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Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial.

ABSTRACT: Blood glucose control in the intensive care unit (ICU) has the potential to save lives. However, maintaining blood glucose concentrations within a chosen target range is difficult in clinical practice and holds risk of potentially harmful hypoglycemia. Clinically validated computer algorithms to guide insulin dosing by nurses have been advocated for better and safer blood glucose control.We conducted an international, multicenter, randomized controlled trial involving 1550 adult, medical and surgical critically ill patients, requiring blood glucose control. Patients were randomly assigned to algorithm-guided blood glucose control (LOGIC-C, n?=?777) or blood glucose control by trained nurses (Nurse-C, n?=?773) during ICU stay, according to the local target range (80-110 mg/dL or 90-145 mg/dL). The primary outcome measure was the quality of blood glucose control, assessed by the glycemic penalty index (GPI), a measure that penalizes hypoglycemic and hyperglycemic deviations from the chosen target range. Incidence of severe hypoglycemia (<40 mg/dL) was the main safety outcome measure. New infections in ICU, duration of hospital stay, landmark 90-day mortality and quality of life were clinical safety outcome measures.The median GPI was lower in the LOGIC-C (10.8 IQR 6.2-16.1) than in the Nurse-C group (17.1 IQR 10.6-26.2) (P?

SUBMITTER: Dubois J

PROVIDER: S-EPMC5557320 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial.

Dubois Jasperina J Van Herpe Tom T van Hooijdonk Roosmarijn T RT Wouters Ruben R Coart Domien D Wouters Pieter P Van Assche Aimé A Veraghtert Guy G De Moor Bart B Wauters Joost J Wilmer Alexander A Schultz Marcus J MJ Van den Berghe Greet G Mesotten Dieter D

Critical care (London, England) 20170814 1

<h4>Background</h4>Blood glucose control in the intensive care unit (ICU) has the potential to save lives. However, maintaining blood glucose concentrations within a chosen target range is difficult in clinical practice and holds risk of potentially harmful hypoglycemia. Clinically validated computer algorithms to guide insulin dosing by nurses have been advocated for better and safer blood glucose control.<h4>Methods</h4>We conducted an international, multicenter, randomized controlled trial in ...[more]

PMID: 28806982

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Project description:BACKGROUND:Continuous glucose monitoring (CGM) has not yet been implemented in the intensive care unit (ICU) setting. The purpose of this study was to evaluate reliability, feasibility, nurse acceptance and accuracy of the Medtronic Sentrino(®) CGM system in critically ill patients. METHODS:Sensors were inserted into the subcutaneous tissue of the patient's thigh, quantifying interstitial glucose concentration for up to 72 h per sensor. Reliability and feasibility analysis included frequency of data display, data gaps and reasons for sensor removal. We surveyed nurse acceptance in a questionnaire. For the accuracy analysis, we compared sensor values to glucose values obtained via blood gas analysis. Potential benefits of CGM were investigated in intra-individual analyses of factors, such as glycemic variability or time in target range achieved with CGM compared to that achieved with intermittent glucose monitoring. RESULTS:The device generated 68,655 real-time values from 31 sensors in 20 critically ill patients. 532 comparative blood glucose values were collected. Data were displayed during 32.5 h [16.0/62.4] per sensor, which is 45.1 % of the expected time of 72 h and 84.8 % of 37.9 h actual monitoring time. 21 out of 31 sensors were removed prematurely. 79.1 % of the nursing staff rated the device as not beneficial; the response rate was one-third. Mean absolute relative difference was 15.3 % (CI 13.5-17.0 %). Clarke error grid: 76.9 % zone A, 21.6 % zone B, 0.2 % zone C, 0.9 % zone D, 0.4 % zone E. Bland-Altman plot: mean bias +0.53 mg/dl, limits of agreement +64.6 and -63.5 mg/dl. Accuracy deteriorated during elevated glycemic variability and in the hyperglycemic range. There was no reduction in dysglycemic events during CGM compared to 72 h before and after CGM. If CGM was measuring accurately, it identified more hyperglycemic events when compared to intermittent measurements. This study was not designed to evaluate potential benefits of CGM on glucose control. CONCLUSIONS:The subcutaneous CGM system did not perform with satisfactory accuracy, feasibility, or nursing acceptance when evaluated in 20 medical-surgical ICU patients. Low point accuracy and prolonged data gaps significantly limited the potential clinical usefulness of the CGM trend data. Accurate continuous data display, with a MARD < 14 %, showed potential benefits in a subgroup of our patients. Trial registration NCT02296372; Ethic vote Charité EA2/095/14.

Dataset Information

Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial.

Publications

Software-guided versus nurse-directed blood glucose control in critically ill patients: the LOGIC-2 multicenter randomized controlled clinical trial.

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