Journal of Diabetes Science and Technology最新文献

{"title":"First in Human Feasibility Study: Automated Insulin Delivery Utilizing a Self-Adapting Algorithm in Adults With Type 1 and Type 2 Diabetes.","authors":"Tom Wilkinson, Solita Donnelly, Claire Lever, Jonathan Williman, Renee Meier, Alisa Boucsein, Shirley Jones, Dave Ballagh, Reon van Rensburg, Rachael Sampson, Enrique Campos-Náñez, Steve Patek, Ryan Paul, Benjamin Wheeler, Martin de Bock","doi":"10.1177/19322968251349528","DOIUrl":"10.1177/19322968251349528","url":null,"abstract":"<p><strong>Background: </strong>This feasibility study assessed a novel self-adapting closed-loop system which does not require carbohydrate announcement, in adults with type 1 and type 2 diabetes.</p><p><strong>Methods: </strong>Single-arm study, comprising a 14-day run-in using participants' usual insulin therapy with a blinded continuous glucose monitor (CGM), followed by 12 weeks use of the novel closed-loop system. The algorithm adjusted its own parameters after 4, 6, 8, and 10 weeks of use.</p><p><strong>Results: </strong>Thirty-two participants with type 1 and 10 participants with type 2 diabetes were enrolled. Mean time in range (TIR; % CGM readings = 70-180 mg/dL) was 37.7% at baseline and 55.9% during the intervention period in type 1 diabetes; 17.6% at baseline and 51.5% during the intervention period in type 2 diabetes. Median time <70 mg/dL during the intervention period was 1.1% in type 1 and 0.0% in type 2 diabetes. Median TIR was 65% following the fourth algorithm adaptation. Median daily insulin delivered by manual bolus was 1.0 units in type 1 and 0.0 units in type 2 diabetes, consistent with no meal announcement. There were four serious adverse events: worsening retinopathy, severe hypoglycemia following a period of paused automation, and two hospitalizations unrelated to the device.</p><p><strong>Conclusions: </strong>A closed-loop algorithm that adjusts its own parameters and requires no meal announcement was feasible in a cohort of adults with type 1 and type 2 diabetes. Clinical benefits were most apparent with the fully adapted algorithm.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968251349528"},"PeriodicalIF":4.1,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12226515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553609","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative Performance Analysis of Manual and Updated Optional Calibration Algorithms for the CareSens Air CGM System.","authors":"Nina Jendrike, Manuel Eichenlaub, Manuela Link, Sükrü Öter, Anne Beltzer, Marta Gil Miró, Cornelia Haug, Jung Hee Seo, Moon Hwan Kim, Stefan Pleus, Guido Freckmann","doi":"10.1177/19322968251351318","DOIUrl":"10.1177/19322968251351318","url":null,"abstract":"<p><strong>Background: </strong>The CE-marked CareSens Air continuous glucose monitoring (CGM) system (CSAir) features a 15-day sensor lifetime, a 2-hour warm-up period and mandatory manual calibrations. During subsequent product development, the algorithm was updated to reduce the warm-up period to 30 minutes and make user-entered calibrations optional. This study compared the CSAir's performance between the manual and updated algorithms.</p><p><strong>Methods: </strong>Thirty adults with diabetes wore three CSAir sensors on their upper arms for 15 days. The study included three in-clinic sessions with capillary comparator measurements at 15-minute intervals over seven hours and glucose manipulation in the hypo- or hyperglycemic range. Point accuracy was assessed via mean absolute relative difference (MARD), 20/20 agreement rates (AR) stratified by BG range, and sensor wear time. Further evaluations included clinical point accuracy, alert reliability, technical reliability, safety and user satisfaction.</p><p><strong>Results: </strong>The CSAir's updated algorithm exhibited improved accuracy compared with the manual calibration algorithm, with a total 20/20 AR of 93.9% (vs 90.1%) and an MARD of 8.7% (vs 9.9%). Accuracy remained stable across measurement ranges and sensor lifetime. Diabetes Technology Society Error Grid analysis revealed high clinical accuracy, with 88.0% and 92.4% of data pairs in zone A for the manual and updated algorithms, respectively. The estimated survival probability was 88.8%. Participants reported positive user satisfaction. No safety concerns were identified.</p><p><strong>Conclusions: </strong>Both algorithms of CSAir demonstrated robust performance and reliability with improved accuracy with the updated version. The study results of the CSAir suggest its suitability for nonadjunctive use.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"19322968251351318"},"PeriodicalIF":4.1,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12226519/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144553608","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimal Alphabet for Encoding Daily Continuous Glucose Monitoring Time Series Into Compressed Text: Correspondence.","authors":"Hinpetch Daungsupawong, Viroj Wiwanitkit","doi":"10.1177/19322968251334665","DOIUrl":"10.1177/19322968251334665","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1163"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11985465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144016808","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Research Gaps, Challenges, and Opportunities in Automated Insulin Delivery Systems.","authors":"Peter G Jacobs, Carol J Levy, Sue A Brown, Michael C Riddell, Ali Cinar, Charlotte K Boughton, Marc D Breton, Eyal Dassau, Greg Forlenza, Robert J Henderson, Roman Hovorka, David M Maahs, Medha Munshi, Helen Murphy, Sarit Polsky, Richard Pratley, Melissa S Putman, Viral N Shah, Leah M Wilson, Howard Zisser, Laya Ekhlaspour","doi":"10.1177/19322968251338754","DOIUrl":"10.1177/19322968251338754","url":null,"abstract":"<p><strong>Background: </strong>Since the discovery of the life-saving hormone insulin in 1921 by Dr Frederick Banting in 1921, there have been many critical discoveries and technical breakthroughs that have enabled people living with type 1 diabetes (T1D) to live longer, healthier lives. The development of insulin pumps, continuous glucose monitoring (CGM) systems, and automated insulin delivery (AID) systems have enabled people living with T1D to safely manage their glucose, reduce their HbA1c, and improve their overall health and quality of life. Nevertheless, AID systems are not yet designed for all people with T1D, and they perform best during the overnight period when meals and exercise are not occurring. AID systems are not fully automated in that they require the person using the system to announce meals and exercise to the system to avoid dangerous hyper- or hypoglycemia, respectively.</p><p><strong>Methods: </strong>In this review, which is one of a collection of manuscripts to commemorate the 75th anniversary of the National Institute for Diabetes and Digestive and Kidney Diseases, we celebrate the commercialization of the AID and discuss the major challenges and research gaps that remain to be solved to enable single- and multi-hormone AID systems to more fully support glucose management in people living with T1D.</p><p><strong>Results: </strong>More research is required to design and evaluate more intelligent AID systems that do not require accurate carbohydrate estimations or announcements for meals and exercise. Current AID systems are also not designed to be used by older adults or pregnant people. Results are presented on new AID systems that can automatically respond to meals and exercise. Results are also presented on evaluations of AID systems in older adults and pregnant people.</p><p><strong>Conclusions: </strong>Next-generation AID systems will need to support all people, including older adults, people during pregnancy, athletes, and people who may be too busy to announce carbohydrates or exercise to the system. Solutions are now becoming available that will enable AID systems to support a broader range of people living with T1D by leveraging the latest technologies in artificial intelligence and adaptive control.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":"19 4","pages":"937-949"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12213545/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540373","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparability Evaluation of Three Benchtop Glucose Analyzers With the Recently Withdrawn YSI 2300 Stat Plus.","authors":"Gareth J Dunseath, Iulius-Dumitru Vatavu, Stephen D Luzio","doi":"10.1177/19322968241230337","DOIUrl":"10.1177/19322968241230337","url":null,"abstract":"<p><strong>Background: </strong>We compared the performance of three currently available laboratory benchtop glucose analyzers with the outgoing YSI 2300 Stat Plus.</p><p><strong>Methods: </strong>Plasma samples (100), across a wide glucose concentration range were analysed on the YSI 2500, Randox daytona+ (glucose oxidase) and EKF Biosen in a single laboratory and compared to the YSI 2300 Stat Plus.</p><p><strong>Results: </strong>All three analyzers showed good agreement with the YSI 2300 Stat Plus, and only a small bias (≤1% YSI 2500 and Randox daytona+, 4.6% EKF Biosen) was observed for each analyzer. None of the three comparator analyzers were affected by either proportional or constant bias, thus no significant differences between the YSI 2300 Stat Plus and the comparator methods were identified.</p><p><strong>Conclusions: </strong>The results from this study suggest all could be considered as suitable reference laboratory glucose analyzers and replacements for the recently withdrawn YSI 2300 Stat Plus.</p>","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1068-1071"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11572045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139702663","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continuous Glucose Monitor Agreement Rates: A Questionable Metric.","authors":"Jan S Krouwer","doi":"10.1177/19322968251335934","DOIUrl":"10.1177/19322968251335934","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1150-1151"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12021857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144026935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Artificial Pancreas: The First 20 Years.","authors":"Francis J Doyle, Boris P Kovatchev","doi":"10.1177/19322968251330920","DOIUrl":"10.1177/19322968251330920","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":"19 4","pages":"875-882"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12213539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Diabetes Camp Attendance on Decision to Use Insulin Pumps Among Youth With Type 1 Diabetes.","authors":"Neha Parimi, Risa M Wolf","doi":"10.1177/19322968251331968","DOIUrl":"10.1177/19322968251331968","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1154-1155"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11982058/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing Duration of Usage of Insulin Infusion Sets: A Response.","authors":"Timothy Kwa, Robert A Vigersky, Gina Zhang, Toni L Cordero, Ohad Cohen, Sarnath Chattaraj","doi":"10.1177/19322968251334663","DOIUrl":"10.1177/19322968251334663","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1161-1162"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12021853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143987825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"Experience Is Simply the Name We Give to Our Mistakes\": A New Opportunity to Improve Outcomes in Type 2 Diabetes.","authors":"Theocharis Koufakis, Djordje S Popovic, Giuseppe Maltese","doi":"10.1177/19322968251342254","DOIUrl":"10.1177/19322968251342254","url":null,"abstract":"","PeriodicalId":15475,"journal":{"name":"Journal of Diabetes Science and Technology","volume":" ","pages":"1156-1157"},"PeriodicalIF":4.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12075173/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144006008","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}