Diabetes technology & therapeutics最新文献

{"title":"Continuous Glucose Monitoring in Insulin-Treated Type 2 Diabetes Mellitus in Sweden: A Scoping Review and Policy Landscape Analysis.","authors":"Johan Jendle, Peter Adolfsson, Jarl Hellman, Boris Klanger, Neda Rajamand Ekberg","doi":"10.1177/15209156261442987","DOIUrl":"10.1177/15209156261442987","url":null,"abstract":"<p><strong>Background: </strong>Type 2 diabetes mellitus (T2DM) is one of the most common chronic diseases in Sweden. Continuous glucose monitoring (CGM) is an increasingly important alternative to self-monitoring of blood glucose (SMBG), particularly for people receiving insulin.</p><p><strong>Objectives: </strong>To summarize the evidence for CGM in insulin-treated T2DM and conduct a policy landscape analysis of national and local guidelines to explore access to CGM in Sweden relative to other countries.</p><p><strong>Methods: </strong>A scoping review was conducted to identify evidence on the clinical, patient, and economic value of CGM, supplemented with searches of Swedish and European guidelines. Current recommendations for CGM in T2DM in Sweden were compared with European-wide and country-specific recommendations. Regional recommendations and funding processes within Sweden were reviewed to examine heterogeneity in local access to CGM.</p><p><strong>Results: </strong>Across international and Swedish studies, CGM was associated with improved clinical outcomes compared with SMBG, both for people with intensive insulin-treated T2DM and those on basal insulin only. The clinical benefits likely translate into fewer long-term diabetes complications and reduced resource utilization and budget impact versus SMBG. Health economic evaluations show that CGM can be considered a cost-effective intervention for all individuals treated with insulin in Sweden. European-wide guidance supports consideration of CGM for all insulin-treated individuals, but access in Sweden remains limited outside of the high-risk intensive insulin-treated population. This is exacerbated by regional heterogeneity in access, which partly stems from the attribution of budget responsibility to individual primary care units.</p><p><strong>Conclusions: </strong>The benefits associated with CGM show that an expansion of the Swedish recommendations to cover all insulin-treated people with T2DM is warranted. Persistent regional disparities must be addressed to ensure equitable access to care for people with T2DM in Sweden. The establishment of dedicated funding mechanisms within primary care should be considered to promote more equitable and sustainable access.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1007-1024"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147688797","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Continuous Glucose Monitoring Identifies Youth with Prediabetes at Risk for Glycemic Progression.","authors":"Natalie Segev, Nancy A Crimmins, Roohi Kharofa, Amy S Shah","doi":"10.1177/15209156261435244","DOIUrl":"10.1177/15209156261435244","url":null,"abstract":"<p><strong>Objective: </strong>Pediatric prediabetes is common among youth with obesity, yet most do not progress to type 2 diabetes, and many regress to normoglycemia. Youth-onset type 2 diabetes has a severe course not well predicted by degree of adiposity or hemoglobin A1c (HbA1c) alone. This study used continuous glucose monitoring (CGM) to characterize glycemic patterns in youth with prediabetes and to determine whether baseline CGM metrics identify those at highest risk for HbA1c progression over 6 months.</p><p><strong>Research design and methods: </strong>Youth aged 10-18 years with obesity and HbA1c 5.7%-6.4% were enrolled in a prospective 6-month observational cohort study, with baseline and follow-up assessments including HbA1c and 14 days of CGM wear. CGM metrics were derived using the R <i>iglu</i> package. Changes over time and associations with follow-up HbA1c and HbA1c change were analyzed using paired <i>t</i>-tests and PRESS-based forward-selected linear regression models, adjusting for clinical covariates.</p><p><strong>Results: </strong>Among 29 youth with prediabetes, HbA1c and most CGM metrics remained stable over 6 months, with 32% regressing to normoglycemia. One participant progressed to HbA1c 6.5% who demonstrated markedly elevated baseline CGM glycemic variability and hyperglycemia. While multiple baseline CGM metrics were associated with follow-up HbA1c and HbA1c change in univariable analyses, PRESS-based multivariable models identified time spent above 140 mg/dL as the strongest and only consistent independent predictor of both higher follow-up HbA1c and worsening glycemic trajectory.</p><p><strong>Conclusions: </strong>CGM metrics outperformed HbA1c in predicting short-term glycemic progression in youth with prediabetes, supporting CGM as a promising adjunctive tool for early risk stratification.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1063-1070"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147497853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Inhaled Technosphere Insulin Reduces Postmeal Glucose Excursion in Youth Living with Type 1 Diabetes.","authors":"Laya Ekhlaspour, Lauren Kanapka, Asheesh Dewan, Linda A DiMeglio, Mark Kipnes, Michael A Wood, Michael J Haller, Thomas J Mouse, Roy W Beck","doi":"10.1177/15209156261432138","DOIUrl":"10.1177/15209156261432138","url":null,"abstract":"<p><strong>Objective: </strong>To assess postprandial glucose excursions following a meal bolus of inhaled technosphere insulin (TI) in youth with type 1 diabetes.</p><p><strong>Methods: </strong>As part of a multicenter randomized controlled trial, 217 youth 4-17 years old with type 1 diabetes using multiple daily injections (MDI) completed an in-clinic standardized meal challenge with their first TI dose. Glucose levels were monitored for 2 h. Outcomes were compared with outcomes in MDI-using adults with T1D who received a TI (<i>N</i> = 51) or a rapid-acting analogue (RAA, <i>N</i> = 25) bolus for a similar meal challenge in a separate trial.</p><p><strong>Results: </strong>Following TI inhalation, the glucose excursion and glycemic metrics were similar in the pediatric cohort to those of the adult TI cohort. In contrast, compared with the adult RAA cohort, the pediatric TI cohort had a smaller glucose excursion (<i>P</i> < 0.001), lower peak glucose (<i>P</i> < 0.001), smaller AUC180 (<i>P</i> < 0.001), and higher time-in-range 70-180 mg/dL (<i>P</i> = 0.002). A glucose value < 70 mg/dL occurred in 14 (6%) of the pediatric TI cohort versus 1 (2%) of the adult TI cohort. Children 4-12 years old had a significantly higher peak glucose and excursion (<i>P</i> < 0.001) than those 13-17 years old. No significant difference in response to meal challenges was observed between groups with baseline HbA1c < 8.5% and HbA1c ≥ 8.5%. The mean ratio of TI inhaled units to the calculated RAA bolus that would be given for the number of carbohydrates was 1.9 ± 0.6 in the pediatric cohort and 1.9 ± 0.2 in the adult cohort.</p><p><strong>Conclusions: </strong>In children with type 1 diabetes, the postmeal glucose excursion following a TI bolus was similar to the postmeal glucose excursion that occurs with TI in adults and significantly lower than the excursion that has been observed with RAA in adults. These findings are consistent with the known pharmacokinetic profile of TI.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1044-1051"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13489622/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147456198","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Virtual Diabetes Control and Complications Trial #4: Relationship of HbA1c and Continuous Glucose Monitoring Metrics with Severe Hypoglycemic Events.","authors":"Anika Bilal, William B Horton, Boris P Kovatchev, Anna Casu, Richard E Pratley, Lauren G Kanapka, Roy W Beck","doi":"10.1177/15209156261432166","DOIUrl":"10.1177/15209156261432166","url":null,"abstract":"<p><strong>Objective: </strong>To evaluate how continuous glucose monitoring (CGM)-derived metrics relate to severe hypoglycemia (SH) events in individuals with type 1 diabetes by utilizing a multistep machine-learning approach to generate virtual CGM profiles from glycemic data in the Diabetes Control and Complications Trial (DCCT).</p><p><strong>Research design and methods: </strong>Virtual CGM profiles were created for each DCCT participant using previously validated methods. HbA1c values and CGM metrics were analyzed as predictors of SH events within the subsequent 90 days using Poisson regression models. Sensitivity, specificity, and positive predictive value of time-below-range (TBR) <70 mg/dL for SH prediction were also assessed.</p><p><strong>Results: </strong>All CGM-derived measures, including TBR, level 2 hypoglycemia (glucose <54 mg/dL), time-in-range 70-180 mg/dL, time-in-tight-range 70-140 mg/dL, low blood glucose index, and coefficient of variation, were higher, while the mean HbA1c was lower for participants who experienced at least one SH event compared with participants who did not. Each 1% increase in TBR and each 0.5% increase in level 2 hypoglycemia were associated with rate ratios of 1.23 (95% CI, 1.20-1.27) and 1.36 (95% CI, 1.30-1.43) for SH events, respectively. A similar pattern was seen when assuming a 0.5 standard deviation change in these metrics. Despite this association, TBR threshold of >6% demonstrated only 13% positive predictive value for SH events.</p><p><strong>Conclusion: </strong>Hypoglycemia-focused CGM metrics reproduced by virtual CGM data from the DCCT were strongly associated with SH events, although the positive predictive value was low.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1034-1043"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147467324","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Early Initiation of Automated Insulin Delivery at Type 1 Diabetes Diagnosis in Children and Adolescents Is Associated with Improved Outcomes.","authors":"Elizabeth A Mann, Priya Prahalad, Risa Wolf, Nestoras Mathioudakis, Nicole Rioles, Saketh Rompicherla, Ori Odugbesan, Susan Thapa, Robert Vigersky, Osagie Ebekozien","doi":"10.1177/15209156261441491","DOIUrl":"10.1177/15209156261441491","url":null,"abstract":"<p><strong>Introduction: </strong>This retrospective cohort study evaluates the impact of timing of automated insulin delivery (AID) initiation on glycemic outcomes in youth with type 1 diabetes.</p><p><strong>Methods: </strong>Data from 9856 children and adolescents diagnosed with type 1 diabetes between 2020 and 2022 across 27 U.S. centers were analyzed. Participants were grouped by AID initiation timing in months: <6, 6-12, 13-24, or no AID use. Hemoglobin A1c (HbA1c) trajectories, diabetes-associated ketoacidosis (DKA), and severe hypoglycemia rates were assessed over 24 months after T1D diagnosis.</p><p><strong>Results: </strong>Earlier AID initiation was associated with lower HbA1c at 24 months (median 7.1% in the <6-month group vs. 9.8% in non-users, <i>P</i> < 0.001). DKA rates were threefold higher in non-AID users. Adjusted models confirmed the timing of AID initiation independently predicted HbA1c outcomes.</p><p><strong>Conclusions: </strong>Early AID initiation is associated with improved glycemic control and reduced DKA risk, underscoring the importance of timely and equitable access to AID systems.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1082-1089"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147632810","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical Efficacy Evaluation of a Continuous Glucose Monitoring-Guided Forecasting Algorithm to Mitigate Postbariatric Hypoglycemia: A Randomized Controlled Trial.","authors":"Arlette Journeaux, Selina Zbinden, Francesco Prendin, Luca Cossu, Olivia Streicher, Eva Rolfes, María Carolina Fragozo-Ramos, Camillo Piazza, Dean Vukovic, Philipp Nett, Daniel Giachino, Joerg Zehetner, Giacomo Cappon, David Herzig, Andrea Facchinetti, Lia Bally","doi":"10.1177/15209156261432146","DOIUrl":"10.1177/15209156261432146","url":null,"abstract":"<p><p>Postbariatric hypoglycemia (PBH) after Roux-en-Y gastric bypass predisposes to health risks and impaired quality of life. Given limited therapeutic options, we evaluated the efficacy of a continuous glucose monitoring (CGM)-guided forecasting algorithm to reduce PBH. In this randomized trial, 59 participants underwent a standardized meal test and were assigned to receive 5 g of glucose either upon the algorithm's predictive alert (intervention, <i>n</i> = 32) or when plasma glucose declined below 3.0 mmol/L (control, <i>n</i> = 27). Hypoglycemia incidence (<3.0 mmol/L) was 31% in the intervention group and 44% in the control group (<i>P</i> = 0.30). Nadir glucose and time spent below 3.9 and 3.0 mmol/L did not differ significantly between groups. Extrapolation based on previously published glucose dose-response data suggests that increasing the preventive glucose dose to 10 g could reduce hypoglycemia incidence to 9%. While a 5 g preventive dose was insufficient, these simulations indicate that CGM-guided hypoglycemia forecasting warrants evaluation as an approach for reducing postprandial hypoglycemia in individuals with PBH.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1098-1103"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147456259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Ketone Testing Patterns Among People Using FreeStyle Libre.","authors":"Richard M Bergenstal, Naunihal Virdi, Farhan Quadri, Casey C Curl, Samia Rahman","doi":"10.1177/15209156261446059","DOIUrl":"10.1177/15209156261446059","url":null,"abstract":"<p><strong>Objective: </strong>Ketone testing behavior in relation to glucose control is not well characterized. We aimed to describe ketone testing patterns and assess glucose control among individuals using a FreeStyle Libre (FSL) reader and blood ketone test strips in a real-world dataset of over 2.5 million ketone readings.</p><p><strong>Research design and methods: </strong>Historical glucose and ketone data from September 2014 to September 2024 were analyzed. As data are recorded for individual readers, the analysis is performed by readers. Ketone excursions were categorized by initial ketone level: ≤0.5, 0.6-1.4, 1.5-2.9, and ≥3.0 mmol/L. Glucose concentrations were evaluated 24 h before and after the initial ketone test. Ketone test frequency and concentrations within 72 h post-test were also assessed.</p><p><strong>Results: </strong>A total of 92.4% of readers never recorded a ketone test, and only 5% of readers performed a ketone test when glucose exceeded 250 mg/dL. Users with ketone levels ≥3.0 mmol/L had higher glucose concentrations in the 24 h preceding the ketone test. Among those with ketones ≥1.5 mmol/L, ketone testing was typically delayed by 5-8 h after glucose surpassed 250 mg/dL, and retesting ketones within 24-72 h was rare.</p><p><strong>Conclusions: </strong>Most readers did not demonstrate adherence to standard-of-care recommendations for ketone monitoring and infrequently recheck ketones after elevated readings. Incorporation of continuous ketone monitoring into FSL would address limitations with current ketone testing methodologies and adherence to ketone monitoring guidelines.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1090-1097"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147867134","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Operational and Clinical Insights from a Fully Decentralized Clinical Study Evaluating Protocol Adherence, Participant Satisfaction, and Connected Device Data in Individuals with Type 2 Diabetes on Different Treatment Regimens.","authors":"Kirsten Nørgaard, Uffe Christian Braae, Anne Kaas, Sarah Amandine Caroline Voisin, Lise Sylvest Helledi","doi":"10.1177/15209156261437512","DOIUrl":"10.1177/15209156261437512","url":null,"abstract":"<p><strong>Objective: </strong>Traditional clinical trials place a substantial burden on participants owing to the need for frequent, tightly controlled site visits, which can limit access and participation. Advances in digital health allow for decentralized clinical trials (DCTs), with site visits replaced by virtual contact and data collection, potentially reducing burden and broadening access. This proof-of-concept study assessed the operational feasibility of a fully remote, digitalized DCT.</p><p><strong>Methods: </strong>This was a 12-week observational study conducted in Denmark; adults with type 2 diabetes were recruited via social media. Following e-consent, participants were provided with continuous glucose monitoring (CGM) devices and an activity tracker, with data collected via smartphone apps. All visits and support were conducted remotely. Primary endpoints were: proportion consenting via e-signature (weeks -2 to 0), proportion with ≥ 70% unblinded CGM coverage (weeks 2-12), and percentage of scheduled telemedicine visits and questionnaires completed (weeks 0-12). Safety was monitored remotely through adverse event (AE) reporting during telemedicine visits.</p><p><strong>Results: </strong>Most study places were filled within 2 days of advertisement. Of 166 invited individuals, 100% consented electronically; 156 were enrolled, and 87% completed the study. Among participants starting unblinded CGM, 95% achieved ≥70% data coverage, meeting international completeness standards. Adherence to remote interactions was high: 97% attended all telemedicine visits, and 77% completed all questionnaires; 72% completed all scheduled remote interactions. Satisfaction with the study and CGM devices was very high, although adherence to the activity tracker was low (12% with ≥70% coverage) owing to technical issues. Safety monitoring via remote AE reporting revealed no unexpected findings.</p><p><strong>Conclusions: </strong>A fully remote study was feasible to set up and conduct in Denmark, with rapid recruitment, high retention, and high compliance with CGM and telemedicine visits. DCTs have the potential to reduce participant burden, improve recruitment, and increase the representativeness of clinical trial populations.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1071-1081"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147716167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Erratum to:</i> \"HbA1c and Glucose Management Indicator Discordance: A Real-World Analysis\".","authors":"","doi":"10.1177/15209156261455409","DOIUrl":"10.1177/15209156261455409","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1118"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148344188","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Letter:</i> Fully Automated Glycemic Control with Ultra-Rapid Insulin in a Bihormonal Closed-Loop System in People with Type 1 Diabetes.","authors":"Theodorus J P Jansen, Deborah Hubers, Job S de Haan, Jolanda Geessink-Mennink, Alexandra H Mulder, Yvonne Klootwijk-van der Voort, Jeroen P H van Wijk, Michel Klaassen, Lyan B Vlaskamp, Arianne C van Bon","doi":"10.1177/15209156261438922","DOIUrl":"10.1177/15209156261438922","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"1115-1117"},"PeriodicalIF":7.4,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580911","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}