Efficacy and Safety of Intensive Versus Nonintensive Supplemental Insulin With a Basal-Bolus Insulin Regimen in Hospitalized Patients With Type 2 Diabetes: A Randomized Clinical Study

• Type of Material: Article
• Authors: Priyathama Vellanki, Emory University; Saumeth Cardona, Emory University; Rodolfo Galindo, Emory University; Maria Urrutia, Emory University; Francisco Javier Pasquel, Emory University; Georgia Davis, Emory University; Maya Fayfman, Emory University; Alexandra Migdal, Emory University; Limin Peng, Emory University; Guillermo E. Umpierrez, Emory University
• Language: English
• Date: 2022-06-08
• Publisher: The American Diabetes Association
• Publication Version: Final Published Version
• Copyright Statement: © 2022 by the American Diabetes Association
• License: Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International
• Final Published Version (URL): https://doi.org/10.2337%2Fdc21-1606
• Title of Journal or Parent Work: Diabetes Care
• Volume: 45
• Issue: 10
• Start Page: 2217
• End Page: 2223
• Grant/Funding Information: This work was partially supported by grants from National Institute of Diabetes and Digestive and Kidney Diseases/National Institutes of Health (NIH) (K23DK DK113241-A1 to P.V., 5K23DK123384-02 to R.J.G., 1K23124647-01 to M.F., 2P30DK111024-06 to R.J.G. and G.E.U., and 1K23DK122199-01A1 to G.M.D.), National Institute of General Medical Sciences/NIH (1K23GM128221-01A3 to F.J.P.), and NIH/National Center for Advancing Translational Sciences (3UL1TR002378-05S2 to G.E.U.).
• Keywords: clinical trials; hospitalized patients; type 2 diabetes; efficacy assessment; supplemental insulin
• Research Categories: Health Sciences, Medicine and Surgery; Health Sciences, Pharmacology

Abstract

OBJECTIVE: Administration of supplemental sliding scale insulin for correction of hyperglycemia in non–intensive care unit (ICU) patients with type 2 diabetes is frequently used with basal-bolus insulin regimens. In this noninferiority randomized controlled trial we tested whether glycemic control is similar with and without aggressive sliding scale insulin treatment before meals and bedtime in patients treated with basal-bolus insulin regimens. RESEARCH DESIGN AND METHODS: 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 nonintensive (correction for BG >260 mg/dL, n = 107) administration of rapid-acting sliding scale insulin before meals and bedtime. The groups received the same amount of sliding scale insulin for BG >260 mg/dL. Primary outcome was difference in mean daily BG levels between the groups during hospitalization. RESULTS: Mean daily BG in the nonintensive group was noninferior to BG in the intensive group with equivalence margin of 18 mg/dL (intensive 172 ± 38 mg/dL vs. nonintensive 173 ± 43 mg/dL, P = 0.001 for noninferiority). There were no differences in the proportion of target BG readings of 70–180 mg/dL, <70 or <54 mg/dL (hypoglycemia), or >350 mg/dL (severe hyperglycemia) or total, basal, or prandial insulin doses. Significantly fewer subjects received sliding scale insulin in the nonintensive (n = 36 [34%]) compared with the intensive (n = 98 [91%] [P < 0.0001]) group with no differences in sliding scale insulin doses between the groups among those who received sliding scale insulin (intensive 7 ± 4 units/day vs. nonintensive 8 ± 4 units/day, P = 0.34). CONCLUSIONS: Among non-ICU patients with type 2 diabetes on optimal basal-bolus insulin regimen with moderate hyperglycemia (BG <260 mg/dL), a less intensive sliding scale insulin treatment did not significantly affect glycemic control.