Real-World Effectiveness and Safety of Hydrogen Inhalation in Chinese Patients with Type 2 Diabetes: A Single-Arm, Retrospective Study

Figures & data

Table 1 Baseline Characteristics of the T2DM Patients in the Study (n=431)

Parameters	Baseline Value
Male (%)	197(45.7%)
Age (years)	59.3±9.3
Body weight (kg)	74.7±7.1
BMI (kg/m^2)	27.9±2.9
Diabetes duration (years)	11.2±3.3
SBP (mmHg)	140.5±15.2
DBP (mmHg)	89.5±7.5
Heart rate (beats/min)	83.2±9.9
HbA1c (%)	9.04±0.82
HbA1c <7% proportion (%)	3(0.7%)
FPG (mg/dL)	165.6±40.2
Fasting c-peptide (ng/mL)	2.06±0.50
eGFR (mL/min/1.73 m2)	76.2±20.0
Creatinine (mg/dL)	0.90±0.30
Hematocrit (%)	41.8±4.6
Uric acid (mg/dL)	5.1±1.2
TG (mg/dL)	154.5±38.1
TC (mg/dL)	167.6±33.6
LDL (mg/dL)	98.9±14.5
HDL (mg/dL)	45.1±8.2
Hypertension (%)	309(71.7%)
Dyslipidemia (%)	287(66.6%)
Microvascular complications (%)	38(8.8%)
Macrovascular complications (%)	25(5.8%)

Notes: All data are presented as mean ± standard deviation or as number (%).

Abbreviations: BMI, body mass index; SBP, systolic blood pressure; DBP diastolic blood pressure; HbA1c, glycated hemoglobin; FPG, fasting plasma glucose; eGFR, estimated glomerular filtration rate; TG, triglycerides; TC, Total Cholesterol; LDL, low-density lipoprotein; HDL, high-density lipoprotein.

Figure 1 Comparation of HbA1c (A), FPG (B), weight (C), insulin dose (D) levels at different visit point during the study (n=431 except insulin dose n=280). Data are shown as mean ± sd. ^&p<0.05 represents V1 vs V0; *p < 0.05 vs V1; ^#p < 0.05 vs V2.

Abbreviations: HbA1c, glycated hemoglobin; FPG, fasting plasma glucose.

Figure 2 Change of daily glycemic profile at 4 time points from baseline to the study end (n=431). Data are shown as mean. *p < 0.05 vs baseline; #p < 0.05 vs 3 month.

Figure 3 The difference of Lipid profile (A), islet function index (B) at 4 visit points during treatment (n=431 except islet function index n=151). Data are shown as mean ± sd. ^&p<0.05 represents V1 vs V0; *p < 0.05 vs V1; ^#p < 0.05 vs V2.

Abbreviations: TG, triglycerides; TC, Total Cholesterol; LDL, low-density lipoprotein; HDL, high-density lipoprotein; HOMA-IR, homeostasis model assessment of insulin resistance; HOMA-β, homeostasis model assessment of β-cell function.

Table 2 Change in Anti-Diabetic Medication During the Study (n=431)

Time Point	V1	V2	V3
Biguanide	258(59.9%)	271(62.9%)	213(49.4%)
Sulphonylurea or glinides	150(34.8%)	126(29.2%)	127(29.5%)
Thiazolidinedione	44(10.2%)	86(20%)	36(8.4%)
α-glucosidase inhibitor	44(10.2%)	52(12.1%)	67(15.5%)
DPP-4 inhibitor	85(19.7%)	47(10.9%)	69(16%)
SGLT-2 inhibitor	22(5.1%)	46(10.7%)	53(12.3%)
GLP-1 receptor agonists	36(8.4%)	25(5.8%)	21(4.9%)
Insulin	280(65%)	280(65%)	280(65%)

Note: Data are presented as number (%).

Abbreviations: V1, baseline; V2, 3±1 month after the baseline; 6±1 month after the baseline; DPP-4 dipeptidyl peptidase-4; SGLT-2, sodium-glucose co-transporter-2; GLP-1 glucagon-like peptide-1.

Figure 4 The proportion of participants maintaining different HbA1c levels at baseline and follow-up (n=431).

Figure 5 Change in HbA1c after the treatment stratified by glycemic control at baseline (A) and average duration of HI per day (B) (n=431). *p < 0.001.

Abbreviation: HbA1c, glycated hemoglobin.

Table 3 Linear Regression Analysis of Baseline Parameters in Relation to HbA1c Change at the End of Study (n=431)

Parameter	Univariate		Multivariate
	β	P	β	P
Age	−0.006	0.232
Gender	0.014	0.531
Baseline HbA1c	−0.122	<0.001	−0.120	<0.001
Baseline FPG	−0.039	0.053
Baseline fasting c-peptide	0.009	0.836
Weight	−0.019	0.004	−0.013	0.075
Duration	0.025	<0.001	0.004	0.047
eGFR	−0.013	0.403

Abbreviations: HbA1c, glycated hemoglobin; FPG, fasting plasma glucose; eGFR, estimated glomerular filtration rate.

Table 4 Adverse Event Recorded Throughout the Study (n=431)

Adverse Event		Occurrence
Any, n (%)		23(5.3)
Hypoglycemia	Symptomatic	6(1.4)
	Asymptomatic	2(0.5)
	Daytime	2(0.5)
	Nocturnal	4(0.9)
Urinary tract infections		2(0.5)
Vomiting		1(0.2)
Abdominal pain		3(0.7)
Diarrhea		4(0.9)
Vertigo		5(1.2)

Notes: Data are displayed as number (%). Several patients were recorded more than one adverse event.