Enio A M Santos, Tatiana A Zaccara, Cristiane F Paganoti, Rossana P V Francisco, Rafaela A Costa
{"title":"Extrapolated Time in Range and Pregnancy Outcomes in Patients with Type 1 Diabetes.","authors":"Enio A M Santos, Tatiana A Zaccara, Cristiane F Paganoti, Rossana P V Francisco, Rafaela A Costa","doi":"10.1177/15209156251374706","DOIUrl":"10.1177/15209156251374706","url":null,"abstract":"<p><p><b><i>Aims:</i></b> To assess the relationship between time in range (TIR), extrapolated from self-monitoring of blood glucose (SMBG) measures, and adverse perinatal outcomes in pregnant women with type 1 diabetes (T1D). <b><i>Methods:</i></b> A retrospective cohort study was conducted, including singleton pregnancies that began antenatal care before 20 weeks of gestation and delivered live newborns without malformations between 2010 and 2019. Glycemic data from SMBG were categorized into TIR (63-140 mg/dL or 3.5-7.8 mmol/L), based on guidelines for real-time continuous glucose monitoring. Extrapolated TIR (eTIR) was defined as the proportion of time spent within the target range and categorized into three intervals: eTIR <50%, eTIR 50%-70%, and eTIR >70%. Clinical characteristics and obstetric outcomes were compared across these intervals. Multivariate logistic regression was used to evaluate the prediction of adverse outcomes, including preeclampsia, nephropathy, cesarean section, preterm birth, macrosomia, large for gestational age (LGA), small for gestational age (SGA), 5-minute Apgar score <7, shoulder dystocia, neonatal respiratory distress, neonatal hypoglycemia, and neonatal intensive care unit (NICU) admission. <b><i>Results:</i></b> Data from 140 pregnancies were analyzed. Of these, 20% had eTIR <50%, 53.6% had eTIR 50%-70%, and 26.4% had eTIR >70%. Women with eTIR 50%-70% and eTIR >70% were less likely to experience preterm birth (OR: 0.271; 95% CI: 0.094-0.786 and OR: 0.219; 95% CI: 0.058-0.826), neonatal respiratory distress (OR: 0.341; 95% CI: 0.124-0.936 and OR: 0.122; 95% CI: 0.029-0.516), and LGA infants (OR: 0.246; 95% CI: 0.084-0.719 and OR: 0.115; 95% CI: 0.028-0.469) compared with women with eTIR <50%. <b><i>Conclusions:</i></b> Higher eTIR values were associated with a reduced risk of preterm birth, neonatal respiratory distress, and LGA infants. For pregnant women with T1D, achieving an eTIR above 50% was sufficient to decrease the risk of these adverse outcomes, highlighting the importance of glucose control even in challenging circumstances.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999915","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}
Julia Ware, Simon Bergford, Peter Calhoun, Judy Sibayan, Malgorzata E Wilinska, Yue Ruan, Roman Hovorka
{"title":"Real-World Clinical Impact of Using Personal Glucose Targets in a Hybrid Closed-Loop System Differs According to Age.","authors":"Julia Ware, Simon Bergford, Peter Calhoun, Judy Sibayan, Malgorzata E Wilinska, Yue Ruan, Roman Hovorka","doi":"10.1177/15209156251376010","DOIUrl":"10.1177/15209156251376010","url":null,"abstract":"<p><p><b><i>Objective:</i></b> CamAPS FX is a customizable hybrid closed-loop app with a default target glucose of 105 mg/dL. The personal glucose target is user-adjustable in 1 mg/dL increments between 80 and 198 mg/dL in 30-min segments over 24 h. We assessed the impact of different personal glucose targets on glycemic control during real-world use of CamAPS FX in different age-groups. <b><i>Methods:</i></b> We retrospectively analyzed data from real-world CamAPS FX users from 11 countries across all age-groups (1 to 90 years), who used the system between December 1, 2022 and November 30, 2023, and had a minimum of 8 weeks of closed-loop use. Every sensor glucose reading was matched to the user-specified glucose target. <b><i>Results:</i></b> In total, 8604 users (mean age 32 ± 19 years, median days of data 89 [IQR 59, 119]) were included. Personal glucose targets were most frequently used by very young children (>50%), followed by school-aged children (>40%). All other age-groups used the default target 65%-68% of the time. Overall, personal glucose targets >120 mg/dL were associated with time in target range <70%. Time <70 mg/dL remained <4% across targets, apart from at the lowest (80-89 mg/dL). Older adults achieved time in range ≥70% across all targets. Very young children and young adults were only able to achieve time in range >70% with targets set below the default, which was associated with time <70 mg/dL of >4% in very young children. <b><i>Conclusions:</i></b> Personal glucose targets are frequently used, with clinical impact differing depending on user-age. Adjusting glucose targets may help to achieve recommended glycemic targets and individual glycemic goals.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999918","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}
Ben Ehlert, Dhruv Aron, Dalia Perelman, Yue Wu, Michael P Snyder
{"title":"Glucose360: An Open-Source Python Platform with Event-Based Integration for Continuous Glucose Monitoring Data Analysis.","authors":"Ben Ehlert, Dhruv Aron, Dalia Perelman, Yue Wu, Michael P Snyder","doi":"10.1177/15209156251374711","DOIUrl":"10.1177/15209156251374711","url":null,"abstract":"<p><p><b><i>Background and Aims:</i></b> Continuous glucose monitoring (CGM) devices provide real-time actionable data on blood glucose levels, making them essential tools for effective glucose management. Integrating blood glucose data with food log data is crucial for understanding how dietary choices impact glucose levels. Despite their utility, many CGM applications lack integration with other external services, such as food trackers, and do not generate useful glycemic variability (GV) metrics or advanced visualizations. Existing solutions vary in functionality: some are proprietary, many require additional user programming or custom preprocessing to meet diverse research needs, and few have created solutions to connect CGM data with external services. Recent reviews highlight gaps such as insufficient postprandial analytics, absence of composite indices, and inadequate tools for nontechnical users. <b><i>Methods:</i></b> Glucose360 and commonly used alternative CGM applications and tools were compared by calculating GV metrics on 60 participant datasets and by contrasting their general applications for research workflows. <b><i>Results:</i></b> To address limitations, we developed Glucose360, featuring (1) an open-source python framework for event-based CGM data integration and analysis; (2) automated calculation of glucose metrics specific for meals and exercise events and other short-interval events; and (3) a user-friendly web application, designed for users with minimal programming experience and accessible at vurhd2.shinyapps.io/glucose360/. <b><i>Discussion:</i></b> Overall, Glucose360 provides a holistic analysis pipeline that is useful for both individuals and researchers to track and analyze CGM data. The source code for Glucose360 can be found at github.com/vurhd2/Glucose360.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946228","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}
Simon Lebech Cichosz, Niels Væver Hartvig, Thomas Kronborg, Stine Hangaard, Peter Vestergaard, Morten Hasselstrøm Jensen
{"title":"Biases in Glucose Metrics Are Directly Related to Low Coverage of Continuous Glucose Monitoring: Insights from Diverse Populations.","authors":"Simon Lebech Cichosz, Niels Væver Hartvig, Thomas Kronborg, Stine Hangaard, Peter Vestergaard, Morten Hasselstrøm Jensen","doi":"10.1177/15209156251376007","DOIUrl":"10.1177/15209156251376007","url":null,"abstract":"<p><p>The aim was to investigate the association between continuous glucose monitoring (CGM) data coverage and glycemic metrics. This study included over 97,000 clinical study participants and real-world data from type 1 or type 2 diabetes treated with multiple daily insulin injections, closed-loop systems, or basal-only insulin regimens. Over 35 million days of CGM data were analyzed with multilevel modeling. Low coverage was observed in 6.4%-10.1% of days and was significantly associated with lower time in range (TIR) across sources (<i>P</i> < 0.001). Each 1% increase in coverage was associated with a within-person increase of 0.07%-0.13% in mean daily TIR (<i>P</i> < 0.001). Our analysis shows that higher daily sensor coverage is significantly associated with higher daily TIR, suggesting that missing CGM data may be missing not-at-random. Although low-coverage days are included in TIR calculations, they contribute fewer measurements and may underrepresent periods of poor glycemic control, potentially leading to a systematic overestimation and bias of overall TIR.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":6.3,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946182","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":"Review of Monogenic Diabetes: Clinical Features and Precision Medicine in Genetic Forms of Diabetes.","authors":"Erin C Cobry, Andrea K Steck","doi":"10.1089/dia.2024.0602","DOIUrl":"10.1089/dia.2024.0602","url":null,"abstract":"<p><p>Monogenic diabetes is a group of diseases that encompasses a growing number of genetic abnormalities affecting pancreatic function/development leading to glycemic dysregulation. This includes conditions that have historically been referred to as maturity onset diabetes of the young or MODY in addition to neonatal diabetes mellitus. While recognition of a genetic or inherited form of diabetes has been known for decades, advances in molecular genetic testing have resulted in identification of specific forms of monogenic diabetes. Despite this, these genetic forms of diabetes remain widely underreported. It is important to be able to identify genetic forms of diabetes as treatment, monitoring for microvascular and macrovascular complications, and overall management varies for the different forms of monogenic diabetes. Furthermore, the identification of a specific monogenic form of diabetes can significantly impact the person's quality of life and other family members, as well as health care costs. This article highlights the identification, treatment, and management for various forms of monogenic diabetes and addresses some unmet needs in caring for people with monogenic forms of diabetes.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"675-686"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143771540","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}
Michelle Katz, Christof Kazda, Jie Xue, Juan Frías, Ronald Brazg, Jit Mitra, Stephanie Gleissner, Eyal Dassau
{"title":"Safety and Functionality of a Novel Clinical Decision-Support Algorithm with Insulin Efsitora Alfa in Adults with Type 2 Diabetes: Early Feasibility Study.","authors":"Michelle Katz, Christof Kazda, Jie Xue, Juan Frías, Ronald Brazg, Jit Mitra, Stephanie Gleissner, Eyal Dassau","doi":"10.1089/dia.2025.0051","DOIUrl":"10.1089/dia.2025.0051","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> For people with type 2 diabetes (T2D), optimal glycemic control is critical. Digital health interventions are a practical approach to improve T2D self-management. This study explored the safety and functionality of a novel clinical decision-support (CDS) application for individualized dosing of insulin efsitora (efsitora), a once-weekly basal insulin receptor agonist. <b><i>Participants and Methods:</i></b> This was a 16-week, multicenter, open-label early feasibility study in adults with T2D with or without basal insulin. Investigators requested an efsitora dose from the CDS algorithm and either overrode or accepted the recommendation. Dose recommendation overrides (primary endpoint), finger-stick glucose, blinded continuous glucose monitoring metrics, and hypoglycemic events were evaluated. <b><i>Results:</i></b> Two sequential cohorts consisted of 68 participants; each cohort included insulin-naïve and basal-switch participants. In both cohorts, mean glycated hemoglobin (HbA1c) for basal-switch participants ranged from 7.9% to 8.5%. Mean HbA1c for insulin-naïve participants ranged from 8.1% to 8.3%. CDS dosing recommendation overrides occurred for 0.7% of injections for basal-switch participants and for 1.0% of injections for insulin-naïve participants in Cohort 1. For Cohort 2, overrides occurred for 1.3% of injections for insulin-naïve participants, with no overrides for basal-switch participants. HbA1c was significantly reduced <i>(P</i> < 0.05) from baseline to Week 16 in both subgroups for both cohorts. The proportion of participants with fasting blood glucose within the targets increased from baseline to Week 16 in both subgroups for both cohorts. No level 3 hypoglycemia was observed. <b><i>Conclusions:</i></b> The novel CDS algorithm showed promising clinical performance and favorable investigator confidence as determined by a low rate of dose overrides.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"737-746"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062631","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}
Martina Zahradnická, Lenka Nemétová, Michal Kahle, David Vávra, Robert Bém, Peter Girman, Martin Haluzík, František Saudek
{"title":"Glucose Control in Type 1 Diabetes after Pancreas Transplantation: Does Automated Delivery Offer Comparable Results?","authors":"Martina Zahradnická, Lenka Nemétová, Michal Kahle, David Vávra, Robert Bém, Peter Girman, Martin Haluzík, František Saudek","doi":"10.1089/dia.2024.0606","DOIUrl":"10.1089/dia.2024.0606","url":null,"abstract":"<p><p><b><i>Objectives:</i></b> Pancreas transplantation provides long-term near-normal glycemic control for recipients with type 1 diabetes, but it is unknown how this control compares with an automated insulin delivery (AID) system. <b><i>Methods:</i></b> In this prospective study, we compared parameters from 31 consecutive pancreas-kidney transplantation recipients versus from 377 people using an AID-either MiniMed<sup>TM</sup> 780G (<i>n</i> = 200) or Tandem t:slim X2<sup>TM</sup> Control-IQ<sup>TM</sup> (<i>n</i> = 177). <b><i>Results:</i></b> Compared with the MiniMed and Tandem AID groups, transplant recipients at 1 month (mean ± standard deviation [SD]: 36 ± 12 days) after pancreas transplantation exhibited significantly lower glycated hemoglobin (38 mmol/mol [36, 40] vs. 55 [53, 56.5] and 56 [54.7, 57.2], respectively), lower mean glycemia (6.4 mmol/L [6, 6.8] vs. 8.5 [8.3, 8.7] and 8.2 [8.0, 8.4], respectively), and spent more time in range (90% [86, 93] vs. 72% [70, 74] and 75% [73, 77], respectively). Time in hypoglycemia did not differ significantly between the groups. <b><i>Conclusions:</i></b> Overall, compared with AID treatment, pancreas transplantation led to significantly better diabetes control parameters, with the exception of time below range. Clinical trials registration number is Eudra CT No. 2019-002240-24.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"728-736"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699972","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}
Grazia Aleppo, Peter Calhoun, Ryan Bailey, Jordan E Pinsker, Carol J Levy, John W Lum, Roy W Beck
{"title":"Reduction of Postprandial Glucose Excursions in Adults, Adolescents, and Children with Type 1 Diabetes Using Ultra-Rapid Lispro Insulin and Control-IQ+ Technology.","authors":"Grazia Aleppo, Peter Calhoun, Ryan Bailey, Jordan E Pinsker, Carol J Levy, John W Lum, Roy W Beck","doi":"10.1089/dia.2025.0077","DOIUrl":"10.1089/dia.2025.0077","url":null,"abstract":"<p><p>This study evaluated the effects of ultra-rapid lispro (URLi) insulin versus insulin lispro on postprandial glucose excursions in 176 individuals with type 1 diabetes using Control-IQ+ technology. Postprandial glycemia differed the most between URLi and lispro at 60 min (mean glucose 166 ± 69 mg/dL vs. 178 ± 70 mg/dL; adjusted mean difference [AMD] = -11 mg/dL; <i>P</i> < 0.001). The URLi had slightly lower mean glucose excursion compared with lispro (AMD = -4 mg/dL; <i>P</i> = 0.001), but the differences between treatments were larger following breakfast (AMD = -9 mg/dL) compared with lunch (AMD = -2 mg/dL) and dinner (AMD = -2 mg/dL). Participants with insulin-to-carbohydrate ratio (ICR) <5 g/U had a larger treatment group difference favoring URLi on mean glucose excursion (AMD = -11 mg/dL) compared with those with ICR 5-15 g/U (AMD = -2 mg/dL) and ICR >15 g/U (AMD = 1 mg/dL). In conclusion, compared with insulin lispro, the use of URLi with Control-IQ+ technology modestly improved postprandial glucose excursions with the greatest amount of improvement for breakfast and in those with insulin resistance.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"753-759"},"PeriodicalIF":6.3,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763290","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}