• C D Saudek, W C Duckworth, A Giobbie-Hurder, W G Henderson, R R Henry, D E Kelley, S V Edelman, F J Zieve, R A Adler, J W Anderson, R J Anderson, B P Hamilton, T W Donner, M S Kirkman, and N A Morgan.
• Johns Hopkins University School of Medicine, Baltimore, Md 21205, USA.
• JAMA. 1996 Oct 23; 276 (16): 132213271322-7.

ObjectiveTo determine whether implantable insulin pump (IIP) therapy and multiple daily insulin (MDI) injections could equally attain improved blood glucose control, and to compare the 2 treatments with respect to reducing daily blood glucose fluctuations, reducing serious hypoglycemic insulin reactions, and improving patients' quality of life.DesignRandomized clinical trial.SettingSeven Veterans Affairs medical centers.PatientsOne hundred twenty-one male type II diabetic patients between the ages of 40 and 69 years, receiving at least 1 injection of insulin per day and having hemoglobin A1c (HbA1c) levels of 8% or above.InterventionIntensive therapy (IIP or MDI) for 1 year.Main Outcome MeasuresHemoglobin A1c and blood glucose levels.ResultsBlood glucose levels declined to 7.96+/-1.08 mmol/L (143.4+/-19.5 mg/dL) and 8.30+/-1.52 mmol/L (149.6+/-27.4 mg/dL) (mean +/- SD) for IIP and MDI, respectively (P=.57). Hemoglobin A1c levels improved in both groups (time effect P<.001), to means of 7.54%+/-0.83% (MDI) vs 7.34%+/-0.79% (IIP). IIP reduced blood glucose fluctuations compared with MDI (P<.001), and reduced the incidence of mild clinical hypoglycemia by 68% (P<.001); IIP also eliminated the weight gain associated with MDI therapy and yielded better overall quality-of-life (P=.03) and impact-of-disease subscale scores (P=.05). Adverse events included 25% of subjects with episodes of insulin underdelivery due to microprecipitates of insulin within the pump.ConclusionsIntensive insulin therapy with IIP and MDI is effective in controlling non-insulin-dependent diabetes mellitus. IIP has significant advantages in reducing glycemic variability, clinical hypoglycemia, and weight gain, while improving aspects of quality of life.

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