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

NCT01992965 | Unknown DMC

• 1 other identifier: CGM-ky0521
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia

Keywords

continuous glucose monitoring；; critically ill;

Outcome Measures

Primary Outcomes (1)

• Glycemic Control Measures including: Percentage of target blood glucose levels (defined as between 8mmol/L and 10mmol/L); Time of hyperglycemia (defined as >10mmol/L); Hypoglycemia rate (defined as < 2.2mmol/L); Glucose lability index

  Glycemic control measures will be assessed up to five days.

Secondary Outcomes (2)

• Prognosis Measures including: Duration of mechanical ventilation；Time of ICU stay; Time of hospital stay; 28 days - mortality rate

  All the participants will be followed for the duration of hospital stay or 28 days.

• Cost

  Cost associated with glucose monitoring

Study Arms (2)

Continuous Glucose Monitoring Group

EXPERIMENTAL

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.

Other: Different methods of blood glucose monitoring between groups

Conventional Group

ACTIVE COMPARATOR

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.

Other: Different methods of blood glucose monitoring between groups

Interventions

Different methods of blood glucose monitoring between groups OTHER

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

Continuous Glucose Monitoring Group; Conventional Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant or lactating women;
• ICU stays less than 72 hours;
• Usage of real-time continuous glucose monitoring system is considered as a contraindication.

Sponsors & Collaborators

• Kang Yan: lead

Study Sites (1)

Intensive care unit of West China Hospital

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Conditions

Hyperglycemia; Critical Illness

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yan Kang, MD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Yan Kang, MD

CONTACT

86-028-85422508; kang_yan_123@163.com

Yan-yan Zuo, MM

CONTACT

86-028-85422506; zyyan21@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Intensive Care Unit

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 25, 2013
• Study Start: April 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 7, 2014

Record last verified: 2014-05

Locations

CN (1)