CClinicalTrials.gg
Status unknownNCT01992965Updated May 7, 2014

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

An interventional study of Different methods of blood glucose monitoring between groups in Hyperglycemia, sponsored by Kang Yan. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-05-07.

Sponsored by Kang Yan · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
144
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Hyperglycemia

Keywords

  • continuous glucose monitoring;
  • critically ill;
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In context

Hyperglycemia

699 studies on the registry are indexed under Hyperglycemia; 105 are open to participants now.

This study's planned enrollment of 144 is above the median of 46 across 521 interventional studies indexed under Hyperglycemia.

Browse Hyperglycemia studies →

Lead sponsor

Kang Yan is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
144 participants (estimated)

Study arms

  • Experimental
    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.

    Other: Different methods of blood glucose monitoring between groups

  • Active comparator
    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.

    Other: Different methods of blood glucose monitoring between groups

Interventions

  • OtherDifferent 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

06

What researchers measure

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

    Time frame: Glycemic control measures will be assessed up to five days.

Secondary outcomes

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

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

  2. Cost

    Time frame: Cost associated with glucose monitoring

07

Study locations

1 of 1 sites recruiting
  • Intensive care unit of West China Hospital
    Chengdu, Sichuan 610000, China
    • Yan Kang, MD · Contact · kang_yan_123@163.com · 028-85422508
    • Yan Kang, MD · Principal investigator
    • Yan-yan Zuo, MD · Sub investigator
    • Mei-zhu Lu, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01992965
Lead sponsor
Kang Yan
Responsible party
Kang Yan (Director of Intensive Care Unit, West China Hospital) — Sponsor-investigator
First posted
Nov 25, 2013
Start date
Apr 2014
Primary completion
May 2016 (estimated)
Completion
May 2016 (estimated)
Last update
May 7, 2014

Study contacts

Yan Kang, MD
Contact
kang_yan_123@163.com
86-028-85422508
Yan-yan Zuo, MM
Contact
zyyan21@163.com
86-028-85422506
Yan Kang, MD
study director · West China Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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