Background and Aims: Prediabetes, characterized by elevated blood glucose levels below diabetes diagnostic thresholds, presents a significant global health challenge due to high prevalence and associated risks for developing type 2 diabetes. Traditional diabetes prevention programs (DPPs) often face challenges in scalability and accessibility, particularly in underserved communities. Digital therapeutics (DTx), like TH-001, offer potential scalable solutions requiring clinical validation. This randomized, open-label, controlled, parallel-group clinical trial aimed to evaluate the efficacy and safety of TH-001, a digital therapeutic application, reducing hemoglobin A1c (HbA1c) among adults with prediabetes over a 90-day intervention period. Methods: 68 eligible adults were randomly assigned to either standard care alone or standard care plus the TH-001 intervention. Primary outcomes measured were glycaemic parameters including HbA1c, fasting glucose, 2-h post-load glucose from an oral glucose tolerance test, and insulin levels, while secondary outcomes included anthropometric measures. User engagement metrics were also assessed. Results: The intervention significantly reduced HbA1c levels (mean difference −0.22%, p =  .023) and body weight (−2.53 kg, p <  .001) compared to the control group. Although fasting glucose and insulin levels showed positive trends, differences were not statistically significant. User engagement was high, correlating strongly with HbA1c reduction ( r =  .95, p <  .001), demonstrating the critical role of sustained interaction with TH-001. Conclusions: TH-001 demonstrates significant effectiveness in HbA1c reduction and body weight, with strong user engagement suggesting it may effectively overcome traditional barriers of DPPs. Long-term studies are needed to confirm sustained benefits. Efficacy and Safety of Digital Therapeutic in Adults with Prediabetes; https://clinicaltrials.gov/study/NCT05668819 ; ClinicalTrials.gov ID: NCT05668819

Background/Objectives: Schizophrenia (SCH), bipolar disorder (BPD), and major depressive disorder (MDD) are increasingly viewed as neuroimmune disorders shaped by viral exposure and inflammation. Disorder-specific immunovirological profiles, however, remain poorly defined. Methods: In this cross-sectional study, we assessed Epstein–Barr Virus (EBV) and Herpes Simplex Virus type 1 (HSV-1) seropositivity and measured serum CRP, IL-6, and IL-1β in 708 participants: 110 with SCH, 121 with BPD, 135 with MDD, and 342 healthy controls (HC). Statistical analyses included Shapiro–Wilk tests for normality; Kruskal–Wallis with Bonferroni-adjusted Dunn post hoc comparisons; and logistic regression adjusted for age, sex, and marital status. Results: EBV seropositivity was higher in SCH (90.9%) than in HC (78.9%) (OR = 3.46, 95% CI: 1.68–7.12; p = 0.001) but not in BPD or MDD. HSV-1 seropositivity was elevated in BPD (83.5%) versus HC (67.0%) (OR = 2.29, 95% CI: 1.34–3.92; p = 0.003), with no differences in SCH or MDD. Inflammatory biomarkers were significantly increased in SCH and MDD compared to HC (p < 0.001), while BPD showed no differences. Conclusions: The findings delineate distinct immunovirological patterns across major psychiatric disorders. Schizophrenia was characterized by EBV seropositivity accompanied by systemic inflammatory activation, bipolar disorder by HSV-1 seropositivity in the absence of inflammatory changes, and major depressive disorder by inflammatory dysregulation independent of viral exposure. These disorder-specific profiles highlight heterogeneity in neuroimmune pathways and underscore the potential relevance of biomarker-based stratification for generating hypotheses regarding targeted antiviral or anti-inflammatory interventions in psychiatric populations.