The purpose of this study is to evaluate the safety, accuracy and performance of the Symphony CGM System in patients admitted to the Intensive Care Unit (ICU). The Symphony CGM system will be evaluated for 24 hours in ICU patients who meet the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
N/A
Background summary
Critically ill patients admitted at the intensive care unit (ICU) commonly
develop hyperglycemia, hypoglycemia, and glycemic variability following major
surgery and medical illness. Continuous glucose monitoring (CGM) in ICUs has
the potential to improve glycaemic control and thereby enhance patient safety
and outcomes. The Symphony CGM System is a non-invasive transdermal real-time
glucose sensor to identify glucose trend data and to help maintain a
hospitalized patient*s glucose levels in the desired range, while minimizing
the risk for hypoglycaemia.
Study objective
The purpose of this study is to evaluate the safety, accuracy and performance
of the Symphony CGM System in patients admitted to the Intensive Care Unit
(ICU). The Symphony CGM system will be evaluated for 24 hours in ICU patients
who meet the inclusion criteria for the study and for whom glycaemic control is
indicated.
Study design
Non-randomized, open-label trial
Study burden and risks
The potential risks related to the abrasion site and sensor placement include
erythema (common), skin irritation (common) and infection (rare). The Symphony
CGM System has been used in a number of other clinical trials with no adverse
events. Blood sampling risks will be reduced by using an existing arterial line
during the study period using techniques to minimize the amount of dead-space
blood loss. Approximately 1 mL of blood per sample will be discarded, for a
maximum of 40 mL blood loss during the study. It is expected that this protocol
will yield increased knowledge about the accuracy of the Symphony CGM reported
glucose levels and CGM reliability. The scientific knowledge which could be
gained from this research is a fair balance to aforementioned minimal risks.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL45661.018.13 |