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Can functional electrical stimulation-assisted cycle ergometry replace insulin infusion in patients? A nested substudy in a randomized controlled trial with 6 months' follow-up [with consumer summary]
Waldauf P, Urban T, Krajcova A, Jiroutkova K, Blahutova B, Bakalar B, Rasova K, Grunerova-Lippertova M, Gojda J, Duska F
Journal of Parenteral and Enteral Nutrition 2022 Jan;46(1):249-253
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Functional electrical stimulation-assisted cycle ergometry (FESCE) can deliver active exercise to critically ill patients, including those who are sedated. Aerobic exercise is known to stimulate skeletal muscle glucose uptake. We asked whether FESCE can reduce intravenous insulin requirements and improve insulin sensitivity in intensive care unit (ICU) patients. METHOD: We performed an a priori-planned secondary analysis of data from an outcome-based randomized controlled trial (NCT02864745) of FESCE-based early-mobility program versus standard of care in mechanically ventilated patients. We analyzed glucose profile, glucose intake, and insulin requirements during ICU stay in all enrolled patients. In a nested subgroup, we performed hyperinsulinemic (120 mIU/min/m2) euglycemic clamps at days 0, 7, and 180 (n = 30, 23, and 11, respectively). RESULTS: We randomized 150 patients 1:1 to receive intervention or standard of care. Seventeen (23%) patients in each study arm had a history of diabetes. During ICU stay, patients received 137 +/- 65 and 137 +/- 88 g/day carbohydrate (p = 0.97), and 31 versus 35 (p = 0.62) of them required insulin infusion to maintain blood glucose 8.61 +/- 2.82 versus 8.73 +/- 2.67 mM (p = 0.75, n = 11,254). In those treated with insulin, median daily dose was 53 IU (interquartile range (IQR) 25 to 95) versus 62 IU (IQR 26 to 96) in the intervention and control arm, respectively (p = 0.44). In the subgroup of patients undergoing hyperglycemic clamps, insulin sensitivities improved similarly and significantly from acute and protracted critical illness to 6 months after discharge. CONCLUSION: The FESCE-based early-mobility program does not significantly reduce insulin requirements in critically ill patients on mechanical ventilation.

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