Microburst Insulin Infusion: Results of Observational Studies – Carbohydrate Metabolism, Painful Diabetic Neuropathy, and Hospital/Emergency Department Utilization

Abstract

Background: Pulsed intravenous insulin therapy (PIVIT) has shown equivocal results in studies examining metabolic control. Microburst insulin infusion mimics the periodicity and amplitude of normal pancreatic function more closely than other previous pulsatile insulin therapeutic approaches. Methods: Data from three observational, retrospective studies are reported: carbohydrate metabolism, painful diabetic neuropathy (PDN), and hospital/ emergency department utilization. All studies utilized controlled microbursts of insulin via the Bionica Microdose system in patients with type 1 and type 2 diabetes. Indirect calorimetry was used to determine carbohydrate and metabolic rate measures (n=311). Painful Diabetic Neuropathy (PDN) diagnosis was assessed by the DN4 questionnaire and patients were categorized by neuropathic pain improvement (n=412). Finally, a two-year study of 1,524 diabetic patients was conducted to compare hospital admissions and emergency department visits to homologous patients. Results: Microburst insulin infusion (MII) treatment increased oxygen consumption and energy expenditure by promoting a greater carbohydrate oxidation rate. Respiratory exchange ratio values increased significantly, reflecting a change toward carbohydrate oxidation, and resting metabolic rate increased 29%. Microburst therapy resulted in complete elimination or reduction of pain in 93% of PDN patients. Hospital admissions were reduced to 1.65/1,000/ year (versus National Hospital Discharge Survey reported rate of 46.7/1,000/year), and ED visits were reduced to 2.3/1,000/ year (versus US Healthcare Statistics rate of 58.4/1,000/year). Conclusion: Microburst insulin therapy improved underlying carbohydrate metabolism, reduced neuropathic morbidity, and reduced ED visits and hospital admissions in patients with 2 or more diabetic morbidities. Microburst insulin therapy represents a new advance in the treatment of diabetes and the complications of diabetes.