Randomized Trial Comparing Continuous Subcutaneous Insulin Infusion and Conventional Insulin Therapy in Type II Diabetic Patients Poorly Controlled With Sulfonylureas

Abstract

Objective To compare the effects of continuous subcutaneous insulin infusion (CSII) and conventional insulin therapy (CIT) in patients with poorly controlled sulfonylurea-treated diabetes mellitus. Resarch Design and Methods Twenty-five patients aged 40–65 yr and poorly controlled with sulfonylureas and without severe diabetic complications comprised the study group. Five patients left the study (3 achieved satisfactory glycemic control without insulin, 1 defaulted, 1 developed ketonuria). Ten patients were treated with CSII and 10 with CIT. Outpatient treatment consisted of CIT (twice-daily injections of regular and NPH insulin) or CSII (basal infusion and prandial boluses of regular insulin). Results Glycosylated hemoglobin improved with both methods of insulin delivery (P < 0.01), but 8 of 10 CSII-treated patients achieved satisfactory glycemic control (HbA1 < 50 mmol hydroxymethylfurfural/mol Hb), whereas only 3 of 10 CIT-treated patients achieved this (P < 0.05). Weight gain, insulin dosage, and prevalence of hypoglycemia were similar in the two groups. Retinal deterioration occurred in one CSII-treated patient and three CIT-treated patients, but there were no episodes of infusion site infection or metabolic decompensation. Patients' satisfaction with treatment improved during insulin therapy (P < 0.02), and significant changes in beliefs about diabetes and its treatment were observed in CSII-treated patients (P < 0.05). Concusions Glycemic control improved with both methods of insulin treated patients achieved satisfactory glycemic control (HbA1 < 50 mmol hydroxymethylfurfural?mol Hb), whereas only 3 of 10 CIT-treated patients achieved this CSII. Patients' satisfaction with treatment improved during insulin therapy.