Critical IllnessNCT00494078
Efficiency of Continuous Glucose Monitoring in Critically Ill Patients
A study testing Real-time glucose monitoring system (Guardian, Medtronic) and intensive insulin therapy in people with Critical Illness, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Real-time glucose monitoring system (Guardian, Medtronic) and intensive insulin therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2006to Aug 2008
- 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
- Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy.
- Age > 18 years.
Who cannot join
- Admitted patients expected to stay <48h
- Age ≤ 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
The purpose of this study is to determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.
Read the detailed description
Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.
- Conditions
- Critical Illness
- Being tested
- Real-time glucose monitoring system (Guardian, Medtronic), intensive insulin therapy
- Keywords
- critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring
- Medical subject headings
- Critical Illness, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time glucose monitoring system (Guardian, Medtronic)Device
Also called Guardian (Medtronic), Novorapid (NovoNordisk)
Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.
intensive insulin therapyDrug
Also called Novorapid (NovoNordisk)
intensive insulin therapy according to an algorithm
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system. Receives: Device: Real-time glucose monitoring system (Guardian, Medtronic) |
| 2 | Active comparator | intensive insulin therapy guided by an algorithm Receives: Drug: intensive insulin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
Measured: 72h
Secondary outcomes (1)
Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias
Measured: 72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJun 2006
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Investigators
- Ulrike Holzinger, MD, Principal investigator, Medical University of Vienna, Department of Medicine III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494078
- Sponsor's protocol ID
- 488/2005
- Status last verified
- Jan 2009
- First submitted
- 27 Jun 2007
- Last updated
- 30 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT00494078
- Acronym / sponsor ID
- 488/2005
- Conditions
- Critical Illness
- Keywords
- critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 29 Jun 2007 (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 determine whether, real-time continuous glucose monitoring in critically ill patients with intensive insulin therapy would increase the percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl.
Detailed description
Hyperglycemia is associated with more complications and higher morbidity and mortality in critically ill patients. Therefore, strict glycemic control with a target blood glucose level between 80 and 110 mg/dl is recommended. Intensive insulin therapy requires continuous intravenous insulin infusion according to an algorithm and frequent blood glucose measurements. Implementation of intensive insulin therapy increases workload for both physicians and especially for nurses. The current gold-standard in intensive care units to achieve normoglycemia in critically ill patients is intensive insulin therapy according to a well established algorithm along with frequent blood glucose measurements. However, applying this gold-standard method, normoglycemia, defined as blood glucose levels below 110 mg/dl, can be achieved in approximately 50 percent of time only. We hypothesized, that real-time continuous glucose monitoring would increase the percentage of time of blood glucose levels below 110 mg/dl in critically ill patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Real-time glucose monitoring system (Guardian, Medtronic)Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system. |
| 2 | Active comparator | Drug: intensive insulin therapyintensive insulin therapy guided by an algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy.
- Age > 18 years.
Key exclusion criteria (2 listed)
- Admitted patients expected to stay <48h
- Age ≤ 18 years
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 |
|---|---|---|
| Real-time glucose monitoring system (Guardian, Medtronic)Also: Guardian (Medtronic), Novorapid (NovoNordisk)Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system. | Device | 1 |
| intensive insulin therapyAlso: Novorapid (NovoNordisk)intensive insulin therapy according to an algorithm | Drug | 2 |
Primary outcome
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
Time frame: 72h
1 secondary outcome
Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias
Time frame: 72h
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 30 Nov 2010.
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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.
Ulrike Holzinger, MD principal investigator
Medical University of Vienna, Department of Medicine III
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time glucose monitoring system (Guardian, Medtronic) and intensive insulin therapy in people with Critical Illness, run by Medical University of Vienna at 1 site in Austria.
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 2 inclusion and 2 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 30 Nov 2010. 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 Austria. 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 time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period (time frame: 72h). 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 30 Nov 2010.