Metabolic Stress HyperglycemiaGlucoClearITNCT03047824
Effects of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients
A study testing Intravascular continuous monitoring in people with Metabolic Stress Hyperglycemia, run by Erasme University Hospital.
Trial summary
After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metabolic Stress Hyperglycemia
- What is being tested?
- Intravascular continuous monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jun 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have an anticipated ICU stay of at least 48 hours;
- Participate or have authorized representative participate in the Informed Consent process and sign/date the approved informed consent form.
- Have an expected ICU stay of ≥ 24 hours up to 72 hours
- Have an APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
- Not be participating in any other investigational interventional study.
- Have hyperglycemia (BG > 150 mg/dl) up to 6 hours after admission and / or ongoing insulin therapy.
- Access to a large peripheral vein
Who cannot join
- End stage pre-existing medical conditions that would preclude the subject from being able to complete up to 72 hours of glucose monitoring and follow up (14 ± 3 days after Sensor removal); Restricted peripheral venous access, inadequate access for reference sampling or any contraindication to the placement of peripheral IV catheters.
- Skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude placing the peripheral IV catheters or dressings (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings).
- A known history of heparin-induced thrombocytopenia or any contraindication for anti-coagulation therapy.
- Intolerance to Lactated Ringer's solution ((mEq/liter): Sodium 130; Potassium 4; Calcium 3; Chloride 110; Lactate 28).
- A positive pregnancy test 72 hours prior to Sensor insertion (for subjects of child bearing potential).
- Any condition that, in the opinion of the Investigator, would interfere with their participation in the Study.
- Participated in any other drug, device, or biologic Study within the last 30 days (prior to Sensor insertion) which may clinically interfere with this Study or have not completed the required Protocol follow-up period.
About this study
Official title: A Study on the Effects of the Use of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients
After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort.
After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined.
Read more
Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system.
Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override.
Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl.
After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.
Read the detailed description
Hyperglycemia, hypoglycemia and glycemic variability, the three components of dysglycemia are independently associated with morbidity and mortality of critically ill patients. Blood glucose (BG) control with insulin has the potential to decrease morbidity and mortality of intensive care unit (ICU) patients. Blood glucose control with insulin, however, is associated with an increased risk of hypoglycemia and its effect on glycemic variability is uncertain. BG control with insulin utilizing manual systems for glucose measurement is blood-consuming and time-consuming, since frequent blood draws for glucose measurements are necessary in order to achieve blood glucose control.
Severe hypoglycemia (blood glucose level < 40 mg/dl) is a feared complication of blood glucose control with insulin. Undoubtedly, with implementation of blood glucose with insulin the incidence of hypoglycemia increases. Reported incidences of severe hypoglycemia rise by 5 to 10-fold as compared to conventional glucose control strategies in randomized controlled trials. Several reports showed a significant association between hypoglycemia and patient outcomes. Recently, an association has even been suggested between moderate and mild hypoglycemia (blood glucose level between 40-69 mg/dL) and patient outcomes. Incidences of moderate hypoglycemia are more prevalent than severe hypoglycemia. The risk of developing (severe or moderate) hypoglycemia hampers, at least in part, broad implementation of blood glucose control with insulin, in particular when aiming at normal blood glucose levels [17,18].
Recent studies showed also significant associations between glycemic variability and patient outcomes. BG control algorithms, if properly applied, could decrease glycemic variability. Experimentally, rodent experiment showed that brain damage was not associated with the duration of severe hypoglycemia, but instead with its correction (mainly overcorrection) with intravenous dextrose causing formation of radicals. Hence, a close glucose monitoring to prevent overcorrection is mandatory.
These different arguments strongly support the need for reliable and accurate CGM. The GlucoClearTM Continuous Glucose Monitoring system from Edwards Lifesciences measures blood sugar by Glucose Oxidase Sensing Technology through in-blood measurement. Blood is automatically drawn and analyzed every 5 minutes from a peripheral venous catheter, with real time graphical display. Blood is then returned to the patient and the system automatically self-calibrates. The GlucoClear CGM is designed to be highly accurate. In a recent study performed in critically ill patients, it was shown to comply with the required standards of quality.
The main research question addressed by the present study is: "To which extent a CGM-guided strategy improve the quality of BG control performance"?
- Conditions
- Metabolic Stress Hyperglycemia
- Being tested
- Intravascular continuous monitoring, Standard of care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular continuous monitoringDevice
Bedside usual insulin therapy guided by continuous glucose monitoring
Standard of careOther
Bedside usual insulin therapy guided by intemittent glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Continuous monitoring-guided therapy | Other | Healthcare providers were allowed to use the blood glucose values displayed on the intravascular continuous monitoring to adapt insulin therapy Receives: Device: Intravascular continuous monitoring |
| Standard of care | Other | Healthcare providers used the usual intermittent method to adapt insulin therapy; the blood glucose values measured by the intravascular continuous monitoring were not displayed but recorded. Usual care involves the adjustment of insulin infusion based on BG values measured with a blood gas analyser 4-6 times per day. Receives: Other: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in target
Cumulative time in target band (expressed in percentage) will be calculated from the set of BG values recorded by the CGM in both groups.
Measured: 72 hours
Secondary outcomes (6)
Hypoglycaemic index
Area under the low limit of the target range
Measured: 72 hours
Glycemic variability
Coefficient of variation
Measured: 72 hours
Mortality
ICU, hospital and 28-day mortality
Measured: 28 days
Length of stay
Measured: 28 days
SOFA score
Measured: 72 hours
Time to target
Time to achieve the upper limit of target range (hours)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startMay 2014
- Primary completionMay 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Stress 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
- Single blind
- Who is masked
- Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Edwards Lifesciences
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Vincent, MD PhD, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047824
- Sponsor's protocol ID
- P2014/162 / B406201420742
- Acronym
- GlucoClearIT
- Status last verified
- Feb 2017
- First submitted
- 3 Oct 2016
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Preiser JC, Lheureux O, Thooft A, Brimioulle S, Goldstein J, Vincent JL. Near-Continuous Glucose Monitoring Makes Glycemic Control Safer in ICU Patients. Crit Care Med. 2018 Aug;46(8):1224-1229. doi: 10.1097/CCM.0000000000003157.
PubMed 29677007
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of the Use of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03047824
- Acronym / sponsor ID
- GlucoClearIT / P2014/162 / B406201420742
- Conditions
- Metabolic Stress Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Collaborators
- Edwards Lifesciences
- Study start
- May 2014
- Primary completion
- May 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Feb 2017 (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.
After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort.
After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined.
Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system.
Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override.
Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl.
After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.
Detailed description
Hyperglycemia, hypoglycemia and glycemic variability, the three components of dysglycemia are independently associated with morbidity and mortality of critically ill patients. Blood glucose (BG) control with insulin has the potential to decrease morbidity and mortality of intensive care unit (ICU) patients. Blood glucose control with insulin, however, is associated with an increased risk of hypoglycemia and its effect on glycemic variability is uncertain. BG control with insulin utilizing manual systems for glucose measurement is blood-consuming and time-consuming, since frequent blood draws for glucose measurements are necessary in order to achieve blood glucose control.
Severe hypoglycemia (blood glucose level < 40 mg/dl) is a feared complication of blood glucose control with insulin. Undoubtedly, with implementation of blood glucose with insulin the incidence of hypoglycemia increases. Reported incidences of severe hypoglycemia rise by 5 to 10-fold as compared to conventional glucose control strategies in randomized controlled trials. Several reports showed a significant association between hypoglycemia and patient outcomes. Recently, an association has even been suggested between moderate and mild hypoglycemia (blood glucose level between 40-69 mg/dL) and patient outcomes. Incidences of moderate hypoglycemia are more prevalent than severe hypoglycemia. The risk of developing (severe or moderate) hypoglycemia hampers, at least in part, broad implementation of blood glucose control with insulin, in particular when aiming at normal blood glucose levels [17,18].
Recent studies showed also significant associations between glycemic variability and patient outcomes. BG control algorithms, if properly applied, could decrease glycemic variability. Experimentally, rodent experiment showed that brain damage was not associated with the duration of severe hypoglycemia, but instead with its correction (mainly overcorrection) with intravenous dextrose causing formation of radicals. Hence, a close glucose monitoring to prevent overcorrection is mandatory.
These different arguments strongly support the need for reliable and accurate CGM. The GlucoClearTM Continuous Glucose Monitoring system from Edwards Lifesciences measures blood sugar by Glucose Oxidase Sensing Technology through in-blood measurement. Blood is automatically drawn and analyzed every 5 minutes from a peripheral venous catheter, with real time graphical display. Blood is then returned to the patient and the system automatically self-calibrates. The GlucoClear CGM is designed to be highly accurate. In a recent study performed in critically ill patients, it was shown to comply with the required standards of quality.
The main research question addressed by the present study is: "To which extent a CGM-guided strategy improve the quality of BG control performance"?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous monitoring-guided therapy | Other | Device: Intravascular continuous monitoringHealthcare providers were allowed to use the blood glucose values displayed on the intravascular continuous monitoring to adapt insulin therapy |
| Standard of care | Other | Other: Standard of careHealthcare providers used the usual intermittent method to adapt insulin therapy; the blood glucose values measured by the intravascular continuous monitoring were not displayed but recorded. Usual care involves the adjustment of insulin infusion based on BG values measured with a blood gas analyser 4-6 times per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have an anticipated ICU stay of at least 48 hours;
- Participate or have authorized representative participate in the Informed Consent process and sign/date the approved informed consent form.
- Have an expected ICU stay of ≥ 24 hours up to 72 hours
- Have an APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
- Not be participating in any other investigational interventional study.
Key exclusion criteria (7 listed)
- End stage pre-existing medical conditions that would preclude the subject from being able to complete up to 72 hours of glucose monitoring and follow up (14 ± 3 days after Sensor removal); Restricted peripheral venous access, inadequate access for reference sampling or any contraindication to the placement of peripheral IV catheters.
- Skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude placing the peripheral IV catheters or dressings (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings).
- A known history of heparin-induced thrombocytopenia or any contraindication for anti-coagulation therapy.
- Intolerance to Lactated Ringer's solution ((mEq/liter): Sodium 130; Potassium 4; Calcium 3; Chloride 110; Lactate 28).
- A positive pregnancy test 72 hours prior to Sensor insertion (for subjects of child bearing potential).
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 |
|---|---|---|
| Intravascular continuous monitoringBedside usual insulin therapy guided by continuous glucose monitoring | Device | Continuous monitoring-guided therapy |
| Standard of careBedside usual insulin therapy guided by intemittent glucose monitoring | Other | Standard of care |
Primary outcome
Time in target
Time frame: 72 hours
Cumulative time in target band (expressed in percentage) will be calculated from the set of BG values recorded by the CGM in both groups.
6 secondary outcomes
Hypoglycaemic index
Time frame: 72 hours
Glycemic variability
Time frame: 72 hours
Mortality
Time frame: 28 days
Length of stay
Time frame: 28 days
SOFA score
Time frame: 72 hours
Time to target
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Derived from this study: PubMed 29677007Preiser JC, Lheureux O, Thooft A, Brimioulle S, Goldstein J, Vincent JL. Near-Continuous Glucose Monitoring Makes Glycemic Control Safer in ICU Patients. Crit Care Med. 2018 Aug;46(8):1224-1229. doi: 10.1097/CCM.0000000000003157.
- Individual participant dataSharing planned: Undecided
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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.
Jean-Louis Vincent, MD PhD study director
Erasme University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular continuous monitoring in people with Metabolic Stress Hyperglycemia, run by Erasme University Hospital.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in target (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03047824, which also lists 1 linked publication.
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 13 Mar 2017.