RecruitingACTRN12612000130864

Continuous glucose monitoring in ICU

To investigate the reliability of continuous glucose monitoring in critically ill patients

Sponsor

University of Canterbury

Enrollment

80 participants

Start Date

Jun 22, 2012

Study Type

Observational

Conditions

blood glucose control in critically ill patients

Summary

Control of blood glucose (BG) to a normal range in critical care has shown distinct benefits, but has also proven difficult to obtain. The risk of severe hypoglycaemia (blood glucose < 2.2mmol/L) raises significant concerns for patient safety. Accurate BG measurements are essential for control protocols to work safely and effectively. This study will be completed in two parts: 1 – The current method of measuring BG levels (glucometer) will be assessed/validated in critically ill patients. Glucometer measurements will be compared to paired gold standard BG measurements, determined by the blood gas machine. The goal is to improve care through more accurate bedside BG measurement methods. 2 – Continuous Glucose Monitors (CGMs) offer an automated 5 minute measurement rate with the trade off of reduced accuracy. Compared to glucometers, these devices are capable of capturing glycaemic trends that would normally go unnoticed when measuring 1-4 hourly. CGMs will be used as an observational tool in critically ill patients in this study. Each patients will have 3 CGMs attached concurrently (two in the abdomen, one in the thigh), allowing variability of the device to be assessed. Analysis of the CGM data will help our understanding of the CGM error characteristics. If variability is managed effectively, these devices offer the potential to improve BG control while reducing nursing workload.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing better ways to monitor blood sugar levels in critically ill patients in the intensive care unit (ICU). Keeping blood sugar in a safe range is very important for ICU patients, but it can be difficult and the risk of dangerously low blood sugar is a concern. The study will look at how accurate bedside glucose meters are, and also test small continuous glucose monitoring devices that check sugar levels every five minutes automatically. Participating patients will have up to three of these small devices placed on the skin at the same time. You may be eligible if: - You are 16 years of age or older - You are an ICU patient receiving intensive insulin therapy to control blood sugar - You are expected to remain in the ICU for at least 3 to 5 days - You have a platelet count above 30,000 per microliter You may NOT be eligible if: - You are not expected to survive your ICU stay - Informed consent cannot be obtained - You have skin conditions at the intended device insertion sites - You are pregnant - You are receiving treatment that includes Hydroxyurea Talk to your doctor about whether this trial might be right for you.

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Interventions

This study is investigating the reliability of continuous glucose monitoring devices, which measure blood glucose every 1-5 minutes, in critically ill patients. Enrolled patients are monitored by multiple continuous glucose monitoring devices for up to 6 days. The aim of this study is to assess device performance and quantify the impact of certain drugs or illnesses on performance. Three devices have been approved for use in the study: Medtronic Guardian real-time, Medtronic iPro2 and Medtronic Sentrino. The study will be recruiting up to 80 patients and is approved to run until 30th June 2015.

Locations(1)

Canterbury, New Zealand

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ACTRN12612000130864