ICU/CCU Patients Requiring Blood Glucose MonitoringMANAGE IDENCT02211300
MANAGE Automated Glucose Monitoring
A study testing The OptiScanner and YSI 2300 STAT Plus™ in people with ICU/CCU Patients Requiring Blood Glucose Monitoring, run by OptiScan Biomedical Corporation at 4 sites in United States.
Trial summary
The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects. Accuracy Hypothesis: The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU/CCU Patients Requiring Blood Glucose Monitoring
- What is being tested?
- The OptiScanner and YSI 2300 STAT Plus™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2014to Dec 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
- Signed informed consent by participant or his/her legally authorized representative
- At least 18 years old
- Admitted to the ICU or CCU
- Expected ICU or CCU stay of at least 18 hours at the time of enrollment (as judged by Investigator)
- Requires blood glucose monitoring; and
- A vascular access device that can be dedicated for connection to the OptiScanner is either already in-place, is planned to be placed for another purpose or can, in the opinion of the Investigator be safely placed exclusively for use in this study, and another access device is in place or can be placed for manually drawing samples to be evaluated using the YSI Analyzer. Note that CVCs should not be placed solely for the purposes of conducting this study. Refer to section 1.2.7 for details regarding vascular access devices and guidelines for selection and placement.
Who cannot join
- Pregnant or nursing
- In the Investigator's opinion the subject cannot safely tolerate the amount of saline required to be given to the subject (up to 360 mL per day)
- Hematocrit less than 15% or greater than 60%
- Subjects that require placement of an additional vascular access line will be excluded if they do not have a suitable access site free from any of the following conditions:
- Peripheral vascular disease
- History of placement site neuropathy or chronic pain
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- History of placement extremity coagulopathy or clot formation
- History of vascular surgery on the same extremity as catheter placement
- Any medical condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study, including but not limited to a high risk of complications associated with vascular access; or
- Participation in any other investigational drug or device study in the last 30 days and/or while enrolled in this study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Tufts Medical Center
Boston, Massachusetts, 02111
Robert Carpenter, 210-632-8883, rcarpenter1@tuftsmedicalcenter.org
Stanley Nasraway, MD
- Recruiting
Hermann Memorial Hospital
Houston, Texas, 77030
Carrie Howard, CCRC, 713-500-5461, Carrie.L.Howard@uth.tmc.edu
Laura Moore, MD
- Recruiting
Providence Heart and Vascular Institute
Portland, Oregon, 64111
Heather Aiona, CCRC, 503-216-8770, Heather.M.Aiona@providence.org
Anthony Furnary, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
Stacey Reese, MS, RN, reeses@wudosis.wustl.edu
Grant Bochicchio, MD
About this study
Official title: MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE
The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects.
Accuracy Hypothesis:
The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow Springs, OH).
Safety Hypothesis:
The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated automated blood glucose levels for critically ill subjects.
- Being tested
- The OptiScanner, YSI 2300 STAT Plus™
- Keywords
- glucose monitoring, OptiScanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The OptiScannerDevice
Also called OptiScanner, Yellow Springs Instrument
treatment of blood glucose per standard of care
YSI 2300 STAT Plus™Device
| Study group | Role | What they receive |
|---|---|---|
| Optiscanner values vs YSI | Experimental | Matched samples up to 12 times per 24 hour period Receives: Device: The OptiScanner; Device: YSI 2300 STAT Plus™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Accuracy Endpoint
The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.
Measured: Accurancy up to 72 hours of monitoring per subject
Secondary outcomes (1)
Secondary Accuracy Endpoint
The "population CV" will be computed as the standard deviation of the difference between the glucose level reported by the OptiScanner and the glucose level reported by the YSI Analyzer divided by the mean of the YSI Analyzer values. Repeated measures analyses will be used to account for possible correlation of measurements within patients. The population CV therefore gives an estimate of the extent of the effect of outliers on the accuracy estimation. If the "population CV" is less than 13%, the outcome of the secondary accuracy analysis will be considered a success.
Measured: Accuracy up to 72 hours of subject monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015 (estimated)
- Study completionDec 2015 (estimated)
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 ICU/CCU Patients Requiring Blood Glucose MonitoringStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OptiScan Biomedical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Grant V Bochicchio, MD, MPH, Principal investigator, Washington University School of MedicineStanley A Nasraway, MD, Principal investigator, Tufts Medical CenterAnthony Furnary, MD, Principal investigator, Providence St. Vincents Medical CenterLinda Moore, MD, Principal investigator, Hermann Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02211300
- Sponsor's protocol ID
- 2002055
- Acronym
- MANAGE IDE
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2014
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nohra E, Buckman S, Bochicchio K, Chamieh J, Reese S, Merrill C, Schuerer D, Bochicchio GV. Results of a near continuous glucose monitoring technology in surgical intensive care and trauma. Contemp Clin Trials. 2016 Sep;50:1-4. doi: 10.1016/j.cct.2016.07.007. Epub 2016 Jul 6.
PubMed 27394384
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MANUAL VS. AUTOMATED MONITORING ACCURACY OF GLUCOSE
- ClinicalTrials.gov ID
- NCT02211300
- Acronym / sponsor ID
- MANAGE IDE / 2002055
- Keywords
- glucose monitoring, OptiScanner
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- OptiScan Biomedical CorporationIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 7 Aug 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.
The objective of this study is to demonstrate that the OptiScanner® is safe and can provide accurate blood glucose levels in critically ill subjects.
Accuracy Hypothesis:
The assessment of blood glucose level that results from the OptiScanner is comparable to the YSI 2300 STAT Plus™ Glucose and Lactate Analyzer ("YSI Analyzer"; YSI Life Sciences, Yellow Springs, OH).
Safety Hypothesis:
The OptiScanner has an acceptable risk/benefit profile for a system that can provide repeated automated blood glucose levels for critically ill subjects.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optiscanner values vs YSI | Experimental | Device: The OptiScanner, Device: YSI 2300 STAT Plus™Matched samples up to 12 times per 24 hour period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent by participant or his/her legally authorized representative
- At least 18 years old
- Admitted to the ICU or CCU
- Expected ICU or CCU stay of at least 18 hours at the time of enrollment (as judged by Investigator)
- Requires blood glucose monitoring; and
Key exclusion criteria (10 listed)
- Pregnant or nursing
- In the Investigator's opinion the subject cannot safely tolerate the amount of saline required to be given to the subject (up to 360 mL per day)
- Hematocrit less than 15% or greater than 60%
- Subjects that require placement of an additional vascular access line will be excluded if they do not have a suitable access site free from any of the following conditions:
- Any medical condition that, in the Investigator's opinion, would warrant exclusion from the study or prevent the subject from completing the study, including but not limited to a high risk of complications associated with vascular access; or
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 |
|---|---|---|
| The OptiScannerAlso: OptiScanner, Yellow Springs Instrumenttreatment of blood glucose per standard of care | Device | Optiscanner values vs YSI |
| YSI 2300 STAT Plus™ | Device | Optiscanner values vs YSI |
Primary outcome
Primary Accuracy Endpoint
Time frame: Accurancy up to 72 hours of monitoring per subject
The mean absolute relative difference (MARD) in glucose level between the OptiScanner and the YSI Analyzer (average of 2 measures). To demonstrate accuracy the MARD must be less than or equal to 10%.
1 secondary outcome
Secondary Accuracy Endpoint
Time frame: Accuracy up to 72 hours of subject monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Derived from this study: PubMed 27394384Nohra E, Buckman S, Bochicchio K, Chamieh J, Reese S, Merrill C, Schuerer D, Bochicchio GV. Results of a near continuous glucose monitoring technology in surgical intensive care and trauma. Contemp Clin Trials. 2016 Sep;50:1-4. doi: 10.1016/j.cct.2016.07.007. Epub 2016 Jul 6.
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.
Grant V Bochicchio, MD, MPH principal investigator
Washington University School of Medicine
Stanley A Nasraway, MD principal investigator
Tufts Medical Center
Anthony Furnary, MD principal investigator
Providence St. Vincents Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The OptiScanner and YSI 2300 STAT Plus™ in people with ICU/CCU Patients Requiring Blood Glucose Monitoring, run by OptiScan Biomedical Corporation at 4 sites in United States.
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 6 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 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 Dana Deyette, RN (510-342-5836, ddeyette@optiscancorp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Accuracy Endpoint (time frame: Accurancy up to 72 hours of monitoring per subject). 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 NCT02211300, 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 29 Jun 2015.