An interventional study of experimental: real-time continuous glucose monitoring and Active comparator: blinded continuous glucose monitoring in Critical Illness, sponsored by University Hospital, Antwerp. Completed at 2 sites in Belgium. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-02-26.
Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Treatment
Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit (MICU) and is associated with increased morbidity and mortality. However, randomized controlled trials examining the effects of strict glycemic control demonstrated conflicting results. A common finding in these trials was the high risk of hypoglycaemia.
This randomized controlled trial evaluates the impact of real-time continuous glucose monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 35 is below the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →University Hospital, Antwerp is the lead sponsor of 234 studies on the registry; 68 are open to participants now.
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Exclusion Criteria:
real-time continuous glucose monitoring: Use will be made of the online real-time (RT) monitoring facility of the GlucoDay® (a continuous glucose monitoring (CGM)system). This will allow immediate adaptation of the insulin dose in order to maintain values within an optimal range. The same IV insulin infusion protocol will be used in the experimental and the active comparator group (adapted Yale protocol). When glycaemic changes of \>25 mg/dl per 30 minutes are observed from the RT-CGM - GlucoDay data, this will be checked by measuring arterial blood glucose and the insulin infusion rate will be adapted according to the adapted Yale protocol.
Device: experimental: real-time continuous glucose monitoring
In the active comparator group the same continuous glucose monitoring device (GlucoDay) will be used in a blinded fashion. Glucose data will be analysed retrospectively. IV insulin infusion will be adapted according to arterial blood glucose values, using the adapted Yale protocol.
Device: Active comparator: blinded continuous glucose monitoring
Also known as: RT-CGM using the GlucoDay device (A. Menarini, Italy)
percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
percentage of time that patients are in hypoglycaemic range
after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
accuracy of continuous glucose monitoring
error grid analysis, analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
glycaemic fluctuations
standard deviation of mean glucose value over 4 days, analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
accuracy of continuous glucose monitoring
Bland-Altman bias plot will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
accuracy of continuous glucose monitoring
mean absolute error and mean relative error will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
glycaemic fluctuations
MAGE (mean amplitude of glucose excursions), analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
glycaemic fluctuations
CONGA (continuous overlapping net glycemic action), analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
glycaemic fluctuations
area under curve (within target glycemia range, above target, below target) analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
glycaemic fluctuations
MODD: mean of daily differences; analysing all data of the 4 days of continuous glucose monitoring period
Time frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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University Hospital, Antwerp