The sex-specific association between alcohol consumption and glycemic level and whether the association differs by genetic susceptibility to alcohol is unclear. The present study aimed to examine the association of alcohol consumption and genetic variants in alcohol-metabolizing enzymes with glycemic level, as well as their sex differences, in East Asian individuals with type 2 diabetes.
Materials and Methods
In total, 4,923 Japanese individuals with type 2 diabetes were included. Participants were classified based on alcohol drinking status, alcohol consumption amount (<20, 20–39, or ≥40 g/day), and ADH1B (rs1229984) and ALDH2 (rs671) genotype, and the associations with HbA1c levels were examined cross-sectionally.
Results
In men, compared with never drinkers, an increase in the alcohol consumption amount was associated with a decrease in HbA1c levels (P for trend <0.001). By contrast, in women, a mild-to-moderate consumption amount (<20 g/day) was associated with decreased HbA1c levels, whereas ≥20 g/day consumption was associated with increased HbA1c levels, indicating a J-shaped relationship. Regarding the association with genetic variants in alcohol-metabolizing enzymes, HbA1c increased linearly with an increasing number of A alleles in ALDH2 (P for trend <0.001). However, the HbA1c level did not show a significant trend across the ADH1B genotype. The association between alcohol consumption and HbA1c levels was not modified by genetic variants in ADH1B or ALDH2.
Conclusions
These findings highlight the importance of a sex-specific approach to alcohol drinking habits in managing glycemic control for individuals with type 2 diabetes, irrespective of genetic predisposition to alcohol metabolism.
{"title":"Alcohol consumption, alcohol-metabolizing enzyme genotypes, and glycemic control in type 2 diabetes: Sex-specific findings from the Fukuoka Diabetes Registry","authors":"Toshiaki Ohkuma, Masanori Iwase, Ayaka Oshiro, Taiki Higashi, Takanari Kitazono","doi":"10.1111/jdi.70122","DOIUrl":"10.1111/jdi.70122","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims/Introduction</h3>\u0000 \u0000 <p>The sex-specific association between alcohol consumption and glycemic level and whether the association differs by genetic susceptibility to alcohol is unclear. The present study aimed to examine the association of alcohol consumption and genetic variants in alcohol-metabolizing enzymes with glycemic level, as well as their sex differences, in East Asian individuals with type 2 diabetes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>In total, 4,923 Japanese individuals with type 2 diabetes were included. Participants were classified based on alcohol drinking status, alcohol consumption amount (<20, 20–39, or ≥40 g/day), and ADH1B (rs1229984) and ALDH2 (rs671) genotype, and the associations with HbA<sub>1c</sub> levels were examined cross-sectionally.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In men, compared with never drinkers, an increase in the alcohol consumption amount was associated with a decrease in HbA<sub>1c</sub> levels (<i>P</i> for trend <0.001). By contrast, in women, a mild-to-moderate consumption amount (<20 g/day) was associated with decreased HbA<sub>1c</sub> levels, whereas ≥20 g/day consumption was associated with increased HbA<sub>1c</sub> levels, indicating a J-shaped relationship. Regarding the association with genetic variants in alcohol-metabolizing enzymes, HbA<sub>1c</sub> increased linearly with an increasing number of A alleles in ALDH2 (<i>P</i> for trend <0.001). However, the HbA<sub>1c</sub> level did not show a significant trend across the ADH1B genotype. The association between alcohol consumption and HbA<sub>1c</sub> levels was not modified by genetic variants in ADH1B or ALDH2.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>These findings highlight the importance of a sex-specific approach to alcohol drinking habits in managing glycemic control for individuals with type 2 diabetes, irrespective of genetic predisposition to alcohol metabolism.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1941-1949"},"PeriodicalIF":3.0,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70122","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144787916","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To evaluate the long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes (T2D) and advanced chronic kidney disease (CKD).
Materials and Methods
This open-label, single-arm, multicenter, phase 4 study (TWINKLE) enrolled individuals with T2D and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m2, treated with ≤1 oral hypoglycemic agent. Participants received 500 mg of imeglimin twice daily if eGFR was 15 to <45 mL/min/1.73 m2 or 500 mg once daily if eGFR was <15 mL/min/1.73 m2, as monotherapy or in combination with their existing hypoglycemic agent, for 52 weeks. Dose adjustments were permitted based on safety and eGFR.
Results
Among 60 participants (CKD stages: G3b: n = 42; G4: n = 16; G5: n = 2), adverse events (AEs) occurred in 41 participants (68.3%), with no increased incidence across CKD stages. The most common AE was diarrhea (n = 6, 10.0%). Baseline mean (SD) HbA1c, glycated albumin (GA), and fasting plasma glucose (FPG) levels were 7.59% (0.68%), 22.53% (3.27%), and 151.8 (28.86) mg/dL, respectively. At week 24, mean (SD) changes from baseline were −0.53% (0.51%) for HbA1c, −2.37% (2.08%) for GA, and −13.6 (20.87) mg/dL for FPG. At week 52 (last observation carried forward [LOCF]), mean changes were −0.26% (0.88%), −1.59% (3.04%), and −7.0 (31.17) mg/dL. The proportion achieving HbA1c < 7.0% increased from 13.3% at baseline to 50.0% at week 52 (LOCF).
Conclusions
This study confirmed the favorable safety profile and sustained glycemic efficacy of imeglimin in Japanese individuals with T2D and CKD stages G3b–5, supporting its use with dose adjustment in this population.
目的：评价伊米明在日本2型糖尿病（T2D）和晚期慢性肾脏疾病（CKD）患者中的长期安全性和有效性。材料和方法：这项开放标签、单组、多中心、4期研究（TWINKLE）招募了T2D患者，估计肾小球滤过率（eGFR） 2，接受≤1种口服降糖药治疗。如果eGFR为15 - 2，受试者接受500mg伊米明，每日2次；如果eGFR为2，受试者接受500mg，每日1次，作为单药治疗或与现有降糖药联合治疗，疗程52周。允许根据安全性和eGFR调整剂量。结果：60名参与者(CKD分期：G3b: n = 42；G4: n = 16；G5: n = 2)， 41名参与者（68.3%）发生了不良事件（ae），在CKD分期中发生率没有增加。最常见的AE是腹泻（n = 6, 10.0%）。基线平均（SD） HbA1c、糖化白蛋白（GA）和空腹血糖（FPG）水平分别为7.59%（0.68%）、22.53%（3.27%）和151.8 (28.86)mg/dL。在第24周，与基线相比，HbA1c的平均（SD）变化为-0.53% (0.51%)，GA为-2.37% (2.08%)，FPG为-13.6 (20.87)mg/dL。第52周（最后一次观察结转[LOCF]），平均变化分别为-0.26%（0.88%）、-1.59%（3.04%）和-7.0 (31.17)mg/dL。结论：本研究证实伊米明在日本T2D和CKD G3b-5期患者中具有良好的安全性和持续的降糖疗效，支持在该人群中调整剂量使用。
{"title":"Long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes and chronic kidney disease: A 52-week postmarketing clinical study (TWINKLE)","authors":"Tetsuya Babazono, Takeshi Osonoi, Hideki Okamoto, Yukiko Onishi, Shinya Nakamoto, Masayuki Kashima, Daiji Kawanami, Eitaro Nakashima, Kei Watabe, Noriko Nunami, Katsuhiko Hagi","doi":"10.1111/jdi.70135","DOIUrl":"10.1111/jdi.70135","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aim</h3>\u0000 \u0000 <p>To evaluate the long-term safety and efficacy of imeglimin in Japanese individuals with type 2 diabetes (T2D) and advanced chronic kidney disease (CKD).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>This open-label, single-arm, multicenter, phase 4 study (TWINKLE) enrolled individuals with T2D and estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73 m<sup>2</sup>, treated with ≤1 oral hypoglycemic agent. Participants received 500 mg of imeglimin twice daily if eGFR was 15 to <45 mL/min/1.73 m<sup>2</sup> or 500 mg once daily if eGFR was <15 mL/min/1.73 m<sup>2</sup>, as monotherapy or in combination with their existing hypoglycemic agent, for 52 weeks. Dose adjustments were permitted based on safety and eGFR.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Among 60 participants (CKD stages: G3b: <i>n</i> = 42; G4: <i>n</i> = 16; G5: <i>n</i> = 2), adverse events (AEs) occurred in 41 participants (68.3%), with no increased incidence across CKD stages. The most common AE was diarrhea (<i>n</i> = 6, 10.0%). Baseline mean (SD) HbA1c, glycated albumin (GA), and fasting plasma glucose (FPG) levels were 7.59% (0.68%), 22.53% (3.27%), and 151.8 (28.86) mg/dL, respectively. At week 24, mean (SD) changes from baseline were −0.53% (0.51%) for HbA1c, −2.37% (2.08%) for GA, and −13.6 (20.87) mg/dL for FPG. At week 52 (last observation carried forward [LOCF]), mean changes were −0.26% (0.88%), −1.59% (3.04%), and −7.0 (31.17) mg/dL. The proportion achieving HbA1c < 7.0% increased from 13.3% at baseline to 50.0% at week 52 (LOCF).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study confirmed the favorable safety profile and sustained glycemic efficacy of imeglimin in Japanese individuals with T2D and CKD stages G3b–5, supporting its use with dose adjustment in this population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1808-1819"},"PeriodicalIF":3.0,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70135","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144774387","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ke Huang, Leilei Ma, Shousen Shi, Xi Wang, Sheng Jiang, Yanfang Zhang
<div> <section> <h3> Background</h3> <p>Early-onset type 2 diabetes mellitus (EOD), defined as a metabolic disorder diagnosed before the age of 40, with higher risks of complications, vascular events, and mortality, poses a significant threat to public health. Its prevalence has risen markedly in overweight populations in recent years, yet the underlying mechanisms remain elusive. Emerging evidence highlights a close association between gut microbiota (GM) and metabolic disorders, suggesting that modulating gut microbial dysbiosis may serve as a potential strategy for preventing and managing overweight EOD.</p> </section> <section> <h3> Methods</h3> <p>In this study, we enrolled 30 overweight EOD patients and 30 healthy controls, analyzing their GM profiles and correlations using physicochemical clinical parameters and fecal metabolites.</p> </section> <section> <h3> Results</h3> <p>The results demonstrated significant differences in GM composition between overweight EOD patients and healthy controls. EOD patients exhibited increased the ratio of <i>Firmicutes</i>/<i>Bacteroidetes</i> at the phylum level. At the genus level, <i>Bilophila</i>, <i>Serratia</i>, <i>Lachnospira</i>, and <i>Parabacteroides</i> were enriched in EOD patients, while taxa, such as <i>Faecalibacterium</i>, <i>Ruminococcaceae</i>, and <i>Clostridia_UCG-014</i>, showed significant depletion. Correlation analyses revealed that <i>Clostridia_UCG-014</i> abundance was negatively associated with body mass index (BMI) (<i>P</i> < 0.05), waist-to-height ratio (WHtR) (<i>P</i> < 0.05), fasting plasma glucose (FPG) (<i>P</i> < 0.05), low-density lipoprotein cholesterol (LDL-C) (<i>P</i> < 0.05), and triglycerides (TG) (<i>P</i> < 0.05), but positively correlated with high-density lipoprotein cholesterol (HDL-C) (<i>P</i> < 0.05). Conversely, <i>Bilophila</i> abundance displayed positive correlations with BMI (<i>P</i> < 0.05), WHtR (<i>P</i> < 0.05), FPG (<i>P</i> < 0.05), LDL-C (<i>P</i> < 0.05), and TG (<i>P</i> < 0.05). Meanwhile, biofilm formation (<i>Escherichia coli</i>), nitrogen metabolism, arginine and proline metabolism, beta-lactam resistance, drug metabolism (other enzymes), glycerolipid metabolism and sucrose metabolism showed decreases in overweight EOD patients, respectively (<i>P</i> < 0.05).</p> </section> <section> <h3> Conclusions</h3> <p>These results indicate that <i>Bilophila</i> and <i>Clostridia_UCG-014</i> may serve as microbial biomarkers for the identification of obesity-related EOD.</p> </section>
{"title":"Research on the characteristics of gut microbiota in overweight patients with early-onset type 2 diabetes mellitus","authors":"Ke Huang, Leilei Ma, Shousen Shi, Xi Wang, Sheng Jiang, Yanfang Zhang","doi":"10.1111/jdi.70074","DOIUrl":"10.1111/jdi.70074","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Early-onset type 2 diabetes mellitus (EOD), defined as a metabolic disorder diagnosed before the age of 40, with higher risks of complications, vascular events, and mortality, poses a significant threat to public health. Its prevalence has risen markedly in overweight populations in recent years, yet the underlying mechanisms remain elusive. Emerging evidence highlights a close association between gut microbiota (GM) and metabolic disorders, suggesting that modulating gut microbial dysbiosis may serve as a potential strategy for preventing and managing overweight EOD.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this study, we enrolled 30 overweight EOD patients and 30 healthy controls, analyzing their GM profiles and correlations using physicochemical clinical parameters and fecal metabolites.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The results demonstrated significant differences in GM composition between overweight EOD patients and healthy controls. EOD patients exhibited increased the ratio of <i>Firmicutes</i>/<i>Bacteroidetes</i> at the phylum level. At the genus level, <i>Bilophila</i>, <i>Serratia</i>, <i>Lachnospira</i>, and <i>Parabacteroides</i> were enriched in EOD patients, while taxa, such as <i>Faecalibacterium</i>, <i>Ruminococcaceae</i>, and <i>Clostridia_UCG-014</i>, showed significant depletion. Correlation analyses revealed that <i>Clostridia_UCG-014</i> abundance was negatively associated with body mass index (BMI) (<i>P</i> < 0.05), waist-to-height ratio (WHtR) (<i>P</i> < 0.05), fasting plasma glucose (FPG) (<i>P</i> < 0.05), low-density lipoprotein cholesterol (LDL-C) (<i>P</i> < 0.05), and triglycerides (TG) (<i>P</i> < 0.05), but positively correlated with high-density lipoprotein cholesterol (HDL-C) (<i>P</i> < 0.05). Conversely, <i>Bilophila</i> abundance displayed positive correlations with BMI (<i>P</i> < 0.05), WHtR (<i>P</i> < 0.05), FPG (<i>P</i> < 0.05), LDL-C (<i>P</i> < 0.05), and TG (<i>P</i> < 0.05). Meanwhile, biofilm formation (<i>Escherichia coli</i>), nitrogen metabolism, arginine and proline metabolism, beta-lactam resistance, drug metabolism (other enzymes), glycerolipid metabolism and sucrose metabolism showed decreases in overweight EOD patients, respectively (<i>P</i> < 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>These results indicate that <i>Bilophila</i> and <i>Clostridia_UCG-014</i> may serve as microbial biomarkers for the identification of obesity-related EOD.</p>\u0000 </section>\u0000 ","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1890-1899"},"PeriodicalIF":3.0,"publicationDate":"2025-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70074","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Evidence suggests that the Endothelial Activation and Stress Index (EASIX) predicts mortality in endothelium-related conditions, but its link to mortality risk in diabetes remains unclear. This study investigates the association between EASIX and mortality risk in diabetes patients.
Methods
We included 3,252 diabetes patients from seven National Health and Nutrition Examination Survey cycles (2003–2016). Mortality data were sourced from National Death Index records. Restricted cubic spline (RCS) regression assessed the EASIX-mortality risk relationship, while the maximally selected rank statistics method (MSRSM) identified the optimal EASIX cutoff for survival outcomes. Weighted multivariable Cox regression models evaluated the association of EASIX with all-cause and cardiovascular mortality.
Results
Over a median follow-up of 91 months, 895 (27.5%) of 3,252 diabetes patients died, including 260 (8.0%) from cardiovascular and 635 (19.5%) from noncardiovascular causes. RCS analysis showed a positive association between EASIX and both all-cause and cardiovascular mortality. Each one-unit EASIX increase raised all-cause and cardiovascular mortality risks by 27% and 24%, respectively. MSRSM classified patients into higher (>0.70) and lower (≤0.70) EASIX groups. Those with higher EASIX had a significantly greater risk of all-cause (HR 1.56, 95% CI 1.21–2.01) and cardiovascular mortality (HR 2.05, 95% CI 1.33–3.16). Time-dependent receiver operating characteristic analysis showed AUCs for 1-, 3-, 5-, and 10-year survival were 0.78, 0.72, 0.70, and 0.69 (all-cause) and 0.90, 0.81, 0.76, and 0.73 (cardiovascular).
Conclusions
Elevated EASIX is independently associated with increased all-cause and cardiovascular mortality in diabetes patients, highlighting its potential as a valuable clinical biomarker.
有证据表明，内皮激活和应激指数（EASIX）可以预测内皮相关疾病的死亡率，但其与糖尿病死亡风险的关系尚不清楚。本研究探讨EASIX与糖尿病患者死亡风险的关系。方法：纳入2003-2016年7个国家健康与营养调查周期的3252例糖尿病患者。死亡率数据来源于国家死亡指数记录。限制性三次样条（RCS）回归评估了EASIX与死亡风险的关系，而最大选择秩统计方法（MSRSM）确定了EASIX生存结局的最佳截止点。加权多变量Cox回归模型评估EASIX与全因死亡率和心血管死亡率的关系。结果：在91个月的中位随访中，3252例糖尿病患者中有895例（27.5%）死亡，其中260例（8.0%）死于心血管原因，635例（19.5%）死于非心血管原因。RCS分析显示EASIX与全因死亡率和心血管死亡率呈正相关。EASIX每增加一个单位，全因和心血管死亡风险分别增加27%和24%。MSRSM将患者分为EASIX高（≤0.70）组和EASIX低（≤0.70）组。EASIX较高的患者的全因风险（HR 1.56, 95% CI 1.21-2.01）和心血管死亡率（HR 2.05, 95% CI 1.33-3.16）显著增加。时间依赖性受试者工作特征分析显示，1年、3年、5年和10年生存率的auc分别为0.78、0.72、0.70和0.69（全因），0.90、0.81、0.76和0.73（心血管）。结论：EASIX升高与糖尿病患者全因死亡率和心血管死亡率增加独立相关，突出了其作为有价值的临床生物标志物的潜力。
{"title":"Endothelial Activation Stress Index predicts all-cause and cardiovascular mortality in patients with diabetes: A nationwide study","authors":"Gaiying Dong, Tingting Wu, Xiaofan Gu, Yuyi Feng, Liangliang Wu, Zhiwen Hu","doi":"10.1111/jdi.70130","DOIUrl":"10.1111/jdi.70130","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>Evidence suggests that the Endothelial Activation and Stress Index (EASIX) predicts mortality in endothelium-related conditions, but its link to mortality risk in diabetes remains unclear. This study investigates the association between EASIX and mortality risk in diabetes patients.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We included 3,252 diabetes patients from seven National Health and Nutrition Examination Survey cycles (2003–2016). Mortality data were sourced from National Death Index records. Restricted cubic spline (RCS) regression assessed the EASIX-mortality risk relationship, while the maximally selected rank statistics method (MSRSM) identified the optimal EASIX cutoff for survival outcomes. Weighted multivariable Cox regression models evaluated the association of EASIX with all-cause and cardiovascular mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Over a median follow-up of 91 months, 895 (27.5%) of 3,252 diabetes patients died, including 260 (8.0%) from cardiovascular and 635 (19.5%) from noncardiovascular causes. RCS analysis showed a positive association between EASIX and both all-cause and cardiovascular mortality. Each one-unit EASIX increase raised all-cause and cardiovascular mortality risks by 27% and 24%, respectively. MSRSM classified patients into higher (>0.70) and lower (≤0.70) EASIX groups. Those with higher EASIX had a significantly greater risk of all-cause (HR 1.56, 95% CI 1.21–2.01) and cardiovascular mortality (HR 2.05, 95% CI 1.33–3.16). Time-dependent receiver operating characteristic analysis showed AUCs for 1-, 3-, 5-, and 10-year survival were 0.78, 0.72, 0.70, and 0.69 (all-cause) and 0.90, 0.81, 0.76, and 0.73 (cardiovascular).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Elevated EASIX is independently associated with increased all-cause and cardiovascular mortality in diabetes patients, highlighting its potential as a valuable clinical biomarker.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1870-1880"},"PeriodicalIF":3.0,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70130","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144740751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hyperglycemic emergencies are broadly classified into diabetic ketoacidosis and hyperosmotic hyperglycemic state. The purpose of this study was to develop a clinical model for predicting treatment of hyperglycemic emergencies.
Methods
This study is a multicenter, retrospective cohort study. We used information on patients admitted to four medical institutions for treatment for hyperglycemic emergencies by diabetologists between April 1, 2010, and March 31, 2024, as the machine learning's training data. Multiple regression analysis was performed to find parameters that correlated with the difference between blood glucose levels before and after treatment initiation (ΔGlu), and a gradient boosting decision tree (GBDT) was created to predict ΔGlu.
Results
Patients with type 1 diabetes (n = 47) and type 2 diabetes (n = 116) were included in the analysis of this study. We created a GBDT model using the following parameters as features: blood glucose level at the start of continuous intravenous insulin therapy, bicarbonate concentration, insulin flow rate, time elapsed since the start of continuous insulin therapy, and drip flow, which are important parameters for continuous intravenous insulin therapy for hyperglycemic emergencies. As a result, the correlation coefficient between predicted ΔGlu and actual ΔGlu was 0.83, showing a strong positive correlation.
Conclusions
A GBDT model was developed to predict treatment after continuous intravenous insulin therapy using several variables during emergency care of patients with hyperglycemic emergencies. It is hoped that the application of this GBDT will allow appropriate provision of initial treatment, especially in nonspecialized medical facilities.
{"title":"A clinical model for highly accurate prediction of blood glucose depression after continuous intravenous insulin therapy in hyperglycemic emergencies, a multicenter retrospective cohort study","authors":"Yuichiro Iwamoto, Tomohiko Kimura, Masashi Shimoda, Yuichi Morimoto, Kazunori Dan, Hideyuki Iwamoto, Junpei Sanada, Yoshiro Fushimi, Yukino Katakura, Hayato Isobe, Fuminori Tatsumi, Yukiko Kimura, Fumiko Kawasaki, Mizuho Yamabe, Michihiro Matsuki, Shuhei Nakanishi, Tomoatsu Mune, Kohei Kaku, Hideaki Kaneto","doi":"10.1111/jdi.70109","DOIUrl":"10.1111/jdi.70109","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Hyperglycemic emergencies are broadly classified into diabetic ketoacidosis and hyperosmotic hyperglycemic state. The purpose of this study was to develop a clinical model for predicting treatment of hyperglycemic emergencies.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>This study is a multicenter, retrospective cohort study. We used information on patients admitted to four medical institutions for treatment for hyperglycemic emergencies by diabetologists between April 1, 2010, and March 31, 2024, as the machine learning's training data. Multiple regression analysis was performed to find parameters that correlated with the difference between blood glucose levels before and after treatment initiation (ΔGlu), and a gradient boosting decision tree (GBDT) was created to predict ΔGlu.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Patients with type 1 diabetes (<i>n</i> = 47) and type 2 diabetes (<i>n</i> = 116) were included in the analysis of this study. We created a GBDT model using the following parameters as features: blood glucose level at the start of continuous intravenous insulin therapy, bicarbonate concentration, insulin flow rate, time elapsed since the start of continuous insulin therapy, and drip flow, which are important parameters for continuous intravenous insulin therapy for hyperglycemic emergencies. As a result, the correlation coefficient between predicted ΔGlu and actual ΔGlu was 0.83, showing a strong positive correlation.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>A GBDT model was developed to predict treatment after continuous intravenous insulin therapy using several variables during emergency care of patients with hyperglycemic emergencies. It is hoped that the application of this GBDT will allow appropriate provision of initial treatment, especially in nonspecialized medical facilities.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1820-1828"},"PeriodicalIF":3.0,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70109","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726248","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maternal hyperglycemia is associated with heavy for date (HFD) infants. Considering the association between body composition and hyperglycemia, we investigated the changes in maternal body composition and their relationship with HFD infants in pregnant women with diabetes.
Materials and Methods
Body composition was measured during pregnancy using a bioelectrical impedance analysis system. This retrospective study included 151 pregnant women; 27 women had type 1 diabetes mellitus (DM), 21 had type 2 DM, 101 were diagnosed with gestational DM, and 2 had overt DM. The number of HFD infants was 40.
Results
In the non-type 1 DM group, change in fat mass (ΔFM) (P < 0.01) and pre-pregnancy BMI (P < 0.05) were risk factors for HFD. In the insulin group, ΔFM, pre-pregnancy BMI, and age (all P < 0.05) were risk factors for HFD. The area under the curve was 0.813 for the predictive model combined with ΔFM and pre-pregnancy BMI in the non-type 1 DM group and 0.818 for the model combined with ΔFM, pre-pregnancy BMI, and age in the insulin group.
Conclusions
The combination of body composition parameters and clinical data may predict HFD in pregnant women with diabetes.
{"title":"Relationship between maternal body composition changes and heavy for date infants in pregnant women with diabetes","authors":"Eriko Eto, Masakazu Kato, Satoe Kirino, Chiaki Kuriyama, Syujiro Sakata, Hikari Nakato, Sakurako Mishima, Akiko Ohira, Hisashi Masuyama","doi":"10.1111/jdi.70131","DOIUrl":"10.1111/jdi.70131","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims/Introduction</h3>\u0000 \u0000 <p>Maternal hyperglycemia is associated with heavy for date (HFD) infants. Considering the association between body composition and hyperglycemia, we investigated the changes in maternal body composition and their relationship with HFD infants in pregnant women with diabetes.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>Body composition was measured during pregnancy using a bioelectrical impedance analysis system. This retrospective study included 151 pregnant women; 27 women had type 1 diabetes mellitus (DM), 21 had type 2 DM, 101 were diagnosed with gestational DM, and 2 had overt DM. The number of HFD infants was 40.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the non-type 1 DM group, change in fat mass (ΔFM) (<i>P</i> < 0.01) and pre-pregnancy BMI (<i>P</i> < 0.05) were risk factors for HFD. In the insulin group, ΔFM, pre-pregnancy BMI, and age (all <i>P</i> < 0.05) were risk factors for HFD. The area under the curve was 0.813 for the predictive model combined with ΔFM and pre-pregnancy BMI in the non-type 1 DM group and 0.818 for the model combined with ΔFM, pre-pregnancy BMI, and age in the insulin group.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The combination of body composition parameters and clinical data may predict HFD in pregnant women with diabetes.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1910-1918"},"PeriodicalIF":3.0,"publicationDate":"2025-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70131","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726249","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
HbA1c and body weight were assessed across selected subgroups of adults with type 2 diabetes receiving oral semaglutide in clinical practice.
Methods
In this non-interventional study, changes in HbA1c and body weight to end of study (EoS) and safety were assessed by subgroup: baseline age, body mass index (BMI), type 2 diabetes duration, participants switching from dipeptidyl peptidase-4 inhibitors, and semaglutide dose at EoS.
Results
All subgroups experienced reductions in HbA1c and body weight. Younger participants had greater reductions in HbA1c than older participants (−0.9, −0.7, −0.7, and −0.5 percentage points for participants aged <55, ≥55–<65, ≥65–<75, and ≥75 years, respectively [P = 0.0467]). Shorter type 2 diabetes duration and lower EoS semaglutide dose were associated with greater HbA1c reductions (−0.8, −0.7, and −0.6 percentage points with ≤5, >5–≤10, and >10 years' duration, respectively [P < 0.0001]; −1.2, −0.7, and −0.4 percentage points with 3, 7, and 14 mg, respectively [P < 0.0001]). Changes in HbA1c were not significantly different across other subgroups. Lower EoS semaglutide dose was associated with greater body weight reductions (−3.8, −2.9, and −2.8 kg with 3, 7, and 14 mg, respectively [P < 0.0001]); body weight reductions were not significantly different across other subgroups. Adverse events were similar between subgroups, except that older subgroups experienced more events.
Conclusions
HbA1c and body weight decreased across all subgroups, providing insights into oral semaglutide use in clinical practice for individuals with different characteristics in the real-world setting.
{"title":"A multicenter, prospective, real-world study of oral semaglutide in adults with type 2 diabetes in Japanese clinical practice (PIONEER REAL Japan): Subgroup analyses","authors":"Daisuke Yabe, Yoshiyuki Hamamoto, Daiji Kawanami, Rimei Nishimura, Yasuo Terauchi, Hanan Amadid, Uffe Christian Braae, Atheline Major-Pedersen, Ryo Suzuki","doi":"10.1111/jdi.70099","DOIUrl":"10.1111/jdi.70099","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Aims</h3>\u0000 \u0000 <p>HbA<sub>1c</sub> and body weight were assessed across selected subgroups of adults with type 2 diabetes receiving oral semaglutide in clinical practice.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>In this non-interventional study, changes in HbA<sub>1c</sub> and body weight to end of study (EoS) and safety were assessed by subgroup: baseline age, body mass index (BMI), type 2 diabetes duration, participants switching from dipeptidyl peptidase-4 inhibitors, and semaglutide dose at EoS.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>All subgroups experienced reductions in HbA<sub>1c</sub> and body weight. Younger participants had greater reductions in HbA<sub>1c</sub> than older participants (−0.9, −0.7, −0.7, and −0.5 percentage points for participants aged <55, ≥55–<65, ≥65–<75, and ≥75 years, respectively [<i>P</i> = 0.0467]). Shorter type 2 diabetes duration and lower EoS semaglutide dose were associated with greater HbA<sub>1c</sub> reductions (−0.8, −0.7, and −0.6 percentage points with ≤5, >5–≤10, and >10 years' duration, respectively [<i>P</i> < 0.0001]; −1.2, −0.7, and −0.4 percentage points with 3, 7, and 14 mg, respectively [<i>P</i> < 0.0001]). Changes in HbA<sub>1c</sub> were not significantly different across other subgroups. Lower EoS semaglutide dose was associated with greater body weight reductions (−3.8, −2.9, and −2.8 kg with 3, 7, and 14 mg, respectively [<i>P</i> < 0.0001]); body weight reductions were not significantly different across other subgroups. Adverse events were similar between subgroups, except that older subgroups experienced more events.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>HbA<sub>1c</sub> and body weight decreased across all subgroups, providing insights into oral semaglutide use in clinical practice for individuals with different characteristics in the real-world setting.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1794-1807"},"PeriodicalIF":3.0,"publicationDate":"2025-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70099","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144715039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We read with great interest the article ‘A prediction model for diabetes complications using the Kokuho Database and its application to public health services in Japan’1. This study represents a valuable endeavor in developing a diabetes complication prediction model leveraging large-scale data, with substantial implications for public health practice in Japan. However, two methodological considerations warrant further clarification to enhance the scientific rigor and clinical translatability of the findings.
First, the selection of a 6-year historical stratification window for ischemic heart disease and cerebrovascular disease requires mechanistic and empirical justification. Epidemiological evidence consistently indicates that diabetic macrovascular complications exhibit stronger associations with short-term metabolic control parameters (1–3 years) such as glycemic variability and blood pressure trajectories, rather than distant historical data2, 3. A 6-year window may introduce collinearity by over-including less relevant historical records, potentially attenuating the weight of dynamic, time-sensitive risk factors. In addition, long-term indicators may not directly reflect the current risk status of the patient. The overall risk factor status of the patient during this period may change due to various factors (such as improved lifestyle, changes in medication, and the occurrence of other comorbidities). We urge the authors to clarify whether systematic comparisons of alternative time frames (1, 3, and 6 years) were performed to validate the optimal stratification criteria for predictive accuracy.
Second, the comparative prognostic value of early lifestyle determinants vs late biochemical markers in the model merits discussion. Lifestyle factors (sedentary behavior, dietary patterns, and smoking) typically precede biochemical abnormalities by 5–10 years, offering a critical window for primordial prevention. From a translational perspective, these modifiable behaviors represent more actionable targets for public health interventions compared to established metabolic derangements. Did the authors perform subgroup analyses to quantify the relative predictive power of these variables, particularly regarding their incremental value in early risk stratification?
Addressing these points would significantly strengthen the study's methodological robustness and public health relevance. We commend the authors for their contribution to this important field and anticipate their clarifications.
The authors declare no conflict of interest.
Approval of the research protocol: N/A.
Informed consent: N/A.
Registry and the registration no. of the study/trial: N/A.
Animal studies: N/A.
None.
Yanna Le and Qingyun Xu: methodology, writing—review and editing. Feiqi Xu: methodology, writing.
{"title":"Letter to the Editor in Response to ‘A prediction model for diabetes complications using the Kokuho Database and its application to public health services in Japan’","authors":"Yanna Le, Feiqi Xu, Qingyun Xu","doi":"10.1111/jdi.70128","DOIUrl":"10.1111/jdi.70128","url":null,"abstract":"<p>Dear Editor,</p><p>We read with great interest the article ‘A prediction model for diabetes complications using the Kokuho Database and its application to public health services in Japan’<span><sup>1</sup></span>. This study represents a valuable endeavor in developing a diabetes complication prediction model leveraging large-scale data, with substantial implications for public health practice in Japan. However, two methodological considerations warrant further clarification to enhance the scientific rigor and clinical translatability of the findings.</p><p>First, the selection of a 6-year historical stratification window for ischemic heart disease and cerebrovascular disease requires mechanistic and empirical justification. Epidemiological evidence consistently indicates that diabetic macrovascular complications exhibit stronger associations with short-term metabolic control parameters (1–3 years) such as glycemic variability and blood pressure trajectories, rather than distant historical data<span><sup>2, 3</sup></span>. A 6-year window may introduce collinearity by over-including less relevant historical records, potentially attenuating the weight of dynamic, time-sensitive risk factors. In addition, long-term indicators may not directly reflect the current risk status of the patient. The overall risk factor status of the patient during this period may change due to various factors (such as improved lifestyle, changes in medication, and the occurrence of other comorbidities). We urge the authors to clarify whether systematic comparisons of alternative time frames (1, 3, and 6 years) were performed to validate the optimal stratification criteria for predictive accuracy.</p><p>Second, the comparative prognostic value of early lifestyle determinants vs late biochemical markers in the model merits discussion. Lifestyle factors (sedentary behavior, dietary patterns, and smoking) typically precede biochemical abnormalities by 5–10 years, offering a critical window for primordial prevention. From a translational perspective, these modifiable behaviors represent more actionable targets for public health interventions compared to established metabolic derangements. Did the authors perform subgroup analyses to quantify the relative predictive power of these variables, particularly regarding their incremental value in early risk stratification?</p><p>Addressing these points would significantly strengthen the study's methodological robustness and public health relevance. We commend the authors for their contribution to this important field and anticipate their clarifications.</p><p>The authors declare no conflict of interest.</p><p>Approval of the research protocol: N/A.</p><p>Informed consent: N/A.</p><p>Registry and the registration no. of the study/trial: N/A.</p><p>Animal studies: N/A.</p><p>None.</p><p>Yanna Le and Qingyun Xu: methodology, writing—review and editing. Feiqi Xu: methodology, writing.</p>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70128","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144688483","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Erythropoietin-producing hepatoma A2 (EphA2), a receptor for progranulin (PGRN), which is a growth factor associated with metabolic disorders, is implicated in inflammation and atherosclerotic diseases. Since both EphA2 and PGRN play roles in diabetic kidney disease (DKD) and cardiovascular disease (CVD), this study examined their association with renal function and CVD markers in individuals with diabetes. In addition, the diagnostic value of EphA2 and PGRN in predicting renal impairment was evaluated.
Methods
Circulating EphA2 and PGRN levels were measured using enzyme-linked immunosorbent assay in 735 participants with diabetes. Clinical data, including biometric parameters, physiological measurements, and comorbidities, were collected for analysis.
Results
Both EphA2 and PGRN levels positively correlated with older age, elevated blood pressure, higher urinary albumin-to-creatinine ratio (UACR), and brain natriuretic peptide (BNP) levels but negatively correlated with estimated glomerular filtration rate (eGFR). Multivariate logistic regression analysis revealed that EphA2 was an independent predictor of eGFR <60 mL/min/1.73 m2, even after adjusting for UACR and CVD risk factors and glycated hemoglobin. Although PGRN was also independently associated with eGFR <60 mL/min/1.73 m2, its association was weaker than that of EphA2. Conversely, when UACR ≥30 mg/g was used as the dependent variable, PGRN emerged as a stronger independent determinant than EphA2, even after adjusting for eGFR and CVD risk factors.
Conclusions
EphA2 and PGRN levels are significantly associated with renal function in individuals with diabetes. These findings suggest that EphA2 and PGRN could serve as novel biomarkers for kidney impairment, independent of established CVD markers in this population.
{"title":"Association among circulating erythropoietin-producing hepatoma A2, progranulin, and kidney function in individuals with diabetes","authors":"Maki Murakoshi, Nozomu Kamei, Kenichiro Abe, Takumi Iwasawa, Kazunori Kato, Marenao Tanaka, Tatsuya Sato, Masato Furuhashi, Mitsunobu Kubota, Michiyoshi Sanuki, Yusuke Suzuki, Tomohito Gohda","doi":"10.1111/jdi.70116","DOIUrl":"10.1111/jdi.70116","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Erythropoietin-producing hepatoma A2 (EphA2), a receptor for progranulin (PGRN), which is a growth factor associated with metabolic disorders, is implicated in inflammation and atherosclerotic diseases. Since both EphA2 and PGRN play roles in diabetic kidney disease (DKD) and cardiovascular disease (CVD), this study examined their association with renal function and CVD markers in individuals with diabetes. In addition, the diagnostic value of EphA2 and PGRN in predicting renal impairment was evaluated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Circulating EphA2 and PGRN levels were measured using enzyme-linked immunosorbent assay in 735 participants with diabetes. Clinical data, including biometric parameters, physiological measurements, and comorbidities, were collected for analysis.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Both EphA2 and PGRN levels positively correlated with older age, elevated blood pressure, higher urinary albumin-to-creatinine ratio (UACR), and brain natriuretic peptide (BNP) levels but negatively correlated with estimated glomerular filtration rate (eGFR). Multivariate logistic regression analysis revealed that EphA2 was an independent predictor of eGFR <60 mL/min/1.73 m<sup>2</sup>, even after adjusting for UACR and CVD risk factors and glycated hemoglobin. Although PGRN was also independently associated with eGFR <60 mL/min/1.73 m<sup>2</sup>, its association was weaker than that of EphA2. Conversely, when UACR ≥30 mg/g was used as the dependent variable, PGRN emerged as a stronger independent determinant than EphA2, even after adjusting for eGFR and CVD risk factors.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>EphA2 and PGRN levels are significantly associated with renal function in individuals with diabetes. These findings suggest that EphA2 and PGRN could serve as novel biomarkers for kidney impairment, independent of established CVD markers in this population.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1836-1843"},"PeriodicalIF":3.0,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70116","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144697219","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jhon E. Goez-Mora MSc, Natalia Arbelaez-Córdoba MSc, Norman Balcazar-Morales PhD, Pablo S. Rivadeneira PhD
Introduction
This study assesses the accuracy of an ultra-low-cost insulin pump for regulating blood glucose, an essential component of the artificial pancreas.
Objectives
The primary objective is to assess the accuracy of blood glucose regulation using an ultra-low-cost insulin pump compared with insulin injections.
Methods
The study was conducted using 14 male Wistar rats aged 14 weeks, which were induced with diabetes through a streptozotocin procedure. The control group (seven subjects) was treated with subcutaneous insulin injections, and the study group (seven subjects) was treated with the experimental insulin pump.
Results
Our findings reveal that the ultra-low-cost insulin pump performs comparably to insulin injections for glycemia regulation using standard clinical insulin treatment. The blood glucose records obtained by CGM indicate that trends in both methods correspond, with a glycemia median absolute relative difference of 6.1748 mg/dL and an interquartile range of 14.57 mg/dL. The response time to reach glucose levels between 70 and 180 mg/dL was around 55 min, testing different amounts of insulin units ranging from 0.09 to 2.06 U. Also, four obstruction cases were detected by the system in an average time of 3 s, showing compliance with the EN60601-2-24 standard.
Conclusions
The in vivo experiments with diabetic rats and ultra-low-cost insulin pumps demonstrate that these prototypes can be used for glucose regulation in clinical trials while complying with the conditions of the EN60601-2-24 standard. Future work should focus on conducting insulin pump tests in a closed loop and a cybersecurity study to prevent any possible external attack.
{"title":"Study of insulin infusion in diabetic rats with an ultra-low-cost insulin pump for managing blood glucose levels","authors":"Jhon E. Goez-Mora MSc, Natalia Arbelaez-Córdoba MSc, Norman Balcazar-Morales PhD, Pablo S. Rivadeneira PhD","doi":"10.1111/jdi.70072","DOIUrl":"10.1111/jdi.70072","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Introduction</h3>\u0000 \u0000 <p>This study assesses the accuracy of an ultra-low-cost insulin pump for regulating blood glucose, an essential component of the artificial pancreas.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Objectives</h3>\u0000 \u0000 <p>The primary objective is to assess the accuracy of blood glucose regulation using an ultra-low-cost insulin pump compared with insulin injections.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The study was conducted using 14 male Wistar rats aged 14 weeks, which were induced with diabetes through a streptozotocin procedure. The control group (seven subjects) was treated with subcutaneous insulin injections, and the study group (seven subjects) was treated with the experimental insulin pump.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Our findings reveal that the ultra-low-cost insulin pump performs comparably to insulin injections for glycemia regulation using standard clinical insulin treatment. The blood glucose records obtained by CGM indicate that trends in both methods correspond, with a glycemia median absolute relative difference of 6.1748 mg/dL and an interquartile range of 14.57 mg/dL. The response time to reach glucose levels between 70 and 180 mg/dL was around 55 min, testing different amounts of insulin units ranging from 0.09 to 2.06 U. Also, four obstruction cases were detected by the system in an average time of 3 s, showing compliance with the EN60601-2-24 standard.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The <i>in vivo</i> experiments with diabetic rats and ultra-low-cost insulin pumps demonstrate that these prototypes can be used for glucose regulation in clinical trials while complying with the conditions of the EN60601-2-24 standard. Future work should focus on conducting insulin pump tests in a closed loop and a cybersecurity study to prevent any possible external attack.</p>\u0000 </section>\u0000 </div>","PeriodicalId":51250,"journal":{"name":"Journal of Diabetes Investigation","volume":"16 10","pages":"1782-1793"},"PeriodicalIF":3.0,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/jdi.70072","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144688484","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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