diabetes mellitus
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Age * 21 years; - Diabetic and non-diabetic patients with an anticipated stay of 24 hours of admission to intensive care - Expected to be admitted to the ICU after elective cardiothoracic surgery and expected to require glycaemic control; - Patient or surrogate understands and signs informed consent document.
Exclusion criteria
Exclusion criteria: - History of allergic reaction to medical adhesives - History of allergic reaction to alcohol antiseptic solution or wipes - Abnormal skin at the anticipated glucose sensor attachment sites (burn, inflammation, infection, rash, and/or tattoo) - History of severe congenital immunodeficiency or HIV infection - Pregnant by history or pregnancy test - Current participation in an industry sponsored drug or device clinical trial during the proposed 24 hour study period - Any other clinical condition, at the discretion of the physician investigator - Life expectancy of less than 48 hours - Patient expected to need an MRI during the 24 hour study period. If patient unexpectedly to need an MRI, the Symphony sensor must be removed prior to the MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters will include reference analyzer blood glucose values, Symphony glucose values and duration of sensor use. The Safety Endpoint will be assessed using a dermatological erythema skin scale. The subject will be evaluated using a four point scale. | — |
Countries
Netherlands
Outcome results
None listed