Efficiency of Real Time Continuous Glucose Monitoring to Achieve Normoglycemia in Critically Ill Patients - a Prospective, Randomized Study
Overview
- Phase
- Not Applicable
- Intervention
- Real-time glucose monitoring system (Guardian, Medtronic)
- Conditions
- Critical Illness
- Sponsor
- Medical University of Vienna
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1
Patients randomised to this arm are treated with intensive insulin therapy guided by the continuous glucose monitoring system.
Intervention: Real-time glucose monitoring system (Guardian, Medtronic)
2
intensive insulin therapy guided by an algorithm
Intervention: intensive insulin therapy
Outcomes
Primary Outcomes
Percentage of time of normoglycemia, defined as glucose levels below 110 mg/dl, during the study period
Time Frame: 72h
Secondary Outcomes
- Median glucose levels during the study period; median time from start of intensive insulin therapy to achievement of normoglycemia; rate of hypoglycemias(72h)