Implantable insulin pump vs multiple-dose insulin for non-insulin-dependent diabetes mellitus - A randomized clinical trial

Objective.-To 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, Design.-Randomized clinical trial, Setting.-Seven Veterans Affairs medical centers. Patients.-One 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 A(1c) (HbA(1c)) levels of 8% or above, Intervention.-Intensive therapy (IIP or MDI) for 1 year, Main Outcome Measures.-Hemoglobin A(1c) and blood glucose levels, Results.-Blood 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 A(1c) 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, Conclusions.-Intensive 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.