Diabetes technology & therapeutics最新文献

{"title":"Continuous Glucose Monitoring-Based Titration of Once-Weekly Insulin Icodec in Insulin-Naive Individuals with Type 2 Diabetes (ONWARDS 9): A Phase 3b, Multicenter, Single-Arm, Treat-to-Target Clinical Trial.","authors":"Richard M Bergenstal, Björg Ásbjörnsdóttir, Tanvir Johanning Bari, Satish Hulkund, Yvonne Winhofer, Carol Wysham","doi":"10.1089/dia.2025.0050","DOIUrl":"10.1089/dia.2025.0050","url":null,"abstract":"<p><p><b><i>Background:</i></b> ONWARDS 9 explored, for the first time, the effect of continuous glucose monitoring (CGM)-based titration of once-weekly insulin icodec (icodec) on glycemic control and safety outcomes in individuals with type 2 diabetes (T2D). <b><i>Methods:</i></b> In this 26-week, multicenter, single-arm, treat-to-target, phase 3b trial, insulin-naive adults with T2D (glycated hemoglobin [HbA1c] 7.0%-11.0%) initiated icodec at a starting dose of 70 U/week. Participants were provided with an intermittently scanned CGM device, and icodec doses were titrated weekly based on pre-breakfast CGM values (target: 80-130 mg/dL). The primary endpoint was change in HbA1c from week 0 to week 26. Exploratory endpoints included the percentage of time in range (TIR; 70-180 mg/dL), time above range (TAR; >180 mg/dL), and time below range (TBR; <54 mg/dL) from week 22 to week 26. Safety outcomes, including the number of hypoglycemia episodes, were assessed. <b><i>Results:</i></b> Of 58 participants screened, 51 received icodec treatment. HbA1c decreased from an observed mean of 8.18% at week 0 to an estimated mean of 7.00% at week 26. There was a statistically significant reduction in HbA1c of -1.17%-points (95% confidence interval: -1.36; -0.99, <i>P</i> < 0.0001). From week -2 to 0 to week 22-26, a concomitant clinically meaningful increase in TIR (54.4% to 76.4%) and decrease in TAR (45.2% to 22.9%) was observed; TBR remained low throughout the trial (week -2 to 0: 0.03%; week 22-26: 0.04%). No severe hypoglycemic episodes were reported during the trial, and no new safety concerns for icodec were identified. <b><i>Conclusion:</i></b> After 26 weeks of treatment with icodec titrated based on CGM data, there was a statistically significant reduction in HbA1c from baseline, and the internationally recommended CGM targets for TIR, TAR >180 mg/dL, and TBR <54 mg/dL were achieved. These findings suggest that CGM-based titration of icodec is a feasible method for initiating insulin therapy in T2D. <b><i>Trial registration:</i></b> ClinicalTrials.gov identifiers: NCT05823948.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"527-536"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143556095","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":"Once-Weekly Insulins.","authors":"J Hans DeVries, Tim Heise","doi":"10.1089/dia.2024.0653","DOIUrl":"10.1089/dia.2024.0653","url":null,"abstract":"<p><p>One hundred years after insulin became commercially available, new formulations are still being developed. A first once-weekly insulin has been introduced on various markets, and results of the registration studies of a second once-weekly insulin are becoming available. In this narrative review, we discuss the mechanisms of prolongation, early clinical research study results, and the registration studies of these insulins, with a critical appraisal.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"503-510"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255187","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":"Omnipod5 Real-World Data from the First Pediatric Users' Universal Coverage Under the UK National Health Service.","authors":"Sze May Ng, Zoe Tattersall, Violet Swain, Katherine Quirk, Gursagar Sandhu, Astha Soni","doi":"10.1089/dia.2024.0666","DOIUrl":"10.1089/dia.2024.0666","url":null,"abstract":"<p><p><b><i>Background:</i></b> Hybrid closed-loop (HCL) systems combine continuous glucose monitoring (CGM) with insulin pumps to automate insulin delivery through specific algorithms and user input. This real-world study aimed to evaluate the effectiveness of the Omnipod5 HCL system on HbA1c, time-in-range (TIR), hypoglycemia frequency, and sensor glucose variability over 3 and 6 months in children and young people with type 1 diabetes at two National Health Service (NHS)-funded pediatric diabetes centers in North West England. <b><i>Methods:</i></b> Children younger than 18 years in two teaching hospital-based diabetes centers were started on Omnipod5 between August 2023 and January 2024. Sensor glucose metrics and HbA1c were collected within 3 months before Omnipod5 initiation and compared at 3 and 6 months postinitiation. Metrics included % TIR (sensor glucose 70-180 mg/dL), % time above range (TAR) (sensor glucose >180 mg/dL and >250 mg/dL), and % time below range (TBR) (sensor glucose <70 mg/dL mmol/L and <54 mg/dL), with variability assessed by coefficient of variation (CV) and standard deviation (SD). <b><i>Results:</i></b> A total of 144 children were included, with 46% males and a mean age of 7.1 years (SD 4.3). The cohort was predominantly White (80%), with diabetes duration averaging 4.4 years (SD 3.9). Before Omnipod5, 54% used multiple daily injections, 41% a nonintegrated pump, and 5% another HCL system. At 3 and 6 months postinitiation, there were significant improvements in HbA1c from 7.7% (60.2 mmol/mol) to 7.1% (54.4 mmol/mol) at 3 months and 7.2% (55.2 mmol/mol) at 6 months. TIR improved from 53.3% at baseline to 67.4% at 3 months and 68.8% at 6 months), and reductions in TAR, TBR, and CV were also observed. <b><i>Conclusions:</i></b> These findings highlight the Omnipod5 system's safety and effectiveness in improving glycemic control for children and young people (CYP) with type 1 diabetes in a real-world NHS setting. Further research is needed to explore the long-term benefits and cost-effectiveness of this tubeless HCL system in routine clinical care.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"562-566"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413648","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":"Open-Source Versus Commercial Automated Insulin Delivery System for Type 1 Diabetes Management: A Prospective Observational Comparative Study from Canada.","authors":"Zekai Wu, Maha Lebbar, Anne Bonhoure, Marie Raffray, Marie Devaux, Caroline Grou, Virginie Messier, Valérie Boudreau, Andréanne Vanasse, Anne-Sophie Brazeau, Rémi Rabasa-Lhoret","doi":"10.1089/dia.2024.0561","DOIUrl":"10.1089/dia.2024.0561","url":null,"abstract":"<p><p><b><i>Objective:</i></b> This study compares unregulated open-source (OS) automated insulin delivery (AID) systems and commercial-AID (C-AID) systems regarding glucose management, patient-reported outcomes (PROs), and safety among adults with type 1 diabetes (T1D). <b><i>Methods:</i></b> We conducted a 12-week, prospective, observational, noninferiority, comparative, real-world study involving 78 adults with T1D and having used an AID system for ≥3 months (26 OS-AID and 52 C-AID users). A total of 4-week data from a blinded continuous glucose monitor was used to assess the effectiveness in glucose management (primary outcome: 24 h time in range [TIR%] for 4 weeks, with a noninferiority margin of 5%). <b><i>Results:</i></b> Our study suggested that OS-AIDs were noninferior to C-AIDs regarding the 24 h TIR% (78.3% [standard deviation or SD 11.0] vs. 71.2% [SD 10.9], mean difference 7.2% [95.08% confidence interval or CI: 1.9% to 12.5%], <i>P</i> < 0.001), even after adjusting for various confounding factors. OS-AIDs spent more time in hypoglycemia (<3.9 mmol/L) than C-AIDs (3.9% [SD 3.1] vs. 1.8% [SD 1.3], <i>P</i> < 0.001) yet within the recommended range. OS-AID users reported less fear of hypoglycemia, while other PRO measures (diabetes distress, hypoglycemia awareness, sleep, fear of hypoglycemia, treatment satisfaction, and overall quality of life) were not different between groups. No severe hypoglycemia or diabetic ketoacidosis was reported in either group, with a similar occurrence rate of technical issues during the 12-week study period. <b><i>Conclusions:</i></b> OS-AIDs are safe and noninferior to C-AIDs for TIR% among adults with T1D in real-world settings. Both OS-AID and C-AID systems can be considered for T1D management.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"517-526"},"PeriodicalIF":6.3,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656279","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":"Registration and Real-Life Studies on Automated Insulin Delivery Systems.","authors":"Halis Kaan Akturk, Sue A Brown, Roy W Beck, Jennifer L Sherr, Richard M Bergenstal, Boris P Kovatchev, Robert Vigersky, Marc D Breton, Roman Hovorka, David C Klonoff, Satish K Garg","doi":"10.1089/dia.2025.0130","DOIUrl":"https://doi.org/10.1089/dia.2025.0130","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> The Diabetes Control and Complications Trial (DCCT) clearly documented long-term beneficial effects on both micro- and macrovascular complications associated with type 1 diabetes (T1D) by using intensive insulin therapy (IIT) via multiple daily injections or insulin pumps more than 30 years ago. IIT, both during the DCCT and with translation into clinical practice, has been demonstrated to increase the risk of severe hypoglycemia and weight gain. Automated insulin delivery (AID) systems have become the standard of care in T1D management in the developed countries. <b><i>Materials and Methods:</i></b> We reviewed the registration and real-life studies for different AID systems reported to date. Many of the registration studies were sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. A systematic literature search was conducted using the MEDLINE (PubMed) database. Studies with the longest duration and/or with the largest number of participants were included. <b><i>Results:</i></b> In the last decade, the introduction of many AID systems for patients with T1D has shown improvements in glycemic metrics as documented by hemoglobin A1c values, time in range, time below range, and quality of life. Most of the registration and real-life studies have shown safe and effective use of AID systems for all age groups living with T1D. <b><i>Conclusions:</i></b> In this review, we summarize the registration and real-life studies of U.S. Food and Drug Administration-approved AID systems. Real-life studies confirmed the glycemic outcomes of AID systems reported from registration studies.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 S3","pages":"S48-S59"},"PeriodicalIF":5.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539485","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":"Impact of Meal Carbohydrate Content on Postprandial Hyperglycemia During Inpatient Use of Fully Automated Insulin Delivery.","authors":"Gabija Krutkyte, Nicolas Banholzer, David Herzig, Lia Bally","doi":"10.1089/dia.2025.0248","DOIUrl":"https://doi.org/10.1089/dia.2025.0248","url":null,"abstract":"<p><p>In this study, we aimed to explore the impact of meal carbohydrate (CHO) content on postprandial hyperglycemia in hospitalized patients receiving fully automated insulin delivery (AID). We performed a post-hoc analysis of two trials and analyzed 844 postprandial periods from 48 adults treated with fully AID (FlorenceD2W-T2 or CamAPS HX) in hospital using generalized additive regression models. Meal CHO content had a nonlinear effect on postprandial hyperglycemia risk (<i>P</i> < 0.001). Postprandial hyperglycemia was more likely at breakfast compared with lunch and dinner (odds ratio or OR [95% confidence interval or CI] 1.8 [1.2, 2.6], <i>P</i> = 0.006; and 1.5 [1.1, 2.2], <i>P</i> = 0.05, respectively) and more frequent on days with glucocorticoid administration (OR [95% CI] 3.3 [2.1, 5.1]; <i>P</i> < 0.001). In conclusion, during fully AID in hospitalized patients, the risk of postprandial hyperglycemia remained <50% for meals ≤50 g CHO. The CHO tolerance was lowest at breakfast and with concomitant glucocorticoid therapy across all meals.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144495000","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 Metrics as a Predictor of Acute Complications in Youth with Type 1 Diabetes.","authors":"Julie K Sklar, Lisa K Volkening, Liane J Tinsley, Lori M Laffel","doi":"10.1089/dia.2025.0233","DOIUrl":"https://doi.org/10.1089/dia.2025.0233","url":null,"abstract":"<p><p>Continuous glucose monitors (CGMs) offer insight into glycemic control but have not been established as predictors of acute diabetes complications. Using data from 120 youth with type 1 diabetes (ages 8-17) enrolled in a 24-month study, we investigated associations of CGM-derived metrics (time-in-range [TIR] 70-180 mg/dL, time <70, time >180, time >250, mean glucose, glucose coefficient of variation [CV]) with incidence rates of severe hypoglycemia and diabetic ketoacidosis (DKA)/severe hyperglycemia. Over 285 person-years of follow-up, there were 75 events of severe hypoglycemia and 15 events of DKA/severe hyperglycemia. TIR and CV were significantly associated with severe hypoglycemia. Those with <45% TIR had 2.09 times the rate of severe hypoglycemia than those with ≥45% TIR (<i>P</i> = 0.003). Those with CV ≥41% had 2.03 times the rate of severe hypoglycemia than those with CV <41% (<i>P</i> = 0.006). No CGM metrics were significantly associated with DKA/severe hyperglycemia. CGM data could serve as additional predictors for acute complications, particularly severe hypoglycemia.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474233","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":"Time in Tight Range Across Menstrual Cycle Phases in Women with Type 1 Diabetes Using the MiniMed 780G System: From the 780MENS Study.","authors":"Gabriela Monroy, María José Picón-César, Jorge García-Alemán, Francisco J Tinahones, José Ignacio Martínez-Montoro","doi":"10.1089/dia.2025.0234","DOIUrl":"https://doi.org/10.1089/dia.2025.0234","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144289325","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":"The Association of Continuous Glucose Monitoring Metrics with Hospital-Related Clinical Outcomes in Nonintensive Care Units.","authors":"Kristen L Flint, Mollie Y O'Connor, Amy Sabean, Annabelle Ashley, Hui Zheng, Joyce Yan, Barbara A Steiner, Nillani Anandakugan, Melissa Calverley, Rachel Bartholomew, Evelyn Greaux, Mary Larkin, Steven J Russell, Melissa S Putman","doi":"10.1089/dia.2024.0628","DOIUrl":"https://doi.org/10.1089/dia.2024.0628","url":null,"abstract":"<p><p><b><i>Aims:</i></b> We investigated the association between continuous glucose monitoring (CGM) metrics and clinical outcomes in the nonintensive care unit (non-ICU) setting. <b><i>Methods:</i></b> In this observational cohort study, patients on non-ICU floors wore blinded Dexcom G6 Pro CGM. CGM metrics and occurrence of CGM-detected severe hypoglycemia were measured. Clinical data, including infection, diabetic ketoacidosis, renal replacement therapy, thrombosis, and 30-day post-discharge readmissions and emergency department (ED) visits were identified from the medical record and participant phone interview. Multivariate regression assessed predictors of CGM-detected severe hypoglycemia and the associations between CGM metrics and clinical outcomes. Regression models using CGM data or reference glucose data were compared with receiver operating characteristic (ROC) curves. <b><i>Results:</i></b> A total of 326 hospitalized adults were enrolled with median % time in range 70-180 mg/dL 44.5% (17.1, 70.2%), % time above range >180 mg/dL 54.8% (28.8, 82.3%), and % time below range 0.6% (0, 0.2%). Predictors of severe hypoglycemia included type 1 diabetes, female gender, lower admission hemoglobin, lower A1c, and longer hospital stay. Regression analyses demonstrated an association of 30-day ED visits with increased %TAR (<i>P</i> = 0.01). ROC curves showed models using CGM data or reference data predicted clinical outcomes similarly. <b><i>Conclusions:</i></b> CGM can be useful in identifying patients at risk of inpatient hypoglycemia and 30-day ED visits.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-06-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224603","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":"Maternal Glucose and Neonatal Hypoglycemia in Pregnancy with Type 1 Diabetes: A Continuous Glucose Monitoring Cohort.","authors":"Lukana Preechasuk, Tamara Thompson, Parizad Avari, Ian Godsland, Rebecca Scott, Chukwuma Uduku, Ed Mullins, Nick Oliver, Rochan Agha-Jaffar","doi":"10.1089/dia.2024.0477","DOIUrl":"https://doi.org/10.1089/dia.2024.0477","url":null,"abstract":"<p><p>Neonatal hypoglycemia (NH) is potentially life-threatening and can lead to long-term neurological sequelae. We retrospectively assessed the association between maternal glycemia in women with type 1 diabetes (T1D) and NH. Continuous glucose monitoring data from 60 mothers, alongside routine capillary blood glucose measurements from their neonates, were analyzed. The analyses used two clinically recognized thresholds for NH (<2.2 mmol/L and <2.6 mmol/L). In total, there were 25 neonates (41.7%) with NH <2.6 mmol/L and 19 neonates (31.7%) with NH <2.2 mmol/L. Neonates with NH <2.2 mmol/L were born at a lower gestational age (37.0 [35.9, 37.7] vs. 37.6 [37.0, 38.4] weeks, <i>P</i> = 0.019), a higher proportion was exposed to antenatal corticosteroids (31.6% vs. 7.3%, <i>P</i> = 0.014), and a higher proportion required admission to the neonatal intensive care unit (42.1% vs.12.2%, <i>P</i> = 0.009). Similar associations were observed for NH <2.6 mmol/L, although admission rates to the neonatal intensive care unit did not reach statistical significance. Mixed-effects logistic regression analysis identified percentage time above range (odds ratio [OR] 1.047, 95% confidence interval [CI] 1.007-1.087, <i>P</i> = 0.01) and percentage time in range (OR 0.951, 95% CI 0.914-0.989, <i>P</i> = 0.01) as significantly associated with NH <2.2 mmol/L. Our data suggest that careful optimization of glycemia early in pregnancy, rather than in the final trimester alone, may help minimize the risk of NH in infants born to mothers with T1D.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207972","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}