 (7) 1568-1573; DOI: 10.2337/diacare.28.7.1568
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