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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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Critical Care
Published in: Critical Care 4/2014

Open Access 01-08-2014 | Research

Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial

Authors: Daphne T Boom, Marjolein K Sechterberger, Saskia Rijkenberg, Susanne Kreder, Rob J Bosman, Jos PJ Wester, Ilse van Stijn, J Hans DeVries, Peter HJ van der Voort

Published in: Critical Care | Issue 4/2014

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Abstract

Introduction

Glucose measurement in intensive care medicine is performed intermittently with the risk of undetected hypoglycemia. The workload for the ICU nursing staff is substantial. Subcutaneous continuous glucose monitoring (CGM) systems are available and may be able to solve some of these issues in critically ill patients.

Methods

In a randomized controlled design in a mixed ICU in a teaching hospital we compared the use of subcutaneous CGM with frequent point of care (POC) to guide insulin treatment. Adult critically ill patients with an expected stay of more than 24 hours and in need of insulin therapy were included. All patients received subcutaneous CGM. CGM data were blinded in the control group, whereas in the intervention group these data were used to feed a computerized glucose regulation algorithm. The same algorithm was used in the control group fed by intermittent POC glucose measurements. Safety was assessed with the incidence of severe hypoglycemia (<2.2 mmol/L), efficacy with the percentage time in target range (5.0 to 9.0 mmol/L). In addition, we assessed nursing workload and costs.

Results

In this study, 87 patients were randomized to the intervention and 90 to the control group. CGM device failure resulted in 78 and 78 patients for analysis. The incidence of severe glycemia and percentage of time within target range was similar in both groups. A significant reduction in daily nursing workload for glucose control was found in the intervention group (17 versus 36 minutes; P <0.001). Mean daily costs per patient were significantly reduced with EUR 12 (95% CI −32 to −18, P = 0.02) in the intervention group.

Conclusions

Subcutaneous CGM to guide insulin treatment in critically ill patients is as safe and effective as intermittent point-of-care measurements and reduces nursing workload and daily costs. A new algorithm designed for frequent measurements may lead to improved performance and should precede clinical implementation.

Trial registration

Clinicaltrials.gov, NCT01526044. Registered 1 February 2012.
Appendix
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Metadata
Title
Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial
Authors
Daphne T Boom
Marjolein K Sechterberger
Saskia Rijkenberg
Susanne Kreder
Rob J Bosman
Jos PJ Wester
Ilse van Stijn
J Hans DeVries
Peter HJ van der Voort
Publication date
01-08-2014
Publisher
BioMed Central
Published in
Critical Care / Issue 4/2014
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-014-0453-9

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