Priscila Silva Cunegundes, Kenneth Wood, Li Mao, Ulrike Menkes
{"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}
Evangelos C Rizos, Georgios Markozannes, Nikolaos Charitakis, Panagiotis Filis, Anastasia E Stoimeni, Kirsten Nørgaard, Evangelia E Ntzani, Konstantinos K Tsilidis
{"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><sup>2 </sup>= 71%), decrease in TBR <70 mg/dL (WMCD -2.41, 95% CI: -3.46; -1.35, <i>I</i><sup>2 </sup>= 96%), decrease in TBR < 54 mg/dL (WMCD -1.18 95% CI: -1.9; -0.47, <i>I</i><sup>2 </sup>= 97%), decrease in TAR >180 mg/dL (WMCD -2.99, 95% CI: -5.28; -0.71, <i>I</i><sup>2</sup> = 92%), decrease in TAR >250 mg/dL (WMCD -3.99, 95% CI: -5.76; -2.21, <i>I</i><sup>2 </sup>= 92%), and increase in TIR 70-180 mg/dL (WMCD 5.57, 95% CI: 4.13; 7.01, <i>I</i><sup>2 </sup>= 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><sup>2 </sup>= 52%), decrease in TAR > 180 mg/dL (WMCD -6.32, 95% CI: -9.87; -2.78, <i>I</i><sup>2 </sup>= 84%), decrease in TAR > 250 mg/dL (WMCD -5.73, 95% CI: -8.96; -2.49, <i>I</i><sup>2 </sup>= 89%), and increase in TIR 70-180 mg/dL (WMCD 5.46, 95% CI: 2.76; 8.16, <i>I</i><sup>2 </sup>= 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><sup>2 </sup>= 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><sup>2 </sup>= 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}
Richard M Bergenstal, Björg Ásbjörnsdóttir, Tanvir Johanning Bari, Satish Hulkund, Yvonne Winhofer, Carol Wysham
{"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}
Banshi Saboo, Satish Garg, Richard M Bergenstal, Tadej Battelino, Antonio Ceriello, Pratik Choudhary, Martin De Bock, Nancy Elbarbary, Gregory Forlenza, Ana Maria Gomez, Bruno Grassi Corrales, Julia Mader, David O'Neal, Peter Schwarz
{"title":"A Call-to-Action to Eliminate Barriers to Accessing Automated Insulin Delivery Systems for People with Type 1 Diabetes.","authors":"Banshi Saboo, Satish Garg, Richard M Bergenstal, Tadej Battelino, Antonio Ceriello, Pratik Choudhary, Martin De Bock, Nancy Elbarbary, Gregory Forlenza, Ana Maria Gomez, Bruno Grassi Corrales, Julia Mader, David O'Neal, Peter Schwarz","doi":"10.1089/dia.2025.0028","DOIUrl":"10.1089/dia.2025.0028","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"147-151"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143467401","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}
Boris P Kovatchev, Benjamin Lobo, Chiara Fabris, Mohammadreza Ganji, Anas El Fathi, Marc D Breton, Lauren Kanapka, Craig Kollman, Tadej Battelino, Roy W Beck
{"title":"The Virtual DCCT: Adding Continuous Glucose Monitoring to a Landmark Clinical Trial for Prediction of Microvascular Complications.","authors":"Boris P Kovatchev, Benjamin Lobo, Chiara Fabris, Mohammadreza Ganji, Anas El Fathi, Marc D Breton, Lauren Kanapka, Craig Kollman, Tadej Battelino, Roy W Beck","doi":"10.1089/dia.2024.0404","DOIUrl":"10.1089/dia.2024.0404","url":null,"abstract":"<p><p><b><i>Objective:</i></b> Using a multistep machine-learning procedure, add virtual continuous glucose monitoring (CGM) traces to the original sparse data of the landmark Diabetes Control and Complications Trial (DCCT). Assess the association of CGM metrics with the microvascular complications of type 1 diabetes observed during the DCCT and establish time-in-range (TIR) as a viable marker of glycemic control. <b><i>Research Design and Methods:</i></b> Utilizing the DCCT glycated hemoglobin data obtained every 1 or 3 months plus quarterly 7-point blood glucose (BG) profiles in a multistep procedure: (i) utilized archival BG traces to model interday BG variability and estimate glycated hemoglobin; (ii) trained across the DCCT BG profiles and associated each profile with an archival BG trace; and (iii) used previously identified CGM \"motifs\" to associate a CGM trace to a BG trace, for each DCCT participant. <b><i>Results:</i></b> TIR (70-180 mg/dL) computed from virtual CGM data over 14 days prior to each glycated hemoglobin measurement reproduced the observed glycemic control differences between the intensive and conventional DCCT groups, with TIR generally >60% and <40% in these groups, respectively. Similar to glycated hemoglobin, TIR was associated with the risk of development or progression of retinopathy, nephropathy, and neuropathy (all <i>P</i>-values <0.0001). Poisson regressions indicated that TIR predicted retinopathy and microalbuminuria similarly to the original glycated hemoglobin data. <b><i>Conclusions:</i></b> The landmark DCCT was revisited using contemporary data science methods, which allowed adding individual CGM traces to the original data. Fourteen-day CGM metrics predicted microvascular diabetes complications similarly to glycated hemoglobin. <b><i>Clinical Trials Registration:</i></b> Not a clinical trial.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":" ","pages":"209-216"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946160","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":"Diabetes Technology in the \"Real World\": Employing New Paradigms to Improve Outcomes and Address Disparities.","authors":"Stuart A Weinzimer, Ananta Addala","doi":"10.1089/dia.2025.8812.saw","DOIUrl":"https://doi.org/10.1089/dia.2025.8812.saw","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 S1","pages":"S173-S182"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647714","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":"Emerging Trends in MAFLD and MASH.","authors":"Samita Garg, Nizar N Zein","doi":"10.1089/dia.2025.8818.sg","DOIUrl":"https://doi.org/10.1089/dia.2025.8818.sg","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 S1","pages":"S227-S237"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647748","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}
Francesco Prattichizzo, Antonio Ceriello, Viral N Shah
{"title":"Obesity and Diabetes.","authors":"Francesco Prattichizzo, Antonio Ceriello, Viral N Shah","doi":"10.1089/dia.2025.8817.fp","DOIUrl":"https://doi.org/10.1089/dia.2025.8817.fp","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 S1","pages":"S220-S226"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647765","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}