To investigate the feasibility and efficacy, expressed as percentage funcitoning time and time in target range, respectively, of an automated closed-loop glucose control system based on subcutaneous continuous glucose measurements in critically ill…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint will be the time spent in target glucose range (6-9
mmol/l) as recorded by reference glucose measurements.
Secondary outcome
Other study parameters include time spent in glucose levels above and below
target range, mean reference glucose, sensor accuracy metrics, insulin infusion
rates, and nursing workload. Safety measures include frequency of hypoglycaemic
(< 3.0 mmol/l) and hyperglycaemic (>15 mmol/l) events and other adverse
events.
Background summary
Glucose regulation has become a key patient management goal in intensive care
medicine. Closed-loop glucose control modulates insulin delivery according to
glucose levels with use of continuous glucose measurements without nurse
input.
Study objective
To investigate the feasibility and efficacy, expressed as percentage
funcitoning time and time in target range, respectively, of an automated
closed-loop glucose control system based on subcutaneous continuous glucose
measurements in critically ill adults.
Study design
single centre, open-label, randomised controlled study
Intervention
Subjects will be randomized to either closed-loop insulin delivery (intravenous
infusion delivery of insulin and glucose (dextrose), dose calculated by glucose
control algorithm, based on continuous glucose sensor readings) or open-loop
insulin delivery (standard treatment) (standard intravenous insulin infusion
using a sliding scale glucose algorithm as per intensive care unit protocol).
All patients receive a Freestyle Navigator subcutaneous glucose sensor. The
Freestyle Navigator sensor will be blinded in the open-loop group.
Study burden and risks
The Freestyle Navigator CGM System has been used in a number of other clinical
trials with no adverse events. The potential risks related to placement of the
sensor placement include bleeding > 1mL (uncommon), swelling or redness
(infrequent), bruising > 1cm (infrequent) and infection (rare). Extra blood
sampling indicates that approximately 1.5 mL of blood per sample will be
discarded, for a maximum of 22.5 mL (15 x 1.5mL) blood loss during the study.
It is expected that this protocol will yield increased knowledge about the
feasibility and efficacy of a closed loop glucose control system with use of
Freestyle Navigator CGM reported glucose levels. The scientific knowledge which
could be gained from this research is 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
• Diabetic and non-diabetic patients with an anticipated stay of at least 24 hours of admission to the intensive care
• 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 diabetic ketoacidosis or hyperosmolar hyperglycaemic non-ketotic coma
• Patients who are receiving therapeutic hypothermia
• Pregnancy
• 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 |
|---|---|
| ClinicalTrials.gov | NCT |
| CCMO | NL50562.100.14 |