• Prevalence of gestational diabetes mellitus in India: The ICMR-INDIAB national study (ICMR-INDIAB-24).
    3 days ago
    Background & objectives The prevalence of gestational diabetes mellitus (GDM) is known to be high among South Asians. However, there is no national study on prevalence of GDM in India and few data comparing prevalence of GDM in early pregnancy (Early GDM) and late pregnancy (Late GDM). Methods This is an analysis of pregnant women who participated in the nationally representative Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study. Of the 1,206 pregnant women 1,032 who underwent oral glucose tolerance test (OGTT) or had fasting blood glucose measurement and did not have overt diabetes, were included in this study. GDM was diagnosed using the NICE criteria. GDM was classified as Early GDM if diagnosed before 20 wk of gestation and Late GDM if diagnosed ≥ 20 wk of gestation, Results The weighted national prevalence of GDM in India was 22.4 per cent (95% CI: 16.7-28%) with no significant urban rural differences (24.2% vs. 21.6%, NS). The prevalence of Early GDM and Late GDM were 19.2 per cent (9.8-28.7%) and 23.4 per cent (16.7-30.2%), respectively. Central India had the highest prevalence of GDM at 32.9 per cent (17.9-48%), and West India, the lowest at 16 per cent (3.1-29.3%). High systolic blood pressure and family history of diabetes were independently associated with risk of GDM. Interpretation & conclusions Nearly one in four pregnant women in India have GDM with regional variability. The prevalence of Early GDM is also high. Thus, there is a need for screening of all pregnant women for GDM starting in early pregnancy.
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  • SGLT-2 Inhibitors Are Associated With Lower Mortality and Decompensation in Patients With MASH Cirrhosis and Type 2 Diabetes.
    3 days ago
    Metabolic dysfunction-associated steatotic liver disease (MASLD) and steatohepatitis (MASH) represent a spectrum of liver conditions that can gradually progress to cirrhosis. Sodium-glucose co-transporter-2 (SGLT-2) inhibitors have shown benefits in reducing hepatic steatosis and liver-related events in MASLD. This study aims to assess whether SGLT-2 inhibitors are associated with a reduced risk of all-cause mortality and disease-specific outcomes in patients with MASH cirrhosis and type 2 diabetes (T2D).

    A retrospective cohort study was performed using TriNetX. Patients with T2D and MASH cirrhosis on SGLT-2 inhibitors were matched 1:1 with other glucose-lowering drugs (oGLDs) based on demographics, comorbidities and medications. Primary outcomes included all-cause mortality, hepatic decompensation and major adverse liver outcomes (MALO). Cox-proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence interval (CI).

    A total of 51 427 patients with MASH cirrhosis and T2D were identified, of which 6833 (13.28%) were on SGLT-2 inhibitors. Patients on SGLT-2 inhibitors (n = 6449, mean age 63.7 years, 52.9% female) were matched with 6449 individuals (mean age 63.9 years, 53.5% female) on oGLDs. The SGLT-2 inhibitors cohort had statistically significantly lower risk of all-cause mortality (HR: 0.58, 95% CI: 0.53-0.63), hepatic decompensation (HR: 0.85, 95% CI: 0.81-0.90) and MALO (HR: 0.88, 95% CI: 0.83-0.93).

    SGLT-2 inhibitors are associated with a reduced risk of all-cause mortality in patients with MASH cirrhosis and T2DM, which may be partly attributable to a lower risk of hepatic decompensation and subsequent events. Further studies are warranted as SGLT-2 inhibitors may serve as an adjunctive therapy for patients with MASH cirrhosis.
    Diabetes
    Diabetes type 2
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  • African American Youth and Parent Perspectives on Advanced Insulin Delivery Technologies in Diabetes Management: Challenges to Closing the Loop on Health Disparities.
    3 days ago
    PurposeThe purpose of the study was to understand challenges to optimal diabetes management for African American (AA) youth and willingness to use advanced diabetes technologies.MethodsTwenty AA youth with type 1 diabetes mellitus (mean age 13.81 ± 2.10 years; 8 girls and 12 boys) and their parents participated in focus groups or individual interviews addressing adherence barriers and attitudes about new technologies, such as the advanced hybrid closed loop (AHCL) insulin pump. Sessions were video recorded, and based on verbatim transcripts, 2 independent raters coded responses into themes, and a third rater resolved discrepancies; thematic analysis was conducted using NVivo.ResultsQualitative analyses revealed 6 main themes encompassing current regimens, life with diabetes, parenting, culture, willingness to try new technologies, and hesitancy to try an AHCL system. Most families (65%) reported being very willing to try the AHCL system, and a third were open but not ready to commit, citing concerns about reliance on technology and need for more information.ConclusionsInnovative technology, such as the AHCL insulin pump system, may help to improve glycemic outcomes and reduce health disparities for AA youth. Many AA youth with type 1 diabetes mellitus and their parents are ready to try advanced technologies but may require additional individualized support from the health care team to achieve optimal outcomes.
    Diabetes
    Diabetes type 1
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  • Neutrophil/albumin ratio positively associates with type 2 diabetes mellitus risk in women with prior gestational diabetes mellitus: moderation by body mass index.
    3 days ago
    To investigate the associations of the neutrophil/albumin ratio (NAR) with type 2 diabetes mellitus (T2DM) in women with a history of gestational diabetes mellitus (GDM).

    We conducted a cross-sectional study involving 782 participants from the National Health and Nutrition Examination Survey. Logistic regression analyses were performed to explore the relationship between NAR and T2DM, adjusting for various confounding factors across different models. Interaction analyses examined the modifying effects of socio-demographic characteristics on the relationship between NAR and T2DM. Mediation analyses were utilized to investigate whether key laboratory indicators and insulin resistance indices mediated the association between NAR and T2DM.

    Higher NAR levels were positively associated with T2DM risk. (OR[95%CI]:1.649[1.181,2.309], p = 0.003). Mediation analyses revealed that the effect of NAR on T2DM was entirely mediated through the regulation of red cell distribution width (RDW Coefficient[95%CI]: 0.009[0.001,0.024], p = 0.020) and high-density lipoprotein cholesterol (HDL-C Coefficient[95%CI]: 0.038[0.017,0.067], p < 0.001). Besides, significant interactions and differences were observed in the relationship between NAR and T2DM risk based on body mass index (BMI) (NAR*BMI: interaction coefficient: -0.651, interaction p = 0.027). In individuals with 25 kg/m2 ≤ BMI < 30 kg/m2, NAR increased the risk of T2DM by regulating the insulin resistance index (HOMA-R) (β[95%CI]: 2.220[0.653,3.787], p = 0.007).

    This study revealed that among women with GDM history, NAR may influence the risk of T2DM through the modulation of RDW and HDL-C. Furthermore, NAR and BMI had a significant interaction affecting T2DM risk, particularly prominent in women with 25 kg/m2 ≤ BMI < 30 kg/m2. Within this subgroup, NAR elevated the risk of T2DM via HOMA-R.
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  • Treatment preference for once-weekly versus once-daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.
    3 days ago
    Although once-weekly and once-daily DPP-4 inhibitors have gained widespread market recognition, patient preference differences remain a key focus. This meta-analysis compares treatment preferences for once-weekly versus once-daily DPP-4 inhibitors in T2DM, offering evidence to guide clinical decisions and healthcare policies.

    PubMed, OVID, EBSCO, Web of Science, CNKI, Wanfang, and clinical trial registries were searched up to June 30, 2025. After screening literature against predefined criteria, a systematic review was conducted to compare the effects of once-weekly and once-daily DPP-4 inhibitors on the treatment preferences of patients with T2DM.

    8 RCTs with 1,575 participants were analyzed. No significant difference in medication adherence and DTSQ total score between the once-weekly and once-daily groups (p > 0.05). HbA1c percentage (MD = -0.21, 95% CI [-0.42, -0.01], p < 0.05) decreased significantly with once-weekly dosing, while GA and FPG showed no change (p > 0.05), this suggests greater improvement in HbA1c percentage levels following a switch to once-weekly DPP-4 inhibitors. Once-weekly DPP-4 inhibitors showed higher musculoskeletal/connective tissue disorder risk (RR = 2.63; 95% CI [1.18, 5.83]), but no significant differences in other adverse events (p > 0.05). No significant differences in treatment burden between both groups (p > 0.05).

    No statistically significant association between treatment preferences for once-weekly versus once-daily DPP-4 inhibitors among T2DM patients and medication adherence, treatment satisfaction, glycemic level changes, safety, or treatment burden for these two dosing regimens. Further research is needed to elucidate the influence of physician prescribing behavior on these preferences.
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  • Age-related heterogeneity of type 1 diabetes mellitus in children: a single-center retrospective study.
    3 days ago
    Type 1 diabetes mellitus is a heterogeneous autoimmune disease with diverse characteristics between ethnicities and ages. Understanding this heterogeneity is essential for optimizing management and developing precision treatments. This study investigates the clinical, metabolic and immunological heterogeneity of type 1 diabetes mellitus in children across different ages of onset.

    A retrospective analysis of 401 children newly diagnosed with type 1 diabetes mellitus at a single center from January 2009 to August 2024 was conducted. We compared the clinical characteristics of our cohort with others from different countries. Patients were categorized into three age groups: 6 months-5 years, 5-10 years and ≥ 10 years at diagnosis. Clinical, metabolic, and immunological features were compared among groups.

    The median cohort age was 8.58 years; 48.9% were male. Diabetic ketoacidosis occurred in 56.1% of patients, higher than in the Finnish and American cohorts. Most clinical characteristics are not significantly different among age groups. The 6 months-5 years group had a lower area under the curve (AUC) for C-peptide compared to the other age groups. The ≥ 10 years group was more likely to be thyroid antibody positive and have vitamin D deficiency. Immunologically, type 1 diabetes mellitus patients showed significantly increased counts of T lymphocytes, CD3 + CD8 + T cells and B lymphocytes, along with decreased interleukin-2 and increased interleukin-6 levels compared to healthy controls. Of note, the 6 months-5 years group had a higher CD4/CD8 ratio, which was negatively correlated with C-peptide AUC.

    Significant heterogeneity in type 1 diabetes mellitus features exists across age groups. Early-onset patients showed poorer islet function and late-onset patients were more prone to metabolic complications. Collectively our study emphasizes the need for age-specific management strategies.
    Diabetes
    Diabetes type 1
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  • Evaluation of formulation on the pharmacokinetics, safety, and tolerability of enavogliflozin in healthy Korean adults.
    3 days ago
    Enavogliflozin is a recently developed novel sodium‒glucose cotransporter-2 inhibitor that is used to treat type 2 diabetes mellitus. During clinical development, a 0.3 mg daily dose regimen was effective at lowering the blood glucose level, whereas a 0.1 mg dose formulation was used in the early clinical phase. This study aimed to evaluate the pharmacokinetic (PK) properties of a low-strength formulation of 0.1 mg of enavogliflozin and two high-strength formulations of 0.3 mg of enavogliflozin. Two clinical trials designed as randomized, open-label, single-dose, two-way crossover studies were conducted in healthy Korean subjects. In Study A, the subjects received either three tablets of 0.1 mg enavogliflozin or one tablet of 0.3 mg enavogliflozin according to their assigned sequence. In Study B, the subjects received a single dose of 0.3 mg of enavogliflozin in one of two different formulations. Blood samples were collected for up to 72 h to assess the PK of enavogliflozin. The maximum concentration (Cmax) and area under the concentration‒time curve from 0 to the last measurable time (AUClast) were calculated to determine bioequivalence. Safety and tolerability were evaluated throughout the studies. In Study A, 42 subjects were enrolled, 38 of whom completed the study, whereas in Study B, 43 subjects were included, 37 of whom completed the study. The geometric mean ratio (GMR) (90% confidence interval, 90% CI) of 0.3 mg of enavogliflozin (Formulation A) to 0.1 mg of enavogliflozin for the Cmax and AUClast were 1.02 (0.98-1.07) and 0.99 (0.95-1.02), respectively. The GMRs (90% CIs) of 0.3 mg of enavogliflozin (Formulation B) to 0.3 mg of enavogliflozin (Formulation A) for the corresponding parameters were 0.96 (0.91-1.02) and 1.00 (0.95-1.04), respectively, which met the conventional bioequivalence criteria. The most common adverse events were headache and diarrhea in both studies. This study demonstrated that three tablets of 0.1 mg enavogliflozin had PK characteristics similar to those of one tablet of 0.3 mg enavogliflozin. Furthermore, the two high-strength formulations showed bioequivalence and were well tolerated.
    Diabetes
    Diabetes type 2
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  • Comparison of Different Side Branch Ballooning Following Provisional Stenting in Coronary Bifurcation Lesion-Related STEMI.
    3 days ago
    The present study retrospectively assessed clinical outcomes of proximal optimization technique (POT)-kissing-POT (PKP) and POT-side-POT (PSP) in ST-segment elevation myocardial infarction (STEMI) patients with culprit coronary bifurcation lesion (CBL) following a provisional stenting (PS). This large-scale multicenter (n = 10) study included STEMI patients with culprit CBLs who underwent PKP or PSP following PS. The primary endpoint was defined as the major adverse cardiac events (MACE; cardiac death, target vessel myocardial infarction [TVMI], or clinically driven target lesion revascularization [TLR]). Consecutive patients (n = 596; male: 491 [82.3%], mean age: 58.1 ± 11.7 years) were included. The study cohort was divided into 2 groups: PKP (n = 386) and PSP (n = 210). In the overall population, mid-term MACE (hazard ratio [HR]: 0.921, P = .461) did not differ in individuals with CBL-related STEMI treated with either PKP or PSP. The frequency of main vessel-TLR (0% vs 30%, P = .001) and main vessel-TVMI (0% vs 20%, P = .014) were significantly lower in the PKP group in the left main bifurcation localization. Diabetes mellitus (HR: 2.628, P < .001), high SYNTAX score (HR: 1.081, P < .001), and bifurcation localization (HR: 2.109, P = .014) were found to be independent predictors of MACE. In the overall population, risk-adjusted MACE rates for culprit CBLs were comparable between both techniques.
    Diabetes
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  • Bridging gaps in oncofertility: evaluation of reproductive dysfunction and fertility assessment in pediatric cancer survivors.
    3 days ago
    With improved survival in pediatric cancers, late effects such as reproductive dysfunction and infertility have emerged as a major concern. Oncofertility services remain underdeveloped in India, particularly in public sector institutions. We aimed to evaluate reproductive function and fertility preservation practices in childhood cancer survivors (CCS) attending a tertiary care center in India.

    This was a cross-sectional study of CCS enrolled at the Pediatric Cancer Survivor Clinic of AIIMS, New Delhi, between January 2022 and December 2024. Survivors ≥ 8 years of age with prior gonadotoxic therapy were included. Hormonal assays, semen analysis, and ovarian reserve evaluations were conducted. Interventions were offered based as indicated.

    The cohort included 87 males and 45 females, mostly treated for hemato-lymphoid malignancies. Hypogonadism was identified in 76.3% of males based on low testosterone, and azoospermia in 50% of those tested. Among females, 56.8% of those tested had low anti-Müllerian hormone (AMH) levels, and 62.5% of those tested had reduced antral follicle count. Despite high-risk features, fertility preservation uptake was poor. Only five females received hormone replacement therapy. Cultural barriers and financial constraints were major deterrents.

    There is a high burden of reproductive dysfunction among Indian CCS, with significant gaps in fertility preservation. Early integration of oncofertility services within oncology care is feasible and essential. Structured, multidisciplinary models and non-governmental organization (NGO) support can help bridge current gaps in LMICs.
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  • Design an open-access dynamic spot-scanning proton arc system controller for quantitative and comprehensive investigation of delivery efficiency.
    3 days ago
    Proton arc therapy enables continuous treatment delivery while rotating the gantry. One of the key components in the proton arc system is the controller's design, which determines the irradiation sequence and gantry mechanical rotation.

    This study aims to develop a novel and open-access proton arc system controller (controller-SPArc) and comprehensively investigates the treatment delivery time in a relationship of different mechanical parameters.

    The controller-SPArc applied control theory to iteratively optimize and calculate the irradiation sequence across the control points to ensure an efficient treatment delivery while meeting the mechanical constraints. The calculation considers the parameters such as tolerance window, buffer window, and maximum acceleration and deceleration speed of the gantry. Five different disease sites, e.g., liver, head, and neck, intracranial, lung, and prostate cancer cases were used for testing purposes. Various parameters and settings were used to quantitatively investigate the dynamic spot-scanning proton arc (SPArc) treatment delivery time and total momentum changes.

    The result indicates that the significant impact of dynamic treatment delivery time comes from the buffer window setting relative to the tolerance window, in which a large buffer leads to a slower delivery process. On the other hand, the maximum acceleration and deceleration speed plays an important role in the treatment delivery efficiency if the buffer window occupies large portion of each tolerance window. Additionally, the buffer window setting also impacts the total momentum changes during the dynamic treatment delivery.

    The study introduced the first open-access controller-SPArc for dynamic treatment delivery simulation, allowing clinical users or investigators to adjust various machine parameters for testing purposes. This platform could serve as a foundation for testing future advancements in the dynamic SPArc technology, including hardware, system controller, and treatment planning optimization algorithm design.
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