Glucose Control in the ICU Using Continuous Glucose Monitoring (REGIMEN)

Antwerp University Hospital (UZA)

Status: Completed

Conditions: Critical Illness

Treatments: Device: experimental: real-time continuous glucose monitoring; Device: Active comparator: blinded continuous glucose monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT01799512

REGIMEN

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 2 patient groups

real-time continuous glucose monitoring

Experimental group

Description:

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.

Treatment:

Device: experimental: real-time continuous glucose monitoring

blinded continuous glucose monitoring

Active Comparator group

Description:

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.

Treatment:

Device: Active comparator: blinded continuous glucose monitoring