Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-05-31

Brief Summary

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The purpose of the study is to evaluate the effect of real-time continuous glucose monitoring system on glucose control and outcomes of critically ill patients.

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Detailed Description

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Real-time continuous glucose monitoring system has shown great accuracy and feasibility in critically ill patients. However, its impact on glucose control and outcomes has nearly unknown. Thus, Investigators designed this study to evaluate the effect of real-time continuous glucose monitoring system on glucose control and outcomes of critically ill patients.

Conditions

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Hyperglycemia

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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Continuous Glucose Monitoring Group

Continuous Glucose Monitoring Group:

Different methods of blood glucose monitoring between groups, and this group will use real-time continuous glucose monitoring system with alarm limits（high and low limit is 10 mmol/L and 8 mmil/L , respectively ) up to five days for glucose control, the target mean glucose level is between 8 and 10 mmol/L.

Group Type EXPERIMENTAL

Different methods of blood glucose monitoring between groups

Intervention Type OTHER

Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group

Conventional Group

Conventional Group：

Different methods of blood glucose monitoring between groups, and this group will use finger prick blood glucose measurements for glucose control with the same target mean glucose level of 8 -10 mmol/L. Patients also wear real-time continuous glucose monitoring system to collect glucose measurements. The values of real-time continuous glucose monitoring system are blinded to investigator and patients.

Group Type ACTIVE_COMPARATOR

Different methods of blood glucose monitoring between groups

Intervention Type OTHER

Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group

Interventions

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Different methods of blood glucose monitoring between groups

Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* More than 18 years old male or female;

* Expected ICU stays longer than 72 hours;

* Glucose level more than 8 mmol/L when enrolls in the ICU;

* Patients or their legal surrogates have signed the informed consent.

Exclusion Criteria

* Pregnant or lactating women;

* ICU stays less than 72 hours;

* Usage of real-time continuous glucose monitoring system is considered as a contraindication.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No