Efficiency of Continuous Glucose Monitoring in Critically Ill Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Critical Illness |
Device: Real-time glucose monitoring system (Guardian, Medtronic) Drug: intensive insulin therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study |
- Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period [ Time Frame: 72h ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 120 |
| Study Start Date: | June 2006 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
|
Device: Real-time glucose monitoring system (Guardian, Medtronic)
Patients randomised to the intervention arm are treated with intensive insulin therapy guided by the real time glucose monitoring system.
Other Names:
|
|
Active Comparator: 2
intensive insulin therapy guided by an algorithm
|
Drug: intensive insulin therapy
intensive insulin therapy according to an algorithm
Other Name: Novorapid (NovoNordisk)
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Admitted critically ill patients expected to stay >48h on the ICU after initiation of intensive insulin therapy.
- Age > 18 years.
Exclusion Criteria:
- Admitted patients expected to stay <48h
- Age ≤ 18 years
Contacts and Locations| Austria | |
| Medical University of Vienna | |
| Vienna, Austria, 1090 | |
| Principal Investigator: | Ulrike Holzinger, MD | Medical University of Vienna, Department of Medicine III |
More Information
No publications provided
| Responsible Party: | Ulrike Holzinger MD, Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00494078 History of Changes |
| Other Study ID Numbers: | 488/2005 |
| Study First Received: | June 27, 2007 |
| Last Updated: | November 29, 2010 |
| Health Authority: | Austria: Ethikkommission |
Keywords provided by Medical University of Vienna:
|
critical illness hyperglycemia intensive insulin therapy glucose monitoring |
Additional relevant MeSH terms:
|
Critical Illness Disease Attributes Pathologic Processes Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013