HyperglycemiaNCT01992965
Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
A study testing Different methods of blood glucose monitoring between groups in people with Hyperglycemia, run by Kang Yan at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hyperglycemia
- What is being tested?
- Different methods of blood glucose monitoring between groups
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- Apr 2014to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant or lactating women;
- ICU stays less than 72 hours;
- Usage of real-time continuous glucose monitoring system is considered as a contraindication.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Intensive care unit of West China Hospital
Chengdu, Sichuan, 610000
Yan Kang, MD, 028-85422508, kang_yan_123@163.com
Yan Kang, MD
About this study
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.
- Conditions
- Hyperglycemia
- Being tested
- Different methods of blood glucose monitoring between groups
- Keywords
- continuous glucose monitoring；, critically ill;
- Medical subject headings
- Hyperglycemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different methods of blood glucose monitoring between groupsOther
Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Different methods of blood glucose monitoring between groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: All the participants will be followed for the duration of hospital stay or 28 days.
Cost
Measured: Cost associated with glucose monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startApr 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kang Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kang Yan, West China Hospital
- Investigators
- Yan Kang, MD, Study director, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992965
- Sponsor's protocol ID
- CGM-ky0521
- Status last verified
- May 2014
- First submitted
- 13 Nov 2013
- Last updated
- 7 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Real-time Continuous Glucose Monitoring on Glucose Control and Outcomes of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01992965
- Acronym / sponsor ID
- CGM-ky0521
- Conditions
- Hyperglycemia
- Keywords
- continuous glucose monitoring；, critically ill;
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Kang YanUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring Group | Experimental | Other: Different methods of blood glucose monitoring between groupsContinuous 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. |
| Conventional Group | Active comparator | Other: Different methods of blood glucose monitoring between groupsConventional 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- More than 18 years old male or female;
Key exclusion criteria (3 listed)
- Pregnant or lactating women;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different methods of blood glucose monitoring between groupsFinger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group | Other | Continuous Glucose Monitoring Group, Conventional Group |
Primary outcome
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.
2 secondary outcomes
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.
Cost
Time frame: Cost associated with glucose monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Kang, MD study director
West China Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different methods of blood glucose monitoring between groups in people with Hyperglycemia, run by Kang Yan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Kang, MD (86-028-85422508, kang_yan_123@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2014.