Development and validation of a hypoglycemia risk prediction tool for hospitalized patients with type 2 diabetes mellitus treated with insulin

doi:10.4239/wjd.v16.i9.104290

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World Journal of Diabetes

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1948-9358

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Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA

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World J Diabetes. Sep 15, 2025; 16(9): 104290
Published online Sep 15, 2025. doi: 10.4239/wjd.v16.i9.104290

Table 1 Incidence and characteristics of hypoglycemia events in patients with type 2 diabetes mellitus treated with insulin (n = 716)

	n (%) or mean ± SD		*n (%)/M (P25, P75)*
Frequency of hypoglycemic events		FPG before hypoglycemia	5.80 (4.80, 7.30)
0	442 (55.1)	Days of insulin treatment when hypoglycemia occurred	6.50 (4.00, 9.00)
1	166 (20.7)	Occurrence time
2	108 (13.5)	Before breakfast	106 (14.8)
3 and more	86 (10.7)	After breakfast	117 (16.3)
Hypoglycemia (mmol/L)	3.53 ± 0.40	Before lunch	187 (26.1)
Symptoms of hypoglycemia		After lunch	86 (12.0)
No symptom	455 (63.5)	Before dinner	69 (9.6)
Sweating	67 (9.4)	After dinner	48 (6.7)
Fatigue	37 (5.2)	Before sleep	76 (10.6)
Palpitation	56 (7.8)	Midnight/before dawn	27 (3.8)
Sense of hunger	54 (7.5)	Hypoglycemic trigger
Hands tremble	19 (2.7)	None	630 (88.0)
Dizzy	69 (9.6)	Reduced food intake	58 (8.1)
Blurred vision	6 (0.8)	Excessive exercise	11 (1.5)
Types of hypoglycemia		Examination related	15 (2.1)
Clinically significant	81 (11.3)	Excessive insulin dosage	2 (0.3)
Blood glucose alert value	617 (86.2)	Methods for alleviating hypoglycemia
Relative hypoglycemia	18 (2.5)	Eating food	475 (66.3)
Duration of hypoglycemia		Oral GS	172 (24.0)
15 minutes	617 (86.2)	Intravenous injection of GS	10 (1.4)
30 minutes	87 (12.1)	Eating food + Oral GS	59 (8.2)
> 30 minutes	12 (1.7)

FPG: Fasting blood glucose; GS: Glucose solution.

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Table 2 Differences in sociodemographic and treatment-related characteristics of patients with type 2 diabetes mellitus between the non-hypoglycemic and hypoglycemic groups, n (%), mean ± SD

	Non-hypoglycemic group (n = 442)	Hypoglycemic group (n = 360)	t/χ²	P value
Age (years)	54.04 ± 13.84	56.06 ± 12.94	-2.11	0.04^a
Age (years)			6.36	0.10
18-44	116 (63.0)	68 (37.0)
45-59	173 (52.6)	156 (47.4)
60-74	127 (52.3)	116 (47.7)
≥ 75	26 (56.5)	20 (43.5)
Gender			3.59	0.06
Male	147 (50.7)	143 (49.3)
Female	295 (57.6)	217 (42.4)
BMI (kg/m²)	24.79 ± 3.38	23.36 ± 3.34	5.98	< 0.001^a
BMI (kg/m²)			26.56	< 0.001^a
< 18.5	12 (37.5)	20 (62.5)
18.5-23.9	174 (47.0)	196 (53.0)
≥ 24.0	256 (64.0)	144 (36.0)
Systolic blood pressure (mmHg)	130.24 ± 20.27	130.88 ± 20.67	-0.44	0.66
Diastolic blood pressure (mmHg)	82.23 ± 11.53	82.40 ± 11.37	1.02	0.31
Smoking			0.23	0.63
No	345 (54.7)	286 (45.3)
Yes	97 (56.7)	74 (43.3)
Alcohol consumption			1.87	0.17
No	384 (54.2)	324 (45.8)
Yes	58 (61.7)	36 (38.3)
Education level			4.77	0.10
Primary school or lower	99 (52.1)	91 (47.9)
Middle school	191 (52.8)	171 (47.2)
College or higher	152 (60.8)	98 (39.2)
Occupational status			12.29	0.002^a
Employed	278 (60.3)	183 (39.7)
Unemployed	49 (45.4)	59 (54.6)
Retired	115 (49.4)	118 (50.6)
Marital status			1.82	0.40
Married	412 (55.2)	335 (44.8)
Unmarried	22 (61.1)	14 (38.9)
Divorced/widowed	8 (42.1)	11 (57.9)
Treatment before admission			0.55	0.97
None	133 (55.4)	107 (44.6)
Oral antidiabetic drugs¹	183 (54.5)	153 (45.5)
Insulin	45 (52.9)	40 (47.1)
Oral antidiabetic drugs² + insulin	76 (57.6)	56 (42.4)
Others	5 (55.6)	4 (44.4)
Treatment time (days)	9.20 ± 3.13	10.34 ± 3.56	−4.81	< 0.001^a
Insulin injection therapy			0.42	0.52
Basal-before meal	4 (44.4)	5 (55.6)
CSII	438 (55.2)	355 (44.8)
Total insulin dose (IU/d)	34.63 ± 9.14	34.07 ± 9.79	0.84	0.40
Combined oral hypoglycemic drugs³			6.18	0.01^a
No	341 (53.0)	303 (47.0)
Yes	101 (63.9)	57 (36.1)
Combined antihypertensive drugs			1.25	0.26
No	307 (53.9)	263 (46.1)
Yes	135 (58.2)	97 (41.8)

^aP < 0.05.

¹Including metformin, SGLT2 inhibitor, alpha-glucosidase inhibitor, DPP4 inhibitor, sulfonylureas, triple hypoglycemic therapy.

²Including metformin, SGLT2 inhibitor, alpha-glucosidase inhibitor, DPP4 inhibitor, one or two antidiabetic drugs combined with insulin.

³Including metformin, SGLT2 inhibitor, alpha-glucosidase inhibitor, intensive insulin therapy combined with one or two oral drugs.

BMI: Body mass index.

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Table 3 Differences in disease-related and biochemical characteristics of patients with type 2 diabetes mellitus between the non-hypoglycemic and hypoglycemic groups

	Non-hypoglycemic group (n = 442)	Hypoglycemic group (n = 360)	Z/χ²	P value
	*n (%)/M (P25, P75)*	*n (%) /M (P25, P75)*	Z/χ²	P value
Duration of diabetes	5.00 (0.96, 10.00)	8.00 (1.00, 12.00)	-2.49	0.01
Duration of diabetes			12.26	< 0.001^a
< 10 years	308 (59.7)	208 (40.3)
≥ 10 years	134 (46.9)	152 (53.1)
Diabetic nephropathy			0.10	0.76
No	326 (54.8)	269 (45.2)
Yes	116 (56.0)	91 (44.0)
Diabetic neuropathy			0.02	0.89
No	284 (54.9)	233 (45.1)
Yes	158 (55.4)	127 (44.6)
Diabetic vascular disease			0.05	0.83
No	182 (54.7)	151 (45.3)
Yes	260 (55.4)	209 (44.6)
High blood pressure			0.01	0.94
No	270 (55.2)	219 (44.8)
Yes	172 (55.0)	141 (45.0)
Cardiovascular diseases			1.04	0.31
No	381 (55.9)	301 (44.1)
Yes	61 (50.8)	59 (49.2)
Hyperlipidemia			7.59	0.01^a
No	276 (51.7)	258 (48.3)
Yes	166 (61.9)	102 (38.1)
Fatty liver			3.46	0.06
No	235 (52.2)	215 (47.8)
Yes	207 (58.8)	145 (41.2)
History of hypoglycemia within a year			6.73	0.01
No	435 (55.9)	343 (44.1)
Yes	7 (29.2)	17 (70.8)
Blood glucose status
Random blood glucose (mmol/L)	13.1 (10.3, 17.3)	13.9 (10.53, 18.18)	-1.42	0.16
FPG (mmol/L)	7.6 (6.4, 9.2)	6.7 (5.2, 9.1)	-4.31	< 0.001^a
SDBG (mmol/L)	3.75 (2.72, 4.97)	3.92 (2.86, 5.47)	-1.64	0.10
HbA1c (%)	9.5 (8.1, 11.2)	9.85 (8.1, 11.6)	-0.96	0.34
Pancreas islet function
HOMA-β (%)	40.27 (26.45, 75.93)	39.08 (22.91, 95.24)	-0.48	0.63
HOMA-IR	3.21 (1.91, 5.26)	2.03 (1.29, 3.86)	-6.50	< 0.001^a
Fasting insulin (mu/L)	8.96 (5.77, 14.22)	6.82 (4.31, 11.17)	-5.01	< 0.001^a
Fasting C-peptide (nmol/L)	0.36 (0.22, 0.55)	0.24 (0.15, 0.42)	-6.75	< 0.001^a
Liver and renal functions
AST	19 (15, 26)	19 (15, 24)	-1.49	0.14
AST			1.21	0.27
≤ 40 U/L	395 (54.5)	330 (45.5)
> 40 U/L	47 (61.0)	30 (39.0)
ALT	23 (15, 34)	19 (14, 29)	-3.39	0.001^a
ALT			2.87	0.09
≤ 35 U/L	342 (53.6)	296 (46.4)
> 35 U/L	100 (61.0)	64 (39.0)
Cr	64 (52, 77)	66 (54, 80)	-1.37	0.17
Cr			0.07	0.80
≤ 133 μmol/L	431 (55.2)	350 (44.8)
> 133 μmol/L	11 (52.4)	10 (47.6)
GFR	102.77 (89.30, 113.93)	98.675 (81.31, 109.32)	-3.31	0.001^a
GFR			7.56	0.006^a
< 90	114 (47.7)	125 (52.3)
≥ 90	328 (58.3)	235 (41.7)
Blood lipid level
TC	4.87 (3.89, 5.61)	4.73 (3.78, 5.41)	-1.36	0.18
TC			0.81	0.37
< 4.5 mmol/L	174 (53.2)	153 (46.8)
≥ 4.5 mmol/L	268 (56.4)	207 (43.6)
TG	1.52 (1.05, 2.42)	1.25 (0.89, 1.81)	-5.55	< 0.001^a
TG			19.31	< 0.001^a
< 1.7 mmol/L	249 (49.2)	257 (50.8)
≥ 1.7 mmol/L	193 (65.2)	103 (34.8)
HDL-C	0.92 (0.79, 1.08)	0.99 (0.82, 1.18)	-3.04	0.002^a
HDL-C			6.86	0.01^a
≤ 1 mmol/L	281 (58.9)	196 (41.1)
> 1 mmol/L	161 (49.5)	164 (50.5)
LDL-C	3.09 (2.16, 3.74)	3.06 (2.20, 3.80)	-0.40	0.69
LDL-C			0.30	0.58
< 2.6 mmol/L	163 (56.4)	126 (43.6)
≥ 2.6 mmol/L	279 (54.4)	234 (45.6)
CRP	1.8 (1.00, 3.73)	1.8 (0.80, 3.50)	-0.94	0.35
CRP			0.17	0.68
≤ 6 mg/L	327 (55.9)	258 (44.1)
> 6mg/L	115 (53.0)	102 (47.0)

^aP < 0.05.

FPG: Fasting blood glucose; SDBG: Standard deviation of blood glucose; HbA1c: Glycated hemoglobin A1c; HOMA-β: Homeostasis model assessment for β-cell function; HOMA-IR: Homeostasis assessment of insulin resistance; AST: Aspartate aminotransferase; ALT: Alanine aminotransferase; Cr: Creatinine; GFR: Glomerular filtration rate; TC: Total cholesterol; TG: Triglyceride; HDL-C: High-density lipoprotein cholesterol; LDL-C: Low-density lipoprotein cholesterol; CRP: C-reactive protein.

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Table 4 Logistic regression analysis of predictors for hypoglycemia

Variables	β	*S.E*	Z	OR (95%CI)	P value
BMI	-0.10	0.02	-4.30	0.90 (0.86-0.95)	< 0.001
Duration of diabetes
< 10 years	Reference
≥ 10 years	0.26	0.16	1.63	1.30 (0.95-1.78)	0.10
History of hypoglycemia within 1 year
No	Reference
Yes	0.89	0.48	1.86	2.42 (0.99-6.56)	0.06
DII	0.09	0.02	3.68	1.09 (1.04-1.14)	< 0.001
GFR
< 90	Reference
≥ 90	-0.34	0.17	-2.02	0.71 (0.51-0.99)	0.04
TG
< 1.7 mmol/L	Reference
≥ 1.7 mmol/L	-0.48	0.16	-3.01	0.62 (0.45-0.85)	0.003

BMI: Body mass index; DII: Duration of intensive insulin therapy; GFR: Glomerular filtration rate; TG: Triglyceride.

Full Size Table

Citation: Zhang Y, Hu XL, Xu WR, Chen YM, Guo XD, Liu SH, Gao LL. Development and validation of a hypoglycemia risk prediction tool for hospitalized patients with type 2 diabetes mellitus treated with insulin. World J Diabetes 2025; 16(9): 104290
URL: https://www.wjgnet.com/1948-9358/full/v16/i9/104290.htm
DOI: https://dx.doi.org/10.4239/wjd.v16.i9.104290