Critical IllnessNCT00494455
Continuous Glucose Monitoring in Critically Ill Patients
A study testing continuous subcutaneous glucose monitoring 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 subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- continuous subcutaneous glucose monitoring
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2005to Mar 2007
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted patients expected to stay >48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock.
Who cannot join
- Admitted patients expected to stay <48h
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy
The purpose of this study is to determine whether subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.
Read the detailed description
Hyperglycemia is 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.
Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.
- Conditions
- Critical Illness
- Being tested
- continuous subcutaneous glucose monitoring
- Keywords
- critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring, shock
- Medical subject headings
- Critical Illness, Hyperglycemia, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
continuous subcutaneous glucose monitoringDevice
Also called CGMS (Medtronic)
continuous subcutaneous glucose monitoring for 72h
continuous subcutaneous glucose monitoringDevice
Also called CGMS (Medtronic)
continuous subcutaneous glucose monitoring for 72h
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Continuous subcutaneous glucose monitoring in patients without shock Receives: Device: continuous subcutaneous glucose monitoring |
| 2 | Active comparator | continuous subcutaneous glucose monitoring in patients with shock Receives: Device: continuous subcutaneous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock
Measured: 72h
Secondary outcomes (1)
influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation
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 startApr 2005
- Primary completionApr 2006
- Study completionMar 2007
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 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 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
- NCT00494455
- Sponsor's protocol ID
- 108/2005
- Status last verified
- Jun 2007
- First submitted
- 27 Jun 2007
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Holzinger U, Warszawska J, Kitzberger R, Herkner H, Metnitz PG, Madl C. Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring. Intensive Care Med. 2009 Aug;35(8):1383-9. doi: 10.1007/s00134-009-1471-y. Epub 2009 Apr 7.
PubMed 19350213
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Reliability of Continuous Glucose Monitoring in Critically Ill Patients With Shock Requiring Norepinephrine Therapy
- ClinicalTrials.gov ID
- NCT00494455
- Acronym / sponsor ID
- 108/2005
- Conditions
- Critical Illness
- Keywords
- critical illness, hyperglycemia, intensive insulin therapy, glucose monitoring, shock
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Apr 2005
- Primary completion
- Apr 2006 (actual)
- Study completion
- Mar 2007 (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 subcutaneous continuous glucose monitoring in critically ill patients is clinically feasible accurate and reliable.
Detailed description
Hyperglycemia is 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.
Continuous glucose measurement would facilitate blood glucose control in critically ill patients. Numerous studies have shown accuracy of the subcutaneous continuous glucose monitoring derived glucose values compared to blood glucose measurements in diabetics. Studies evaluating the subcutaneous continuous glucose monitoring in an inpatient-population especially in an ICU-setting are rare. Therefore the aim of this study is the prospective evaluation of continuous subcutaneous glucose monitoring in critically ill patients with circulatory shock demanding norepinephrine therapy as compared to critically ill patients without shock.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: continuous subcutaneous glucose monitoringContinuous subcutaneous glucose monitoring in patients without shock |
| 2 | Active comparator | Device: continuous subcutaneous glucose monitoringcontinuous subcutaneous glucose monitoring in patients with shock |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Admitted patients expected to stay >48h either with circulatory shock requiring norepinephrine therapy or without circulatory shock.
Key exclusion criteria (1 listed)
- Admitted patients expected to stay <48h
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 subcutaneous glucose monitoringAlso: CGMS (Medtronic)continuous subcutaneous glucose monitoring for 72h | Device | 1 |
| continuous subcutaneous glucose monitoringAlso: CGMS (Medtronic)continuous subcutaneous glucose monitoring for 72h | Device | 2 |
Primary outcome
correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock
Time frame: 72h
1 secondary outcome
influence of norepinephrine therapy, body mass index, severity of Illness (APACHE III, SAPS II) and blood glucose level on correlation
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 29 Feb 2008.
- Derived from this study: PubMed 19350213Holzinger U, Warszawska J, Kitzberger R, Herkner H, Metnitz PG, Madl C. Impact of shock requiring norepinephrine on the accuracy and reliability of subcutaneous continuous glucose monitoring. Intensive Care Med. 2009 Aug;35(8):1383-9. doi: 10.1007/s00134-009-1471-y. Epub 2009 Apr 7.
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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 continuous subcutaneous glucose monitoring 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 1 inclusion and 1 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 29 Feb 2008. 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?
correlation of continuous glucose monitoring derived glucose values and arterial blood glucose measurements in critically ill patients with and without shock (time frame: 72h). 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 NCT00494455, 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 Feb 2008.