Efficacy and Safety of Intensive vs Non-Intensive Supplemental Insulin with a Basal Bolus Insulin Regimen in Hospitalized Patients with Type 2 Diabetes: A Randomized Clinical Study

Abstract

<p> </p> <p><strong>Objective: </strong> Administration of supplemental sliding scale insulin (SSI) for correction of hyperglycemia in non-ICU patients with type 2 diabetes is frequently used with basal-bolus insulin regimens. This non-inferiority randomized controlled trial tested whether glycemic control is similar with and without aggressive SSI before meals and bedtime in patients treated with basal-bolus insulin regimens. </p> <p><strong>Research Design and Methods: </strong>Patients with type 2 diabetes, with admission blood glucose (BG)140-400 mg/dl treated with basal-bolus insulin were randomized to Intensive (correction for BG>140 mg/dl, n=108) or to Non-Intensive (correction for BG>260 mg/dl, n=107) administration of rapid-acting SSI before meals and bedtime. Both groups received the same amount of SSI for BG>260 mg/dl. Primary outcome was difference in mean daily BG levels between the groups during hospitalization. </p> <p><strong>Results:</strong> Mean daily BG in the Non-Intensive group was non-inferior to BG in the Intensive group with equivalence margin of 18 mg/dl (Intensive: 172±38 mg/dl vs Non-Intensive: 173±43 mg/dl, p=0.001 for non-inferiority). There were no differences in the proportion of target BG readings of 70-180 mg/dl, hypoglycemia (<70 or <54 mg/dl), severe hyperglycemia (>350 mg/dl), or total, basal or prandial insulin doses. Significantly fewer subjects received SSI in the Non-Intensive (n=36,34%) compared to the Intensive group (n=98,91% [p<0.0001]) with no differences in SSI doses between the groups within those that received SSI (Intensive: 7±4 vs. Non-Intensive: 8±4 U/day, p=0.34). </p> <p><strong>Conclusions:</strong> Among non-ICU patients with type 2 diabetes on optimal basal-bolus insulin regimen with moderate hyperglycemia (BG<260 mg/dl), a less intensive SSI did not significantly affect glycemic control.</p>