Background
Methods
Study design
Study population
Sample size, countries and sites
Space GlucoseControl
Insulin administration
Blood glucose ranges, time in target range
Blood sampling
Data documentation
Statistical analysis
Results
Study participants
Patients characteristics (N = 508) | |
---|---|
Female | 198 (39.0) |
Male | 310 (61.0) |
Age [years] | 65.6 ± 12.9 |
Height [m] | 1.70 ± 0.1 |
Weight [kg] | 85.1 ± 20.5 |
BMI [kg/m2] | 29.0 ± 6.5 |
BMI above 25 kg/m2
| 375 (73.8) |
BMI above 30 kg/m2
| 184 (36.2) |
APACHE II [points] | 21.1 ± 7.4 |
BG level at study entry [mmol/l] | 10.6 ± 5.6 |
History of Diabetes
| |
Total | 280 (55.1) |
Type 1 | 33 (6.5) |
Type 2 | 244 (48.0) |
Other | 3 (0.6) |
Admission diagnosis | |
Heart insufficiency | 152 (29.9) |
Respiratory insufficiency | 104 (20.5) |
Sepsis, septic shock | 63 (12.4) |
Gastrointestinal disease, bleeding | 38 (7.5) |
Diabetes, diabetic ketoacidosis | 21 (4.1) |
Acute pancreatitis | 21 (4.1) |
Cerebral hematoma, bleeding, infarction | 19 (3.7) |
Myocardial infarction | 14 (2.8) |
Vascular diseases | 11 (2.2) |
Renal insufficiency | 11 (2.2) |
Liver diseases | 10 (2.0) |
Infections | 8 (1.6) |
Meningitis/ Encephalitis | 6 (1.2) |
Other | 30 (5.9) |
Blood glucose measurement
Blood glucose Level
Blood glucose control characteristics | Number | |
---|---|---|
Total study time [days] | 508 | 2.9 (1.9–6.1) |
Blood glucose level at entry [mmol.l−1] | 508 | 9.3 (6.8–12.3) |
Time to reach target range [hours] | 293 | 4.5 (2.3–8.3) |
Mean insulin infusion rate [U/h] | 508 | 3.3 (2.3–5.1) |
Whole study period
| ||
Mean blood glucose level [mmol.l−1] | 508 | 6.9 (6.6–7.7) |
Severe hypoglycaemia <2.2 mmol.l−
[Number of patients/number of episodes] | 508 | 4 (0.8)/4 (0.01) |
Hypoglycaemia (2.2–4.3 mmol.l−1) [% of time] | 271 | 0.2 (0–1.4) |
Target range [% of time] | 508 | 83.0 (68.7–93.1) |
Hyperglycaemia >8.3 mmol.l−1 [% of time] | 485 | 14.7 (6.1–29.5) |
After reaching target range
| ||
Mean blood glucose level [mmol.l−1] | 501 | 6.9 (6.6–7.2) |
Severe hypoglycaemia <2.2 mmol.l−1
[Number of patients/number of episodes] | 508 | 4 (0.8)/4 (0.01) |
Hypoglycaemia (2.2–4.3 mmol.l−1) [% of time] | 269 | 0.2 (0.0–1.4) |
Target range [% of time] | 501 | 88.2 (77.5–95.1) |
Hyperglycaemia >8.3 mmol.l−1 [% of time] | 437 | 10.5 (3.4–20.4) |
Technical parameters of the SGC system performance
Nutrition
Nutrition (carbohydrates) | |
---|---|
Enteral nutrition
| |
Enteral bolus [g] (N = 61; 12.0 %) | 1.3 (0.5–57) |
Enteral infusion [g/kg/day] (N = 287; 56.2 %) | 2.1 (1.4–2.8) |
Time with enteral infusion [% of total study time] | 81.2 (58.7–94.7) |
Parenteral nutrition
| |
Parenteral bolus [g] (N = 77; 15.2 %) | 4.0 (0.5–10) |
Parenteral infusion [g/kg/day] (N = 340; 66.9 %) | 1.8 (1.2–2.7) |
Time with parenteral infusion [% of total study time] | 89.0 (60.9–97.3) |
Total nutrition
| |
Enteral/parenteral [g/hour] (N = 464; 91.3 %) | 7.2 (4.7–9.6) |
Users’ opinion
How well was the patient’s blood glucose stabilised in the target range? | Excellent | Good | Fair | Adequate | Poor |
---|---|---|---|---|---|
15 % | 61 % | 16 % | 6 % | 2 % | |
Do you think that control of the patient’s blood glucose was maintained more effectively by the use of the SGC system compared with normal practice? | Yes | No | |||
74 % | 26 % | ||||
Is the SGC system user friendly? | 83 % | 17 % | |||
Did you feel confident using the SGC system? | 81 % | 19 % | |||
Do you think that using the SGC system can help to avoid making mistakes when controlling the blood glucose? | 77 % | 23 % | |||
How did you rate your work load using the SGC system compared with normal practise? | Decreased | Slightly decreased | Equal | Slightly increased | Increased |
1 % | 2 % | 6 % | 31 % | 60 % |