To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and greater glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome will be the extent of glucose variability, defined as the
mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr,
measured by continuous glucose monitoring technology.
Secondary outcome
Secondary outcomes include: time in target range (between 6-9 mmol/l) and below
and above target range, mean (sensor) glucose, standard deviation of glucose
values, severe hypo- and hyperglycaemic events (<2.2 mmol/l and > 15.0 mmol/l),
amount of insulin use, daily nutritional administration, clinical
gastrointestinal symptoms.
Background summary
Glucerna® is a reduced-carbohydrate, modified-fat, fiber-containing enteral
formula, which is designed to improve glucose control in patients prone to
hyperglycaemia. The potential role for Glucerna as a non-insulin alternative to
better control glucose levels in critically ill patients has not been
established yet.
Study objective
To investigate whether the administration of Glucerna achieves less glycaemic
variability, defined as the mean absolute glucose (MAG) change, and greater
glycaemic control compared to a standard high-carbohydrate enteral formula.
Continuous glucose monitoring technology will be used to evaluate glycaemic
variability and glycaemic control.
Study design
Single centre, open-label randomised controlled study
Intervention
Subjects will be randomized to either Glucerna® 1.5 kcal (Abbott, USA), the
standard enteral formula used at our ICU and the investigational enteral
feeding, or Fresubin® Energy Fibre (Fresenius, UK), the control enteral
feeding. All subjects will receive a Freestyle Navigator subcutaneous
continuous glucose monitoring (CGM) system to record the glycaemic status of
the subject.
Study burden and risks
No risks related to the type of enteral feeding are expected. Both types of
enteral feeding are now used (Glucerna) or have been used (Fresubin) as the
standard enteral feeding in our ICU for a considerable amount of time. The
Freestyle Navigator CGM system has already been used in a number of other
clinical trials without any adverse events. Risk related to the placement of
the Freestyle Navigator CGM system include bleeding > 1ml (uncommon), swelling
or redness (infrequent) bruising > 1cm (infrequent) or infection (rare). The
Freestyle Navigator will be calibrated during the study at five set time
points, which requires 0,5mL blood drawn from an existing arterial line (in
total 5x0,5mL = 2,5mL during the study). It is expected that this protocol will
yield increased knowledge about the glycaemic effects of a disease-specific
enteral feeding. The scientific knowledge which could be gained from this
research is in a fair balance to aforementioned minimal risks.
Oosterpark 9
Amsterdam 1091 AC
NL
Oosterpark 9
Amsterdam 1091 AC
NL
Listed location countries
Age
Inclusion criteria
Age >= 18 years
Patients with an anticipated stay of at least 24 hours of admission to the intensive care
Expected to receive enteral feeding for at least 72 hours
Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
Patient or surrogate understands and signs informed consent document
Exclusion criteria
Patients with pre-existing contraindications to enteral feeding or to placement of a CGM system
Patients previously randomised into the GluCip trial
Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.
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 | NL51918.100.14 |