Glucose Control in the ICU Using Continuous Glucose Monitoring

Not Applicable

Completed

• Conditions: Critical Illness

• Registration Number: NCT01799512
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2010-09
• Status Verified: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-22
• Last Update Submitted: 2013-02-22
• Study First Posted: 2013-02-26
• Last Update Posted: 2013-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Middelheim General Hospital; 🇧🇪 Antwerp, Belgium

Antwerp University Hospital; 🇧🇪 Edegem, Belgium