Endocrinology and metabolism (Seoul, Korea)最新文献

{"title":"Postpartum Glucose Intolerance in Women with a History of Gestational Diabetes Mellitus: An In-Depth Review.","authors":"Kyung-Soo Kim, Soo-Kyung Kim, Yong-Wook Cho","doi":"10.3803/EnM.2025.2852","DOIUrl":"10.3803/EnM.2025.2852","url":null,"abstract":"<p><p>Gestational diabetes mellitus (GDM) is increasing in prevalence worldwide, and postpartum glucose intolerance represents one of the major complications after delivery in women with GDM. A wide range of risk factors for postpartum glucose intolerance have been identified, including ethnicity, genetic predisposition, age, obesity, pre-pregnancy body mass index, gestational weight gain, history of GDM, family history of diabetes, degree of hyperglycemia, insulin treatment, lipid profiles, and other metabolic factors. Lifestyle interventions, including weight loss, are thought to reduce the risk of postpartum glucose intolerance. Careful attention should be paid to the screening of postpartum glucose intolerance in women with GDM, and concerted efforts should be made to prevent or delay the development of diabetes and other metabolic disorders.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":"26-33"},"PeriodicalIF":4.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12963773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146109606","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"From Anabolic to Reponic: Reclassifying Insulin's Primary Metabolic Role.","authors":"Shelby Ford, Daniel Bryce, Joshua Moen","doi":"10.3803/EnM.2025.2558","DOIUrl":"10.3803/EnM.2025.2558","url":null,"abstract":"<p><p>The classification of insulin as primarily an anabolic hormone is inconsistent with its metabolic signature of energy storage. This categorization, shared with anabolic hormones such as testosterone, obscures insulin's role in the pathophysiology of metabolic disease. We propose a more precise classification: reponic, meaning 'to store.' To empirically support this framework, we analyzed data from 2,910 U.S. adults in the National Health and Nutrition Examination Survey 2011-2018. Higher insulin levels were strongly associated with increased central adiposity and dyslipidemia. In contrast, higher testosterone, particularly in males, was associated with a leaner phenotype, reflecting a metabolic profile antagonistic to insulin. These findings reinforce well-established physiology indicating that insulin's primary role is energy storage. Adoption of the reponic classification provides a clearer conceptual framework for understanding hyperinsulinemia and its clinical consequences.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":"185-189"},"PeriodicalIF":4.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12963764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145902250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Carbohydrate Intake Fluctuations on Glucose Profiles: Insights from Continuous Glucose Monitoring-Based Patient Clustering.","authors":"Hyun Ah Kim, Kyung Hee Kim, Young Lee, Yoon-Ju Song, Joon Ho Moon, Sung Hee Choi, Tae Jung Oh","doi":"10.3803/EnM.2025.2486","DOIUrl":"10.3803/EnM.2025.2486","url":null,"abstract":"<p><strong>Backgruound: </strong>Continuous glucose monitoring (CGM) is widely applied in daily glucose management. However, its potential to categorize individuals based on glucose profiles is not fully established. This study employed CGM-based patient clustering and examined nutritional factors influencing glucose patterns.</p><p><strong>Methods: </strong>This prospective observational study enrolled 34 individuals with diabetes. Retrospective professional CGM was conducted over 7 days, during which food intake was recorded. K-means clustering was performed using CGM-derived coefficient of variation (CV) and time in range. Macronutrient intake and its fluctuations were compared across clusters.</p><p><strong>Results: </strong>Participants were grouped into cluster 1 (well-controlled), cluster 2 (highest CV), and cluster 3 (highest mean glucose). Baseline clinical characteristics, daily energy intake (kcal), and macronutrient intake did not differ significantly among clusters. However, carbohydrate intake fluctuations were greater in cluster 3 (CV 41.0%±32.1%, standard deviation [SD] 502.1±363.4 kcal) than in cluster 1 (CV 21.9%±9.0%, SD 260.2±94.1 kcal) and cluster 2 (CV 19.2%±9.1%, SD 250.2±126.1 kcal) (P=0.123 for CV; P=0.024 for SD). The SD (kcal) of carbohydrate intake was positively correlated with mean glucose levels (rho=0.88, P=0.023).</p><p><strong>Conclusion: </strong>CGM enables categorization of individuals based on glucose profiles, and higher carbohydrate intake fluctuations are associated with poorer glycemic control. Personalized dietary strategies, particularly stabilizing carbohydrate intake, may support better glucose management in individuals with high mean glucose and low CV.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":"152-161"},"PeriodicalIF":4.2,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12963765/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145759274","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Decline in Years of Life Lost Due to Diabetes in Korea, 2008-2019: A Cause-Specific Decomposition Analysis.","authors":"Da Hea Seo, Kyoung Hwa Ha, Dae Jung Kim","doi":"10.3803/EnM.2025.2622","DOIUrl":"https://doi.org/10.3803/EnM.2025.2622","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to evaluate trends in years of life lost (YLL) attributable to diabetes and to identify cause-specific contributors to these changes in Korea.</p><p><strong>Methods: </strong>We analyzed data from the Korean National Health Insurance Service-National Sample Cohort between 2008 and 2019. Standardized mortality ratios (SMRs) were calculated using indirect standardization with age-specific mortality rates of individuals without diabetes as the reference. YLL was defined as the difference in life expectancy between individuals with and without diabetes at a given age. Cause-specific contributions to changes in YLL were estimated using Arriaga's decomposition method.</p><p><strong>Results: </strong>From 2008 to 2019, SMRs declined from 2.19 to 1.55 in males and from 2.04 to 1.36 in females. At age 40, life expectancy among individuals with diabetes increased from 32.53 to 37.81 years in males and from 39.41 to 43.77 years in females, accompanied by a reduction in diabetes-attributable YLL from 8.36 to 5.70 years in males and from 7.51 to 5.21 years in females, representing an approximate 30% decrease. The YLL gap narrowed with increasing age. At age 40, cause-specific decomposition showed that the largest relative reductions in YLL were attributable to diabetes (-40% in males, -46% in females), cardiovascular disease (-37% in males, -52% in females), and kidney disease (-33% in both sexes).</p><p><strong>Conclusion: </strong>Diabetes-related YLL in Korea declined substantially over the past decade, primarily driven by reductions in mortality from diabetes, cardiovascular disease, and kidney disease.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146069413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Associations between Metabolic Syndrome Indicators and Colon Polyps: A Mendelian Randomization Study.","authors":"Dongya Chen, Hong Xu, Zhaolin Zhang, Fang Chen, Qingqing Lu, Feng Pan","doi":"10.3803/EnM.2025.2379","DOIUrl":"https://doi.org/10.3803/EnM.2025.2379","url":null,"abstract":"<p><strong>Background: </strong>While observational studies have suggested a potential link between metabolic syndrome (MetS) and an increased risk of colon polyps, the causal nature of this association remains uncertain. This study used a two-sample Mendelian randomization (MR) approach to evaluate the relationship between MetS and colon polyps.</p><p><strong>Methods: </strong>A two-sample MR analysis was performed using data on MetS, its indicators, and colon polyps obtained from publicly available genome-wide association studies in the Integrative Epidemiology Unit (IEU) and MAGIC databases. Outliers were removed using Mendelian Randomization Pleiotropy RESidual Sum and Outlier (MR-PRESSO), followed by MR calculations and false discovery rate (FDR) correction. The primary analysis was conducted with the inverse variance-weighted (IVW) method.</p><p><strong>Results: </strong>The IVW results indicated no association between hypertension, hyperlipidemia, or diabetes and the risk of colon polyps. High-density lipoprotein cholesterol (HDL-C) (P=0.005), 2-hour glucose (P=0.004), glycated hemoglobin A1c (P=0.004), and the ratio of omega-6 to omega-3 fatty acids (P<0.001) were negatively associated with colon polyps. Conversely, body mass index (BMI) (P<0.001), body fat percentage (P=0.002), waist-to-hip ratio adjusted for BMI (P=0.001), total cholesterol (TC) (P=0.002), triglycerides (TG) (P<0.001), and both omega-3 (P<0.001) and omega-6 fatty acid levels (P=0.02) were positively associated with colon polyps. The relationships between these metabolic indicators and colon polyps remained significant after FDR correction.</p><p><strong>Conclusion: </strong>Obesity-related traits, TC, and TG may increase the risk of colon polyps, while HDL-C may have a protective effect.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021205","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association between the Chinese Visceral Adiposity Index and Multimorbidity in Middle-Aged and Older Chinese Adults: A Prospective Cohort Study.","authors":"Weihao Shao, Zuolin Lu, Xiaoxia Wei, Yutong Long, Enying Gong, Yueqing Wang, Yunyuan Kong, Yue Zhang, Ruitai Shao","doi":"10.3803/EnM.2025.2525","DOIUrl":"https://doi.org/10.3803/EnM.2025.2525","url":null,"abstract":"<p><strong>Background: </strong>The association between visceral adiposity and multimorbidity in Chinese middle-aged and older adults remains underexplored. This study used data from the China Health and Retirement Longitudinal Study (CHARLS) to examine the relationship between visceral adiposity, measured by the Chinese visceral adiposity index (CVAI), and multimorbidity.</p><p><strong>Methods: </strong>This prospective cohort study analyzed data from 6,410 participants who were multimorbidity-free in the 2015 CHARLS wave, with follow-up assessments in 2018 and 2020. CVAI was calculated using age, body mass index, waist circumference, triglycerides, and high-density lipoprotein cholesterol. Latent class analysis (LCA) identified multimorbidity patterns, defined as the presence of ≥2 chronic conditions based on self-reported physician diagnoses. Cox regression and restricted cubic spline (RCS) analyses assessed the impact of CVAI on multimorbidity risk.</p><p><strong>Results: </strong>Over a median 5.0-year follow-up (interquartile range [IQR], 3.0 to 5.0), 2,809 participants (43.8%) developed multimorbidity. Each IQR increase in CVAI significantly elevated the risk of multimorbidity (hazard ratio [HR], 1.20; 95% confidence interval [CI], 1.16 to 1.24). Higher risks were observed in the second (HR, 1.16; 95% CI, 1.04 to 1.30), third (HR, 1.28; 95% CI, 1.14 to 1.43), and fourth (HR, 1.76; 95% CI, 1.58 to 1.96) quartiles compared with the first. The RCS analysis demonstrated a dose-response relationship (Pnonlinearity=0.109). LCA identified four multimorbidity clusters. CVAI increments were significantly associated with the cardio- metabolic cluster (HR, 1.51; 95% CI, 1.42 to 1.62) and the arthritis-renal cluster (HR, 1.29; 95% CI, 1.21 to 1.39).</p><p><strong>Conclusion: </strong>Elevated CVAI is a strong risk factor for incident multimorbidity among middle-aged and older Chinese adults, emphasizing its importance in the development of distinct disease clusters.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146021212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Global Burden of Early-Onset Cancers Attributable to Metabolic Risk Factors from 1990 to 2021 and Projections to 2040.","authors":"Wenmei Qiao, Kaijian Zhou, Liang He, Jiahui Guo, Qiqiang Guo, Jing Zhang, Yongze Li","doi":"10.3803/EnM.2025.2577","DOIUrl":"https://doi.org/10.3803/EnM.2025.2577","url":null,"abstract":"<p><strong>Background: </strong>Early-onset cancers (diagnosed in individuals under 50 years of age) are increasingly contributing to the global cancer burden. Among the known contributors, specific metabolic risk factors-namely high body mass index (BMI) and high fasting plasma glucose (FPG)-have emerged as significant determinants. This study assessed the global burden of early-onset cancers attributable to these two metabolic risk factors and projected their trends through 2040.</p><p><strong>Methods: </strong>Using data from the Global Burden of Disease 2021 study, we analyzed mortality, disability-adjusted life years (DALYs), and estimated annual percentage changes for early-onset cancers linked to metabolic risk factors, stratified by age, sex, and sociodemographic index (SDI). Future trends were projected based on these data.</p><p><strong>Results: </strong>In 2021, the two metabolic risk factors (high FPG and high BMI) together accounted for 34,112 (95% uncertainty interval [UI], 15,037 to 54,888) deaths and 1,691,418 (95% UI, 762,923 to 2,698,657) DALYs from early-onset cancers, corresponding to mortality and DALY rates of 0.9 (95% UI, 0.4 to 1.4) and 42.8 (95% UI, 19.3 to 68.3) per 100,000 population, respectively. Between 1990 and 2021, both mortality and DALY rates rose significantly, with the greatest increases observed in individuals aged 30-34 years and in low-middle SDI regions. High FPG and high BMI were the leading contributors, with colorectal cancer showing the highest burden and liver cancer the most rapid growth. While high BMI predominated in most SDI regions, high FPG was more prominent in low-SDI countries, particularly among females. Projections indicate a continued rise in mortality and DALY rates through 2040.</p><p><strong>Conclusion: </strong>High BMI and high FPG are major contributors to the global burden of early-onset cancers, with marked sex and socioeconomic disparities necessitating targeted interventions. Urgent strategies are required to mitigate metabolic risks and enhance early cancer detection, especially among vulnerable populations.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145902230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in Prevalence of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Nationwide Survey in Korea.","authors":"Junhyun Kwon, Hanbit Shin, Dae Ho Lee, Eunji Kim","doi":"10.3803/EnM.2025.2578","DOIUrl":"https://doi.org/10.3803/EnM.2025.2578","url":null,"abstract":"<p><strong>Background: </strong>The global burden of metabolic dysfunction-associated steatotic liver disease (MASLD), which is associated with higher risks of obesity, type 2 diabetes mellitus, cardiovascular disease, chronic kidney disease, and extrahepatic cancer, is increasing. This study aimed to examine the temporal trends in MASLD prevalence among Korean adults, with a focus on age-stratified patterns and related health conditions.</p><p><strong>Methods: </strong>This secondary analysis of Korea National Health and Nutrition Examination Survey data included data of 90,912 adults aged ≥19 years from 2007 to 2023. MASLD was defined as having the presence of at least one cardiometabolic risk factor and no heavy alcohol consumption. Temporal trends in MASLD prevalence and associated cardiometabolic risk factors were examined across age groups using weighted prevalence estimates and log-linear regression models.</p><p><strong>Results: </strong>The overall prevalence of MASLD increased from 25.0% in 2007-2009 to 31.0% in 2022-2023 (annual percent change [APC], 1.36%). The most substantial increase was observed in young adults aged 19-44 years (22.3% to 30.5%; APC=2.09%), particularly among men. Middle-aged (45-64 years) and older (≥65 years) adults showed relatively stable or modest increases over time. Among young adults with MASLD, chronic kidney disease prevalence increased from 2.1% to 5.7%.</p><p><strong>Conclusion: </strong>This nationwide study revealed a significant and continuous increase in MASLD prevalence among Korean adults, particularly in younger age groups. The disproportionate burden in these populations, along with high rates of metabolic comorbidities, underscores an emerging public health concern that may place considerable strain on future healthcare systems.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145822639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Higher Circulating Kynurenine Levels Linked to Higher Risk of Sarcopenia in Older Adults: A Cohort Study and UK Biobank Analysis.","authors":"June Yeon Kim, Yunju Jo, So Jeong Park, Ji Yeon Baek, Geonyoung Jang, Eunju Lee, Hyuk Sakong, Su Jung Kim, Sung-Jin Kim, Dongryeol Ryu, Hyun Ju Yoo, Beom-Jun Kim","doi":"10.3803/EnM.2025.2586","DOIUrl":"https://doi.org/10.3803/EnM.2025.2586","url":null,"abstract":"<p><strong>Background: </strong>While experimental studies show kynurenine, a tryptophan metabolite, drives muscle catabolism through pro-oxidative and inflammatory mechanisms, clinical evidence linking circulating kynurenine to sarcopenia in humans remains scarce.</p><p><strong>Methods: </strong>In a cross-sectional study of 165 community-dwelling older adults, sarcopenia was diagnosed using Asian-specific criteria and serum kynurenine levels were measured by liquid chromatography-tandem mass spectrometry. Using UK Biobank datasets, plasma indoleamine 2,3-dioxygenase 1 (IDO1)-the enzyme converting tryptophan to kynurenine-was quantified via Olink proteomics, and Mendelian randomization was used to assess the causal effect of plasma IDO1 on sarcopenia risk based on genomewide association study data.</p><p><strong>Results: </strong>In multivariable adjusted analyses, older adults with sarcopenia, low muscle mass, or weak muscle strength had 21.3%-29.2% higher serum kynurenine concentrations than controls (P<0.001 to 0.010). Circulating kynurenine levels were inversely correlated with skeletal muscle index and grip strength (P=0.001 and 0.022, respectively). Each standard deviation increase in serum kynurenine was associated with a 1.80-2.97-fold increased risk for sarcopenia-related outcomes (P<0.001 to 0.010). In the UK Biobank, higher IDO1 activity was associated with reduced muscle mass and strength (P=0.007 and P=0.004, respectively), and Mendelian randomization indicated a significant causal relationship between plasma IDO1 levels and increased sarcopenia risk (P= 0.010, β=0.105).</p><p><strong>Conclusion: </strong>These findings extend previous experimental evidence to the clinical setting, suggesting that elevated kynurenine-driven by IDO1 activity-contributes to sarcopenia in older adults. Circulating kynurenine may serve as an exploratory biomarker candidate for identifying individuals at heightened risk for muscle deterioration, warranting further validation in future studies.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145746567","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol.","authors":"Ji Yoon Kim, Nam Hoon Kim, Soo Heon Kwak, Chang Hee Jung, Eun Seok Kang, Jun Sung Moon, Sun Joon Moon, So Yoon Kwon, Jee Hee Yoo, Younghoon Kim, Tae-Min Lee, Chung-Il Yang, Jae Hyeon Kim, Sang-Man Jin","doi":"10.3803/EnM.2025.2579","DOIUrl":"https://doi.org/10.3803/EnM.2025.2579","url":null,"abstract":"<p><strong>Background: </strong>Stage 2 or 3 connected insulin pens (CIPs) refer to tracking insulin pens that are capable of transmitting insulin dose data via cloud connectivity. Stage 4 CIPs feature a bolus calculator that determines appropriate insulin doses based on real-time continuous glucose monitoring (CGM) data, carbohydrate intake, previous dosing history, and preset parameters. Stage 5 CIPs additionally offer advanced decision-support features, such as education modules and coaching. However, the efficacy and safety of Stage 5 CIPs have not yet been established.</p><p><strong>Methods: </strong>In this prospective, open-label, parallel-group, multicenter, randomized controlled trial, we will include adults aged ≥19 and <75 years with type 1 or type 2 diabetes receiving multiple daily insulin injections (MDI) and having glycosylated hemoglobin (HbA1c) levels of 7.5% to 12.0%. In total, 152 participants will be randomized in a 1:1 ratio to receive either Stage 5 CIPs with CGM or tracking insulin pens with CGM. Stage 5 CIPs include a Setup Wizard that recommends individualized initial settings and an algorithm that provides advanced insulin dosing guidance based on analyses of each participant's CGM and insulin injection data. The primary outcome will be the change in HbA1c levels from baseline to week 12 (ClinicalTrials.gov, NCT07004153).</p><p><strong>Conclusion: </strong>This trial will determine whether Stage 5 CIPs are superior to tracking insulin pens in improving glycemic control among adults with type 1 or type 2 diabetes treated with MDI. Overall, this study may offer a promising strategy for enhancing the management and outcomes of patients with diabetes.</p>","PeriodicalId":520607,"journal":{"name":"Endocrinology and metabolism (Seoul, Korea)","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145759310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}