The primary objective of the study is to demonstrate the effectiveness of the computer algorithm (LOGIC-Insulin) against the standard routine protocol for the normalisation of blood glucose concentrations in the ICU.The secondary objective of the…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Adequacy of reaching and maintaining the target range for blood glucose, as
assessed by the Glycaemic Penalty Index (GPI) (up to 14 days)
Secondary outcome
Clinical secondary endpoints
- Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or <3.9
mmol/L) per patient (up to 14 days)
- Mean and median arterial blood glucose concentration (up to 14 days)
- Adequacy of reaching and maintaining the target range for blood glucose, as
assessed by the Hyperglycaemic index (HGI)(1) (up to 14 days)
- Time in target range (up to 14 days)
- Time to target range (up to 14 days)
- Daily maximal blood glucose difference, as a marker of blood glucose
fluctuations (up to 14 days)
- Incidence of severe hypoglycaemia (blood glucose level < 40 mg/dL or 2.2
mmol/L) per patient (up to 14 days)
- Incidence of severe hypoglycaemia (blood glucose level < 40 mg/dL or 2.2
mmol/L) as a proportion of all blood glucose measurements (up to 14 days)
- Incidence of mild hypoglycaemia (blood glucose level < 70 mg/dL or 3.9
mmol/L) as a proportion of all blood glucose measurements (up to 14 days)
- Interval between blood glucose measurements, as a marker of workload (up to
14 days)
- Protocol compliance in the intervention group (up to 14 days): the number and
proportion of patients in which the LOGIC-Insulin was not followed for at least
8 hours, which is the duration of one nurse shift.
- Overrules in the intervention group (up to 14 days): the number and
proportions of recommendation by the software that were overruled by the
bed-side nurses.
o Minor overrules: absolute insulin dose difference of >0.1 and < 1IU/h
o Major overrules: absolute insulin dose difference of >= 1IU/h
o The major overrules will also be qualitatively assessed
- Incidence of new infections in the ICU (up to 90 days): Diagnosis of *new
infection* will be based on the administration of antibiotics beyond the
prophylactic scope
- Length of stay in the ICU (up to 90 days)
- Length of stay in the hospital (up to 90 days)
- Mortality in the ICU (up to 90 days)
- Mortality in the hospital (up to 90 days)
- Landmark 90-day mortality
Economic secondary endpoints
- All direct costs from a healthcare payer*s perspective (time horizon from
randomisation to hospital discharge, up to 90 days)
- The EuroQol-5D questionnaire at ICU and hospital discharge (up to 90 days)
Background summary
Glycemic control with insulin infusion is standard ICU care. Nurses titrate the
insuline infusion, which is based on a local paper-based protocol and the
intuition of the nurse. Recently a computer algorithm assistance is developed
for blood glucoe control, LOGIC-insulin algorithm, which advises the nurse on
the insulin dosage (or a dextrose bolus in case of hypoglycaemia) as well as on
the next blood sampling interval.
In the first step of clinical validation, the LOGIC-Insulin algorithm was
tested in a single-centre randomized controlled trial with 300 patients. In
this study the LOGIC-Insulin algorithm improved the efficacy of blood glucose
control (avoiding persistent hyperglycaemia) without increasing the rate of
hypoglycaemia in comparison with blood glucose control by the expert Leuven
nursing team.
Study objective
The primary objective of the study is to demonstrate the effectiveness of the
computer algorithm (LOGIC-Insulin) against the standard routine protocol for
the normalisation of blood glucose concentrations in the ICU.
The secondary objective of the study is to demonstrate cost-effectiveness of
the implementation of the LOGIC-Insulin algorithm.
Study design
A multicentre, pragmatic, open-label, randomized, parallel group interventional
study
Intervention
Blood glucose control by computer algorithm assistance (intervention) versus
blood glucose control by nurses, with extensive expertise in blood glucose
control (control)
Study burden and risks
During the study there are no additional blood draws, besides the standard
care. Patients can leave the study at any time for any reason if they wish to
do so without any consequences. Although the computer algorithm is designed to
prevent hypoglycaemic en hyperglycaemic episodes, there is a risk of developing
severe hypoglycaemic episodes (blood glucose < 40 mg/dL or 2.2 mmol/L) and
hyperglycaemic episodes (blood glucose > 180 mg/dL or 10 mmol/L) under
treatment with the computer algorithm. However in LOGIC-1 this did not happen.
Potential benefits for the patients include improved blood glucose control,
with reduced risk of hypoglycaemia and hyperglycaemia.
Waaistraat 6
Leuven 3000
BE
Waaistraat 6
Leuven 3000
BE
Listed location countries
Age
Inclusion criteria
- patients admitted to the ICU with an expected stay of at least two days and already receiving or potentially needing insulin infusion for blood glucose control. These patients should already have or need an arterial and central venous line;
- patients should be 18 years or older.
Exclusion criteria
- age under 18 years
- patient deemed not critically ill (*monitoring only* patients, no arterial or central line)
- patients expected to die within 12 hours (=moribund patients).
- patients already enrolled in another intervention RCT.
- pregnancy or lactating
- patients suffering from ketoacidotic or hyperosmolar coma on admission
- patients who have been previously been included in the LOGIC-2 study
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 | NCT02056353 |
| CCMO | NL44968.018.13 |