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

Kang Yan

Status: Unknown

Conditions: Hyperglycemia

Treatments: Other: Different methods of blood glucose monitoring between groups

Study type: Interventional

Funder types: Other

Identifiers

NCT01992965

CGM-ky0521

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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144 participants in 2 patient groups

Continuous Glucose Monitoring Group

Experimental group

Description:

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.

Treatment:

Other: Different methods of blood glucose monitoring between groups

Conventional Group

Active Comparator group

Description:

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.

Treatment:

Other: Different methods of blood glucose monitoring between groups