Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

Medical University of Vienna

Status: Completed

Conditions: Critical Illness

Treatments: Drug: intensive insulin therapy; Device: Real-time glucose monitoring system (Guardian, Medtronic)

Study type: Interventional

Funder types: Other

Identifiers

NCT00494078

488/2005

Details and patient eligibility

About

The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.

Full description

Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy.
• Age > 18 years.

Exclusion criteria

• Admitted patients expected to stay <48h
• Age ≤ 18 years

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

1

Active Comparator group

Description:

Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.

Treatment:

Device: Real-time glucose monitoring system (Guardian, Medtronic)

2

Active Comparator group

Description:

intensive insulin therapy guided by an algorithm

Treatment:

Drug: intensive insulin therapy