Diabetes technology & therapeutics最新文献

{"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}

{"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":"Virtual Clinics for Diabetes Care.","authors":"Satish K Garg, Drew Renner, Amanda Rewers","doi":"10.1089/dia.2025.8801.skg","DOIUrl":"https://doi.org/10.1089/dia.2025.8801.skg","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 S1","pages":"S2-S13"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647822","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 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}

{"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}

{"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}

{"title":"Technologies in Diabetes-the Sixteenth ATTD Yearbook.","authors":"Moshe Phillip, Tadej Battelino","doi":"10.1089/dia.2025.8819","DOIUrl":"https://doi.org/10.1089/dia.2025.8819","url":null,"abstract":"","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 S1","pages":"S1"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647797","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 13-Week Single-Arm Evaluation of Inhaled Technosphere Insulin Plus Insulin Degludec for Adults with Type 1 Diabetes.","authors":"Roy W Beck, Ryan J Bailey, Halis K Akturk, Shafaq Rizvi, Yogish Kudva, Thomas Blevins, Mei Mei Church, Anastasios Manessis, Peter Calhoun, Katrina J Ruedy, Irl B Hirsch","doi":"10.1089/dia.2024.0581","DOIUrl":"https://doi.org/10.1089/dia.2024.0581","url":null,"abstract":"<p><p><b><i>Background:</i></b> Inhaled technosphere insulin (TI, Afrezza®) has a more rapid onset of action than rapid-acting insulin analogs (RAA). <b><i>Methods:</i></b> Forty-nine adults with type 1 diabetes (T1D) initiated a regimen of TI plus insulin degludec for 13 weeks after completing 17 weeks in the usual-care control group of a randomized trial. The initial TI dose, based on bioequivalence, was approximately two times the RAA dose being used. The primary outcome was noninferiority for daytime time-in-range (TIR) 70-180 mg/dL at 13 weeks. <b><i>Results:</i></b> During the preceding 17-week period (baseline), 41% of the 49 participants were using automated insulin delivery (AID), 6% a predictive-low-glucose-suspend pump, 4% a sensor-augmented pump (SAP), and 49% multiple daily injections (MDI) plus continuous glucose monitoring. Daytime TIR increased from 50% ± 17% at baseline to 55% ± 20% after 13 weeks (mean change 5.1%, 95% confidence interval [CI]: 0.3% to 9.8%, noninferiority <i>P</i> < 0.001, superiority <i>P</i> = 0.04), with an increase of 8.6% compared with baseline MDI/SAP and no change compared with baseline AID. Mean HbA1c change from baseline was -0.23% (95% CI: -0.42% to -0.04%, noninferiority <i>P</i> < 0.001, superiority <i>P</i> = 0.02), with mean change of -0.36% compared with MDI/SAP and 0.0% compared with AID. Participants meeting the HbA1c target of <7.0% increased from 14% to 31% (<i>P</i> = 0.02). Among baseline AID users, overnight TIR decreased by 15.6% when switched to TI-degludec, whereas among baseline MDI/SAP users, overnight TIR increased by 2.0%. Mean time <54 mg/dL was 0.5% ± 0.7% at baseline and 0.7% ± 0.8% after 13 weeks (mean change 0.2%, 95% CI: -0.1% to 0.5%). After 13 weeks, 40% of participants indicated a desire to continue using TI. <b><i>Conclusions:</i></b> In adults with T1D, glycemic outcomes were comparable or slightly better with TI-degludec after switching from AID or MDI. TI should be considered as an option for individuals who want an alternative to using an insulin pump or MDI for insulin delivery.</p>","PeriodicalId":11159,"journal":{"name":"Diabetes technology & therapeutics","volume":"27 3","pages":"161-169"},"PeriodicalIF":5.7,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647675","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}