Blood Glucose Monitoring in Medical ICUMICUNCT02142088
Comparative Study of GlySure Continuous Intra-vascular Glucose Monitoring and Intermittent Monitoring in Medical ICU
A study testing GlySure Intravascular Continuous glucose monitoring sensor in people with Blood Glucose Monitoring in Medical ICU, run by GlySure.
Trial summary
It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Glucose Monitoring in Medical ICU
- What is being tested?
- GlySure Intravascular Continuous glucose monitoring sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2014
- 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
- Patient or legal representative MUST be willing to sign an informed consent document
- Patient is male or female aged 18 years or above
- Patient requires a CVC to be inserted as part of disease management and treatment
- Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study
Who cannot join
- Patient or legal representative is unable to provide written informed consent
- Patient who is pregnant
- Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
- Patient with history of pulmonary embolism (PE)
- Patient with history of thrombosis
- Patient with known hyper-coagulation
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- Patient with known history of heparin hypersensitivity
- Patient with history of heparin induced thrombocytopenia
- Participation in a clinical study involving an unlicensed pharmaceutical product or device within the 3 months prior to enrolment in this study
- Patient with known hypersensitivity/allergy to adhesive I.V. dressings such as 3M Tegaderm film or StatLock® devices
About this study
Official title: A Clinical Study to Evaluate the Safety of the GlySure Continuous Intra-vascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients
It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose monitoring system in patients in a surgical ICU environment after cardiac surgery. This study seeks to evaluate the same equipment being used in a wider range of patients with a range of underlying conditions who require treatment in medical ICU's. The GlySure device consists of a sensor that is placed into the patient's blood through a central venous catheter. It measures blood glucose levels continuously which allows for more rapid control of blood glucose levels to be achieved as compared to existing methods where blood samples are taken repeatedly every 15 minutes or so.
The study is designed to show that the sensor can be used for a protracted period of time, giving accurate results when compared to a reference technique using the i-STAT device. The investigators intend to show that the device performs safely for the required time within the ICU.
- Conditions
- Blood Glucose Monitoring in Medical ICU
- Being tested
- GlySure Intravascular Continuous glucose monitoring sensor
- Keywords
- Glycaemic Control, Glucose Monitoring, Intravascular Glucose Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlySure Intravascular Continuous glucose monitoring sensorDevice
Also called Devices not yet issued for study, so serial numbers not yet linked to study.
Comparator device is an iSTAT device from Abbott Diagnostics
| Study group | Role | What they receive |
|---|---|---|
| Glucose Monitoring | Other | Each patient will undergo simultaneous Glucose monitoring with 2 devices. One is GlySure's intervascular continuous measurement sensor (test device) introduced through a CVC, and the other measures glucose intermittently from repeated venous blood samples drawn through an indwelling ventflon style catheter Receives: Device: GlySure Intravascular Continuous glucose monitoring sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety in Use
No Serious Adverse Events causally related to the device
Measured: During ICU Stay, normally less than 7 days
MARD Score
Average aggregate MARD to be below 10%, 95% of subjects to have a MARD of less than 25%
Measured: During ICU stay, normally less than 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Glucose Monitoring in Medical ICUStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlySure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kentron
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142088
- Sponsor's protocol ID
- 2014.01.CE
- Acronym
- MICU
- Status last verified
- May 2014
- First submitted
- 16 May 2014
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety of the GlySure Continuous Intra-vascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT02142088
- Acronym / sponsor ID
- MICU / 2014.01.CE
- Conditions
- Blood Glucose Monitoring in Medical ICU
- Keywords
- Glycaemic Control, Glucose Monitoring, Intravascular Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- GlySureIndustry (pharma, biotech, devices)
- Collaborators
- Kentron
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 20 May 2014 (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.
It has been shown that close control of blood glucose levels in the intensive care unit patient has benefits for patient morbidity and mortality rates as well as an impact upon discharge times. GlySure has previously completed an evaluation of its intra-vascular glucose monitoring system in patients in a surgical ICU environment after cardiac surgery. This study seeks to evaluate the same equipment being used in a wider range of patients with a range of underlying conditions who require treatment in medical ICU's. The GlySure device consists of a sensor that is placed into the patient's blood through a central venous catheter. It measures blood glucose levels continuously which allows for more rapid control of blood glucose levels to be achieved as compared to existing methods where blood samples are taken repeatedly every 15 minutes or so.
The study is designed to show that the sensor can be used for a protracted period of time, giving accurate results when compared to a reference technique using the i-STAT device. The investigators intend to show that the device performs safely for the required time within the ICU.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glucose Monitoring | Other | Device: GlySure Intravascular Continuous glucose monitoring sensorEach patient will undergo simultaneous Glucose monitoring with 2 devices. One is GlySure's intervascular continuous measurement sensor (test device) introduced through a CVC, and the other measures glucose intermittently from repeated venous blood samples drawn through an indwelling ventflon style catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient or legal representative MUST be willing to sign an informed consent document
- Patient is male or female aged 18 years or above
- Patient requires a CVC to be inserted as part of disease management and treatment
- Patient is expected to remain in the intensive care unit for at least 36 hours post enrolment to the study
Key exclusion criteria (10 listed)
- Patient or legal representative is unable to provide written informed consent
- Patient who is pregnant
- Patient who is currently being administered Mannitol and/or may require the administration of Mannitol whilst in the ICU
- Patient with history of pulmonary embolism (PE)
- Patient with history of thrombosis
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 |
|---|---|---|
| GlySure Intravascular Continuous glucose monitoring sensorAlso: Devices not yet issued for study, so serial numbers not yet linked to study.Comparator device is an iSTAT device from Abbott Diagnostics | Device | Glucose Monitoring |
Primary outcome
Safety in Use
Time frame: During ICU Stay, normally less than 7 days
No Serious Adverse Events causally related to the device
MARD Score
Time frame: During ICU stay, normally less than 7 days
Average aggregate MARD to be below 10%, 95% of subjects to have a MARD of less than 25%
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing GlySure Intravascular Continuous glucose monitoring sensor in people with Blood Glucose Monitoring in Medical ICU, run by GlySure.
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 10 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 20 May 2014. 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?
Results are not available in the source record.
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?
Safety in Use (time frame: During ICU Stay, normally less than 7 days). The study lists 2 primary outcomes in all. 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 20 May 2014.