PeRiOperative Glucose PRAgMatic (PROGRAM): a randomized trial of standardized insulin management in surgical patients

Background: Perioperative hyperglycemia is associated with adverse patient outcomes including surgical site infections. This study examined whether an automated insulin dosing reminder is associated with a lower risk for postoperative hyperglycemia and other secondary and safety outcomes in patients at high risk for intraoperative hyperglycemia. Methods: We conducted a pragmatic trial using a sequential and repeated crossover design between October 5, 2022, and October 26, 2023. We sequentially assigned anesthesia providers to receive either an automated insulin dosing reminder (intervention) or a glucose check reminder (routine care) periodically throughout surgery for a consecutive sample of adult patients at high risk for intraoperative hyperglycemia undergoing major surgery at our quaternary medical center. Our primary outcome was hyperglycemia (glucose >180 mg/dL) at the first postoperative measurement ≤3 hours postoperatively. The primary analysis studied the association between automated insulin dosing reminder and postoperative hyperglycemia adjusted for demographics, surgery characteristics, preoperative glucose, time period, and the interaction of intervention and time period. Results: A total of 4558 cases qualified for primary analysis: 2611 cases in the routine care group and 1947 cases in the intervention group. 970 (37%) and 675 (35%) cases, respectively, experienced the primary outcome. We found no evidence of an association between treatment and postoperative hyperglycemia in the overall study period (OR, 0.90, 95% CI, 0.78 to 1.03, P = 0.165). There was no evidence of difference in intraoperative glucose monitoring (OR, 0.99, 95% CI, 0.83 to 1.19, P = 0.369), and intraoperative insulin use (OR, 1.00, 95% CI, 0.83 to 1.20, P = 0.995). The odds of surgical site infections were higher in the intervention group (overall unadjusted OR, 2.52, 95% CI, 1.37 to 4.64, P = 0.006). No difference in safety endpoints were observed between groups. Conclusions: Among surgical patients at high risk of intraoperative hyperglycemia, an automated insulin dosing reminder did not improve glycemic control or other outcomes compared with a glucose check reminder.