NCT01799512

Glucose Control in the ICU Using Continuous Glucose Monitoring

Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Critical Illness

Interventions

Type	Name	Description
DEVICE	experimental: real-time continuous glucose monitoring
DEVICE	Active comparator: blinded continuous glucose monitoring

Timeline

• Start date: 2007-07-01
• Primary completion: 2010-09-01
• Completion: 2013-02-01
• First posted: 2013-02-26
• Last updated: 2013-02-26

Locations

2 sites across 1 country: Belgium