RAndomized Study of Basal Bolus Insulin Therapy in the Inpatient Management of Patients with Type 2 Diabetes Undergoing General Surgery (RABBIT 2 Surgery)
Abstract Number: 571-P
Authors: DAWN SMILEY, MONICA RIZZO, DENISE UMPIERREZ, MIGUEL CERON, ANGEL TEMPONI, PATRICK MULLIGAN, SOL JACOBS, LIMIN PENG, CHRISTOPHER NEWTON, GUILLERMO UMPIERREZ
Institutions: Atlanta, GA
Results: Few studies have focused on the optimal treatment of hyperglycemia in general surgery patients with T2DM. Accordingly, we conducted an open-label, randomized multicenter trial to compare the efficacy and safety of a basal/bolus regimen to sliding scale regular insulin (SSRI) in general surgery. Study outcomes included differences in daily BG levels, hypoglycemia rate, hospital complications and mortality. A total of 130 patients (M63/F67; age: 56±12 yr, BG: 193±96 mg/dl, A1C: 7.8±2%, ±SD) with a BG between 140-400 mg/dl and a history of T2DM >3 months were randomized to glargine + glulisine (Gla+Glu, n=67) or SSRI (n= 63). Total daily dose of Gla+Glu was started at 0.5 U/kg, given half as glargine once daily and half as glulisine before meals. SSRI was given 4 times/day for BG >140 mg/dl. The mean daily BG level after the 1st day of Gla+Glu vs. SSRI was 146±53 mg/dl and 159±48 mg/dl, respectively, p=0.45. A target BG <140 mg/dl before meals was achieved in 51% in the Gla+Glu and in 36% in the SSRI group, p=0.15. Eight patients (13%) treated with SSRI had persistent BG >240 mg/dl and required a switch to Gla+Glu. In the Gla+Glu group, 19 patients (28.3%) had a BG <70 mg/dl, 11 (16.4%) had a BG <60 mg/dl and 3 (4.5%) had a BG <40 mg/dl. In the SSRI group, 7 patients (11.1%) had a BG <70 mg/dl, 4 (6.3%) had a BG <60 mg/dl and none had a BG <40 mg/dl (BG <70, p=0.02; BG <60, p=0.10; BG <40 mg/dl, p=0.24). There were no differences in the rate of wound infections (3 cases/group) or in LOS (9.1±7.5 vs. 9.9±7.9 days, p= NS); however, Gla+Glu treatment was associated with a lower rate of non-wound infections (13% vs. 22%, p=0.28), acute renal failure (0% vs. 13%, p=0.002), and mortality (0% vs. 1.6%, p= 0.48) vs. SSRI treatment.
In summary, treatment with glargine once daily plus glulisine before meals in general surgery patients with T2DM resulted in greater improvement in glycemic control and reduced hospital complications compared to the sole use of SSRI. Our study indicates that basal/bolus insulin regimen is the preferred treatment regimen in the hospital management of surgical patients with type 2 diabetes.