diabetes mellitus stress-hyperglycaemia
Conditions
Interventions
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
Sponsors
Onze Lieve Vrouwe Gasthuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the time spent in target glucose range (6-9 mmol/l) as recorded by reference glucose measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 (15 mmol/l) events and other adverse events. | — |
Countries
Netherlands
Outcome results
None listed