Adult Intensive Care PatientsNCT02421107
GlySure Acute Care Settings Study
A study testing Glysure CGM and iStat intermittent testing in people with Adult Intensive Care Patients, run by GlySure.
Trial summary
The company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels. This was done with patients in the intensive care unit (ICU) after heart surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Intensive Care Patients
- What is being tested?
- Glysure CGM and iStat intermittent testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 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
- 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 Central Venous Catheter (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
Show all 11Show fewer
- 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
- Patient who is being managed in a cardiac ICU setting after cardiac surgery
About this study
Official title: A Clinical Study to Evaluate the Safety of the GlySure Continuous Intravascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients
The company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels. This was done with patients in the intensive care unit (ICU) after heart surgery.
The company now want to confirm that the GlySure product is accurate at measuring blood glucose levels on all patients who stay in the ICU.
Read more
This clinical study requires 40 patients and is to check the safety of a continuous Glucose Monitoring System (GlySure) and it's performance in comparison to separate individual blood glucose testing using a hand held blood tester called i-STAT. Each patient must be in the study for at least 36 hours.
The main benefit of continuous blood glucose monitoring is that it gives a true picture of the glucose status of a patient and this can potentially help avoid the glucose level dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can intervene based on 'real-time' data on the glucose levels.
In this study patient treatment is not dictated by the data measured during the study. Clinicians are blind to the results on the GlySure monitor.
- Conditions
- Adult Intensive Care Patients
- Being tested
- Glysure CGM, iStat intermittent testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glysure CGMOther
iStat intermittent testingOther
| Study group | Role | What they receive |
|---|---|---|
| all patients | Other | all patients Receives: Other: Glysure CGM; Other: iStat intermittent testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety as assessed by serious adverse events attributed to the study investigational product
Measured: 0-7 days
mean absolute relative difference (MARD) % (accuracy)
Measured: 0-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Intensive Care PatientsStudies 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlySure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02421107
- Sponsor's protocol ID
- 2014.02.CE
- Status last verified
- Apr 2015
- First submitted
- 3 Nov 2014
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. 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 Intravascular Glucose Monitoring System, and Its Performance in Comparison to Intermittent Blood Glucose Monitoring in Adult Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT02421107
- Acronym / sponsor ID
- 2014.02.CE
- Conditions
- Adult Intensive Care Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- GlySureIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 20 Apr 2015 (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 company who have developed the GlySure product have previously carried out a study to be able to show that the GlySure system is accurate in measuring blood sugar (glucose) levels. This was done with patients in the intensive care unit (ICU) after heart surgery.
The company now want to confirm that the GlySure product is accurate at measuring blood glucose levels on all patients who stay in the ICU.
This clinical study requires 40 patients and is to check the safety of a continuous Glucose Monitoring System (GlySure) and it's performance in comparison to separate individual blood glucose testing using a hand held blood tester called i-STAT. Each patient must be in the study for at least 36 hours.
The main benefit of continuous blood glucose monitoring is that it gives a true picture of the glucose status of a patient and this can potentially help avoid the glucose level dropping too low (hypoglycaemic) or staying too high (hyperglycaemia) as clinicians can intervene based on 'real-time' data on the glucose levels.
In this study patient treatment is not dictated by the data measured during the study. Clinicians are blind to the results on the GlySure monitor.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all patients | Other | Other: Glysure CGM, Other: iStat intermittent testingall patients |
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 Central Venous Catheter (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 (11 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 CGM | Other | all patients |
| iStat intermittent testing | Other | all patients |
Primary outcome
safety as assessed by serious adverse events attributed to the study investigational product
Time frame: 0-7 days
mean absolute relative difference (MARD) % (accuracy)
Time frame: 0-7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
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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.
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 CGM and iStat intermittent testing in people with Adult Intensive Care Patients, 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 11 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 Apr 2015. 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 as assessed by serious adverse events attributed to the study investigational product (time frame: 0-7 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 Apr 2015.