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

An implantable insulin pump appears to have many advantages over multiple daily insulin injections in people with adult-onset diabetes but is also more costly. This was demonstrated in a study of 121 men with non-insulin-dependent diabetes (NIDDM) who were randomly assigned to inject insulin or have an insulin pump surgically implanted. Both types of insulin administration lowered blood glucose levels, but the insulin pump reduced glucose fluctuations and reduced the incidence of hypoglycemia. Those with the pump did not gain weight and reported higher quality of life measures.
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.sub.1c] ([HbA.sub.1c]) levels of 8% or above. Intervention.--Intensive therapy (lip or MDI) for 1 year. Main Outcome Measures.--Hemoglobin [A.sub.1c] and blood glucose levels. Results.--Blood glucose levels declined to 7.96[+ or -]1.08 mmol/L (143.4[+ or -]19.5 mg/dL) and 8.30[+ or -]1.52 mmol/L (149.6[+ or -]27.4 mg/dL) (mean[+ or -] SD) for lip and MDI, respectively (P=.57). Hemoglobin [A.sub.1c] levels improved in both groups (time effect P Conclusions.--Intensive insulin therapy with lip and MDI is effective in controlling non-insulin-dependent diabetes mellitus. lip has significant advantages in reducing glycemic variability, clinical hypoglycemia, and weight gain, while improving aspects of quality of life. JAMA. 1996;276:1322-1327