The Space GlucoseControl system for managing blood‑glucose in critically ill patients in intensive care

Study component

Description

Objectives/hypotheses

To investigate the performance of the Space GlucoseControl system, which is a nurse‑driven, computer‑assisted device for glycaemic control combining infusion pumps with the enhanced Model Predictive Control algorithm, in medical critically ill patients in 2 ICU sites. The primary aim was to evaluate the complete strict glucose control system in these patients at the 2 different sites.

Study design

Prospective non‑controlled open clinical investigation.

Setting

The study was conducted in 2 medical ICUs in tertiary centres in Graz, Austria and Zurich, Switzerland. Outcomes were reported for a period of 6.5 days (SD=3.7).

Inclusion/exclusion criteria

Inclusion criteria: adult medical ICU patients, blood glucose >6.1 mmol/l or already on insulin therapy, presumed to stay ≥72 hours at the ICU. Exclusion criteria: insulin allergy, presence of ketoacidosis, moribund patients likely to die within 24 hours.

Primary outcomes

Glucose control assessed by the percentage of time within the predefined glucose the target range (4.4–8.3 mmol/l).

Statistical methods

Data analysis was performed using SPSS version 19.0, on an ITT basis. Intermediate blood glucose values were linearly interpolated.

Participants

Adult medical ICU patients with blood glucose >6.1 mmol/l or already on insulin therapy (n=40).

Results^*

For the study period, the predefined target glucose range was reached in 88.3% (SD± 9.3%) of time and mean arterial blood glucose was 6.7 (SD ±0.4) mmol/l. The mean sampling interval was 2.2 (SD ±0.4) hours. The percentage of time spent in a moderately hypoglycaemic range (2.2–3.3 mmol/l) was 0.07% (SD ±0.26%). One severe hypoglycaemic episode (<2.2 mmol/l) occurred (2.5% of patients or 0.03% of glucose readings). There was a high adherence to the given insulin dose advice (98.2%) and the mean daily insulin dose was 87.2 (SD±64.6) IU. Six patients died during the study period.

Conclusions

The authors concluded that the Space GlucoseControl system is a safe and efficient method to control blood glucose in critically ill patients as assessed in 2 European medical ICUs.

Abbreviations: ICU, intensive care unit; IU, insulin unit; ITT, intention to treat; SD, standard deviation.

*Data reported as mean (SD).

Outcome measures

Results ^a

Primary outcome (n=40)

88.3 (9.3)

Selected secondary outcomes (n=40)

6.7 (0.4)

2.2 (0.4)

87.2 (64.6)

98.2

0.07 (0.26)

Safety (n=40)

2.5% (1/40)

Abbreviations: h, hour; IU, insulin unit.

^a Data reported as mean (standard deviation) unless otherwise specified.

^b Moderately hypoglycaemic range was defined as 2.2–3.3 mmol/l.

^c Hypoglycaemia was defined as <2.2 mmol/l.

Study component

Description

Objectives/hypotheses

To test the performance (efficacy, safety, and usability) of the Space GlucoseControl system for tight glycaemic control in patients at a medical ICU for a period of 72 hours.

Study design

Prospective non‑controlled open clinical investigation.

Setting

The study was conducted at a medical ICU in Medical University of Graz. Follow‑up duration was 72 hours.

Inclusion/exclusion criteria

Inclusion criteria: adult medical ICU patients; mechanically ventilated and presumed to need at least 3 days of intensive care; blood glucose level >6.1 mmol/l or already on insulin therapy.

Primary outcomes

Blood glucose control assessed by percentage of time in the predefined glucose target range 4.4‑6.1 mmol/l (arterial blood glucose measurements).

Statistical methods

Statistical analysis was performed on an ITT basis. Data were reported as mean (SD) if not otherwise indicated. Normality of data was checked by Kolmogorov‑Smirnov and Shapiro‑Wilk tests. For comparison of glucose data with results from historical data, Kruskall‑Wallis and subsequent Mann‑Whitney U tests with Bonferroni correction for group comparisons were applied. Data analysis was performed using SPSS version 15.0.

Participants

Mechanically ventilated adult medical ICU patients with blood glucose >6.1 mmol/l or already on insulin therapy (n=10).

Results^a

The percentage of values in time in target was 47.0% (SD±13.0%). The average blood glucose concentration and hyperglycaemic index were 6.05 mmol/l (SD±0.72) and 0.55 mmol/l (SD ±0.50) respectively. No hypoglycaemic episode (<2.2 mmol/l) was detected. The nurses overruled the given advice of the system 11 times (1.5% of all given advice). The treatment had to be stopped ahead of schedule in 3 patients due to several technical malfunctions of the device (failures of system integration, such as repetitive error messages and missing data in the data log due to communication problems between the new hardware components are shortcomings of the present version of the device).

Conclusions

The authors concluded that tight glycaemic control in patients at a medical ICU could be established following the advice of the decision support system. Accordingly, and with technical improvement required, the system had the capacity to be a reliable tool for routine establishment of glycaemic control for critically ill patients.

Abbreviations: ICU, intensive care unit; ITT, intention to treat.

^a Data reported as mean (standard deviation).

Outcome measures

Results ^a

Primary outcome (n=10)

47.0 (13.0)

Selected secondary outcomes (n=40)

6.05 (0.72)

0.55 (0.50)

0.53 (0.88)

6.65 (8.79)

4.2 (2.8)

7.5 (2.0)

86.3 (26.0)

11 (1.5%)

Safety (n=10)

0

Abbreviations: h, hour, IU, insulin unit.

^a Data reported as mean (standard deviation) unless otherwise specified.

^b Defined as input of glucose values into the system.

^c Hypoglycaemia was defined as <2.2 mmol/l.

Study component

Description

Objectives/hypotheses

To compare blood glucose control with the eMPC computer‑based model predictive control algorithm with a variable sampling rate, against a routine glucose management protocol during the peri‑ and post‑operative periods of elective cardiac surgery.

Study design

Single‑centre non‑blinded randomised controlled trial.

Setting

The study was performed at the Department of Cardiac Surgery, General University Hospital, Prague. A screening visit was performed 1 day before the surgery. The treatment visit was the start of surgery and continued for up to 24 hours at the ICU.

Inclusion/exclusion criteria

Inclusion criteria were not specified, but it was stated that threshold glucose level was not defined as an inclusion criterion. Exclusion criteria: insulin allergy, mental incapacity, and language barrier.

Primary outcomes

The main outcome measures were mean blood glucose, percentage of time in target range (4.4‑6.1 mmol/l), and hypoglycaemia events.

Statistical methods

The analysis was performed using SigmaStat (Jandel Scientific). The results are expressed as mean (SD). Differences between the comparison groups were evaluated using the t‑test or Mann‑Whitney U rank sum test as appropriate. No sample size calculation was stated.

Participants

Participants were adult patients admitted for major elective cardiac surgery (n=60).

Results

Blood glucose control was better with the eMPC than the routine management for mean blood glucose and percentage of time in the target range. No severe hypoglycaemia occurred in either of the groups. Under the eMPC there was a higher insulin infusion rate and shorter mean sampling interval.

Conclusions

The authors concluded that, compared with routine glucose management protocol, the eMPC algorithm was more effective and comparably safe in maintaining euglycemia in cardiac surgery patients.

Abbreviations: eMPC, enhanced model predictive control; ICU, intensive care unit; n, number of patients; SD, standard deviation.

eMPC

Routine protocol

Analysis

Randomised

n=30

n=30

Efficacy

n=30

n=30

Primary outcomes

6.6 (1.8)

7.1 (1.2)

p<0.01

6.0 (1.0)

7.3 (1.3)

p<0.01

27.5 (16.2)

60.4 (22.8)

p<0.01

0

0

Selected secondary outcomes

14.5 (5.5)

6.6 (3.9)

p<0.01

0

0

N/A

4.7 (3.3)

2.6 (1.7)

p<0.01

7.4 (4.7)

16.7 (4.1)

p<0.01

111 (67)

69 (45)

p<0.01

1.9 (1.7)

0.6 (1.5)

p<0.01

1.5 (0.3)

2.1 (0.2)

p<0.01

Abbreviations: eMPC, enhanced model predictive control; h, hour; ICU, intensive care unit; N/A, not applicable; n, number of patients; p, p value; SD, standard deviation.

^a Outcomes were measured as mean (standard deviation) unless otherwise specified.

Study component

Description

Objectives/hypotheses

To demonstrate that glycaemic control as established by the eMPC algorithm is not inferior to that achieved by the standard insulin treatment algorithm implemented in a medical ICU.

Study design

Single‑centre non‑blinded randomised controlled trial. Randomisation was performed using serial numbers with concealment.

Setting

The study was conducted in a medical ICU in a tertiary teaching hospital, Graz. Follow‑up period was 72 hours and the outcomes were measured at day 1, day 2 and day 3.

Inclusion/exclusion criteria

Inclusion criteria: mechanically ventilated adult medical ICU patients, presumed to require at least 3 days of intensive care, and blood glucose >6.1 mmol/l or already on insulin therapy. No exclusion criteria were specified.

Primary outcomes

Glucose control, measured as hyperglycaemic index defined as the area under the curve above the upper limit of normal (glucose level 6.1 mmol/l, modified from the original 6.0 mmol/l) divided by the total length of stay (time in study).

Statistical methods

Sample size was calculated based on non‑inferiority analysis; a significance level of 0.025 and a power of 80% were defined. Data were tested for normality and subsequently comparisons between groups were performed using unpaired student t test or the Mann‑Whitney U‑test as necessary. The conventional significance level of alpha=0.05 was used. The SPSS13.0.1 software package was applied for the statistical analysis, which was performed on an ITT basis.

Participants

Mechanically ventilated medical ICU patients (n=50) with glucose >6.1 mmol/l or already on insulin therapy.

Results

Compared with the control group, the eMPC group had significantly lower hyperglycaemic index and blood glucose. There was one hypoglycaemic episode in the eMPC with none in the control group. Sampling interval was significantly shorter in the eMPC group than in the control.

Conclusions

The authors concluded that, the eMPC algorithm was effective in maintaining tight glycaemic control in severely ill medical ICU patients.

Abbreviations: eMPC, enhanced model predictive control; ITT, intention to treat; ICU, intensive care unit; n, number of patients.

eMPC

Standard care

Analysis

Randomised

n=25

n=25

Efficacy

n=25

n=25

Primary outcome

0.4 
(0.2–0.9)

1.6 
(1.1–2.4)

p<0.001

– Day 1

0.5 
(0.1–1.0)

1.6 
(0.7–2.9)

p<0.01

– Day 2

0.4 
(0.1–1.0)

1.6 
(1.1–2.7)

p<0.001

– Day 3

0.1 
(0.0–0.3)

1.0
(0.5–2.0)

p<0.001

Selected secondary outcomes

5.9 
(5.5–6.3)

7.4 
(6.9–8.6)

p<0.001

– Day 1 

5.9 
(5.5–7.0)

7.8 
(6.5–9.5)

p<0.001

– Day 2

6.1 
(5.4–6.9)

7.6 
(7.2–8.8)

p<0.001

– Day 3

5.3 
(5.1–5.7)

7.1 
(6.2–8.1)

p<0.001

117 (34)

174 (27)

p<0.001

– Day 1

110 (30)

162 (34)

p<0.001

– Day 2

127 (46)

196 (43)

p<0.001

– Day 3

134 (44)

187 (31)

p<0.001

3.0
(2.0–5.6)

2.3 
(1.7–4.0)

p=0.22

– Day 1

3.4 
(1.4–6.0)

2.7 
(1.4–3.6)

NS

– Day 2

3.2 
(1.8–6.6)

2.1 
(1.6–4.7)

NS

– Day 3

3.5 
(2.4–7.2)

2.2 
(1.4–4.8)

NS

35.5 (12.7)

12.0 (4.2)

p<0.001

7.1 (3.4)

7.1 (2.5)

p=0.97

– Day 1

5.5 (3.4)

5.7 (3.4)

NS

– Day 2

8.3 (3.8)

7.8 (3.1)

NS

– Day 3

8.8 (2.9)

7.8 (3.0)

NS

Abbreviations: eMPC, enhanced model predictive control; h, hour; IQR, inter quartile range; NS, no statistical significance; n, number of patients; p, p value; SD, standard deviation.

Study component

Description

Objectives/hypotheses

To compare 3 insulin‑titration protocols for tight glycaemic control in a surgical intensive care unit in patients admitted to the postoperative ICU after elective cardiac surgery: the enhanced model predictive control (eMPC) algorithm, a computer-based model predictive control algorithm with variable sampling rate; the Matias protocol which was based on the absolute glucose value; the Bath protocol, based on the relative glucose change.

Study design

A single-centre open‑label randomised trial.

Setting

A surgical ICU at a university hospital, Prague. Only data for up to 48 hours were used for the comparison of the 3 protocols.

Inclusion/exclusion criteria

Patients included were aged 18–90 years and admitted to the postoperative ICU after elective cardiac surgery. Exclusion criteria were insulin allergy, mental incapacity, and language barrier.

Primary outcomes

Not specified. Outcomes measured:

Statistical methods

Data analysis was performed using STATISTICA software. The three insulin‑titration protocols were compared using ANOVA followed by a Holm‑Sidak test, Student's t‑test, or Mann‑Whitney U test as appropriate. The significance level was set at p=0.05. No sample size calculation was stated.

Participants

Patients aged 18 to 90 years and admitted to the postoperative ICU after elective cardiac surgery (n=120).

Results

For both the entire study period of 48 hours and after reaching the target range, the eMPC protocol group had significantly lower blood glucose than either the Matias or the Bath group.

For the eMPC, the time to target range was significantly shorter compared with the Bath, but was not significantly different from that of the Matias. The eMPC had significantly longer time within the target range and significantly higher percentage of time within the target range compared with either the Matias or the Bath.

There was no significant difference between the protocols for severe hypoglycaemia episodes or percentage of time in hypoglycaemia.

Compared with either the Matias or the Bath group, the eMPC group had significantly higher percentage of time in risk of hypoglycaemia, and significantly lower percentage of time in hyperglycaemia and percentage of time in risk of hyperglycaemia.

There was no significantly difference in sampling interval for the entire study period between the 3 protocols. After reaching the target range, sampling interval was significantly longer in the eMPC group than in the Bath with no significant difference between the eMPC and the Matias groups.

Conclusions

The authors concluded that the eMPC algorithm provided the best tight glycaemic control without increasing the risk of severe hypoglycaemia, while needing the fewest glucose measurements compared with the Matias and Bath protocols. Overall, all 3‑protocols were safe and effective in the maintenance of tight glycaemic control in cardiac surgery patients.

Abbreviations: ANOVA, analysis of variance; eMPC, enhanced model predictive control; ICU, intensive care unit; n, number of patients; p, p value.

eMPC

Matias

Bath

Analysis

Randomised

n=40

n=40

n=40

Efficacy

n=40

n=40

n=40

Outcomes (not specified which was primary outcome)^a

Entire study blood glucose control data (or 48 h)

5.9 (0.2)

6.7 (0.1)

6.5 (0.2)

p<0.05 for eMPC vs either Matias or Bath

2.1 (0.1)

2.0 (0.1)

1.7 (0.1)

NS

8.8 (2.2)

10.9 (1.0)

12.3 (1.9)

p<0.05 for eMPC vs Bath;

NS for eMPC vs Matias

46.0 (3.0)

38.2 (2.9)

39.7 (3.1)

p<0.05 for eMPC vs either Matias or Bath

Blood glucose control after reaching the target range

5.2 (0.1)

6.2 (0.1)

5.8 (0.1)

p<0.05 for eMPC vs either Matias or Bath

2.3 (0.1)

2.1 (0.1)

1.8 (0.1)

p<0.05 for eMPC vs Bath;

NS for eMPC vs Matias

62.8 (4.4)

48.4 (3.2)

55.5 (3.2)

p<0.05 for eMPC vs either Matias or Bath

22.2 (1.9)

10.9 (1.5)

13.1 (1.6)

p<0.05 for eMPC vs either Matias or Bath

0.0 (0.0)

0.4 (0.2)

0.4 (0.3)

NS

0

1

2

NS

13.7 (2.6)

27.5 (2.2)

24.5 (2.4)

p<0.05 for eMPC vs either Matias or Bath

1.3 (1.2)

12.8 (2.2)

6.5 (2.0)

p<0.05 for eMPC vs either Matias or Bath

Abbreviations: eMPC, enhanced model predictive control; h, hour; NS, no statistical significance; n, number of patients; p, p value; SEM, standard error of the mean; vs, versus.

^a Data reported as mean (SEM).

Study component

Description

Objectives/hypotheses

To investigate the effectiveness of the eMPC algorithm for intravenous insulin infusion aimed at achieving tight glucose control in critically ill patients in 2 intensive care units (RBH and KUL) compared with standard insulin management regimens.

Study design

Randomised, controlled, open‑label, 2‑centre, feasibility study. Within each ICU, patients were randomised to intravenous insulin infusion advised by the eMPC algorithm or the respective ICU's standard insulin infusion management regimen.

Setting

Two adult ICUs in University Hospitals (in London and Leuven); study duration was 72 hours.

Inclusion/exclusion criteria

Patients admitted to ICU, aged at least 18 years, with arterial plasma glucose greater than 120 mg/dl (6.7 mmol/l) or already receiving intravenous insulin infusion, and expected to be receiving mechanical ventilation for more than 72 hours from the study start. Patients with known diabetes mellitus were not excluded. Exclusion criteria: known allergy to insulin and chronic mental incapacity.

Primary outcomes

The following outcome measures were compared between the ICUs by management protocol, as well as between eMPC and standard care by ICU:

Statistical methods

Student t‑test or Mann‑Whitney U test was used when appropriate for continuous data and Fisher's exact test for categorical data (GraphPad Prism). A p value of <0.05 was taken to signify statistical significance. No sample size calculation was stated.

Participants

Participants were critically ill patients (n=34) with hyperglycaemia (glucose>120 mg/dl;6.7 mmol/l) or already receiving insulin infusion.

Results

The comparison of eMPC and the standard care showed differences that were contrary for each ICU for blood glucose concentration, hyperglycaemic index, time to achieve glucose control, percentage of time in target glucose range, and insulin infusion rates or alteration to insulin infusion rate. For example, in the RBH ICU the eMPC achieved significantly better blood glucose control than the standard care, while in the KUL ICU the standard care achieved significantly better blood glucose control.

Conclusions

The authors concluded that the eMPC algorithm provided similar, effective and safe tight glucose control over 72 hours in critically ill patients in 2 different ICUs. Further development is required to reduce glucose sampling interval while maintaining a low risk of hypoglycaemia.

Abbreviations: eMPC, enhanced Model Predictive Control; ICU, intensive care unit; KUL, University Hospital Gasthuisberg, Leuven; n, number of patients; RBH, Royal Brompton Hospital, London.

eMPC

Standard care

Analysis

Randomised

n=16

n=18

Efficacy

n=16

n=18

Outcomes^a

– RBH

6.0 (0.28)

7.1 (0.50)

p<0.001

– KUL

6.2 (0.22)

5.7 (0.28)

p<0.01

– RBH

5.9 (0.28)

7.1 (0.50)

p<0.001

– KUL

5.7 (0.22)

97 (0.28)

p<0.05

– RBH

0.50 (0.30)

1.20 (0.50)

p<0.0001

– KUL

0.31 (0.16)

0.27 (0.14)

NS

– RBH

257 (96)

473 (431)

p<0.0001

– KUL

465 (180)

359 (236)

NS

– RBH

57.7 
(46.5–72.3)

23.5 
(12.9–66.3)

p<0.01

– KUL

66.1 
(52.3–85.9)

63.4 
(38.1–80.5)

p>0.05

– RBH

1.1 (0.06)

1.9 (0.7)

P=0.02

– KUL

1.8 (0.4)

2.5 (0.4)

p<0.01

– RBH

4.1 (2.7)

3.1 (1.8)

P=0.5

– KUL

5.2 (2.6)

4.1 (2.5)

NS

– RBH

Not reported

Not reported

NS

– KUL

14 
(10–23)

5.4 
(3–9)

p<0.0001

– RBH

Not reported

Not reported

NS

– KUL

10.6 (3.1)

10.5 (3.8)

NS

– RBH

Not reported

Not reported

NS

– KUL

0.5 (1.0)

1.4 (4.2)

NS

Abbreviations: CHO, carbohydrate; CI, confidence interval; h, hour; KUL: University Hospital Gasthuisberg, Leuven; NS, no statistical significance; n, number of patients; p, p value; RBH, Royal Brompton Hospital, London; SD: standard deviation.

^a There are some minor discrepancies on the result figures between table 3, 4 and 5 and the text in the study paper.

Study component

Description

Objectives/hypotheses

To investigate the of the eMPC algorithm for glycaemic control in medical critically ill patients for the whole length of intensive care unit stay.

Study design

Prospective non‑controlled open clinical investigation.

Setting

The study was conducted at a medical ICU in Medical University of Graz from Sep 2008 to Jan 2009. Follow‑up duration was the whole length of intensive care unit stay.

Inclusion/exclusion criteria

Inclusion criteria: adult medical ICU patients; assumed to require at least 5 days of intensive care treatment; blood glucose level>6.1 mmol/l or already on insulin therapy. Exclusion criteria: insulin allergy; presence of ketoacidosis.

Primary outcomes

Blood glucose control assessed by: percentage of time within the predefined glucose target range (4.4–6.1 mmol/l, arterial blood glucose measurements).

Statistical methods

Statistical analysis was performed on an ITT basis. Data were reported as mean (SD) if not otherwise indicated. For the day‑by‑day comparison of blood glucose values, the Friedeman test and the nonparametric test were used. Data analysis was performed using SPSS version 14.0.

Participants

Adult medical ICU patients with blood glucose >6.1mmol/l or already on insulin therapy (n=20).

Results^a

During the study period of 7.3 days (median; interquartile range 4.4–10.2), the percentage of values in time in target was 58.12 % (10.05). For all patients with at least 7 days in the ICU, there was no statistically significant difference between the daily mean percentage of times in target range in respect of the averages. Mean blood glucose concentration was 5.8 (0.5) mmol/l. Insulin requirement was 101.3 (50.7) IU. Mean carbohydrate intake (enteral and parenteral nutrition) was 176.4 (61.9) g/day. Three hypoglycaemic episodes occurred in three subjects, corresponding to a rate of 0.02 per treatment day.

Conclusions

The authors concluded that, in the study the eMPC algorithm was a safe and reliable method to control blood glucose in critically medical ICU patients for the whole length of ICU stay.

Abbreviations: ICU, intensive care unit; ITT, intention to treat; mmol/l, millimoles per litre; n, number of patients.

^a Data reported as mean (standard deviation).

Outcome measures

Results ^a

Primary outcome (n=20)

58.12 (10.05)

Selected secondary outcomes (n=20)

0.02 (0.08)

6.59 (7.15)

5.8 (0.5)

101.3 (50.7)

4.22

176.4 (61.9)

1.69 

Safety (n=20)

3

Abbreviations: h, hour; mmol/l, millimoles per litre; n, number of patients.

^a Data reported as mean (standard deviation) unless otherwise specified.

^b Severe hypoglycaemia was defined as <2.2 mmol/l.

Study

Objective

Study design and follow‑up

Population

Comparison

Outcome measures

Goss 2012

To compare glycaemic control using the B. Braun Space GlucoseControl system with standard Bath protocol.

Retrospective cohort study; data was compared from patients on Space GlucoseControl system from June 2011 to February 2012 with that from patients from March to December 2011 who had received the standard protocol.

Population: critically ill patients in the general ICU at the Royal Cornwall Hospital, Truro, UK.

Comparison:

Outcome measure:

Blaha 2014

To evaluate the performance (efficiency) of Space GlucoseControl system under routine conditions in adult ICU patients requiring blood glucose control.

The study had 7 centres from nine European countries and included a total of 508 patients. No further information in the abstract on study design and follow‑up.

Population: adult ICU patients requiring blood glucose control (n=508).

Comparison:

Outcome measure:

The primary endpoint was the percentage of time within the target range, and secondary outcome measures were the frequency of hypoglycaemic episodes and blood glucose measurement intervals.

Roubicek 2007^a

To compare blood glucose control by the eMPC algorithm (with variable sampling rate) with routine glucose management protocol in peri‑ and post‑operative period in cardiac surgery patients.

Randomised controlled trial; follow‑up 24 hours.

Population: patients in peri‑ and post‑operative cardiac surgery period (n=20).

Comparison:

Outcome measures:

Abbreviations: eMPC, enhanced model predictive control; ICU, intensive care unit; n, number of patients.

^a Article in Czech; not retrieved.

ID

Status

Study design

PICO

Publication

NCT01886365

Completed

Randomised, open label

P: cardio‑surgical patients undergoing cardiopulmonary bypass with blood cardioplegia, n=75.

I: Space GlucoseControl.

C: conventional therapy with a fixed insulin dosing scheme.

O: time within a blood glucose corridor of 4.4–8.3 mmol/l (time frame: from start of cardiopulmonary bypass during surgery until discharge from ICU, which is approximately after 48–72 hrs).

Not identified

NCT01146847

Completed

Non‑randomised, open label

P: surgical ICU patients, n=20.

I: Space GlucoseControl system.

C: N/A.

O: arterial blood glucose values, percentage of time within predefined glucose target range 4.4–6.1 mmol/l (time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment, i.e. stop of intravenous insulin treatment, up to a maximum of 72 hours).

Not identified

NCT01233271

Completed

Non‑randomised, open label

P: postoperative cardiac surgery patients in the ICU, n=10.

I: Space GlucoseControl System (with incorporated software‑algorithm eMPC).

C: N/A.

O: arterial blood glucose values, percentage of time within predefined glucose target range 4.4–8.3 mmol/l (time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment, i.e. stop of intravenous insulin treatment, up to a maximum of 48 hours).

Listed on the register page: Cordingley JJ, Vlasselaers D, Dormand NC, et al. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med 2009; 35(1):123–8.

Note: this publication does not appear to be a report of the patient group enrolled in the NCT01233271 registered trial. For example, in the Cordingley study the patients were admitted to ICU for various reasons (e.g. respiratory failure, major trauma), but in the registered trial patients were postoperative cardiac surgery patients in the ICU.

NCT00444171

Completed

Randomised, open label

P: cardiac surgery patients.

I: eMPC .

C: insulin infusion rate guided by in‑house glucose management protocol.

O: mean blood glucose; percentage of time in target range.

Not identified

Abbreviations: C, comparator; I, intervention; ICU, intensive care unit; n, number of patients; N/A, not applicable; O, outcome; P, population.