Glucose Control in the ICU Using Continuous Glucose Monitoring

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2013-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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real-time continuous glucose monitoring

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.

Group Type EXPERIMENTAL

experimental: real-time continuous glucose monitoring

Intervention Type DEVICE

blinded continuous glucose monitoring

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.

Group Type ACTIVE_COMPARATOR

Active comparator: blinded continuous glucose monitoring

Intervention Type DEVICE

Interventions

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experimental: real-time continuous glucose monitoring

Intervention Type DEVICE

Active comparator: blinded continuous glucose monitoring

Intervention Type DEVICE

Other Intervention Names

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RT-CGM using the GlucoDay device (A. Menarini, Italy)

Eligibility Criteria

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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