Efficiency of Continuous Glucose Monitoring in Critically Ill Patients

Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00494078

Enrollment

120

Registered

2007-06-29

Start date

2006-06-30

Completion date

2008-08-31

Last updated

2010-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring

Brief summary

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.

Detailed 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.

Interventions

DRUGintensive insulin therapy

intensive insulin therapy according to an algorithm

DEVICEReal-time glucose monitoring system (Guardian, Medtronic)

Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period	72h

Secondary

Measure	Time frame
Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias	72h

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026