Simon K Kjær, Lukas Ochsner Reynaud Ridder, Mads Svart, Nikolaj Rittig, Lise Nørkjær Bjerg, Birgitte Sandfeld-Paulsen, Henrik Holm Thomsen
Unlabelled: In our study, a commercially available continuous ketone monitoring device captured β-Hydroxybutyrate (BHB) dynamics during exogenous ketosis but revealed a gradual decline day-to-day BHB concentrations over 14 days in both ketone ester and placebo groups, likely reflecting sensor drift.
{"title":"Continuous Ketone Monitoring: Data From a Randomized Controlled Trial.","authors":"Simon K Kjær, Lukas Ochsner Reynaud Ridder, Mads Svart, Nikolaj Rittig, Lise Nørkjær Bjerg, Birgitte Sandfeld-Paulsen, Henrik Holm Thomsen","doi":"10.2196/85548","DOIUrl":"10.2196/85548","url":null,"abstract":"<p><strong>Unlabelled: </strong>In our study, a commercially available continuous ketone monitoring device captured β-Hydroxybutyrate (BHB) dynamics during exogenous ketosis but revealed a gradual decline day-to-day BHB concentrations over 14 days in both ketone ester and placebo groups, likely reflecting sensor drift.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"11 ","pages":"e85548"},"PeriodicalIF":2.6,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12799078/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145967800","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}
Background: Diabetic kidney disease (DKD) is a major complication of diabetes and the leading cause of end-stage renal disease globally. Artificial intelligence (AI) technologies have shown increasing potential in DKD research for early detection, risk prediction, and disease management. However, the landscape of AI applications in this field remains incompletely mapped, especially in terms of collaboration networks, thematic evolution, and clinical translation.
Objective: This study aims to perform a comprehensive bibliometric and translational analysis of AI-related DKD research published between 2006 and 2024, identifying publication trends, research hotspots, key contributors, collaboration patterns, and the extent of clinical validation and explainability.
Methods: A systematic search of the Web of Science Core Collection was conducted to identify English-language original articles applying AI technologies to DKD. Articles were screened following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Bibliometric visualization was performed using CiteSpace and VOSviewer to assess coauthorship, institutional and country collaboration, keyword evolution, and citation bursts. A qualitative review was conducted to evaluate clinical validation, model explainability, and real-world implementation.
Results: Out of 1158 retrieved records, 384 studies met the inclusion criteria. Global publications on AI in DKD increased rapidly after 2019. China led in publication volume, followed by the United States, India, and Iran. Keyword analysis showed a thematic transition from early biomarker and proteomic research to deep learning, clinical prediction models, and management tools. Despite methodological advances, few studies included external validation or explainability frameworks. Notable translational efforts included DeepMind's acute kidney injury predictor and a chronic kidney disease prediction model developed by Sumit, yet widespread real-world integration remains limited.
Conclusions: AI research in DKD has grown substantially over the past 2 decades, with expanding international collaboration and diversification of research themes. However, challenges persist in clinical applicability, model transparency, and global inclusivity. Future research should prioritize explainable AI, multicenter validation, and integration into clinical workflows to support effective translation of AI innovations into DKD care.
背景:糖尿病肾病(DKD)是糖尿病的主要并发症,也是全球终末期肾脏疾病的主要原因。人工智能(AI)技术在DKD研究的早期发现、风险预测和疾病管理方面显示出越来越大的潜力。然而,人工智能在这一领域的应用前景仍然不完整,特别是在协作网络、主题演变和临床翻译方面。目的:对2006年至2024年间发表的人工智能相关DKD研究进行综合文献计量学和翻译分析,确定出版趋势、研究热点、主要贡献者、合作模式以及临床验证和可解释性程度。方法:对Web of Science核心馆藏进行系统搜索,以识别将AI技术应用于DKD的英语原创文章。文章按照PRISMA(系统评价和荟萃分析首选报告项目)2020指南进行筛选。使用CiteSpace和VOSviewer进行文献计量可视化,以评估合著者、机构和国家合作、关键词演变和引文爆发。进行了定性回顾,以评估临床有效性,模型的可解释性和现实世界的实施。结果:在1158份检索记录中,384项研究符合纳入标准。2019年之后,全球关于DKD领域人工智能的出版物迅速增加。中国的出版物数量最多,其次是美国、印度和伊朗。关键词分析显示了从早期生物标志物和蛋白质组学研究到深度学习、临床预测模型和管理工具的主题转变。尽管方法学有所进步,但很少有研究包括外部验证或可解释性框架。值得注意的转化工作包括DeepMind的急性肾损伤预测器和Sumit开发的慢性肾病预测模型,但广泛的现实应用仍然有限。结论:在过去的20年里,随着国际合作的扩大和研究主题的多样化,DKD领域的人工智能研究取得了长足的发展。然而,在临床适用性、模型透明度和全球包容性方面仍然存在挑战。未来的研究应优先考虑可解释的人工智能,多中心验证,并整合到临床工作流程中,以支持将人工智能创新有效地转化为DKD护理。
{"title":"Artificial Intelligence in Diabetic Kidney Disease Research: Bibliometric Analysis From 2006 to 2024.","authors":"Xingyuan Li, Liming Xiao, Fenghao Yang, Fang Liu","doi":"10.2196/72616","DOIUrl":"10.2196/72616","url":null,"abstract":"<p><strong>Background: </strong>Diabetic kidney disease (DKD) is a major complication of diabetes and the leading cause of end-stage renal disease globally. Artificial intelligence (AI) technologies have shown increasing potential in DKD research for early detection, risk prediction, and disease management. However, the landscape of AI applications in this field remains incompletely mapped, especially in terms of collaboration networks, thematic evolution, and clinical translation.</p><p><strong>Objective: </strong>This study aims to perform a comprehensive bibliometric and translational analysis of AI-related DKD research published between 2006 and 2024, identifying publication trends, research hotspots, key contributors, collaboration patterns, and the extent of clinical validation and explainability.</p><p><strong>Methods: </strong>A systematic search of the Web of Science Core Collection was conducted to identify English-language original articles applying AI technologies to DKD. Articles were screened following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 guidelines. Bibliometric visualization was performed using CiteSpace and VOSviewer to assess coauthorship, institutional and country collaboration, keyword evolution, and citation bursts. A qualitative review was conducted to evaluate clinical validation, model explainability, and real-world implementation.</p><p><strong>Results: </strong>Out of 1158 retrieved records, 384 studies met the inclusion criteria. Global publications on AI in DKD increased rapidly after 2019. China led in publication volume, followed by the United States, India, and Iran. Keyword analysis showed a thematic transition from early biomarker and proteomic research to deep learning, clinical prediction models, and management tools. Despite methodological advances, few studies included external validation or explainability frameworks. Notable translational efforts included DeepMind's acute kidney injury predictor and a chronic kidney disease prediction model developed by Sumit, yet widespread real-world integration remains limited.</p><p><strong>Conclusions: </strong>AI research in DKD has grown substantially over the past 2 decades, with expanding international collaboration and diversification of research themes. However, challenges persist in clinical applicability, model transparency, and global inclusivity. Future research should prioritize explainable AI, multicenter validation, and integration into clinical workflows to support effective translation of AI innovations into DKD care.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"11 ","pages":"e72616"},"PeriodicalIF":2.6,"publicationDate":"2026-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12786635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145946729","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}
Edmund Evangelista, Fathima Ruba, Salman Bukhari, Amril Nazir, Ravishankar Sharma
Background: Gestational diabetes mellitus (GDM) is a prevalent chronic condition that affects maternal and fetal health outcomes worldwide, increasingly in underserved populations. While generative artificial intelligence (AI) and large language models (LLMs) have shown promise in health care, their application in GDM management remains underexplored.
Objective: This study aimed to investigate whether retrieval-augmented generation techniques, when combined with knowledge graphs (KGs), could improve the contextual relevance and accuracy of AI-driven clinical decision support. For this, we developed and validated a graph-based retrieval-augmented generation (GraphRAG)-enabled local LLM as a clinical support tool for GDM management, assessing its performance against open-source LLM tools.
Methods: A prototype clinical AI assistant was developed using a GraphRAG constructed from 1212 peer-reviewed research articles on GDM interventions, retrieved from the Semantic Scholar API (2000-2024). The GraphRAG prototype integrated entity extraction, KG construction using Neo4j, and retrieval-augmented response generation. The performance was evaluated in a simulated environment using clinical and layperson prompts, comparing the outputs of the systems against ChatGPT (OpenAI), Claude (Anthropic), and BioMistral models across 5 common natural language generation metrics.
Results: The GraphRAG-enabled local LLM showed higher accuracy in generating clinically relevant responses. It achieved a bilingual evaluation understudy score of 0.99, Jaccard similarity of 0.98, and BERTScore of 0.98, outperforming the benchmark LLMs. The prototype also produced accurate, evidence-based recommendations for clinicians and patients, demonstrating its feasibility as a clinical support tool.
Conclusions: GraphRAG-enabled local LLMs show much potential for improving personalized GDM care by integrating domain-specific evidence and contextual retrieval. Our prototype proof-of-concept serves two purposes: (1) the local LLM architecture gives practitioners from underserved locations access to state-of-the-art medical research in the treatment of chronic conditions and (2) the KG schema may be feasibly built on peer-reviewed, indexed publications, devoid of hallucinations and contextualized with patient data. We conclude that advanced AI techniques such as KGs, retrieval-augmented generation, and local LLMs improve GDM management decisions and other similar conditions and advance equitable health care delivery in resource-constrained health care environments.
{"title":"GraphRAG-Enabled Local Large Language Model for Gestational Diabetes Mellitus: Development of a Proof-of-Concept.","authors":"Edmund Evangelista, Fathima Ruba, Salman Bukhari, Amril Nazir, Ravishankar Sharma","doi":"10.2196/76454","DOIUrl":"10.2196/76454","url":null,"abstract":"<p><strong>Background: </strong>Gestational diabetes mellitus (GDM) is a prevalent chronic condition that affects maternal and fetal health outcomes worldwide, increasingly in underserved populations. While generative artificial intelligence (AI) and large language models (LLMs) have shown promise in health care, their application in GDM management remains underexplored.</p><p><strong>Objective: </strong>This study aimed to investigate whether retrieval-augmented generation techniques, when combined with knowledge graphs (KGs), could improve the contextual relevance and accuracy of AI-driven clinical decision support. For this, we developed and validated a graph-based retrieval-augmented generation (GraphRAG)-enabled local LLM as a clinical support tool for GDM management, assessing its performance against open-source LLM tools.</p><p><strong>Methods: </strong>A prototype clinical AI assistant was developed using a GraphRAG constructed from 1212 peer-reviewed research articles on GDM interventions, retrieved from the Semantic Scholar API (2000-2024). The GraphRAG prototype integrated entity extraction, KG construction using Neo4j, and retrieval-augmented response generation. The performance was evaluated in a simulated environment using clinical and layperson prompts, comparing the outputs of the systems against ChatGPT (OpenAI), Claude (Anthropic), and BioMistral models across 5 common natural language generation metrics.</p><p><strong>Results: </strong>The GraphRAG-enabled local LLM showed higher accuracy in generating clinically relevant responses. It achieved a bilingual evaluation understudy score of 0.99, Jaccard similarity of 0.98, and BERTScore of 0.98, outperforming the benchmark LLMs. The prototype also produced accurate, evidence-based recommendations for clinicians and patients, demonstrating its feasibility as a clinical support tool.</p><p><strong>Conclusions: </strong>GraphRAG-enabled local LLMs show much potential for improving personalized GDM care by integrating domain-specific evidence and contextual retrieval. Our prototype proof-of-concept serves two purposes: (1) the local LLM architecture gives practitioners from underserved locations access to state-of-the-art medical research in the treatment of chronic conditions and (2) the KG schema may be feasibly built on peer-reviewed, indexed publications, devoid of hallucinations and contextualized with patient data. We conclude that advanced AI techniques such as KGs, retrieval-augmented generation, and local LLMs improve GDM management decisions and other similar conditions and advance equitable health care delivery in resource-constrained health care environments.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"11 ","pages":"e76454"},"PeriodicalIF":2.6,"publicationDate":"2026-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12767777/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145907331","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}
Michelle I Knopp, Ann Marie Castleman, Anna Schwarz, Jamarin Belger-Wallace, Mercedes Falciglia, Aleona Zuzek, Eneida Mendonca
Background: Continuous glucose monitors (CGM) reduce the burden of glycemic monitoring and improve glycemic control, quality of life, and decreased health care use. Despite expanded insurance coverage and adoption, barriers remain, especially in primary care. Existing research largely evaluates specific populations or interventions, leaving limited insight into the broader primary care experience.
Objective: This study aims to examine the experiences of adults with type 2 diabetes mellitus (T2DM) using CGM in primary care, guided by the Health Belief Model and Technology Acceptance Model.
Methods: This qualitative study included in-person semistructured sessions (interviews or a focus group), surveys, and electronic health record data. Participants were recruited from 3 urban primary care (internal medicine and internal medicine-pediatrics) clinics affiliated with a large academic health system in Southwest Ohio, United States, with high rates of public insurance (Medicare or Medicaid). Eligible participants were adults (≥18 y) with T2DM and a CGM prescription. Data were analyzed using theme generation guided by directed content analysis in MAXQDA (VERBI Software GmbH) with codes derived from Health Belief Model and Technology Acceptance Model constructs. Survey data were used to triangulate to enhance validity.
Results: Overall, 16 participants (interviews: n=12; 1 focus group: n=4) were recruited for the study with a mean age of 56.9 (SD 10.5) years. In total, 69% (11/16) identified as Black, 100% (16/16) as Non-Hispanic, and 69% (11/16) as female, and 94% (15/16) used public insurance. Six themes emerged: disease susceptibility, disease severity, influential drivers, perceived ease of use, perceived usefulness, and attitude toward using CGM. All participants found CGM helpful and would recommend it to others. While affirming numerous barriers well-described in other populations, this study uniquely describes the burden of comorbidities, the trust in CGM data compared to glucometer-based monitoring, and the reliance on receivers to use CGM technology in this patient population.
Conclusions: CGM is valued by adults with T2DM in primary care, yet barriers remain. Tailored support for initiation, troubleshooting, and education (especially alarm management and data interpretation) is needed. These insights can inform scalable strategies to enhance CGM use and experience in primary care.
{"title":"Continuous Glucose Monitors Among Adults With Type 2 Diabetes Mellitus in the Primary Care Setting: Qualitative Study Informed by Technology Acceptance Model and Health Belief Model.","authors":"Michelle I Knopp, Ann Marie Castleman, Anna Schwarz, Jamarin Belger-Wallace, Mercedes Falciglia, Aleona Zuzek, Eneida Mendonca","doi":"10.2196/73446","DOIUrl":"10.2196/73446","url":null,"abstract":"<p><strong>Background: </strong>Continuous glucose monitors (CGM) reduce the burden of glycemic monitoring and improve glycemic control, quality of life, and decreased health care use. Despite expanded insurance coverage and adoption, barriers remain, especially in primary care. Existing research largely evaluates specific populations or interventions, leaving limited insight into the broader primary care experience.</p><p><strong>Objective: </strong>This study aims to examine the experiences of adults with type 2 diabetes mellitus (T2DM) using CGM in primary care, guided by the Health Belief Model and Technology Acceptance Model.</p><p><strong>Methods: </strong>This qualitative study included in-person semistructured sessions (interviews or a focus group), surveys, and electronic health record data. Participants were recruited from 3 urban primary care (internal medicine and internal medicine-pediatrics) clinics affiliated with a large academic health system in Southwest Ohio, United States, with high rates of public insurance (Medicare or Medicaid). Eligible participants were adults (≥18 y) with T2DM and a CGM prescription. Data were analyzed using theme generation guided by directed content analysis in MAXQDA (VERBI Software GmbH) with codes derived from Health Belief Model and Technology Acceptance Model constructs. Survey data were used to triangulate to enhance validity.</p><p><strong>Results: </strong>Overall, 16 participants (interviews: n=12; 1 focus group: n=4) were recruited for the study with a mean age of 56.9 (SD 10.5) years. In total, 69% (11/16) identified as Black, 100% (16/16) as Non-Hispanic, and 69% (11/16) as female, and 94% (15/16) used public insurance. Six themes emerged: disease susceptibility, disease severity, influential drivers, perceived ease of use, perceived usefulness, and attitude toward using CGM. All participants found CGM helpful and would recommend it to others. While affirming numerous barriers well-described in other populations, this study uniquely describes the burden of comorbidities, the trust in CGM data compared to glucometer-based monitoring, and the reliance on receivers to use CGM technology in this patient population.</p><p><strong>Conclusions: </strong>CGM is valued by adults with T2DM in primary care, yet barriers remain. Tailored support for initiation, troubleshooting, and education (especially alarm management and data interpretation) is needed. These insights can inform scalable strategies to enhance CGM use and experience in primary care.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e73446"},"PeriodicalIF":2.6,"publicationDate":"2025-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12753101/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145866150","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}
Background: There are many mobile apps for diabetes self-management; however, most target Western populations and lack dietary content relevant to Asian contexts. Our mobile app addresses this gap by providing self-care tools and a database of regionally relevant foods.
Objective: This study aimed to evaluate the effectiveness of the app in improving glycemic control and self-care behaviors among outpatients with uncontrolled type 2 diabetes at our hospital.
Methods: We conducted a randomized controlled trial with adults with type 2 diabetes, hemoglobin A1c (HbA1c) of >7%, and access to a smartphone. Participants were randomized to an intervention group (daily use of the Rama Diabetes Care app) or a control group (standard care), with all receiving diabetes self-management education and support. The app includes 6 features, notably a nutritional logging system with a verified database of Thai and commonly consumed foods, including Asian and Western dishes, as well as blood glucose monitoring, exercise and medication tracking, symptom screening, and weight logging. The primary outcome was HbA1c level, and secondary outcomes included fasting plasma glucose (FPG), low-density lipoprotein cholesterol, estimated glomerular filtration rate, BMI, self-care behaviors, and user satisfaction with the app. The study was conducted between November 29, 2023, and October 30, 2024.
Results: A total of 129 participants were randomized (intervention: n=64, 49.6%; control: n=65, 50.4%). Participants in the intervention group were younger (mean age 54.6, SD 14.3 years vs 61.9, SD 12.0 years; P=.002), whereas baseline HbA1c (mean 9.3%, SD 1.96%) and FPG (mean 179.5, SD 5.9 mg/dL) levels were similar between the groups. Over 6 months, the intervention group showed a greater HbA1c reduction than the control group (mean difference -0.24%), but the difference was not statistically significant (P=.13). Among participants aged <65 years, FPG at 6 months was significantly lower in the intervention group (mean difference -29.3 mg/dL; P=.03). App satisfaction was rated as moderate.
Conclusions: The mobile app achieved glycemic control comparable to that achieved through standard care, with significant improvement in FPG among participants younger than 65 years. Tailor-made apps integrating regionally relevant dietary content may support effective self-management in type 2 diabetes and warrant further evaluation in larger, long-term studies.
{"title":"A Tailor-Made Mobile App With a Local Cuisine Database for Self-Management of Type 2 Diabetes Mellitus: Randomized Controlled Trial.","authors":"Supasuta Wongdama, Wannaporn Paemueang, Chutintorn Sriphrapradang","doi":"10.2196/83685","DOIUrl":"10.2196/83685","url":null,"abstract":"<p><strong>Background: </strong>There are many mobile apps for diabetes self-management; however, most target Western populations and lack dietary content relevant to Asian contexts. Our mobile app addresses this gap by providing self-care tools and a database of regionally relevant foods.</p><p><strong>Objective: </strong>This study aimed to evaluate the effectiveness of the app in improving glycemic control and self-care behaviors among outpatients with uncontrolled type 2 diabetes at our hospital.</p><p><strong>Methods: </strong>We conducted a randomized controlled trial with adults with type 2 diabetes, hemoglobin A1c (HbA1c) of >7%, and access to a smartphone. Participants were randomized to an intervention group (daily use of the Rama Diabetes Care app) or a control group (standard care), with all receiving diabetes self-management education and support. The app includes 6 features, notably a nutritional logging system with a verified database of Thai and commonly consumed foods, including Asian and Western dishes, as well as blood glucose monitoring, exercise and medication tracking, symptom screening, and weight logging. The primary outcome was HbA1c level, and secondary outcomes included fasting plasma glucose (FPG), low-density lipoprotein cholesterol, estimated glomerular filtration rate, BMI, self-care behaviors, and user satisfaction with the app. The study was conducted between November 29, 2023, and October 30, 2024.</p><p><strong>Results: </strong>A total of 129 participants were randomized (intervention: n=64, 49.6%; control: n=65, 50.4%). Participants in the intervention group were younger (mean age 54.6, SD 14.3 years vs 61.9, SD 12.0 years; P=.002), whereas baseline HbA1c (mean 9.3%, SD 1.96%) and FPG (mean 179.5, SD 5.9 mg/dL) levels were similar between the groups. Over 6 months, the intervention group showed a greater HbA1c reduction than the control group (mean difference -0.24%), but the difference was not statistically significant (P=.13). Among participants aged <65 years, FPG at 6 months was significantly lower in the intervention group (mean difference -29.3 mg/dL; P=.03). App satisfaction was rated as moderate.</p><p><strong>Conclusions: </strong>The mobile app achieved glycemic control comparable to that achieved through standard care, with significant improvement in FPG among participants younger than 65 years. Tailor-made apps integrating regionally relevant dietary content may support effective self-management in type 2 diabetes and warrant further evaluation in larger, long-term studies.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e83685"},"PeriodicalIF":2.6,"publicationDate":"2025-12-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12747420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145858858","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}
Akira Kimura, Shinobu Onozawa, Takayuki Ogiwara, Marwan El Ghoch
<p><strong>Background: </strong>Primary care diabetes management lacks objective, scalable methods for continuous physical activity surveillance. Bioelectrical impedance analysis (BIA), routinely collected in diabetes care, offers untapped potential as an automated digital biomarker but requires validation for behavioral phenotyping.</p><p><strong>Objective: </strong>This study aims to evaluate the feasibility and predictive validity of multifrequency bioimpedance for physical activity detection and its association with glycemic control in type 2 diabetes.</p><p><strong>Methods: </strong>This was a pragmatic quasi-experimental study using temporal allocation across three 4-month periods (January 2021-July 2023) in a Japanese primary care clinic, including comprehensive tracking with BIA-guided counseling (n=65), partial tracking (n=31), and standard care (n=100). Adults with type 2 diabetes (hemoglobin A1c [HbA1c] 7.0%-10.0%) underwent monthly segmental multifrequency BIA. The primary outcome was HbA1c <7% at 4 months. Intervention-outcome associations were examined using chi-square trend tests and multivariable logistic regression adjusted for baseline HbA1c, the Walk Score (0-100), and medication indicators. To assess temporal confounding, we conducted ANCOVA on 4-month HbA1c with baseline adjustment (age and BMI added in sensitivity analyses). Effect modification by built environment was tested via Walk Score×Intervention interaction. Predictive validity of left-arm 50-kHz reactance was assessed using area under receiver operating characteristic curve with 95% CI via 10-fold cross-validation.</p><p><strong>Results: </strong>Among 196 participants, the baseline characteristics (age, BMI, HbA1c, diabetes duration, and medications) did not differ across periods (all P>.05). HbA1c <7% achievement showed a gradient: 80% (52/65) comprehensive, 58% (18/31) partial, and 56% (56/100) standard care (χ²4 for trend=14.23; P<.001). ANCOVA of 4-month HbA1c (baseline-adjusted) showed no linear period trend (P=.25). A significant Walk Score×Intervention interaction was observed (β per 10-point Walk Score=-.55; 95% CI -1.03 to -0.06; P=.028), indicating differential effectiveness by neighborhood walkability. Left-arm 50-kHz reactance predicted target achievement (adjusted odds ratio per 1-SD increase =3.04; 95% CI 1.86-4.97; P<.001; area under receiver operating characteristic curve=0.847, 95% CI 0.784-0.910). Among achievers, reactance change correlated with HbA1c change (r=-0.392; P=.032) but not among nonachievers (r=-0.089; P=.54). After the inverse probability weighting was stabilized, each 1-SD increase in left-arm reactance was associated with a 12.1 percentage-point higher probability of target achievement (95% CI 5.2%-19.0%).</p><p><strong>Conclusions: </strong>This pragmatic implementation study demonstrates that automated BIA is feasible for routine diabetes care and suggests potential as a digital biomarker of activity-related glycemic control. Whi
{"title":"Digital Bioimpedance for Physical Activity Detection in Type-2 Diabetes: Quasi-Experimental Validation Study.","authors":"Akira Kimura, Shinobu Onozawa, Takayuki Ogiwara, Marwan El Ghoch","doi":"10.2196/83768","DOIUrl":"10.2196/83768","url":null,"abstract":"<p><strong>Background: </strong>Primary care diabetes management lacks objective, scalable methods for continuous physical activity surveillance. Bioelectrical impedance analysis (BIA), routinely collected in diabetes care, offers untapped potential as an automated digital biomarker but requires validation for behavioral phenotyping.</p><p><strong>Objective: </strong>This study aims to evaluate the feasibility and predictive validity of multifrequency bioimpedance for physical activity detection and its association with glycemic control in type 2 diabetes.</p><p><strong>Methods: </strong>This was a pragmatic quasi-experimental study using temporal allocation across three 4-month periods (January 2021-July 2023) in a Japanese primary care clinic, including comprehensive tracking with BIA-guided counseling (n=65), partial tracking (n=31), and standard care (n=100). Adults with type 2 diabetes (hemoglobin A1c [HbA1c] 7.0%-10.0%) underwent monthly segmental multifrequency BIA. The primary outcome was HbA1c <7% at 4 months. Intervention-outcome associations were examined using chi-square trend tests and multivariable logistic regression adjusted for baseline HbA1c, the Walk Score (0-100), and medication indicators. To assess temporal confounding, we conducted ANCOVA on 4-month HbA1c with baseline adjustment (age and BMI added in sensitivity analyses). Effect modification by built environment was tested via Walk Score×Intervention interaction. Predictive validity of left-arm 50-kHz reactance was assessed using area under receiver operating characteristic curve with 95% CI via 10-fold cross-validation.</p><p><strong>Results: </strong>Among 196 participants, the baseline characteristics (age, BMI, HbA1c, diabetes duration, and medications) did not differ across periods (all P>.05). HbA1c <7% achievement showed a gradient: 80% (52/65) comprehensive, 58% (18/31) partial, and 56% (56/100) standard care (χ²4 for trend=14.23; P<.001). ANCOVA of 4-month HbA1c (baseline-adjusted) showed no linear period trend (P=.25). A significant Walk Score×Intervention interaction was observed (β per 10-point Walk Score=-.55; 95% CI -1.03 to -0.06; P=.028), indicating differential effectiveness by neighborhood walkability. Left-arm 50-kHz reactance predicted target achievement (adjusted odds ratio per 1-SD increase =3.04; 95% CI 1.86-4.97; P<.001; area under receiver operating characteristic curve=0.847, 95% CI 0.784-0.910). Among achievers, reactance change correlated with HbA1c change (r=-0.392; P=.032) but not among nonachievers (r=-0.089; P=.54). After the inverse probability weighting was stabilized, each 1-SD increase in left-arm reactance was associated with a 12.1 percentage-point higher probability of target achievement (95% CI 5.2%-19.0%).</p><p><strong>Conclusions: </strong>This pragmatic implementation study demonstrates that automated BIA is feasible for routine diabetes care and suggests potential as a digital biomarker of activity-related glycemic control. Whi","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e83768"},"PeriodicalIF":2.6,"publicationDate":"2025-12-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12707439/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145769967","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}
Cassie D Turner, Kishor Patel, Katherine Freeman, Lyndsay Ruff, Jamie Michaels, Timothy Bodnar, Laura R Saslow, James Henderson, Lauren Oshman, Caroline R Richardson, Devvrat Malhotra, A Mark Fendrick, Garth Strohbehn, Dina H Griauzde
<p><strong>Background: </strong>One in 4 Veterans who receive care through the Veterans Health Administration has type 2 diabetes (T2D). Dietary carbohydrate restriction can promote weight loss and improve blood glucose control, but Veterans taking certain medications (eg, insulin) may experience serious complications (eg, hypoglycemia) without adequate support and monitoring.</p><p><strong>Objective: </strong>This study aims to develop and evaluate the feasibility, acceptability, and clinical effectiveness of a pilot low-carbohydrate (LC) nutrition counseling program guided by continuous glucose monitoring (CGM) for Veterans with T2D receiving insulin (ie, LC-CGM).</p><p><strong>Methods: </strong>This is a pragmatic, nonrandomized, pre-post quality improvement pilot program. Eligible patients were Veterans with T2D who were prescribed ≥3 daily injections of insulin. The 24-week LC-CGM program consisted of virtual visits with a registered dietitian (RD) and clinical pharmacy practitioner (CPP); CGM data were used to guide tailored nutrition counseling and de-escalation or cessation of glucose-lowering medications. To evaluate changes from baseline, intention-to-treat analyses were conducted for all enrollees, with separate analyses for program completers. Primary outcomes were program feasibility and acceptability (ie, program enrollment and completion rates and mean number of RD and CPP visits). Secondary outcomes included mean weight change, percent weight loss, achievement of ≥5% and ≥10% weight loss, change in glucose-lowering medication use, and change in laboratory measures (eg, hemoglobin A1c [HbA1c]).</p><p><strong>Results: </strong>Program evaluation occurred from March 19, 2021, to May 3, 2024. Among 43 Veterans referred to the LC-CGM program, 38 (88%) enrolled. Most were men (37/38, 97%), white (29/38, 76%), with an average age of 63.7 (SD 9.6) years. Mean BMI and HbA1c were 38.1 (SD 5.8) kg/m2 and 7.8% (SD 1.3). Of 38 enrollees, 27 (71%) completed the program. Enrollees averaged 9.5 (SD 3.3) RD visits and 12.8 (SD 4.7) CPP visits. In intention-to-treat analyses, mean weight change was -11.5 kilograms (SD 8.7; 95% CI -14.4 to -8.6), corresponding to 9.5% weight loss (SD 7.2; 95% CI -14.9 to -4.2), with 58% (22/38) achieving ≥5% weight loss and 32% (12/38) achieving ≥10% weight loss. Overall, use of glucose-lowering medications decreased from 3.5 (SD 0.8) per patient at baseline to 2.4 (SD 0.9) per patient at 24 weeks (P<.001), with 72% (26/36) of Veterans discontinuing short-acting insulin and 50% (18/36; P<.001) discontinuing long-acting insulin. Use of glucagon-like peptide-1 receptor agonists increased from 39% (15/38) at baseline to 61% (23/38) at 24 weeks (P=.02). Among program completers (n=27), mean percent weight loss was -11.8% (SD 6.5) and median HbA1c decreased by 0.7% (95% CI -0.9 to -0.3; P=.001).</p><p><strong>Conclusions: </strong>This pilot program provides preliminary evidence that supports feasibility, acceptability,
背景:四分之一接受退伍军人健康管理局护理的退伍军人患有2型糖尿病(T2D)。饮食碳水化合物限制可以促进减肥和改善血糖控制,但退伍军人服用某些药物(如胰岛素)可能会遇到严重的并发症(如低血糖),没有足够的支持和监测。目的:本研究旨在为接受胰岛素治疗的t2dm退伍军人(即LC-CGM)制定并评估以连续血糖监测(CGM)为指导的低碳水化合物(LC)营养咨询试点方案的可行性、可接受性和临床效果。方法:这是一个务实的、非随机的、岗前质量改进试点项目。符合条件的患者是患有T2D的退伍军人,每天注射胰岛素≥3次。为期24周的LC-CGM计划包括与注册营养师(RD)和临床药学从业者(CPP)进行虚拟访问;CGM数据用于指导量身定制的营养咨询和降糖药物的降级或停止。为了评估从基线开始的变化,对所有入组者进行意向治疗分析,并对项目完成者进行单独分析。主要结果是项目的可行性和可接受性(即项目的入组率和完成率以及RD和CPP就诊的平均次数)。次要结局包括平均体重变化、体重减轻百分比、体重减轻≥5%和≥10%、降糖药物使用的变化和实验室测量的变化(如血红蛋白A1c [HbA1c])。结果:项目评估时间为2021年3月19日至2024年5月3日。在参与LC-CGM项目的43名退伍军人中,38人(88%)注册。多数为男性(37/ 38,97%),白人(29/ 38,76%),平均年龄63.7岁(SD 9.6)。平均BMI和HbA1c分别为38.1 (SD 5.8) kg/m2和7.8% (SD 1.3)。在38名参与者中,27人(71%)完成了该项目。受试者平均RD访问9.5次(SD 3.3), CPP访问12.8次(SD 4.7)。在意向治疗分析中,平均体重变化为-11.5 kg (SD 8.7; 95% CI -14.4至-8.6),相当于体重减轻9.5% (SD 7.2; 95% CI -14.9至-4.2),其中58%(22/38)达到体重减轻≥5%,32%(12/38)达到体重减轻≥10%。总体而言,降糖药物的使用从基线时的每名患者3.5 (SD 0.8)下降到24周时的每名患者2.4 (SD 0.9)。结论:该试点项目为t2dm退伍军人的可行性、可接受性和临床有效性提供了初步证据。需要进一步的研究来严格测试更大的符合条件的退伍军人群体的长期临床和成本效益。
{"title":"Low-Carbohydrate Nutrition Counseling With Continuous Glucose Monitoring to Improve Metabolic Health Among Veterans With Type 2 Diabetes: Pilot Quality Improvement Initiative Study.","authors":"Cassie D Turner, Kishor Patel, Katherine Freeman, Lyndsay Ruff, Jamie Michaels, Timothy Bodnar, Laura R Saslow, James Henderson, Lauren Oshman, Caroline R Richardson, Devvrat Malhotra, A Mark Fendrick, Garth Strohbehn, Dina H Griauzde","doi":"10.2196/75672","DOIUrl":"10.2196/75672","url":null,"abstract":"<p><strong>Background: </strong>One in 4 Veterans who receive care through the Veterans Health Administration has type 2 diabetes (T2D). Dietary carbohydrate restriction can promote weight loss and improve blood glucose control, but Veterans taking certain medications (eg, insulin) may experience serious complications (eg, hypoglycemia) without adequate support and monitoring.</p><p><strong>Objective: </strong>This study aims to develop and evaluate the feasibility, acceptability, and clinical effectiveness of a pilot low-carbohydrate (LC) nutrition counseling program guided by continuous glucose monitoring (CGM) for Veterans with T2D receiving insulin (ie, LC-CGM).</p><p><strong>Methods: </strong>This is a pragmatic, nonrandomized, pre-post quality improvement pilot program. Eligible patients were Veterans with T2D who were prescribed ≥3 daily injections of insulin. The 24-week LC-CGM program consisted of virtual visits with a registered dietitian (RD) and clinical pharmacy practitioner (CPP); CGM data were used to guide tailored nutrition counseling and de-escalation or cessation of glucose-lowering medications. To evaluate changes from baseline, intention-to-treat analyses were conducted for all enrollees, with separate analyses for program completers. Primary outcomes were program feasibility and acceptability (ie, program enrollment and completion rates and mean number of RD and CPP visits). Secondary outcomes included mean weight change, percent weight loss, achievement of ≥5% and ≥10% weight loss, change in glucose-lowering medication use, and change in laboratory measures (eg, hemoglobin A1c [HbA1c]).</p><p><strong>Results: </strong>Program evaluation occurred from March 19, 2021, to May 3, 2024. Among 43 Veterans referred to the LC-CGM program, 38 (88%) enrolled. Most were men (37/38, 97%), white (29/38, 76%), with an average age of 63.7 (SD 9.6) years. Mean BMI and HbA1c were 38.1 (SD 5.8) kg/m2 and 7.8% (SD 1.3). Of 38 enrollees, 27 (71%) completed the program. Enrollees averaged 9.5 (SD 3.3) RD visits and 12.8 (SD 4.7) CPP visits. In intention-to-treat analyses, mean weight change was -11.5 kilograms (SD 8.7; 95% CI -14.4 to -8.6), corresponding to 9.5% weight loss (SD 7.2; 95% CI -14.9 to -4.2), with 58% (22/38) achieving ≥5% weight loss and 32% (12/38) achieving ≥10% weight loss. Overall, use of glucose-lowering medications decreased from 3.5 (SD 0.8) per patient at baseline to 2.4 (SD 0.9) per patient at 24 weeks (P<.001), with 72% (26/36) of Veterans discontinuing short-acting insulin and 50% (18/36; P<.001) discontinuing long-acting insulin. Use of glucagon-like peptide-1 receptor agonists increased from 39% (15/38) at baseline to 61% (23/38) at 24 weeks (P=.02). Among program completers (n=27), mean percent weight loss was -11.8% (SD 6.5) and median HbA1c decreased by 0.7% (95% CI -0.9 to -0.3; P=.001).</p><p><strong>Conclusions: </strong>This pilot program provides preliminary evidence that supports feasibility, acceptability, ","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e75672"},"PeriodicalIF":2.6,"publicationDate":"2025-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12705128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145764416","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}
Ida Ayu Made Kshanti, Nadya Magfira, Anak Agung Arie Widyastuti, Jerry Nasarudin, Marina Epriliawati, Md Ikhsan Mokoagow
Background: Insulin therapy is crucial for managing type 2 diabetes mellitus, with its use steadily increasing in Indonesia and its effectiveness well established. However, prescribing insulin poses various challenges that can impact the effectiveness of insulin. Patient education is crucial for the successful implementation of insulin therapy. Proper insulin use remains insufficient in Indonesia.
Objective: This study aims to investigate physicians' knowledge and practice in providing education on insulin use to patients with type 2 diabetes mellitus in Indonesia.
Methods: This study recruited potential participants (all physicians in Indonesia) through the internet using a convenience sampling method. The participants were asked to fill out a questionnaire. The questionnaire had 32 questions divided into 4 sections: demographics and clinical practice, practice of insulin education, the Indonesian insulin injection technique guideline, and knowledge of insulin injection techniques. The instrument used in this study was developed based on the Pedoman Teknik Menyuntik Insulin Indonesia, which was adapted from the international consensus by the Forum for Injection Technique and Therapy Expert Recommendations. The survey lasted from February 2021 to March 2021. Data were analyzed using the Kruskal-Wallis tests.
Results: A total of 823 participants were included in the analysis. Out of 823 participants, 680 (82.6%) had given insulin education to patients at least once during the last 30 days. However, out of 823 participants, only 479 (58.2%) used specific guidelines in their practice, with only 280 (34.0%) aware of the Indonesian guidelines. Out of 823 participants, 815 (99.1%) agreed that insulin injection techniques would affect clinical results. The median score of knowledge about insulin injection techniques was 7 (IQR 2) among the study participants, indicating good knowledge. Profession was the only variable significantly associated with knowledge scores, with consultants in endocrinology, metabolism, and diabetes achieving the highest median scores, and other physicians the lowest (P<.001).
Conclusions: Most physicians in this study reported providing education to their patients. However, there was still a gap between the guidelines and the practice of insulin education, as indicated by the lack of awareness and a fair level of knowledge about the Indonesian guidelines.
背景:胰岛素治疗对2型糖尿病的治疗至关重要,在印度尼西亚胰岛素的使用稳步增加,其有效性也得到了很好的证实。然而,处方胰岛素带来了各种各样的挑战,可能会影响胰岛素的有效性。患者教育对于胰岛素治疗的成功实施至关重要。在印度尼西亚,适当的胰岛素使用仍然不足。目的:了解印尼医生对2型糖尿病患者进行胰岛素使用教育的知识和实践情况。方法:本研究采用方便的抽样方法,通过互联网招募潜在的参与者(印度尼西亚的所有医生)。参与者被要求填写一份问卷。问卷共32题,分为人口统计学与临床实践、胰岛素教育实践、印尼胰岛素注射技术指南、胰岛素注射技术知识4个部分。本研究中使用的仪器是根据印度尼西亚的Pedoman Teknik Menyuntik胰岛素开发的,该胰岛素是根据注射技术和治疗专家建议论坛的国际共识改编的。该调查从2021年2月持续到2021年3月。使用Kruskal-Wallis检验分析数据。结果:共纳入823名参与者。在823名参与者中,680名(82.6%)在过去30天内至少对患者进行过一次胰岛素教育。然而,在823名参与者中,只有479人(58.2%)在实践中使用了具体的指导方针,只有280人(34.0%)知道印度尼西亚的指导方针。在823名参与者中,815人(99.1%)同意胰岛素注射技术会影响临床结果。研究对象对胰岛素注射技术知识的中位数得分为7分(IQR 2),表明知识较好。职业是唯一与知识得分显著相关的变量,内分泌科、代谢科和糖尿病科的咨询师的中位数得分最高,而其他医生的中位数得分最低(结论:本研究中大多数医生报告向患者提供教育。但是,指南与胰岛素教育的实践之间仍然存在差距,这表明缺乏对印度尼西亚指南的认识和相当程度的知识。
{"title":"Insulin Injection Technique Education and Associated Knowledge Factors Among Physicians: Cross-Sectional Survey Study.","authors":"Ida Ayu Made Kshanti, Nadya Magfira, Anak Agung Arie Widyastuti, Jerry Nasarudin, Marina Epriliawati, Md Ikhsan Mokoagow","doi":"10.2196/65359","DOIUrl":"10.2196/65359","url":null,"abstract":"<p><strong>Background: </strong>Insulin therapy is crucial for managing type 2 diabetes mellitus, with its use steadily increasing in Indonesia and its effectiveness well established. However, prescribing insulin poses various challenges that can impact the effectiveness of insulin. Patient education is crucial for the successful implementation of insulin therapy. Proper insulin use remains insufficient in Indonesia.</p><p><strong>Objective: </strong>This study aims to investigate physicians' knowledge and practice in providing education on insulin use to patients with type 2 diabetes mellitus in Indonesia.</p><p><strong>Methods: </strong>This study recruited potential participants (all physicians in Indonesia) through the internet using a convenience sampling method. The participants were asked to fill out a questionnaire. The questionnaire had 32 questions divided into 4 sections: demographics and clinical practice, practice of insulin education, the Indonesian insulin injection technique guideline, and knowledge of insulin injection techniques. The instrument used in this study was developed based on the Pedoman Teknik Menyuntik Insulin Indonesia, which was adapted from the international consensus by the Forum for Injection Technique and Therapy Expert Recommendations. The survey lasted from February 2021 to March 2021. Data were analyzed using the Kruskal-Wallis tests.</p><p><strong>Results: </strong>A total of 823 participants were included in the analysis. Out of 823 participants, 680 (82.6%) had given insulin education to patients at least once during the last 30 days. However, out of 823 participants, only 479 (58.2%) used specific guidelines in their practice, with only 280 (34.0%) aware of the Indonesian guidelines. Out of 823 participants, 815 (99.1%) agreed that insulin injection techniques would affect clinical results. The median score of knowledge about insulin injection techniques was 7 (IQR 2) among the study participants, indicating good knowledge. Profession was the only variable significantly associated with knowledge scores, with consultants in endocrinology, metabolism, and diabetes achieving the highest median scores, and other physicians the lowest (P<.001).</p><p><strong>Conclusions: </strong>Most physicians in this study reported providing education to their patients. However, there was still a gap between the guidelines and the practice of insulin education, as indicated by the lack of awareness and a fair level of knowledge about the Indonesian guidelines.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e65359"},"PeriodicalIF":2.6,"publicationDate":"2025-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12685283/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145710005","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}
Unlabelled: We developed an innovative bilingual toolkit comprising a personalized action plan and educational videos to encourage insulin dose self-titration by adults living with type 2 diabetes.
{"title":"An Innovative Insulin Dose Self-Titration Toolkit for Adults Living With Type 2 Diabetes Mellitus.","authors":"Nadin Abbas, Heather Lochnan, Sandhya Goge, Annie Garon-Mailer, Cathy J Sun","doi":"10.2196/75903","DOIUrl":"10.2196/75903","url":null,"abstract":"<p><strong>Unlabelled: </strong>We developed an innovative bilingual toolkit comprising a personalized action plan and educational videos to encourage insulin dose self-titration by adults living with type 2 diabetes.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e75903"},"PeriodicalIF":2.6,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12661589/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145642647","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}
Daniel Gasca Garcia, Hood Thabit, Paul W Nutter, Simon Harper
Background: Basal rate (BR) adjustment is crucial for managing type 1 diabetes mellitus, accounting for 30% to 50% of total daily insulin needs. All current closed-loop systems revert to the user's usual pump BR (known as manual mode) in the event of closed loop failure. Furthermore, access to closed-loop systems remains relatively low in low- and middle-income countries and among those without suitable health insurance. Accurately adjusting the BR remains challenging, leading to hypo- or hyperglycemia, and research on optimizing the BR is limited.
Objective: This study proposed an adaptive algorithm that uses continuous glucose monitoring data to identify BR inaccuracies without requiring meal intake information.
Methods: The OhioT1DM dataset formed the basis for implementing this methodology. Each composite day was generated by excluding bolus insulin profiles lacking meal intake information and by calculating hourly blood glucose (BG) relative levels along with their corresponding reliability measures, enabling assessment of deviations from the recommended BR (ie, a BG relative change of 0 mg/dL). Both a noninferiority analysis and a classification precision metric were used to assess the practicality of this approach compared to using meal data.
Results: Data from 12 participants showed noninferiority of the no-meal method: using a 20% noninferiority margin on absolute BG relative change, 9 of 12 participants met the criterion (1-sided P<.05). Classification precision was 73.9% (139/188) of meals correctly classified on average per participant (SD 11.8%; 95% CI 67.2%-79.7%). The daily cumulative BG average was 200.6 mg/dL (SD 61.7 mg/dL; 11.1 mmol/L, SD 3.4 mmol/L; 95% CI 161.4-239.8 mg/dL), with peak values reaching 270.15 mg/dL (14.99 mmol/L). Furthermore, 99.3% (286/288) of the BG relative values (SD 0.5%; 95% CI 97.5%-99.8%) that were unaffected by external factors were associated with incorrect BR settings, with deviations ranging from -25.5 to 46 mg/dL (-1.58 to 2.59 mmol/L).
Conclusions: Current strategies to optimize BR settings are inadequate, and our approach of a personalized basal tuner (PBT) helps better analyze BR without relying on meal intake information. Indeed, without an optimally set BR, in the event of the closed loop reverting to manual mode, patients may be exposed to persistent hypo- or hyperglycemia, leading to safety and efficacy issues. Future work will focus on generating BR recommendations through the application of this algorithm in clinical practice to assist clinicians in setting BR in low- and middle-income countries, where closed-loop systems are not prevalent, to help increase time in range.
{"title":"Toward a Personalized Basal Tuner for Detecting Basal Rate Inaccuracies in Type 1 Diabetes Mellitus Without Meal Data: Algorithm Development and Retrospective Validation Study.","authors":"Daniel Gasca Garcia, Hood Thabit, Paul W Nutter, Simon Harper","doi":"10.2196/72769","DOIUrl":"10.2196/72769","url":null,"abstract":"<p><strong>Background: </strong>Basal rate (BR) adjustment is crucial for managing type 1 diabetes mellitus, accounting for 30% to 50% of total daily insulin needs. All current closed-loop systems revert to the user's usual pump BR (known as manual mode) in the event of closed loop failure. Furthermore, access to closed-loop systems remains relatively low in low- and middle-income countries and among those without suitable health insurance. Accurately adjusting the BR remains challenging, leading to hypo- or hyperglycemia, and research on optimizing the BR is limited.</p><p><strong>Objective: </strong>This study proposed an adaptive algorithm that uses continuous glucose monitoring data to identify BR inaccuracies without requiring meal intake information.</p><p><strong>Methods: </strong>The OhioT1DM dataset formed the basis for implementing this methodology. Each composite day was generated by excluding bolus insulin profiles lacking meal intake information and by calculating hourly blood glucose (BG) relative levels along with their corresponding reliability measures, enabling assessment of deviations from the recommended BR (ie, a BG relative change of 0 mg/dL). Both a noninferiority analysis and a classification precision metric were used to assess the practicality of this approach compared to using meal data.</p><p><strong>Results: </strong>Data from 12 participants showed noninferiority of the no-meal method: using a 20% noninferiority margin on absolute BG relative change, 9 of 12 participants met the criterion (1-sided P<.05). Classification precision was 73.9% (139/188) of meals correctly classified on average per participant (SD 11.8%; 95% CI 67.2%-79.7%). The daily cumulative BG average was 200.6 mg/dL (SD 61.7 mg/dL; 11.1 mmol/L, SD 3.4 mmol/L; 95% CI 161.4-239.8 mg/dL), with peak values reaching 270.15 mg/dL (14.99 mmol/L). Furthermore, 99.3% (286/288) of the BG relative values (SD 0.5%; 95% CI 97.5%-99.8%) that were unaffected by external factors were associated with incorrect BR settings, with deviations ranging from -25.5 to 46 mg/dL (-1.58 to 2.59 mmol/L).</p><p><strong>Conclusions: </strong>Current strategies to optimize BR settings are inadequate, and our approach of a personalized basal tuner (PBT) helps better analyze BR without relying on meal intake information. Indeed, without an optimally set BR, in the event of the closed loop reverting to manual mode, patients may be exposed to persistent hypo- or hyperglycemia, leading to safety and efficacy issues. Future work will focus on generating BR recommendations through the application of this algorithm in clinical practice to assist clinicians in setting BR in low- and middle-income countries, where closed-loop systems are not prevalent, to help increase time in range.</p>","PeriodicalId":52371,"journal":{"name":"JMIR Diabetes","volume":"10 ","pages":"e72769"},"PeriodicalIF":2.6,"publicationDate":"2025-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12661609/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145642680","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}