Effect of Adding Insulin Glargine on Glycemic Control in Critically Ill Patients Admitted to Intensive Care Units: A Prospective Randomized Controlled Study

Figures & data

Figure 1 CONSORT flow diagram.

Table 1 Patient Characteristics and Comorbidities in Treatment Groups

	P-value	Controls (n=55)		Glargine (n=55)
Sex, male/female	0.778	31/19		33/18
Age (years) mean ± SD	0.273	63.2	±13.2	60.2	±14.9
Body weight (kg)	0.110	65.8	±14.0	69.5	±8.3
Body-mass index (gg/m^2)	0.158	25.8	±4.5	27.0	±3.7
Admission diagnosis
Cerebrovascular accidents	0.194	16	32%	6	12%
Neoplastic disease		9	18%	13	26%
Multitrauma		9	18%	7	14%
Respiratory failure		7	14%	7	14%
Spinal cord injury/surgery		3	6%	5	10%
Pulmonary thromboembolic events		3	6%	3	6%
Acute coronary syndrome		2	4%	2	4%
Sepsis		0	0	4	8%
Major urological procedure/surgery		1	2%	2	4%
Poisoning		0	0	2	4%
Enteral/parenteral feeding (nutrition)	0.974	45/5		46/5
Total daily energy intake (kcal)	0.260	1,696.0	±194.2	1,740.0	±193.5
Total daily protein (g)	0.211	57.6	±8.5	59.8	±9.1
Comorbid conditions
Hypertension	0.029	16	32%	7	14%
Dyslipidemia	0.295	12	24%	8	16%
Ischemic heart disease	0.653	9	18%	11	22%
Congestive heart failure	0.563	5	10%	7	14%
Chronic obstructive pulmonary disease	0.082	0	0	3	6%
Diabetes mellitus		32	64%	32	64%
Insulin treatment prior to admission	0.563	5	10%	7	14%
Oral hypoglycemic drugs	0.613	28	56%	26	52%
Metformin treatment	0.491	23	46%	20	40%
Laboratory findings on admission
Admission blood-glucose concentration (mg/dL)	0.108	210	±40	224	±47
Hemoglobin A1c (%)	0.269	7.9	±7.1	6.8	±1.2
Total cholesterol (mg/dL)	0.707	202.9	±14.5	204.1	±17.7
Low-density lipoproteins (mg/dL)	0.477	151.3	±13.5	153.5	±16.8
High-density lipoproteins (mg/dL)	0.403	49.1	±6.8	50.3	±7.7
Serum triglycerides (mg/dL)	0.190	194.4	±27.1	202.3	±32.5
Serum Albumin (gram/dL)	0.431	3.5	±0.4	3.5	±0.4

Table 2 Clinical Outcomes of Patients in Treatment and Control Groups

	P-value	Control (n=55)		Glargine (n=55)
Death within hospital	0.455	11	22%	8	16%
ICU length of stay (days)	0.025	13.8	±5.9	11.3	±5.2
Severe composite adverse events	0.322	27	54%	22	44%
Hospital-associated pneumonia	0.112	16	32%	9	18%
Duration of mechanical ventilation (days)	0.023	9.9	±5.8	7.4	±5.1
Acute kidney injury (AKIN ≥ stage 1)	0.654	14	28%	12	24%
Vasopressor requirement	>0.999	9	18%	9	18%
Progression of sepsis	0.148	4	8%	10	20%
Patients with hypoglycemic events	0.001	2	4%		29%
Duration of hyperglycemia (hours)	0.021	43.1	± 31.5	30.4	±24.2

Notes: Duration of hyperglycemia defined by period blood glucose >180 mg/dL. Frequency of hypoglycemic events defined by blood glucose <60 mg/dL presented in this table for total study duration of 7 days and number of patients who had at least one hypoglycemic event. P-values for these comparisons obtained through nonparametric Mann–Whitney U tests.

Figure 2 Duration that patients in each group spent in target (140< blood glucose <180) every day for 7 days after admission. (A) Mean daily concentrations of blood glucose; (B) daily variation in measured blood-glucose concentration (~24–30 hourly measurements). HbA_1c was adjusted in the analyses.

Figure 3 Repeated-measures analysis of daily additional requirement of regular insulin in the two arms of the study.

Table 3 Clinical Outcome of Patients According to Development of Hypoglycemia (BG <60 mg/dL) and Severe Hypoglycemia (BG <40 mg/dL)

	P-value	No Hypoglycemia (n=84)		Hypoglycemia <60 mg/dL (n=17)
Death within hospital	0.455	15	18%	4	24%
ICU length of stay (days)	0.611	12.7	±5.6	11.9	±6.2
Severe composite adverse events	0.792	40	48%	9	53%
Hospital-associated pneumonia	0.552	22	26%	3	18%
Duration of mechanical ventilation (days)	0.589	8.8	±5.6	8	±5.7
Acute kidney injury	0.132	19	23%	7	41%
Vasopressor requirement	>0.999	15	18%	3	18%
Progression of sepsis	0.057	9	11%	5	29%
	P-value	No Hypoglycemia (n=94)		Hypoglycemia <40 mg/dL (n=7)
Death within hospital	>0.999	18	19%	1	14%
ICU length of stay (days)	0.233	12.3	±5.5	15	±7.6
Severe composite adverse events	0.636	45	48%	4	57%
Hospital-associated pneumonia	0.678	24	26%	1	14%
Duration of mechanical ventilation (days)	0.319	8.5	±5.5	10.7	±7.1
Acute kidney injury	0.369	23	25%	3	43%
Vasopressor requirement	0.605	16	17%	2	29%
Progression of sepsis	0.007	10	11%	4	57%

Note: P-values for these comparisons obtained through nonparametric Mann–Whitney U tests.