Diabetes technology & therapeutics最新文献

{"title":"Nocturnal Hypoglycemia: Characterization with Continuous Glucose Monitoring in a Real-World Setting.","authors":"Michael Mitter, Delphine Theodorou, Bernhard Ruch, Timor Glatzer, Josip Zivkovic","doi":"10.1177/15209156251369884","DOIUrl":"10.1177/15209156251369884","url":null,"abstract":"<p><p><b><i>Background:</i></b> Nocturnal hypoglycemia is a common complication in people with diabetes. The use of continuous glucose monitoring (CGM) has reduced the frequency of hypoglycemia and improved its clinical characterization; however, available CGM data mostly focus on overall or diurnal hypoglycemia in people with type 1 diabetes (T1D). This real-world study compared the frequency and duration of nocturnal versus diurnal hypoglycemia in people with T1D or type 2 diabetes (T2D) and evaluated the subsequent impact of nocturnal hypoglycemia on daytime glucose profiles. <b><i>Methods:</i></b> Between January 2010 and September 2023, CGM data during the first month of use were collected retrospectively from people with T1D (<i>n</i> = 3696) or T2D (<i>n</i> = 441) using multiple daily insulin injections. Hypoglycemic events were identified as CGM readings: <70 mg/dL or <54 mg/dL for at least 15 min. The incidence and duration of hypoglycemic events were calculated for diurnal and nocturnal periods. The effect of nocturnal hypoglycemic events on glycemia the following day was assessed. <b><i>Results:</i></b> Nocturnal hypoglycemia occurred less frequently than diurnal events in both persons with T1D (median [interquartile range, IQR] 0.54 [0.0, 1.5] vs. 2.25 [0.64, 5.25] events per week) and those with T2D (median [IQR] 0 [0.0, 0.52] vs. 0.30 [0.0, 1.21] events per week). In T1D, nocturnal hypoglycemia events had a 65-min median duration compared with 40 min for diurnal events (<i>P</i> < 0.001). Similar trends were observed in T2D, with nocturnal hypoglycemia events lasting 57 min versus 40 min diurnally (<i>P</i> < 0.001). Significant changes in multiple glycemic parameters were observed during days following nocturnal hypoglycemic events versus days following nights without hypoglycemia. These findings suggest a heightened risk of morning hypoglycemia following nocturnal hypoglycemia. <b><i>Conclusion:</i></b> These results showed that nocturnal hypoglycemia is characterized by longer duration and slower recovery than daytime hypoglycemia, with significant effects on next-day glycemic control, which emphasizes the need for improved prevention strategies.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946222","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":"Accuracy of Dexcom G6 Pro and G7 Continuous Glucose Monitors in Patients Treated with Maintenance Dialysis.","authors":"Leila R Zelnick, Subbulaxmi Trikudanathan, Yoshio N Hall, Ernest Ayers, Lisa Anderson, Nathaniel Ashford, Evelin Jones, Andrew N Hoofnagle, Ian H de Boer, Irl B Hirsch","doi":"10.1177/15209156251368934","DOIUrl":"10.1177/15209156251368934","url":null,"abstract":"<p><p><b><i>Background and Aims:</i></b> Continuous glucose monitors (CGMs) can comprehensively assess glycemic patterns in patients treated with dialysis, in whom conventional biomarkers such as glycated hemoglobin are inaccurate. Nonetheless, adoption of recent versions of CGMs in this population has been complicated by concerns about interstitial volume expansion, interfering substances, and effects of dialysis treatment. This study aimed to examine the accuracy of the G6 Pro and G7 CGM systems (Dexcom, Inc.) compared with self-monitored blood glucose (SMBG) in a dialysis population. <b><i>Methods:</i></b> Twelve participants treated with maintenance dialysis (11 hemodialysis, 1 peritoneal dialysis [PD]) with diabetes wore concurrent G6 Pro and G7 CGMs for a period of 10 days, during which they measured SMBG using a Contour Next glucometer. We summarized CGM-glucometer Pearson correlations, calculated the mean absolute relative difference (MARD) of G6 Pro/G7 and SMBG, created Diabetes Technology Society (DTS) error grids, and investigated the CGM lag time that most closely corresponded with SMBG. <b><i>Results:</i></b> Mean (standard deviation [SD]) age of participants was 50 (12) years, 50% were female, mean (SD) diabetes duration was 24 (9) years, and 92% used insulin. Participants collected 245 SMBG measurements over a total of 178 days of CGM. The Pearson correlations of G6 Pro and SMBG, G7 and SMBG, and G6 Pro and G7 were 0.87, 0.88, and 0.95, respectively. The MARDs of G6 Pro versus SMBG and G7 versus SMBG were 21.2% and 16.7%, respectively; excluding one PD participant with highly variable glucose, MARDs were 18.3% and 13.5%. The DTS error grids showed that 96.7% of G6 Pro and 98.0% of G7 measurements were clinically acceptable (Zones A/B) when compared with SMBG. We observed evidence of greater lag times than previously seen in nondialysis populations and substantial between- and within-person variability in CGM performance. <b><i>Conclusions:</i></b> Among patients with diabetes treated with maintenance dialysis, CGM measurements of glucose had high correlation with SMBG, with better performance of the G7 compared with G6 Pro. MARD was higher than previously reported in nondialysis populations, but most values fell within clinically acceptable ranges. While issues around lag time, sensor placement, and interfering substances that may impact CGM performance warrant further investigation, our study findings support the use of CGM to evaluate glycemia in the dialysis population.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871950","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":"Safety and Glycemic Outcomes of the MiniMed 780G System with a Disposable All-in-One Sensor.","authors":"Laura M Nally, Jennifer L Sherr, Satish K Garg, Brynn E Marks, Lori M Laffel, Catherine Pihoker, Siham D Accacha, James R Thrasher, M Jennifer Abuzzahab, John H Reed, Laya Ekhlaspour, Sonali Belapurkar, Dorothy I Shulman, Bhuvana Sunil, Sarah A MacLeish, Kashif Latif, Gregory P Forlenza, Kristin Castorino, Rayhan A Lal, Bruce W Bode, Frances E Broyles, Anders L Carlson, Benjamin U Nwosu, John Shin, Haoxi Ma, Alysha Salbato, Toni L Cordero, Yuri Treminio, Jennifer J McVean, Andrew S Rhinehart, Robert A Vigersky","doi":"10.1177/15209156251368928","DOIUrl":"10.1177/15209156251368928","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> The present study assessed the impact of the disposable Simplera Sync™ sensor with the MiniMed™ 780G (MM780G) advanced hybrid closed-loop (AHCL) system on type 1 diabetes (T1D) glycemic metrics, insulin delivery, and safety. <b><i>Materials and Methods:</i></b> Youths (aged 7-17 years) and adults (aged 18-80 years) with T1D were enrolled in this single-arm, nonrandomized study at 24 sites in the United States. Participants began with an ∼2-week run-in period where hybrid closed-loop (HCL; auto basal only) or open-loop insulin delivery was used, followed by an ∼3-month study period with AHCL activated. Glycemic outcomes and insulin delivery during the last 6-7 weeks of the study, when settings were optimized at investigator's discretion, were compared with the run-in. Glycemic outcomes with the use of recommended optimal settings (ROS, 100 mg/dL glucose target with a 2-h active insulin time) were explored. <b><i>Results:</i></b> Time in automation was high (>93%) and mean time in range (TIR) increased from 54.4% ± 15.7% to 71.4% ± 9.9% (<i>P</i> < 0.001) in youths and from 66.5% ± 12.6% to 80.2% ± 8.1% (<i>P</i> < 0.001) in adults, primarily due to reduced time above range. Youths had a slight increase in time below range (TBR <70 mg/dL) from 1.6% ± 1.7% to 1.9% ± 1.4% (<i>P</i> < 0.001), while adults had no significant difference in TBR. For ROS users, TIR was 74.7% ± 9.3% in youths and 83.8% ± 7.4% in adults. Throughout the study ∼60% of total daily insulin dose was automated (auto basal and auto correction) in both cohorts. There were two cases of severe hypoglycemia and one episode of diabetic ketoacidosis (not related to the device). <b><i>Conclusions:</i></b> MM780G use with the Simplera Sync sensor is safe and demonstrated improved glycemic outcomes in both pediatric and adult participants with T1D, compared with the run-in period.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871952","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 Evaluation of Artificial Intelligence-Based Diabetic Retinopathy Screening Using the Optomed Aurora Handheld Fundus Camera.","authors":"Petri Huhtinen, Anna-Maria Kubin, Kamila Dvořák, Martin Sliva, Jan Bayer, Nina Hautala","doi":"10.1177/15209156251369886","DOIUrl":"10.1177/15209156251369886","url":null,"abstract":"<p><p>Diabetic retinopathy (DR) is a common and potentially sight-threatening complication of diabetes. Early detection of DR through screening can prevent visual loss. Handheld fundus cameras combined with artificial intelligence (AI) technology may improve DR screening. We evaluated the Aireen AI algorithm's performance in grading DR in fundus images captured by the handheld Optomed Aurora. Two retina specialists and Aireen graded 624 fundus images for DR. Sensitivity, specificity, and predictive values were measured against the ophthalmologists' grading. Overall, 97% of images were sufficient for DR classification. Aireen demonstrated 94.8% sensitivity, 91.4% specificity, and 92.7% diagnostic accuracy for DR. Aireen showed high diagnostic accuracy in detecting DR in Optomed Aurora images, suggesting its potential for effective screening. The validated use of AI with a handheld fundus camera may streamline the screening process, reduce the burden on health care professionals, and improve access to screening and patient outcomes through enhanced diagnostic accuracy.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144871951","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 Virtual DCCT #3: Relationship of HbA1c and CGM Metrics with Cardiovascular Outcomes.","authors":"William B Horton, Boris P Kovatchev, Lauren G Kanapka, Roy W Beck","doi":"10.1177/15209156251369538","DOIUrl":"10.1177/15209156251369538","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Using a multistep machine-learning approach, the aim is to create virtual continuous glucose monitoring (CGM) traces from glycemic data collected in the Diabetes Control and Complications Trial (DCCT) to assess the relationship between CGM metrics and DCCT cardiovascular (CV) outcomes in people with type 1 diabetes. <b><i>Research Design and Methods:</i></b> Utilizing the virtual CGM traces created for each DCCT participant, as previously published, discrete Cox proportional hazard models were used to calculate hazard ratios (HRs) for the association between glycemic metrics (hemoglobin A1c [HbA1c] and virtual CGM) and 3 separate DCCT CV outcome definitions: (1) all DCCT-recorded events; (2) a restricted set of \"hard\" CV end points; and (3) a restricted set of major CV and major peripheral vascular events. <b><i>Results:</i></b> Mean HbA1c and CGM metrics reflective of hyperglycemia were consistently higher, and time-in-range (70-180 mg/dL) and time-in-tight-range (70-140 mg/dL) were consistently lower, in DCCT participants who experienced a CV outcome versus those who did not. For the outcome definition encompassing all CV events, specific adjusted HRs for a CV outcome per a 1 standard deviation (SD) change in glucose metrics were 1.29 for HbA1c with nearly identical values of 1.29-1.31 for relevant CGM metrics. A similar pattern was seen when assuming a 0.5 SD change in glucose metrics. Notably, there was no increased risk for experiencing a CV outcome as time-below-range increased, and in fact, there was a trend toward a slightly protective effect when assuming either a 1- or 0.5-SD change in virtual hypoglycemia metrics. <b><i>Conclusions:</i></b> Virtual CGM metrics are associated with CV outcomes in people with type 1 diabetes. These findings support the case for CGM metrics to be included as clinical trial primary endpoints for this population.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844853","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":"Trends in Total Daily Dose and Variability of Insulin Requirements in Newly Diagnosed Children and Adolescents with Type 1 Diabetes over 48 Months.","authors":"Chloë Royston, Julia Ware, Janet M Allen, Malgorzata E Wilinska, Sara Hartnell, Ajay Thankamony, Tabitha Randell, Atrayee Ghatak, Rachel E J Besser, Daniela Elleri, Nicola Trevelyan, Fiona M Campbell, Roman Hovorka, Charlotte K Boughton","doi":"10.1177/15209156251369882","DOIUrl":"10.1177/15209156251369882","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To evaluate trends in insulin delivery and day-to-day variability of insulin requirements over 48 months of hybrid closed-loop use following diagnosis of type 1 diabetes (T1D) in individuals aged 10-16 years. <b><i>Methods:</i></b> A secondary analysis of the closed-loop arm of an open-label, multicenter, randomized, parallel hybrid closed-loop trial assessing closed-loop insulin delivery in newly diagnosed children and adolescents with T1D was conducted. Mean total daily dose (TDD) over 24 h and during the night, as well as mean total basal and bolus insulin over 24 h, were calculated. Day-to-day variability of insulin requirements was evaluated over 24 h and at night. <b><i>Results:</i></b> TDD increased from 27.2 ± 16.1 units/d (mean ± standard deviation) at 0-3 months following diagnosis to 65.7 ± 24.9 units/d at 42-48 months. The proportion of total daily insulin delivered as basal insulin rose from 41% to 61% over 48 months. Day-to-day variability of insulin requirements after diagnosis was high (coefficient of variation at 0-3 months: 23.3 ± 0.9%) and remained stable over 48 months. No clinically relevant sex-based differences were observed in insulin requirements. <b><i>Conclusions:</i></b> During the first 48 months after diagnosis of T1D, insulin requirements in children and adolescents more than double with hybrid closed-loop insulin delivery. Over time, a greater proportion of insulin is administered via the closed-loop algorithm, and the high day-to-day variability in insulin needs underscores the importance of initiating adaptive closed-loop systems from diagnosis.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844854","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> Use of an Advanced Hybrid Closed-Loop Insulin Delivery System in a Hemodialysis Patient with Type 1 Diabetes and Anorexia Nervosa: A Case Report.","authors":"Akinori Hayashi, Haruna Sogabe, Mai Taneda, Takuma Fujita, Yuiko Tani, Nagisa Aoki, Yoshiki Ko, Satoshi Tsuji, Haremaru Kubo, Takeshi Miyatsuka","doi":"10.1177/15209156251368942","DOIUrl":"https://doi.org/10.1177/15209156251368942","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844850","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":"Accuracy of Dexcom G6 Pro Continuous Glucose Monitor in the Intensive Care Setting: TIGHT ICU G6 Study.","authors":"Jagdeesh Ullal, Charles Spanbauer, Jesica D Baran, Rajlaxmi Bais, Hou-Hsien Chiang, Jing H Chao, Dori Khakpour, Patrisia Panfil, Francisco J Pasquel, Nikola Gligorijevic, Morgan S Jones, Cecilia C Low Wang, John B Buse, Boris Draznin, Judy Sibayan, Craig Kollman, Roy W Beck, Irl B Hirsch","doi":"10.1177/15209156251368933","DOIUrl":"https://doi.org/10.1177/15209156251368933","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To evaluate the accuracy of the Dexcom G6 Pro continuous glucose monitoring (CGM) system in the intensive care unit (ICU) setting. <b><i>Methods:</i></b> We performed a prospective, observational, multicenter study in adult ICU patients with a known diagnosis of diabetes or stress hyperglycemia who were being treated with insulin. Two Dexcom G6 Pro sensors were placed. Sensor accuracy was assessed by pairing sensor and blood glucose (BG) measurements obtained as a part of usual ICU care. Accuracy of the G6 Pro also was assessed concurrently in non-ICU hospitalized individuals. <b><i>Results:</i></b> A total of 130 participants were enrolled, with mean (±SD) age of 62 ± 12 years, and preexisting diabetes was present in 73% and stress hyperglycemia in 27%. A total of 9120 sensor-BG pairs were analyzed. The mean relative absolute difference (RAD) was 23% (median 19%), with a mean difference of +25 mg/dL (median 25 mg/dL). Forty-one percent of sensor glucose values were within 15% of BG values for BG values ≥100 mg/dL or within 15 mg/dL of BG values for BG values <100 mg/dL, 53% within 20%/20 mg/dL, and 72% within 30%/30 mg/dL. For the two sensors worn simultaneously, the mean absolute difference was 24 mg/dL (median 19 mg/dL) and the mean RAD was 14% (median 11%). In the non-ICU setting (<i>N</i> = 60; 1318 sensor-BG pairs), the mean difference was 24 mg/dL (median 21 mg/dL) and the mean RAD was 21% (median 17%). <b><i>Conclusions:</i></b> Accuracy of the Dexcom G6 Pro sensor in the ICU setting was worse than has previously been reported for this sensor, with sensor values tending to be biased high. However, this appears to be a function of the G6 Pro sensor and not the setting as similar results were obtained in a non-ICU setting. Results should not be generalized to the real-time G6 or other sensors.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844851","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":"Cost Analysis of the FreeStyle Libre Systems in People with Type 2 Diabetes Mellitus on Basal Insulin with Poor Glycemic Control: A Spanish Perspective.","authors":"Francisco Javier Ampudia-Blasco, Alberto de la Cuadra-Grande, Virginia Bellido, Ana María Cebrián-Cuenca, Pedro Mezquita-Raya, Juana Carretero-Gómez, Antonio-Miguel Hernández Martínez, Itziar Oyagüez, Fernando Gómez-Peralta","doi":"10.1177/15209156251363576","DOIUrl":"https://doi.org/10.1177/15209156251363576","url":null,"abstract":"<p><p><b><i>Background and Aims:</i></b> FreeStyle Libre® systems are effective and convenient glucose flash monitoring (FM) devices. This cost analysis compared FM versus self-monitoring of blood glucose (SMBG) in poorly controlled (glycated hemoglobin [HbA1c] >8%) patients with type 2 diabetes (T2D) on basal insulin in Spain. <b><i>Methods:</i></b> A model was used to compare the costs of FM and SMBG in a 1000-patient cohort. All model inputs were sourced from scientific literature and validated by a multidisciplinary experts' group. Unitary costs were included in euros (2025), including value-added tax (VAT). The daily use of 2.5 strips (€0.57/strip) and 2.5 lancets (€0.14/lancet) was considered for SMBG according to Spanish recommendations. The events/person-year was 2.5 for severe hypoglycemic events (SHEs) (€1403.03/event), 17.02 for non-SHEs (NSHEs) (€3.92/event), and 0.0025 for diabetic ketoacidosis (DKA) (€2523.93/event). FM reduced the use of strips/lancets (-83.0%; sensor: €3.00/day) and acute events (NSHEs/SHEs: -58.0%; DKA: -68.0%). Sensitivity analyses were conducted to test robustness. Two additional scenarios were studied, including chronic diabetic complications (absolute reduction in HbA1c with FM: -1.1%) and absenteeism-related costs (reduction in absenteeism with FM: -58.4%). <b><i>Results:</i></b> The annual cost per patient was €3299.99 with SMBG and €2320.20 with FM. In 1000 patients, FM averted 2162 NSHEs (FM vs. SMBG: -€66,672), 1450 SHEs (FM vs. SMBG: -€2,579,224), and 1.5 DKA (FM vs. SMBG: -€6310), producing total cost savings of €979.706 compared with SMBG. All sensitivity analyses confirmed cost savings of FM versus SMBG, even when strips/lancets were free (-€442,117) or assuming a lower SHE frequency (1.4 events/patient-year; -€321,488). In 1000 patients, when considering chronic diabetic complications (SMBG: €3,745,869; FM: €2,886,785) and absenteeism (SMBG: €237,990; FM: €99,004), the annual cost savings of FM versus SMBG rose to €1,997,777. <b><i>Conclusions:</i></b> FreeStyle Libre could reduce acute events, chronic diabetic complications, and work absenteeism in poorly controlled patients with T2D on basal insulin, generating cost savings for the Spanish health system and society.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844852","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":"A Multicenter Study of an Investigational Extended Wear Insulin Infusion Set in Adults with Type 1 Diabetes.","authors":"Rayhan A Lal, John W Lum, Zachariah W Reed, Davida Kruger, John Chip Reed, Ruth S Weinstock, Anders L Carlson, Yogish C Kudva, David Liljenquist, Erin C Cobry, Camilla M Levister, Grazia Aleppo, Jean Chen, David T Ahn, Irl B Hirsch, Melissa S Putman, Frances Broyles, Jordan E Pinsker, Matt Romey, Alayne Lehman, Douglas B Muchmore, Craig Kollman, Roy W Beck","doi":"10.1177/15209156251364548","DOIUrl":"https://doi.org/10.1177/15209156251364548","url":null,"abstract":"<p><p><b><i>Objective:</i></b> To evaluate the function and safety of the SteadiSet™ infusion set over a continuous 7-day wear period in adults with type 1 diabetes. <b><i>Research Design and Methods:</i></b> Participants used a SteadiSet infusion set with a t:slim X2™ insulin pump with Control-IQ™ technology, and either insulin aspart or insulin lispro, for a target of 7 days for 12 consecutive wear periods. Each set removed before 7 days was adjudicated by an independent committee to assess the cause of early removal and to determine whether criteria for primary or key secondary endpoints were met. <b><i>Results:</i></b> There were 260 participants who inserted 3028 infusion sets. For the primary endpoint, the Kaplan-Meier 7-day survival estimate was 95% (95% CI 94% to 96%). For the key secondary endpoint, which expanded the reasons for a failed infusion set, the Kaplan-Meier 7-day survival estimate was 84% (95% CI 82% to 86%). For both endpoints, the <i>P</i> value was <0.001 compared with a prespecified survival rate of 75%. Time-in-range 70-180 mg/dL (TIR) increased through day 3 of set wear and then decreased through day 7, with the average TIR being 70.6% over the entire wear period across all infusion sets, including those that failed. An increase in total daily insulin was observed from day 4 through day 7. <b><i>Conclusions:</i></b> The 7-day survival of the SteadiSet infusion set was very high for the primary endpoint and at an acceptable level with respect to early removal for any reason related to the device.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144803864","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}