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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

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posted on 08.06.2022, 18:09 authored by Priyathama Vellanki, Saumeth Cardona, Rodolfo J Galindo, Maria A. Urrutia, Francisco J Pasquel, Georgia M Davis, Maya Fayfman, Alexandra Migdal, Limin Peng, Guillermo E. Umpierrez


Objective:  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. 

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 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. 

Results: 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). 

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 SSI did not significantly affect glycemic control.


This work was partially supported by grants from NIH/NIDDK K23DK DK113241-A1 (PV), NIH/NIDDK 5K23DK123384-02 (RJG), NIH/NIDDK 1K23124647-01 (MF), NIH/NIGMS 1K23GM128221-01A3 (FJP), 2P30DK111024-06 (RJG, GEU), NIH/NATS 3UL1TR002378-05S2 (GEU) and NIH/NIDDK 1K23DK122199-01A1 (GMD).