Diabetes technology & therapeutics最新文献

{"title":"Accuracy of Two Continuous Glucose Monitors Differs after Hydroxyurea in Pediatric Patients Undergoing Total Pancreatectomy with Islet Autotransplantation.","authors":"Jennifer M Ladd, Kajal Gandhi, Kelly Friesner-Gephart, Robert P Hoffman, Mary Joy Okafor, Christie Heinzman, Cheryl E Gariepy, Sara K Rasmussen, Jaimie D Nathan, A Jay Freeman","doi":"10.1089/dia.2025.0010","DOIUrl":"https://doi.org/10.1089/dia.2025.0010","url":null,"abstract":"<p><p><b><i>Background:</i></b> Total pancreatectomy with islet autotransplantation (TPIAT) requires strict glycemic management for islet survival using insulin pumps and continuous glucose monitors (CGMs). Hydroxyurea prevents reactive thrombocytosis but interferes with the accuracy of the Dexcom CGM. Hydroxyurea is reported to not interfere with the Libre CGM but has not been studied after TPIAT. <b><i>Methods:</i></b> Seven patients wore both Dexcom and Libre starting approximately a week after TPIAT. Dexcom and Libre values were obtained with point-of-care testing blood glucose (POCT BG) at 560 unique time points. Descriptive statistics included median, interquartile range (IQR), absolute difference between CGM and POCT, and mean absolute relative difference (MARD) for each Dexcom and Libre. Wilcoxon-Mann-Whitney tests were performed to compare parameters between Dexcom and Libre, with two-sided significance of <i>P</i> < 0.05. Clarke error grids and boxplots were constructed. <b><i>Results:</i></b> In the 9 h after hydroxyurea, median POCT BG was 110 mg/dL (IQR 88-143), median Dexcom BG was 172 mg/dL (135-219), and median Libre BG was 106 mg/dL (76-138). MARD for Dexcom was 59.5% and for Libre was 14.8% (<i>P</i> < 0.001). Median absolute difference between Dexcom and POCT BG (56 mg/dL [32-88]) was greater than that for Libre (12 mg/dL [6-23]; <i>P</i> < 0.001). In Clarke error grids, 98.3% of values fell within clinically acceptable Zones A/B for Libre; 77.9% of values fell within these zones for Dexcom. At all other times, median POCT BG was 110 mg/dL (86-133), median Dexcom BG was 124 mg/dL (97-154), and median Libre BG was 104 mg/dL (76-128). MARD for Dexcom was 19.8% and for Libre was 14.7% (<i>P</i> < 0.001). Median absolute difference between Dexcom and POCT BG (18 mg/dL [9-30]) was clinically similar to that for Libre (13 mg/dL [6-23], <i>P</i> < 0.001). <b><i>Conclusion:</i></b> Hydroxyurea does not seem to interfere with the accuracy of Libre in contrast to Dexcom. Use of Libre after TPIAT could facilitate improved glycemic management.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656266","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":"Automated Insulin Delivery Versus Standard of Care in the Management of People Living with Type 1 Diabetes and HbA1c <8%: A Cost-Utility Analysis in The Netherlands.","authors":"Erik H Serné, Maria Ida Buompensiere, Simona de Portu, Jayne Smith-Palmer, Johannes Pöhlmann, Ohad Cohen","doi":"10.1089/dia.2024.0647","DOIUrl":"https://doi.org/10.1089/dia.2024.0647","url":null,"abstract":"<p><p><b><i>Introduction:</i></b> Automated insulin delivery (AID) systems improve glycemic control in people living with type 1 diabetes (PwT1D). AID is cost-effective versus other management approaches in a range of country settings and populations. This cost-utility analysis adds an evaluation of the MiniMed^TM 780G system versus standard of care (SoC) in PwT1D and baseline glycated hemoglobin (HbA1c) level <8% not reaching glycemic targets, conducted from a societal perspective in The Netherlands. <b><i>Methods:</i></b> The analysis was run using the IQVIA CORE Diabetes Model, over 50 years. Costs were discounted at 3% per year, effects at 1.5% per year. Baseline cohort characteristics and treatment effects were sourced from the MiniMed 780G arm of a prospective multicenter study. Costs and utility estimates were taken from Dutch databases and published sources. Sensitivity analyses were conducted to address uncertainty. <b><i>Results:</i></b> AID improved life expectancy by 0.52 years and quality-adjusted life expectancy by 0.99 quality-adjusted life-years (QALYs) versus SoC. AID was associated with an incremental combined cost of EUR 28,635 due to higher acquisition costs, which were partially offset by reduced direct treatment costs for diabetes-related complications and reduced indirect costs due to less time off work. Based on combined costs, the MiniMed 780G system was associated with an incremental cost-utility ratio of EUR 29,836 per QALY gained. <b><i>Conclusions:</i></b> For PwT1D in The Netherlands, who had a baseline HbA1c <8% and do not reach glycemic targets, AID system initiation was projected to improve long-term clinical outcomes and reduce both direct costs for the treatment of diabetes-related complications and productivity losses. From a societal perspective, the MiniMed 780G likely represents good value for money in The Netherlands.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647643","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":"Evaluating the Adequacy of Coefficient of Variation and Standard Deviation as Metrics of Glucose Variability in Type 1 Diabetes Based on Data from the GOLD and SILVER Trials.","authors":"Pavel Fatulla, Henrik Imberg, Sofia Sterner Isaksson, Irl B Hirsch, Johan Mårtensson, Hanna Liljebäck, Tim Heise, Marcus Lind","doi":"10.1089/dia.2024.0540","DOIUrl":"https://doi.org/10.1089/dia.2024.0540","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Evaluate the adequacy of the coefficient of variation (CV) and standard deviation (SD) as metrics of glucose variability (GV) across mean glucose (MG) levels in individuals with type 1 diabetes. <b><i>Methods:</i></b> Data from the GOLD and SILVER trials were analyzed. Glucose metrics were derived from continuous glucose monitoring (CGM). Generalized estimating equations were used to assess the relationship between SD and MG, considering intraindividual correlations. Nonlinear associations were evaluated using restricted cubic splines, and glucose values outside the CGM detection range (<2.22 mmol/L and >22.2 mmol/L) were handled using a censored Gamma model. <b><i>Results:</i></b> In total, 158 individuals with an MG of 10.6 (SD 1.7) mmol/L were included. The SD of glucose values exhibited a nonlinear relationship with the MG during CGM and self-monitoring of blood glucose (SMBG) (both <i>P</i> < 0.001 vs. linear model). The lack of fit of the constant CV model was most distinct at high glucose levels >12 mmol/L. During SMBG, a 25% reduction in MG from 12 to 9 mmol/L was associated with a 16% (95% confidence interval [CI] 10%-21%) reduction in the SD of glucose values. Similar associations were observed during CGM. This deviation was attributed to the censoring of glucose values outside the detection range. After adjusting for censoring, the lack of fit was resolved. When transitioning from SMBG to CGM, the ordinary CV and SD underestimated the treatment effect on GV by 30% and 27%, respectively, compared to estimates adjusted for censoring. Similarly, ordinary CV underestimated the treatment effect by 11% compared with CV adjusted for the nonlinear SD-MG relationship in the GOLD study. <b><i>Conclusion:</i></b> The SD of glucose values does not increase linearly with the MG during glucose-lowering therapy, suggesting that CV is not an optimal measure of GV. After adjusting for censored glucose values, CV remains reliable. Alternatively, nonlinear SD adjustments relative to MG effectively evaluate glucose-lowering therapies' impact on GV.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656267","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":"https://doi.org/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":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","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":"Use of Glucose Monitoring Devices Among Adults with Diabetes in Germany: Results from Nationwide Surveys Conducted in 2017 and 2021/2022.","authors":"Yong Du, Jens Baumert, Maike Buchmann, Reinhard W Holl, Christin Heidemann","doi":"10.1089/dia.2024.0623","DOIUrl":"https://doi.org/10.1089/dia.2024.0623","url":null,"abstract":"<p><p><b><i>Background:</i></b> Devices for continuous glucose monitoring (CGM) have been developed to optimize blood glucose control and liberate people with diabetes from finger-prick glucose measurements. Since 2016, the devices have been reimbursed in Germany for people with diabetes receiving insulin therapy, resulting in their increased use among people with type 1 diabetes (T1D) and type 2 diabetes (T2D). We investigated the prevalence of CGM use and its associated factors among German adults with diabetes in 2017 and 2021/2022. <b><i>Methods:</i></b> Participants aged 18 years or older with diagnosed diabetes were identified from two nationwide population-based telephone surveys in 2017 (<i>n</i> = 1396) and 2021/2022 (<i>n</i> = 1456). Prevalence and dynamics of CGM use were examined overall and stratified by sociodemographic and diabetes-related characteristics. Factors associated with CGM use were obtained from logistic regression models. <b><i>Results:</i></b> The overall prevalence of CGM use was 8.2% in 2017 and 16.6% in 2021/2022. An increase in CGM use was observed across all the subgroups except for those without antidiabetic medications. CGM use increased from 31.1% to 75.4% in adults with T1D, from 6.3% to 13.6% in adults with T2D, and from 14.6% to 36.7% in all insulin users. In both surveys, younger age, insulin use, T1D, and reporting hypoglycemia were associated with CGM use. In addition, in 2017, higher education level and absence of obesity were associated with CGM use, whereas in 2021/2022, participation in the diabetes self-management education program and higher self-assessed quality of diabetes care were associated with CGM use. <b><i>Conclusion:</i></b> Among adults with diabetes in Germany, CGM use increased about twofold within 5 years, irrespective of sociodemographic factors. Educational inequality in CGM use diminished over time. The higher self-rated quality of diabetes care associated with the recent use of CGM provides further evidence to support its use among all adults with diabetes in Germany.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647660","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 Insulin Bolus Timing and Bedtime Snacking on Continuous Glucose Monitoring-Derived Glycemic Metrics in Hospitalized Inpatients.","authors":"Sara M Alexanian, Michael C Cheney, Jenny C Bello Ramos, Nicole L Spartano, Howard A Wolpert, Devin W Steenkamp","doi":"10.1089/dia.2025.0027","DOIUrl":"https://doi.org/10.1089/dia.2025.0027","url":null,"abstract":"<p><p><b><i>Objective:</i></b> In hospitalized inpatients, timely administration of prandial insulin with meals is challenging. Furthermore, the glycemic impact of snacking after dinner (\"bedtime snacking\") without prandial insulin administration has not been previously explored. We present an analysis of the impact of delayed mealtime insulin administration and bedtime snacking on inpatient glycemic control. <b><i>Research Design and Methods:</i></b> We conducted a post hoc analysis from the In-Fi study: a randomized controlled trial comparing Fiasp versus insulin aspart (Novolog) in inpatients with type 2 diabetes. Glycemic outcomes were assessed using the Dexcom G6 PRO continuous glucose monitoring (CGM). We analyzed CGM and insulin administration data from 122 randomized subjects who completed the primary study protocol, which included wearing a CGM for ≥4 meals. This analysis evaluates the impact of delayed mealtime insulin administration and bedtime snacking on glucose control. <b><i>Results:</i></b> Four-hour postprandial time in range (TIR_70-180) was 48% for insulin boluses administered before meals (<i>n</i> = 149) versus 24% when a meal bolus was delayed for >5 min after a meal (mean delay 58.7 min; <i>n</i> = 112; <i>P</i> < 0.001). Bedtime snacking (9 pm-12 am) was associated with significantly higher fasting glucose the next morning (35.2 mg/dL, standard error [SE] = 15.4, <i>P</i> = 0.026) and with a reduced overnight (9 pm-6 am) TIR_70-180 (31.9%, SE = 8.06, <i>P</i> < 0.001), adjusting for bedtime sensor glucose. Bedtime snacking was associated with higher overnight glucose standard deviation (12.3 mg/dL, SE = 3.46, <i>P</i> < 0.001) and with higher overnight glucose percentage coefficient of variation (3.6%; SE = 1.7, <i>P</i> = 0.044), adjusting for initial bedtime sensor glucose. <b><i>Conclusions:</i></b> Delayed mealtime insulin administration and bedtime snacking without insulin administration are significant causes of postprandial and overnight hyperglycemia in hospitalized inpatients. Adjustments in mealtime insulin protocols, attention to food intake, and the potential inpatient adoption of technology, such as CGM and automated insulin delivery systems, are needed to address this shortcoming in inpatient diabetes care.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604173","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":"Automated Insulin Delivery in Elderly with Type 1 Diabetes: A Prespecified Analysis of the Extension Phase.","authors":"Yogish C Kudva, Robert J Henderson, Lauren G Kanapka, Ruth S Weinstock, Michael R Rickels, Richard E Pratley, Naomi Chaytor, Kamille Janess, Donna Desjardins, Vishwanath Pattan, Amy J Peleckis, Anna Casu, Shafaq Raza Rizvi, Suzan Bzdick, Keri J Whitaker, Jorge L Jo Kamimoto, Kellee Miller, Craig Kollman, Roy W Beck","doi":"10.1089/dia.2024.0560","DOIUrl":"https://doi.org/10.1089/dia.2024.0560","url":null,"abstract":"<p><p>The Automated Insulin Delivery in Elderly with Type 1 Diabetes (AIDE T1D) trial randomized 82 adults ≥65 years with type 1 diabetes (T1D) to hybrid closed loop (HCL), predictive low glucose suspend (PLGS), and sensor-augmented pump (SAP) therapy in a randomized crossover trial. Seventy-five of the 78 completers joined an extension phase in which they were offered the pump mode of their choice for an additional 3 months. Mean age was 71 ± 4 years (range 65-86 years) and mean duration of T1D was 42 ± 17 years (range 1-68 years). Use of HCL was selected by 91%, PLGS by 8%, and continuous glucose monitoring with injections by 1%. For participants selecting HCL, time-in-range 70-180 mg/dL was similar in the randomized controlled trial and extension phase (mean 75% ± 10%). One severe hypoglycemic event was reported. HCL was preferred over PLGS or SAP and remained effective in older adults with T1D. Clinical Trial Registration: NCT04016662.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604166","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":"Phenolic Preservatives Are Not the Sole Cause of Eosinophilic Infiltration at Infusion Pump Sites.","authors":"Priscila Silva Cunegundes, Kenneth Wood, Li Mao, Ulrike Menkes","doi":"10.1089/dia.2025.0043","DOIUrl":"10.1089/dia.2025.0043","url":null,"abstract":"<p><p><b><i>Background:</i></b> Skin reactions and discomfort associated with insulin infusion pumps limit user adherence. A recent histopathological study by Kalus et al. (DERMIS study) reported increased eosinophilic infiltration and imputed an inflammatory response to an allergen delivered at the catheter tip. This finding might explain the pruritus reported by pump users. As eosinophils migrate to inflammatory foci, primarily due to IL-5 and CCL11, we aimed to evaluate insulin phenolic preservative (IPP) as a potential allergen in vitro and assess tissue eosinophilic infiltration in vivo. <b><i>Methods:</i></b> Histopathological evaluations for eosinophil recruitment were performed over 1 week following IPP infusions in swine tissue. Additional histopathological investigations of eosinophilic infiltration were conducted using three commercial glucose sensors implanted in swine for up to 3 weeks. <b><i>Results:</i></b> Eosinophilic infiltration in the dermis and subcutaneous tissue was observed following saline and IPP infusion and at glucose sensor implantation at all time points examined. In vitro studies revealed IPP eosinophil cytotoxicity. However, neither CCL11 nor IL-5 was detected in any of the tested tissue cells after IPP treatment. <b><i>Conclusion:</i></b> These findings suggest that IPP is not the only triggering allergen, as IPP did not induce eosinophils in vitro, while glucose sensors also indicated increased eosinophilic infiltration. Therefore, factors other than IPP trigger eosinophil recruitment to insulin infusion pump sets.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143604176","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 in Type 1 Diabetes, Type 2 Diabetes, and Diabetes During Pregnancy: A Systematic Review with Meta-Analysis of Randomized Controlled Trials.","authors":"Evangelos C Rizos, Georgios Markozannes, Nikolaos Charitakis, Panagiotis Filis, Anastasia E Stoimeni, Kirsten Nørgaard, Evangelia E Ntzani, Konstantinos K Tsilidis","doi":"10.1089/dia.2024.0599","DOIUrl":"https://doi.org/10.1089/dia.2024.0599","url":null,"abstract":"<p><p><b><i>Background:</i></b> Continuous glucose monitoring (real-time CGM [RT-CGM] and retrospective [professional] CGM [non-RT-CGM]) is an emerging tool to assess glucose levels and variability. We performed a meta-analysis of randomized controlled trials (RCTs) to assess the effect of RT/non-RT-CGM on type 1 (T1D), type 2 (T2D), and diabetes in pregnancy (DiP) compared with self-monitoring of blood glucose (BGM). <b><i>Methods:</i></b> We searched PubMed/EMBASE/Cochrane Central Register of Controlled Trials until October 2024. The coprimary outcomes were the weighted mean change differences (WMCDs and absolute differences) from baseline in glycated hemoglobin (HbA1c) and in time in range (TIR%), time below range (TBR%), and time above range (TAR%). <b><i>Results:</i></b> A total of 64 RCTs were analyzed: (1) RT-CGM/T1D: CGM was superior to BGM for HbA1c reduction (WMCD -0.24, 95% confidence interval [CI]: -0.35; -0.14, <i>I</i>²= 71%), decrease in TBR <70 mg/dL (WMCD -2.41, 95% CI: -3.46; -1.35, <i>I</i>²= 96%), decrease in TBR < 54 mg/dL (WMCD -1.18 95% CI: -1.9; -0.47, <i>I</i>²= 97%), decrease in TAR >180 mg/dL (WMCD -2.99, 95% CI: -5.28; -0.71, <i>I</i>² = 92%), decrease in TAR >250 mg/dL (WMCD -3.99, 95% CI: -5.76; -2.21, <i>I</i>²= 92%), and increase in TIR 70-180 mg/dL (WMCD 5.57, 95% CI: 4.13; 7.01, <i>I</i>²= 84%); (2) RT-CGM/T2D: CGM was superior to BGM for HbA1c reduction (WMCD -0.40, 95% CI: -0.55; -0.24, <i>I</i>²= 52%), decrease in TAR > 180 mg/dL (WMCD -6.32, 95% CI: -9.87; -2.78, <i>I</i>²= 84%), decrease in TAR > 250 mg/dL (WMCD -5.73, 95% CI: -8.96; -2.49, <i>I</i>²= 89%), and increase in TIR 70-180 mg/dL (WMCD 5.46, 95% CI: 2.76; 8.16, <i>I</i>²= 69%); (3) RT-CGM/DiP: CGM was superior to BGM for TIR 63-140 mg/dL (WMCD: 17.77, 95% CI: 4.17; 31.36, <i>I</i>²= 92%). No benefit was shown for HbA1c, TBR < 63 mg/dL, TAR > 140 mg/dL, and most of the maternal and neonatal outcomes of interest; (4) Non-RT CGM: HbA1c significantly decreased with non-RT CGM compared with BGM in T2D (WMCD -0.35, 95% CI: -0.5; -0.2, <i>I</i>²= 19%). <b><i>Discussion:</i></b> In T1D and T2D, RT-CGM decreased HbA1c and increased time in target range for glycemia (70-180 mg/dL) while decreasing time spent in hypoglycemia (T1D) and time in hyperglycemia (T1D, T2D).</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572423","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-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":"https://doi.org/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":""},"PeriodicalIF":5.7,"publicationDate":"2025-03-05","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}