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

¹ Department of Internal Medicine and Epidemiology, University of Michigan Medical Center, Ann Arbor, Michigan
² Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor, Michigan
³ Department of Biomedical Research, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas
⁴ Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan

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

OBJECTIVE—To compare the efficacy and safety of continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) in older adults with insulin-treated type 2 diabetes and to assess treatment satisfaction and quality of life.

RESEARCH DESIGN AND METHODS—Adults (n = 107) 60 years of age (mean age 66 years) with insulin-treated type 2 diabetes (mean duration 16 years, BMI 32 kg/m², and HbA_1C [A1C] 8.2%) were randomized to CSII (using insulin lispro) or MDI (using insulin lispro and insulin glargine) in a two-center, 12-month, prospective, randomized, controlled clinical trial. Efficacy was assessed with A1C, safety by frequency of hypoglycemia, and treatment satisfaction and quality of life with the Diabetes Quality of Life Clinical Trial Questionnaire and the 36-item short-form health survey, version 2.

RESULTS—Forty-eight CSII subjects (91%) and 50 MDI subjects (93%) completed the study. Mean A1C fell by 1.7 ± 1.0% in the CSII group to 6.6% and by 1.6 ± 1.2% in the MDI group to 6.4%. The difference in A1C between treatment groups was not statistically significant (P = 0.20). Eighty-one percent of CSII subjects and 90% of MDI subjects experienced at least one episode of minor (self-treated) hypoglycemia (P = 0.17), and three CSII and six MDI subjects experienced severe hypoglycemia (P = 0.49). Rates of severe hypoglycemia were similarly low in the two groups (CSII 0.08 and MDI 0.23 events per person-year, P = 0.61). Weight gain did not differ between groups (P = 0.70). Treatment satisfaction improved significantly with both CSII and MDI (P < 0.0001), and the difference between groups was not statistically significant (P = 0.58).

CONCLUSIONS—In older subjects with insulin-treated type 2 diabetes, both CSII and MDI achieved excellent glycemic control with good safety and patient satisfaction.

Abbreviations: CSII, continuous subcutaneous insulin infusion • DQOLCTQ, Diabetes Quality of Life Clinical Trial Questionnaire • MDI, multiple daily injection • SF-36 v2, 36-item short-form health survey, version 2

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Which Is Better for Older Adults With Type 2 Diabetes: Insulin Pump Therapy or Insulin Injection Therapy?

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