Continuous Glucose MeasurementNCT01942902
A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring
A study testing Continuous Glucose Monitoring System in people with Continuous Glucose Measurement, run by GlySure at 2 sites in India.
Trial summary
The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Continuous Glucose Measurement
- What is being tested?
- Continuous Glucose Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesIndia
- Study dates
- Jul 2013to Oct 2013
- 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
- Male and female aged 18 years and above
- Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment
- Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-
Who cannot join
- Patient or legal representative unable to provide written informed consent
- Patient who is pregnant
- Patient who is currently being administered Mannitol
- Patient with history of Pulmonary Embolism (PE)
- Patient with history of thrombosis
- Patient with known hyper-coagulation
Show all 12Show 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 and/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
- Patient likely to require an MRI scan during their stay in the SICU
- Patients likely to require treatment with Mannitol during time in the SICU
Trial locations and contacts
2 sites in 1 country.
India2 sites
Star Hospital
Banjara Hills, Hyderabad, 500034
Care Hospital
Nampally, Hyderabad, 500001
About this study
Official title: A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring Using the Yellow Springs Blood Glucose Analyser for Conformité Européenne (CE) Marking Purposes in a Total of Thirty Patients Admitted to The Surgical Intensive Care Unit (SICU)
The purpose of this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.
- Conditions
- Continuous Glucose Measurement
- Being tested
- Continuous Glucose Monitoring System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring SystemDevice
Also called Glysure
| Study group | Role | What they receive |
|---|---|---|
| Continuous Glucose Monitoring System | Experimental | Not described Receives: Device: Continuous Glucose Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results
The study is designed to evaluate the comparative accuracy between measured blood glucose results obtained from the GlySure Continuous Glucose Monitoring System (CGM) and the YSI, and to determine if any condition or treatment affects the sensor's measured values.
Measured: For at least 30 hours and up to 7 days
Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices
Measured: For at least 30 hours and up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2013 (estimated)
- Study startJul 2013
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Glucose MeasurementStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlySure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Krishna Prasad, MD, Principal investigator, Care Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942902
- Sponsor's protocol ID
- 2013.01.CE
- Status last verified
- Nov 2013
- First submitted
- 15 Aug 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study to Evaluate the Accuracy and Safety of the GlySure Continuous Intravascular Glucose Monitoring System Versus Intermittent Blood Glucose Monitoring Using the Yellow Springs Blood Glucose Analyser for Conformité Européenne (CE) Marking Purposes in a Total of Thirty Patients Admitted to The Surgical Intensive Care Unit (SICU)
- ClinicalTrials.gov ID
- NCT01942902
- Acronym / sponsor ID
- 2013.01.CE
- Conditions
- Continuous Glucose Measurement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- GlySureIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 16 Sep 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 this study is to evaluate the system performance of the GlySure Continuous Glucose Monitoring (CGM) system in patients admitted to the Surgical Intensive Care Unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Glucose Monitoring System | Experimental | Device: Continuous Glucose Monitoring System |
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
- Male and female aged 18 years and above
- Require Central Venous Catheter (CVC) into the right internal Jugular vein as part of disease management and treatment
- Expected to remain in the Surgical Intensive Care Unit (SICU) for at least 30 hours and up to 7 days-
Key exclusion criteria (12 listed)
- Patient or legal representative unable to provide written informed consent
- Patient who is pregnant
- Patient who is currently being administered Mannitol
- 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 |
|---|---|---|
| Continuous Glucose Monitoring SystemAlso: Glysure | Device | Continuous Glucose Monitoring System |
Primary outcome
Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results
Time frame: For at least 30 hours and up to 7 days
The study is designed to evaluate the comparative accuracy between measured blood glucose results obtained from the GlySure Continuous Glucose Monitoring System (CGM) and the YSI, and to determine if any condition or treatment affects the sensor's measured values.
Number of participants experiencing Serious Adverse Events (SAEs) causally related to the devices
Time frame: For at least 30 hours and up to 7 days
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 6 Nov 2013.
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Comparison of Dietetics Support With and Without Continuous Glucose Monitoring in Individuals With Type 2 Diabetes.
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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.
Krishna Prasad, MD principal investigator
Care Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Glucose Monitoring System in people with Continuous Glucose Measurement, run by GlySure at 2 sites in India.
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 12 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 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. 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?
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?
Accuracy of the CGM system as compared with the Yellow Springs Instrument (YSI) blood sample analysis results (time frame: For at least 30 hours and up to 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 6 Nov 2013.