Critical Illness
Conditions
Keywords
medical ICU patients, APACHE-II score ≥20
Brief summary
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.
Interventions
DEVICEexperimental: real-time continuous glucose monitoring
DEVICEActive comparator: blinded continuous glucose monitoring
Sponsors
University Hospital, Antwerp
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients admitted to a medical intensive care unit * age: ≥ 18 y , \< 75 y * APACHE II (Acute Physiology and Chronic Health Evaluation II) score ≥ 20 * expected length of stay in ICU \> 3 days
Exclusion criteria
* pregnancy * patient with a DNR (do not reanimate) code * surgical patient * no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of time that patients are in target range of glycaemia (80-110 mg/dl) | participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of time that patients are in hypoglycaemic range | participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| accuracy of continuous glucose monitoring | participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU | error grid analysis, analysing all data of the 4 days of continuous glucose monitoring period |
| glycaemic fluctuations | participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU | standard deviation of mean glucose value over 4 days, analysing all data of the 4 days of continuous glucose monitoring period |
Countries
Belgium
Outcome results
None listed