Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Antwerp
- Enrollment
- 35
- Locations
- 4
- Primary Endpoint
- percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
Time Frame: 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 Outcomes
- 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)
Investigators
Christophe De Block
MD PhD
University Hospital, Antwerp