Continuous Glucose Monitoring Guided Assessment of Concentrated 200 IU/Ml rDNA Human Premix 30/70 Insulin in Type 2 Diabetes Mellitus Patients

Abstract

Background: Many patients with type 2 diabetes mellitus (T2DM) are on insulin analogues which are costly as well as usage of higher units of insulin on a daily basis increases the cost of the monthly therapy. Concentrated insulin are a way forward for patients who needs higher units of insulin especially Human insulin which address the issues of higher cost and the need for higher concentration in the same or lesser volume of insulin. However, data on 24-hour glycemic control with concentrated insulin in Indian T2DM patients are limited. Hence, this study was conducted to study 24hour glycemic control in T2DM patients treated with U-200 by measuring the variability in 24-hr blood glucose profile measured using a continuous glucose monitoring (CGM) device over 6 days. Material and methods: In this prospective, open label single arm, two center study, adult T2DM patients on treatment with human insulin (regular/NPH/Premix) on stable insulin dose were treated with U-200 for 6 days. Variability in 24-hour blood glucose profile was measured by estimating mean amplitude of glucose excursions (MAGE). Duration and frequency of hypoglycemic (< 70 mg/dl) and hyperglycemic (> 150 mg/dl) episodes were recorded. Results: Sixty patients (mean age of 55.47 ± 9.68 years) were included. Mean number of hyperglycemic and hypoglycemic episodes were 2.64 and 0.22 with mean duration of 165.16 min and 27.35 min respectively. Blood glucose levels were within the normal limits (70-150 mg/dL) for 62.35% of time. MAGE was 77.24 ± 22.50 mg/dL. In this study, not a single patient experienced any adverse event. Conclusion: U200 insulin led to less glycemic variability, minimal hypoglycemia and efficient glucose control in Indian T2DM patients.