N/A
N=76
Continuous Glucose Monitoring With a Subcutaneous Sensor During Critical Illness and Surgery
Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT00694473 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcome: Primary: Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl).
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Freestyle Navigator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sensitivity and Specificity of Navigator Threshold Alarms for Hypoglycemia (<60 mg/dl). |
— | — |
| SECONDARY Sensitivity and Specificity of Navigator Threshold Alarms for Hyperglycemia (>240 mg/dl). |
— | — |
| SECONDARY Accuracy of Navigator CGM as Compared to Reference Blood Glucose Values |
14.5 | — |
| SECONDARY Sensitivity and Specificity of Navigator Projected Low Blood Sugar Alarm Criteria Calculated for Events Defined by a Low Reference BG Value (< 60 mg/dL) |
— | — |
| SECONDARY Sensitivity and Specificity of Navigator Projected High Blood Sugar Alarm Criteria Calculated for Events Defined by a High Reference BG Value (> 250 mg/dl) |
— | — |
| SECONDARY Percentage of Readings in Different Blood Sugar Ranges as Shown by Point of Care Testing: |
10; 23; 41; 12; 14 | — |
| SECONDARY Navigator CGM Accuracy by Category |
15.1; 14.3; 18.8; 9.7; 10.1 | — |
Summary
We hypothesize that measurements of interstitial fluid (ISF) glucose by the FreeStyle Navigator (Abbot Diabetes Care), a continuous glucose monitoring system, will correlate with blood glucose (BG) values in surgical and ICU patients with a clinically useful degree of accuracy.
Eligibility Criteria
Inclusion Criteria
- Patients admitted to the general surgical ICU (SICU), medical ICU (MICU), cardiac surgery intensive care unit (CSICU), or neurological intensive care unit (NeuroICU), are being treated with IIT, and have an arterial line in place
- Patients scheduled for open cardiac surgery or craniotomy that have diabetes mellitus or will be given high dose glucocorticoids. All of these patient will have an arterial line placed at the time of surgery as a part of their usual care
Exclusion Criteria
- Age less than 18 years
- Enrollment in another clinical trial that modifies their glucose management (e.g. trial of modified IIT algorithm or modified glucose monitoring regimen)
In order to obtain adequate representation of patients with physiological alterations that might decrease correspondence between blood and ISF glucose, we will recruit 50 subjects in each of five groups:
- Patients undergoing craniotomy who are either diabetic or will be given high dose corticosteroids
- Diabetic patients undergoing open cardiac surgery
- Patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT who are vasopressor dependent, defined by continuous infusion of at least 60 mg/min phenylephrine, 5 mg/min norepinephrine, or 10 mg/kg/min of dopamine, or any combination of two agents for at least 90 continuous minutes in the last 8 hours
- Patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT with pitting peripheral or dependent edema, defined by the persistence of pitting to at least 5 mm depth for 5 seconds after pressure is applied to a dependent area of the trunk or two limbs.
- Critically ill patients admitted to one of the participating ICUs with an arterial line in place and receiving IIT who do not fall into groups 1-4.
Data sourced from ClinicalTrials.gov (NCT00694473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.