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<.OO1), and reduced the incidence of mild clinical hypoglycemia by 68% (P<.001); lip 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 lip 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.