HyperglycemiaNCT00996099
Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients
A study testing Intensive insulin therapy using standard protocol in people with Hyperglycemia and Cardiac Surgery, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycemia, Cardiac Surgery
- What is being tested?
- Intensive insulin therapy using standard protocol
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCzechia
- Study dates
- Sep 2008to Aug 2009
- 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
- elective cardiac surgery
Who cannot join
- insulin allergy
- mental incapacity
- language barrier
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU
The purpose of this study is to evaluate the safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.
- Conditions
- Hyperglycemia, Cardiac Surgery
- Being tested
- Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment, Intensive insulin therapy using standard protocol
- Keywords
- continuous glucose monitoring, intensive insulin therapy, critically ill, cardiac surgery, hyperglycemia of critically ill
- Medical subject headings
- Hyperglycemia, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatmentDevice
Glucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery
Intensive insulin therapy using standard protocolOther
Insulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague.
| Study group | Role | What they receive |
|---|---|---|
| CGM-eMPC | Active comparator | Not described Receives: Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment |
| Control | Other | Not described Receives: Other: Intensive insulin therapy using standard protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)
Measured: first 24 hours after cardiac surgery
Secondary outcomes (1)
Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range
Measured: first 24 hours after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2009 (estimated)
- Study startSep 2008
- Primary completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Investigators
- Martin Haluzik, Prof, D.Sc., Principal investigator, 3rd Department of Medicine, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00996099
- Sponsor's protocol ID
- CGM-eMPC
- Status last verified
- Oct 2009
- First submitted
- 15 Oct 2009
- Last updated
- 16 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Use of Continuous Glucose Monitoring Combined With Computer-based eMPC Algorithm for Tight Glucose Control in Cardiosurgical ICU
- ClinicalTrials.gov ID
- NCT00996099
- Acronym / sponsor ID
- CGM-eMPC
- Conditions
- Hyperglycemia, Cardiac Surgery
- Keywords
- continuous glucose monitoring, intensive insulin therapy, critically ill, cardiac surgery, hyperglycemia of critically ill
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Aug 2009 (actual)
- First posted
- 16 Oct 2009 (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 safety and efficacy of a system combining continuous glucose measurement with a computer-based algorithm for insulin delivery in patients undergoing elective cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM-eMPC | Active comparator | Device: Continuous glucose monitoring system combined with enhanced model predictive control algorithm for intensive insulin treatment |
| Control | Other | Other: Intensive insulin therapy using standard protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective cardiac surgery
Key exclusion criteria (3 listed)
- insulin allergy
- mental incapacity
- language barrier
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 system combined with enhanced model predictive control algorithm for intensive insulin treatmentGlucose measured with a real-time continuous glucose monitoring system served as an input for the enhanced model predictive control algorithm adjusting insulin infusion every 15 minutes for the first 24 hours after elective cardiac surgery | Device | CGM-eMPC |
| Intensive insulin therapy using standard protocolInsulin dosage according to the standard protocol for intensive insulin delivery used at Department of Cardiothoracic Surgery, General University Hospital, Prague. | Other | Control |
Primary outcome
Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters)
Time frame: first 24 hours after cardiac surgery
1 secondary outcome
Entire study average glycemia level; time within, above and below the target range throughout the whole study period and after reaching the target range
Time frame: first 24 hours after cardiac surgery
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 16 Oct 2009.
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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.
Martin Haluzik, Prof, D.Sc. principal investigator
3rd Department of Medicine, General University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive insulin therapy using standard protocol in people with Hyperglycemia and Cardiac Surgery, run by Charles University, Czech Republic at 1 site in Czechia.
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 1 inclusion and 3 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 16 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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?
Percentage of glycemic values in the A and B zone of Clarke Error Grid Analysis (a tool for assessing the accuracy of glucose meters) (time frame: first 24 hours after cardiac surgery). 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 16 Oct 2009.