Introduction: Prediabetes or intermediate hyperglycemia (IH) represents a critical phase in the trajectory toward type 2 diabetes mellitus (T2DM). Recent evidence from the International Diabetes Federation (IDF) suggests that 1-hour OGTT (1HOGTT) ≥8.6 mmol/L is a more sensitive biomarker for early beta-cell dysfunction, with enhanced detection of IH and future T2DM risk. Conventional screening using hemoglobin A1c (HbA1c) or 2-Hour OGTT (2HOGTT) may delay identification of prediabetes, narrowing the window for early intervention. This study evaluates 1HOGTT as a screening tool for prediabetes among Malaysians. Methodology: This cross-sectional study enrolled adults without prior T2DM or prediabetes. Participants underwent 1HOGTT, 2HOGTT, and HbA1c, classified as per the Malaysian Clinical Practice Guideline for T2DM (6th Edition) and IDF 2024 criteria. Agreement between tests was assessed using McNemar’s test and Cohen’s kappa. Diagnostic accuracy was evaluated via receiver operating characteristic (ROC) curve analysis. Cost-effectiveness was determined using reagent cost only. Results: The majority of the 310 participants were female (71.6%), Malay (87.1%), with average age of 40. The 1HOGTT identified prediabetes in 21.6% (n = 67) compared to 17.1% (n = 53) by HbA1c and 2.6% (n = 8) by 2HOGTT. McNemar’s test confirmed statistically significant discordance between 1HOGTT and 2HOGTT (chi-square = 53.397, p <0.001): 61 participants were prediabetic by 1HOGTT but normal by 2HOGTT, versus only 2 in the reverse direction. No significant discordance was found between 1HOGTT and HbA1c (chi-square = 2.817, p = 0.093). 1HOGTT demonstrated excellent discriminatory ability against 2HOGTT (AUC = 0.908; 95% CI: 0.837–0.978), significantly outperforming HbA1c (AUC = 0.664; CI: 0.462– 0.867; DeLong p = 0.012). In a population-level cost analysis, 1HOGTT achieved lowest cost per prediabetes case detected (RM 5.79) – approximately 8.3 times and 8.1 times more cost-effective than 2HOGTT (RM 48.08) and HbA1c (RM 46.78) respectively. Conclusion 1HOGTT identifies a significant proportion of individuals with prediabetes missed by 2HOGTT and HbA1c. Incorporating 1HOGTT enhances the detection of prediabetes, is cost-effective, and enables timely preventive measures in our population with high diabetes burden.
Glucose Tolerance Test ; Glycated Hemoglobin ; Prediabetic State

Introduction: Hemoglobin A1c (HbA1c) is fundamental in the diagnosis and longitudinal monitoring of diabetes mellitus. Appropriate utilization is essential to ensure optimal glycemic control, cost-effectiveness, and laboratory efficiency. Regular audits are crucial for assessing adherence to testing intervals and for identifying gaps in diabetes management. The aim was to evaluate the utilization pattern and glycemic outcomes of HbA1c testing at Hospital Teluk Intan in 2025. Methodology: A retrospective descriptive audit was conducted using Laboratory Information System data from 1 January to 31 December 2025. All HbA1c tests performed during the study period were included. Rejected samples and duplicate tests within 3 months for the same patient were excluded. Data were analyzed for test volume, inpatient versus outpatient distribution, age group, and glycemic control categories. Results: A total of 10,208 HbA1c tests were performed, with 987 (9.7%) rejected samples. Among valid requests, 3,561 (34.9%) were inpatient and 5,660 (55.4%) were outpatient. Adults accounted for 9,196 tests (90.1%), while paediatric requests were minimal (n = 25). Regarding glycemic status, 4,502 (44.1%) had HbA1c <6.5%, and 828 (8.1%) were between 6.5 and 7.0%. Suboptimal control (7.0–10.0%) was observed in 2,443 patients (23.9%), while 1,448 (14.2%) demonstrated poor control (>10.0%). Overall, 38.1% of patients had HbA1c ≥7.0%, indicating inadequate glycemic control. Conclusion HbA1c testing at Hospital Teluk Intan is predominantly utilized in adult and outpatient settings. Despite substantial testing volume, over one-third of patients demonstrated suboptimal or poor glycemic control, underscoring persistent therapeutic gaps. These findings highlight the need for strengthened diabetes management strategies and targeted quality improvement initiatives to enhance glycemic outcomes and optimize resource utilization.
Glycated Hemoglobin ; Hospitals

BACKGROUND: Alpha-glucosidase inhibitors or dipeptidyl peptidase-4 inhibitors are both hypoglycemia agents that specifically impact on postprandial hyperglycemia. We compared the effects of acarbose and sitagliptin add on to metformin on time in range (TIR) and glycemic variability (GV) in Chinese patients with type 2 diabetes mellitus through continuous glucose monitoring (CGM). METHODS: This study was a randomized, open-label, active-con-trolled, parallel-group trial conducted at 15 centers in China from January 2020 to August 2022. We recruited patients with type 2 diabetes aged 18-65 years with body mass index (BMI) within 19-40 kg/m 2 and hemoglobin A1c (HbA1c) between 6.5% and 9.0%. Eligible patients were randomized to receive either metformin combined with acarbose 100 mg three times daily or metformin combined with sitagliptin 100 mg once daily for 28 days. After the first 14-day treatment period, patients wore CGM and entered another 14-day treatment period. The primary outcome was the level of TIR after treatment between groups. We also performed time series decomposition, dimensionality reduction, and clustering using the CGM data. RESULTS: A total of 701 participants received either acarbose or sitagliptin treatment in combination with metformin. There was no statistically significant difference in TIR between the two groups. Time below range (TBR) and coefficient of variation (CV) levels in acarbose users were significantly lower than those in sitagliptin users. Median (25th percentile, 75th percentile) of TBR below target level <3.9 mmol/L (TBR 3.9 ): Acarbose: 0.45% (0, 2.13%) vs . Sitagliptin: 0.78% (0, 3.12%), P = 0.042; Median (25th percentile, 75th percentile) of TBR below target level <3.0 mmol/L (TBR 3.0 ): Acarbose: 0 (0, 0.22%) vs . Sitagliptin: 0 (0, 0.63%), P = 0.033; CV: Acarbose: 22.44 ± 5.08% vs . Sitagliptin: 23.96 ± 5.19%, P <0.001. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV (group with small wave, moderate wave and big wave). No significant difference was found in the complexity of glucose time series index (CGI) between acarbose users and sitagliptin users. By using time series analysis and clustering, we distinguished three groups of patients with representative metabolism characteristics, especially in GV. CONCLUSIONS: Acarbose had slight advantages over sitagliptin in improving GV and reducing the risk of hypoglycemia. Time series analysis of CGM data may predict GV and the risk of hypoglycemia. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR2000039424.
Humans ; Metformin/therapeutic use* ; Sitagliptin Phosphate/therapeutic use* ; Acarbose/therapeutic use* ; Diabetes Mellitus, Type 2/blood* ; Middle Aged ; Male ; Female ; Adult ; Blood Glucose/drug effects* ; Hypoglycemic Agents/therapeutic use* ; Aged ; Glycated Hemoglobin/metabolism* ; Adolescent ; Young Adult ; China ; East Asian People

Subclinical atherosclerosis underlies most cardiovascular diseases, manifesting before clinical symptoms and representing a key focus for early prevention strategies. Recent advancements highlight the importance of early detection and management of subclinical atherosclerosis. This review underscores that traditional risk factor levels considered safe, such as low-density lipoprotein cholesterol (LDL-C) and glycated haemoglobin (HbA1c), may still permit the development of atherosclerosis, suggesting a need for stricter thresholds. Early-life interventions are crucial, leveraging the brain's neuroplasticity to establish lifelong healthy habits. Preventive strategies should include more aggressive management of LDL-C and HbA1c from youth and persist into old age, supported by public health policies that promote healthy environments. Emphasising early education on cardiovascular health can fundamentally shift the trajectory of cardiovascular disease prevention and optimise long-term health outcomes.
Humans ; Atherosclerosis/diagnosis* ; Risk Factors ; Cardiovascular Diseases/prevention & control* ; Cholesterol, LDL/blood* ; Glycated Hemoglobin ; Cardiology/trends* ; Heart Disease Risk Factors

OBJECTIVE: Recaticimab (SHR-1209) significantly reduces low-density lipoprotein cholesterol levels. However, its effect on glucose metabolism remains unclear. This study aimed to evaluate its effect on glycemic parameters in a Chinese population. METHODS: Recaticimab versus placebo was administered in a 5:1 ratio to 110 hyperlipidemia patients who were followed up for 24 weeks. Glycated hemoglobin (HbA1c) levels were measured at baseline every 12 weeks. Fasting plasma glucose (FPG) levels were measured at baseline at week 1, 3, 5, 8, 12, 16, 20, and 24. Repeated-measures mixed-effects models were used to determine the longitudinal association between reacticimab and FPG and HbA1c levels. RESULTS: Among the 81 participants with normal glucose metabolism, HbA1c levels significantly decreased ( F = 4.568, P = 0.036). In the 29 participants with abnormal glucose metabolism, a significant time effect was observed for FPG levels ( F = 2.492, P = 0.016). For participants with normal and abnormal glucose metabolism, no significant group × time interaction effects on FPG or HbA1c levels were identified. CONCLUSION Recaticimab showed no adverse glycemic effects in participants with normal or abnormal glucose metabolism, indicating its safety in patients with or without diabetes.
Humans ; Male ; Female ; Blood Glucose/drug effects* ; Middle Aged ; Double-Blind Method ; Hyperlipidemias/blood* ; Antibodies, Monoclonal, Humanized/therapeutic use* ; PCSK9 Inhibitors ; Glycated Hemoglobin ; Aged ; Adult ; Proprotein Convertase 9

Hemoglobin A1c (HbA1c) has a unique structure that makes monoclonal antibody (mAb) preparation challenging. This study aims to develop a method for preparing HbA1c mAbs and establish a fluorescent immunochromatographic assay (FICA) for rapid detection of HbA1c. Three glycosylated peptides were synthesized and used to prepare complete antigens, which were identified by dot enzyme-linked immunosorbent assay (Dot-ELISA) and ultraviolet absorption spectroscopy. The complete antigens and natural HbA1c were used for cross-immunization of mice, and the optimal complete antigen was selected. The mouse with the highest serum titer was chosen for mAb preparation. The purity and specificity of the mAbs were verified, and a FICA method was developed. The optimal complete antigen, with a titer of 1:512 000, was successfully prepared and selected. Fusion with splenocytes resulted in four specific HbA1c antibodies (purity > 90%). The best antibody exhibited a binding constant (Ka) of 1.67×10¹⁰ L/mol with the antigen. Based on this antibody, a FICA method was successfully established, capable of producing results within 15 min. The method demonstrated a good linear range (3%-13% HbA1c, y=0.071 3x+0.005 6, R²=0.993 7), recovery rates of 98%-102%, precision < 10.00%, and no nonspecific reactions. Clinical testing of 210 samples showed positive agreement of 96.36%, negative agreement of 97.00%, and overall agreement of 96.68%. The receiver operating characteristic (ROC) curve analysis yielded an area under curve (AUC) of 0.980 9 [95% confidence interval (CI): 0.961 0-1.000 0], with high consistency verified in multicenter studies. We successfully developed a key technique for preparing HbA1c monoclonal antibodies and established a FICA method for rapid detection of HbA1c. It will provide an efficient and convenient detection method for the early diagnosis and long-term management of diabetes and its complications.
Antibodies, Monoclonal/biosynthesis* ; Animals ; Mice ; Glycated Hemoglobin/immunology* ; Mice, Inbred BALB C ; Humans ; Antibody Specificity ; Chromatography, Affinity/methods* ; Enzyme-Linked Immunosorbent Assay/methods* ; Female

BACKGROUND: Adolescence was associated with suboptimal diabetes control. Studies supporting the use of mobile technology to improve glycemic control and adherence to treatment had mixed results.

OBJECTIVES: This study aimed to evaluate the effect of SMS reminders on improving glycemic control in adolescents with Type 1 Diabetes Mellitus (T1DM).

METHODOLOGY: A randomized control study among adolescents with poorly controlled type 1 diabetes mellitus was done. Data were processed from 56 out of 64 subjects who were randomized into control (N=29) who received standard of care and SMS group (N=27), who received standard of care and a daily SMS reminder regarding diabetes self-care for 12 weeks. An adherence form was answered by all participants and glycosylated hemoglobin (HbA1c) before and after intervention was compared.

RESULTS: HbA1c did not significantly differ between SMS and control groups after 12 weeks of intervention (SMS 9.98+2.12 vs control 10.54+2.13, p value of 0.305). Post intervention, there was no significant difference between SMS and control group in terms of adherence to insulin injection (no p value), blood glucose (BG) monitoring (p value 0.106), and diabetic diet (p value 0.803). However, adherence on exercise was significantly higher among control group than SMS group (p value 0.003).

CONCLUSION: A 12-week SMS intervention reminder in adolescents with type 1 diabetes mellitus did not significantly improve glycemic control and adherence to standard of care (insulin injection, blood glucose monitoring, diet and exercise).

RECOMMENDATION: Future researches could include a bigger study population and longer duration of intervention. Other forms of mobile technology could also be used as a form of reminder.

Human ; Male ; Female ; Child: 6-12 Yrs Old ; Adolescent: 13-18 Yrs Old ; Diabetes Mellitus ; Diabetes Mellitus, Type 1 ; Text Messaging ; Glycated Hemoglobin ; Therapeutics ; Technology ; Standard Of Care ; Self Care

OBJECTIVE

To determine the pupillary parameters of adult patients with type 2 diabetes mellitus (DM) using the Reflex PLR© mobile application and to correlate these parameters with glycosylated hemoglobin (HbA1C) levels.

METHODS

This was a single-center, prospective, observational, cross-sectional study conducted at Ospital ng Makati from June to August 2024. Study participants were patients with type 2 DM without diabetic retinopathy and non-diabetics who served as the control group. Participants underwent blood chemistry testing and pupillometry using the Reflex PLR© mobile app. The study outcomes were maximum and minimum pupillary diameters, amplitude, and latency.

RESULTS

There were 44 study participants: 26 non-diabetics and 18 diabetic patients. The two groups had similar pupillary baseline diameters (p = 0.72; p = 0.30), maximum pupillary diameters (p = 0.82; p = 0.89), minimum pupillary diameters (p = 0.85; p = 0.89), pupillary amplitudes (p = 0.88; p = 0.55), and pupillary latencies (p = 0.53; p = 0.47) for the right and left eyes, respectively. The relationship between pupillary parameters and HbA1C levels showed no significant variations in baseline diameter (p = 0.21; p = 0.45), maximum diameter (p = 0.65 for the right eye; p = 0.46 for the left eye), minimum diameter (p = 0.77; p = 0.46), amplitude (p = 0.89; p = 0.83), and latency (p = 0.31; p = 0.22).

CONCLUSION

The study did not demonstrate any significant correlation between pupillary parameters and HbA1C levels. Pupillary changes in diabetes may have been more dependent on factors such as disease duration and the presence of complications rather than glycemic control alone.

Human ; Diabetic Autonomic Neuropathy ; Diabetic Neuropathies ; Glycosylated Hemoglobin ; Glycated Hemoglobin

BACKGROUND: The prevalence of pre-diabetes and diabetes mellitus type 2 (DMT2) among Filipinos exceeds 20%. Progressive loss of insulin sensitivity can occur with fasting blood sugar (FBS) ≥90 mg/dL. Studies among Asians with pre- diabetes show a higher prevalence of DMT2 diagnosed by 75 g oral glucose tolerance test (OGTT), the gold standard, which remains underutilized. OBJECTIVE: This prospective, observational, single-center study included adult patients admitted between January 2022 to August 2022 who were diagnosed with ARF type 1 and/or 2 and who were hooked to NIV as oxygen supplementation. METHODOLOGY: This cross-sectional analysis was conducted in the outpatient departments of two hospitals in Cebu City. Ninety-five adult Filipino patients with FBS < 126 mg/dL but with risk factors for DMT2 had HbA1c and 75 g OGTT taken. Test performance and receiver operating characteristic curves were computed for the optimal FBS and HbA1c threshold. RESULTS: Pre-diabetes or DMT2 was prevalent among 66% of participants. Using 75 g OGTT, 23% reached levels indicative of DMT2 but had normal or impaired fasting glucose, while this was found in 20% with pre-diabetic glycated hemoglobin (HbA1c) levels. HbA1c was more accurate than FBS. CONCLUSION Performing 75 g OGTT for high-risk Filipinos with FBS ≥94.2 mg/dL or HbA1c ≥5.6% is highly predictive of a change in glucose tolerance status to pre-diabetes, while an FBS ≥106 mg/dL or HbA1c ≥5.8% is predictive of DMT2. Lower cut-off levels promote earlier detection and intervention. Hypertension and age ≥35 years old were significantly associated with such conditions.
Human ; Diabetes Mellitus ; Prediabetic State ; Glycated Hemoglobin ; Glucose Tolerance Test

BACKGROUND: Studies on the impact of blood glucose indicators on metabolism remain relatively scarce. The aim of this study was to investigate the associations between blood glucose indicators and metabolic disorders in China. METHODS: Data were from the Thyroid disorders, Iodine status and Diabetes Epidemiological survey (TIDE survey), which randomly selected 31 cities from 31 provinces in the Chinese mainland. A total of 68,383 participants without preexisting diabetes and have complete data on blood glucose, lipids, and blood pressure were included in the analysis. The diabetic population was divided into seven groups based on different types of elevated blood glucose levels, including fasting plasma glucose (FPG), postprandial glucose (PPG), and hemoglobin A1c (HbA1c): FPG ≥7 mmol/L; PPG ≥11.1 mmol/L; HbA1c ≥6.5%; FPG ≥7 mmol/L and PPG ≥11.1 mmol/L; FPG ≥7 mmol/L and HbA1c ≥6.5%; PPG ≥11.1 mmol/L and HbA1c ≥6.5%; FPG ≥7 mmol/L, PPG ≥11.1 mmol/L, and HbA1c ≥6.5%. The effects of each blood glucose indicator on metabolism were investigated separately. Weighted calculation was applied during the analysis, with the weighting coefficient based on the number of people corresponding to the population characteristics of each sample in the 2010 Chinese Census. A logistic regression model with restricted cubic splines (RCS) was employed to characterize the nonlinear associations of age and body mass index (BMI) with the risk of diabetes subtypes defined by distinct blood glucose indicators elevations, as well as the relationships between different blood glucose indicators (FPG, PPG, HbA1c) and the risk of metabolic disorders such as hypertension, hypertriglyceridemia, hypercholesterolemia, high low-density lipoprotein cholesterol (high LDL-C) and low high-density lipoprotein cholesterol (low HDL-C). RESULTS: Among individuals with diabetes, elevated PPG alone was the most common abnormality, affecting 26.96% (1382/5127) of the population. Among the seven groups with only one elevated blood glucose indicator, individuals with elevated PPG alone exhibited the highest mean levels of triglycerides (TG) at 2.11 mmol/L (95% confidence interval [CI]: 1.97-2.25 mmol/L, P = 0.004), total cholesterol (TC) at 5.26 mmol/L (95% CI: 5.18-5.33 mmol/L, P <0.001), and low-density lipoprotein cholesterol (LDL-C) at 3.12 mmol/L, (95% CI: 3.06-3.19 mmol/L, P = 0.001). Individuals with elevated PPG alone showed a high prevalence of hypertension (806/1382, 58.32%), hypertriglyceridemia (676/1382, 48.91%), hypercholesterolemia (694/1382, 50.22%), High LDL-C (525/1382, 37.94%), and Low HDL-C (364/1382, 26.34%). The association of age and BMI with the risk of diabetes revealed that the older the patient, the steeper the RCS curve for the odds ratio (OR) of diabetes with elevated PPG alone (age = 60, OR = 2.79, 95% CI [2.49-3.12], P <0.01). Similarly, as BMI increased, the RCS curve for the OR of diabetes with elevated HbA1c alone also steepened (BMI = 35, OR = 3.75, 95% CI [3.23-4.35], P <0.001). Additionally, the RCS yielded a positive association between blood glucose indicators and metabolic diseases risk. In individuals with diabetes, RCS for both the ORs of metabolic diseases (hypertension, hypertriglyceridemia, hypercholesterolemia, high LDL-C, low HDL-C) and the levels of metabolic indicators (TG, TC, LDL-C, HDL-C) revealed some inflection points within the ranges of FPG 5-6 mmol/L, PPG 6-8 mmol/L, and HbA1c 5.5-6.0%. CONCLUSIONS PPG is more closely related to metabolic disorders than FPG and HbA1c in people with diabetes. For patients with diabetes and metabolic disorders, it may be necessary to monitor blood glucose fluctuations within specific ranges (FPG 5-6 mmol/L, PPG 6-8 mmol/L, and HbA1c 5.5-6.0%).
Humans ; Female ; Cross-Sectional Studies ; Male ; Blood Glucose/metabolism* ; Middle Aged ; Glycated Hemoglobin/metabolism* ; Adult ; Metabolic Diseases/epidemiology* ; Aged ; China ; Diabetes Mellitus/blood* ; East Asian People