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Burden of Current Insulin Therapy and Expectations for Future Insulin Therapy: Results from INBEING, a Web-Based Survey in Japan. 当前胰岛素治疗的负担和对未来胰岛素治疗的期望:日本网络调查 INBEING 的结果。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-11-01 DOI: 10.1007/s13300-024-01664-w
Yasuaki Hayashino, Satoshi Tsuboi, Yuiko Yamamoto, Hitoshi Ishii
{"title":"Burden of Current Insulin Therapy and Expectations for Future Insulin Therapy: Results from INBEING, a Web-Based Survey in Japan.","authors":"Yasuaki Hayashino, Satoshi Tsuboi, Yuiko Yamamoto, Hitoshi Ishii","doi":"10.1007/s13300-024-01664-w","DOIUrl":"10.1007/s13300-024-01664-w","url":null,"abstract":"<p><strong>Introduction: </strong>This survey assessed the perspectives of physicians, people with diabetes (PWD), and caregivers in Japan regarding initiation barriers and treatment burden associated with insulin therapy, and expectations for new insulin therapies.</p><p><strong>Methods: </strong>An online survey, conducted May-June 2023, was completed by physicians (n = 411), PWD (type 1 diabetes, n = 108; type 2 diabetes [T2D]: insulin-naive, n = 114; insulin-treated, n = 108), and caregivers (family members, n = 107; nurses, n = 117; care workers, n = 104). Agreement with statements regarding initiation barriers, current feelings, and burden of insulin therapy was assessed. Physicians' views on ideal glycated hemoglobin (HbA<sub>1c</sub>) levels and actual levels in PWD at insulin initiation were captured.</p><p><strong>Results: </strong>Most PWD agreed with the statements \"I don't want to be bothered with doing injections\" (77.8-92.1%) and \"I don't want to inject myself for the rest of my life\" (78.7-91.2%). Physicians also considered these factors to be of high importance for PWD; however, physician and PWD (insulin-naive T2D) responses were significantly different for 11 statements. The greatest underestimation by physicians was for the statement \"my family will be worried\" (41.8% vs. 66.7%), whereas social factors (e.g., \"my friendships may suffer,\" \"if I take insulin I will be discriminated against\") were overestimated by physicians (49.1% vs. 33.3% and 46.5% vs. 24.6%, respectively). Although > 70% of physicians considered HbA<sub>1c</sub> < 9.0% (< 75 mmol/mol) ideal for insulin initiation, only ~ 30% of PWD started insulin at HbA<sub>1c</sub> < 9.0% (< 75 mmol/mol). Nurses rated the burden of assisting with insulin injections significantly lower than family members or care workers. Respondents agreed the need for less frequent injections and improved glycemic control were important attributes expected from future insulin therapies.</p><p><strong>Conclusion: </strong>Differences in perceptions between physicians and PWD in Japan regarding insulin therapy persist, but this gap may be narrowing. Both groups agreed that future insulin therapies should be simpler and provide better glycemic control.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2537-2555"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562759","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Sodium-Glucose Co-transporter-2 Inhibitors in Type 1 Diabetes Mellitus: The Framework for Recommendations for Their Potential Use. 钠-葡萄糖共转运体-2 抑制剂在 1 型糖尿病中的应用:潜在使用建议框架》。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-16 DOI: 10.1007/s13300-024-01657-9
Djordje S Popovic, Dimitrios Patoulias, Theocharis Koufakis, Paschalis Karakasis, Nikolaos Papanas
{"title":"Sodium-Glucose Co-transporter-2 Inhibitors in Type 1 Diabetes Mellitus: The Framework for Recommendations for Their Potential Use.","authors":"Djordje S Popovic, Dimitrios Patoulias, Theocharis Koufakis, Paschalis Karakasis, Nikolaos Papanas","doi":"10.1007/s13300-024-01657-9","DOIUrl":"10.1007/s13300-024-01657-9","url":null,"abstract":"<p><p>The growing prevalence of overweight/obesity, the persistence of inadequate glycemic control among the majority of affected individuals, and the still unacceptably high risk of cardiovascular morbidity and mortality among population with type 1 diabetes mellitus (T1D), impose an urgent need for the introduction of non-insulin glucose-lowering agents in the therapeutic armamentarium. Given that their antihyperglycemic mechanism of action is independent of endogenous insulin secretion and that the observed cardio-renal benefits are unrelated to their glucose-lowering properties, one can speculate that the use of sodium-glucose co-transporter-2 inhibitors (SGLT2is) could provide benefits in T1D, similar to the ones observed among individuals with type 2 diabetes mellitus, chronic kidney disease (CKD), and heart failure. Available evidence from randomized controlled trials suggests that treatment with SGLT2is as adjunct to insulin in T1D results in modest reductions in glycated hemoglobin and body weight. Additionally, SGLT2is ameliorate albuminuria, and thus delay or prevent the development of CKD in T1D. However, use of SGLT2is is associated with an increased risk of diabetic ketoacidosis (DKA) in T1D. This commentary aims at providing a framework for practical recommendations regarding the potential use of SGLT2is in adults with T1D, based on the individual's risk level for DKA development, the presence of inadequate glycemic control and related cardio-renal complications.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2445-2453"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460204","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Relation of Diabetes Complications to a New Interpretation of Glycaemic Variability from Continuous Glucose Monitoring in People with Type 1 Diabetes. 糖尿病并发症与 1 型糖尿病患者连续血糖监测血糖变异性新解释的关系。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-23 DOI: 10.1007/s13300-024-01648-w
Adrian H Heald, Mike Stedman, John Warner Levy, Lleyton Belston, Angela Paisley, Reena Patel, Alison White, Edward Jude, JMartin Gibson, Hellena Habte-Asres, Martin Whyte, Angus Forbes
{"title":"The Relation of Diabetes Complications to a New Interpretation of Glycaemic Variability from Continuous Glucose Monitoring in People with Type 1 Diabetes.","authors":"Adrian H Heald, Mike Stedman, John Warner Levy, Lleyton Belston, Angela Paisley, Reena Patel, Alison White, Edward Jude, JMartin Gibson, Hellena Habte-Asres, Martin Whyte, Angus Forbes","doi":"10.1007/s13300-024-01648-w","DOIUrl":"10.1007/s13300-024-01648-w","url":null,"abstract":"<p><strong>Introduction: </strong>Microvascular and macrovascular complications in type 1 diabetes (T1D) may be linked to endothelial stress due to glycaemic variability. Continuous glucose monitoring systems (CGMs) provide new opportunities to quantify this variability, utilising the amplitude of glucose change summated over time. The aim of this study was to examine whether this determination of glucose variability (GV) is associated with microvascular clinical sequelae.</p><p><strong>Methods: </strong>Continuous glucose monitoring values were downloaded for 89 type 1 diabetes mellitus (T1D) individuals for up to 18 months from 2021 to 2023. Data for patient demographics was also taken from the patient record which included Sex, Date of Birth, and Date of Diagnosis. The recorded laboratory glycated haemoglobin (HbA1c) test results were also recorded. The glucose management index (GMI) was calculated from average glucose readings for 18 months using the formula GMI (%) = (0.82-(Average glucose/100)). This was then adjusted to give GMI (mmol/mol) = 10.929 * (GMI (%) - 2.15). Average Glucose Fluctuation (AGF) was calculated by adding up the total absolute change value between all recorded results over 18 months and dividing by the number of results minus one. The % Above Critical Threshold (ACT) was calculated by summing the total number of occurrences for each result value. A cumulative 95% limit was then applied to identify the glucose value that only 5% of results exceeded in the overall population. Using this value, we estimated the percentage of total tests that were above the Critical Threshold (ACT).</p><p><strong>Results: </strong>Results for the 89 individuals (44 men and 45 women) were analysed over 18 months. The mean age of participants was 43 years and the mean duration of diabetes was 18 years. A total of 3.22 million readings were analysed, giving an average of 10.3 mmol/L blood glucose. Those with the largest change in glucose from reading to reading, summated over time, showed the greatest change in eGFR of 3.12 ml/min/1.73 m<sup>2</sup> (p = 0.007). People with a higher proportion of glucose readings > 18 mmol/L showed a fall in eGFR of 2.8 ml/min/1.73 m<sup>2</sup> (p = 0.009) and experienced higher rates of sight-threatening retinopathy (44% of these individuals) (p = 0.01) as did 39% of individuals in the highest tertile of glucose levels (p = 0.008).</p><p><strong>Conclusion: </strong>Those individuals with T1D in the highest tertile of reading-to-reading glucose change showed the greatest change in eGFR. Those with a higher proportion of glucose readings > 18 mmol/L also showed a fall in eGFR and experienced higher rates of sight-threatening retinopathy, as did people with higher mean glucose. Discussions with T1D individuals could reflect on how the percentage recorded glucose above a critical level and degree of change in glucose are important in avoiding future tissue complications.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2489-2498"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496859","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Rationale and Design of the Study to Investigate the Metabolic Action of Imeglimin on Patients with Type 2 Diabetes Mellitus (SISIMAI). 调查伊麦格列明对 2 型糖尿病患者代谢作用的研究(SISIMAI)的原理和设计。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-09-30 DOI: 10.1007/s13300-024-01655-x
Tsubasa Tajima, Hideyoshi Kaga, Naoaki Ito, Toshiki Kogai, Hitoshi Naito, Saori Kakehi, Satoshi Kadowaki, Yuya Nishida, Ryuzo Kawamori, Yoshifumi Tamura, Hirotaka Watada
{"title":"Rationale and Design of the Study to Investigate the Metabolic Action of Imeglimin on Patients with Type 2 Diabetes Mellitus (SISIMAI).","authors":"Tsubasa Tajima, Hideyoshi Kaga, Naoaki Ito, Toshiki Kogai, Hitoshi Naito, Saori Kakehi, Satoshi Kadowaki, Yuya Nishida, Ryuzo Kawamori, Yoshifumi Tamura, Hirotaka Watada","doi":"10.1007/s13300-024-01655-x","DOIUrl":"10.1007/s13300-024-01655-x","url":null,"abstract":"<p><strong>Introduction: </strong>Imeglimin is a first-in-class, novel, oral glucose-lowering agent for the treatment of type 2 diabetes mellitus. The efficacy and safety of imeglimin as an antidiabetic agent have been investigated in clinical trials. However, its metabolic effects in humans have not yet been fully elucidated.</p><p><strong>Methods: </strong>The Study to InveStIgate the Metabolic Action of Imeglimin on patients with type 2 diabetes mellitus (SISIMAI) is a single-arm intervention study. In this study, we have recruited 25 patients with type 2 diabetes to receive 2000 mg/day imeglimin for 20 weeks. We perform a 75-g oral glucose tolerance test (OGTT) with double-glucose tracers, a two-step hyperinsulinemic-euglycemic clamp with glucose tracer, ectopic fat measurement by proton magnetic resonance spectroscopy, visceral/subcutaneous fat area measurement by magnetic resonance imaging, muscle biopsy, and evaluation of fitness level by cycle ergometer before and after imeglimin administration.</p><p><strong>Planned outcomes: </strong>The primary outcome is the change in area under the curve of glucose levels during the OGTT after 20 weeks of imeglimin treatment. We also calculate the endogenous glucose production, rate of oral glucose appearance, and rate of glucose disappearance from the data during the 75-g OGTT and compare them between pre- and post-treatment. Additionally, we will compare other parameters, such as the changes in tissue-specific insulin sensitivity, ectopic fat accumulation, visceral/subcutaneous fat area accumulation, and fitness level between each point. This is the first study to investigate the organ-specific metabolic action of imeglimin in patients with type 2 diabetes mellitus using the 75-g OGTT with the double tracer method. The results of this study are expected to provide useful information for drug selection based on the pathophysiology of individual patients with type 2 diabetes mellitus.</p><p><strong>Trial registration: </strong>jRCTs031210600.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2569-2580"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Current Perspectives in Pre- and Diabetic Peripheral Neuropathy Diagnosis and Management: An Expert Statement for the Gulf Region. 糖尿病前期和糖尿病周围神经病变诊断与管理的当前视角:海湾地区专家声明。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-26 DOI: 10.1007/s13300-024-01658-8
Salem A Beshyah, Amin Jayyousi, Ali Saif Al-Mamari, Ashraf Shaaban, Ebaa Al Ozairi, Jalal Nafach, Mahir Khalil Ibrahim Jallo, Said Khader, Marc Evans
{"title":"Current Perspectives in Pre- and Diabetic Peripheral Neuropathy Diagnosis and Management: An Expert Statement for the Gulf Region.","authors":"Salem A Beshyah, Amin Jayyousi, Ali Saif Al-Mamari, Ashraf Shaaban, Ebaa Al Ozairi, Jalal Nafach, Mahir Khalil Ibrahim Jallo, Said Khader, Marc Evans","doi":"10.1007/s13300-024-01658-8","DOIUrl":"10.1007/s13300-024-01658-8","url":null,"abstract":"<p><p>Peripheral neuropathy (PN) significantly impacts the quality of life, causing substantial morbidity and increased mortality, as well as escalating healthcare costs. While PN can have various causes, the most common form, diabetic peripheral neuropathy, poses considerable risks for potential complications. Diabetic peripheral neuropathy (DPN) affects over 50% of people with prediabetes and diabetes. Despite its prevalence, a global gap in diagnosis and management exists, exacerbated by the COVID-19 pandemic. This expert consensus was formulated through a comprehensive evaluation by a panel of experts, informed by a focused literature review, aiming to establish a clinically robust approach to diagnosing and managing pre- and diabetic PN with the early utilization of neurotropic B vitamins. This document offers a consensus perspective on the existing challenges in diagnosing and managing PN, focusing on DPN. The expert panel proposes measures to address this underdiagnosed burden, highlighting the importance of early intervention through innovative screening methods, integrated care approaches, and therapeutic strategies. The document advocates for increased awareness, targeted campaigns, and proactive care strategies to bridge gaps in the patient care of individuals with diabetes, emphasizing the importance of early detection and timely management to improve overall health outcomes. Specific recommendations include incorporating simplified questionnaires and innovative screening methods into routine care, prioritizing neurotropic B vitamin supplementation, optimizing glucagon-like peptide 1 (GLP-1) receptor agonist treatments, and adopting a holistic approach to neuropathy management. The consensus underscores the urgent need to address the underdiagnosis and undertreatment of PN, offering practical measures to enhance early detection and improve health outcomes for individuals with DPN.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2455-2474"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Switching from Premixed Insulin to Insulin Degludec/Insulin Aspart for the Management of Type 2 Diabetes Mellitus: Implications of a Real-World Study on Insulin Degludec Dosing. 从预混胰岛素转用德鲁达胰岛素/阿斯巴特胰岛素治疗 2 型糖尿病:德鲁达胰岛素剂量真实世界研究的意义》。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-26 DOI: 10.1007/s13300-024-01663-x
Yiming Wu, Junqing Zhang, Ang Li
{"title":"Switching from Premixed Insulin to Insulin Degludec/Insulin Aspart for the Management of Type 2 Diabetes Mellitus: Implications of a Real-World Study on Insulin Degludec Dosing.","authors":"Yiming Wu, Junqing Zhang, Ang Li","doi":"10.1007/s13300-024-01663-x","DOIUrl":"10.1007/s13300-024-01663-x","url":null,"abstract":"<p><strong>Introduction: </strong>When switching from premixed insulin to insulin degludec/aspart (IDegAsp), IDegAsp usually starts at the same dose as the premixed insulin according to limited clinical experience or at a dose according to clinician discretion. The dose of insulin degludec used in the real world after switching has been poorly investigated.</p><p><strong>Methods: </strong>A retrospective analysis was conducted on patients with type 2 diabetes who switched from premixed insulin to IDegAsp from October 2016 to December 2023. Repeated measures analysis of variance was used to compare changes in insulin dose, glycated hemoglobin (HbA1c), fasting blood glucose (FBG), and postprandial blood glucose (PBG) before and after switching.</p><p><strong>Results: </strong>Sixty-six patients with prior low-ratio premixed insulin and 22 with prior mid-ratio premixed insulin were included. Among the low-ratio insulin users, the total daily dose of insulin degludec (IDeg) decreased by 21.43% and 19.05% at 3 and 6 months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). Conversely, among mid-ratio insulin users, the IDeg daily dose increased by 10.71% and 32.14% at 3 and 6 months, respectively, after switching, compared with prior basal insulin dose (both p < 0.001). In all patients, HbA1c levels decreased by 0.70%, FBG decreased by 1.00 mmol/l, and PBG decreased by 1.61 mmol/l after 6 months of switching (all p < 0.05); the total daily insulin dose and injection frequency significantly decreased after switching (both p < 0.05); age and disease duration did not affect IDegAsp effects on HbA1c reduction.</p><p><strong>Conclusions: </strong>In the setting of transition to IDegAsp from premixed insulin, the dose of basal insulin in the premixed formulation can be a valuable reference for adjusting insulin degludec dose. IDegAsp is superior to premixed insulin in blood glucose control with reduced total daily dose and injection frequency. IDegAsp could be the best choice for the management of diabetes in elderly patients.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2515-2523"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Unveiling the Spectrum of Glucose Variability: A Novel Perspective on FreeStyle Libre Monitoring Data. 揭示血糖变异的频谱:FreeStyle Libre 监测数据的新视角。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-12-01 Epub Date: 2024-10-23 DOI: 10.1007/s13300-024-01647-x
Adrian H Heald, Mike Stedman, John Warner-Levy, Lleyton Belston, Angela Paisley, Aleksandra Jotic, Nebojsa Lalic, Martin Gibson, Hellena H Habte-Asres, Martin Whyte, Angus Forbes
{"title":"Unveiling the Spectrum of Glucose Variability: A Novel Perspective on FreeStyle Libre Monitoring Data.","authors":"Adrian H Heald, Mike Stedman, John Warner-Levy, Lleyton Belston, Angela Paisley, Aleksandra Jotic, Nebojsa Lalic, Martin Gibson, Hellena H Habte-Asres, Martin Whyte, Angus Forbes","doi":"10.1007/s13300-024-01647-x","DOIUrl":"10.1007/s13300-024-01647-x","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Introduction: &lt;/strong&gt;Since the introduction of insulin therapy, it has become apparent that type 1 diabetes (T1D) is accompanied by long-term microvascular and macrovascular complications. In the context of the many benefits of continuous glucose monitoring (CGM), there remain opportunities to study the large amount of data now available in order to maximise its potential in the endeavour to reduce the occurrence of diabetes tissue complications in the longer term.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Continuous glucose monitoring values were downloaded for 89 type 1 diabetes mellitus (T1D) individuals for up to 18 months from 2021 to 2023. Data for patient demographics was also taken from the patient record which included Sex, Date of Birth, and Date of Diagnosis. The recorded laboratory glycated haemoglobin (HbA1c) test results were also recorded. The glucose management index (GMI) was calculated from average glucose readings for 18 months using the formula GMI (%) = (0.82 - (Average glucose/100)). This was then adjusted to give GMI (mmol/mol) = 10.929 * (GMI (%) - 2.15). Average Glucose Fluctuation (AGF) was calculated by adding up the total absolute change value between all recorded results over 18 months and dividing by the number of results minus one. The % Above Critical Threshold (ACT) was calculated by summing the total number of occurrences for each result value. A cumulative 95% limit was then applied to identify the glucose value that only 5% of results exceeded in the overall population. Using this value, we estimated the percentage of total tests that were above the Critical Threshold (ACT).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The mean age of the participants was 42.6 years, and the mean duration of T1D was 18.4 years. A total of 3.22 million readings were analysed, yielding an average blood glucose level of 10.3 mmol/l and a GMI of 57.2 mmol/mol. There was a strong correlation between GMI and measured HbA1c (r&lt;sup&gt;2&lt;/sup&gt; = 0.82). However, there were patients who had an above-critical threshold (ACT) of 4-10% at a GMI of 60 mmol/mol or less. The percentage average value at the time of day (%AVTD) was applied to all blood glucose readings at each 15-min interval throughout the day, averaged over 18 months. The %AVTD of GMI (overall average 57.2 mmol/mol) increased after midday, dipped at 18:00, and peaked at 22:00. The %AVTD of AGF (overall average 0.60 mmol/l) showed higher change rates after 09:00 declining at the end of the day. The %AVTD of ACT peaked at 22:00, with those having the highest %ACT showing an additional peak at 15:00.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;We have shown here that the percentage glucose results above 18 mmol/l (top 5% of distribution) increased exponentially above 54 mmol/mol HbA1c. The %AVTD is introduced as a useful measure. Our data indicate that over the 24-h period, improvement in metabolic control could be focussed on the afternoon and evening, when there are higher-than-average levels of GMI","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2475-2487"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561226/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496860","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction to: Comparative Efficacy and Safety of Tirzepatide in Asians and Non-Asians with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. 更正:亚洲人和非亚洲人 2 型糖尿病患者服用替扎帕肽的疗效和安全性比较:系统回顾与元分析》。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-11-01 DOI: 10.1007/s13300-024-01632-4
Yuying Cui, Jinming Yao, Xiaodong Qiu, Congcong Guo, Degang Kong, Jianjun Dong, Lin Liao
{"title":"Correction to: Comparative Efficacy and Safety of Tirzepatide in Asians and Non-Asians with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.","authors":"Yuying Cui, Jinming Yao, Xiaodong Qiu, Congcong Guo, Degang Kong, Jianjun Dong, Lin Liao","doi":"10.1007/s13300-024-01632-4","DOIUrl":"10.1007/s13300-024-01632-4","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2443"},"PeriodicalIF":3.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11467149/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142281853","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality of Life in Japanese People with Type 2 Diabetes Switching from Multiple Daily Insulin Injections to Once-Daily iGlarLixi: SIMPLIFY Japan. 日本 2 型糖尿病患者从每天多次注射胰岛素转为每天注射一次 iGlarLixi 后的生活质量:日本 SIMPLIFY。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-30 DOI: 10.1007/s13300-024-01645-z
Hitoshi Ishii, Hideki Kamiya, Yoko Takahashi, Yukiko Morimoto, Daisuke Yabe
{"title":"Quality of Life in Japanese People with Type 2 Diabetes Switching from Multiple Daily Insulin Injections to Once-Daily iGlarLixi: SIMPLIFY Japan.","authors":"Hitoshi Ishii, Hideki Kamiya, Yoko Takahashi, Yukiko Morimoto, Daisuke Yabe","doi":"10.1007/s13300-024-01645-z","DOIUrl":"10.1007/s13300-024-01645-z","url":null,"abstract":"<p><strong>Introduction: </strong>Previous studies have shown that iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, provides effective glycemic control in people with type 2 diabetes (T2D). The SIMPLIFY Japan study assessed the impact of switching from multiple daily insulin injections (MDI) to once-daily iGlarLixi on health-related quality of life (HRQOL) and glycemic parameters in Japanese people with moderately controlled T2D.</p><p><strong>Methods: </strong>This 24-week, prospective, observational cohort study enrolled Japanese adults with T2D who switched from MDI therapy to iGlarLixi. Data were collected at baseline, 12, and 24 weeks; changes in Diabetes Therapy-Related Quality of Life (DTR-QOL) questionnaire score, glycated hemoglobin (HbA1c), body weight and self-reported treatment adherence were evaluated; the primary endpoint was change in DTR-QOL at 24 weeks.</p><p><strong>Results: </strong>Sixty-six participants were enrolled and 61 were included in the full analysis set. Significant improvements were observed in total DTR-QOL score from baseline to week 24 (mean change + 10.8 points; P < 0.001), with higher scores observed in individual domains related to social/daily activities, treatment satisfaction, and reductions in treatment-related anxiety (P < 0.05). A small HbA1c increase was noted at week 24 (P < 0.001), while this did not appear to adversely affect HRQOL or treatment satisfaction. A significant reduction in body weight was observed at week 12 (mean change - 0.7 kg; P = 0.046). Self-reported treatment adherence increased from baseline to week 24, with the proportion of participants who never missed an insulin injection increasing from 55.7 to 77.6%. At week 24, the incidence of hypoglycemia and gastrointestinal adverse events was 18.2 and 27.3%, respectively.</p><p><strong>Conclusions: </strong>Switching from MDI to iGlarLixi therapy in Japanese people with T2D was associated with enhanced HRQOL (despite slight elevation in HbA1c) and improved treatment adherence, with a favorable safety profile. These findings support the beneficial role of iGlarLixi in the management of T2D in real-world Japanese clinical practice.</p><p><strong>Study registration: </strong>Japan Registry of Clinical Trials (jRCT1041210151).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2381-2400"},"PeriodicalIF":3.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11466927/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343458","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Safety and Effectiveness of Concomitant iGlarLixi and SGLT-2i Use in People with T2D During Ramadan Fasting: A SoliRam Study Sub-analysis. 斋月禁食期间 T2D 患者同时服用 iGlarLixi 和 SGLT-2i 的安全性和有效性:SoliRam研究子分析。
IF 3.8 3区 医学
Diabetes Therapy Pub Date : 2024-11-01 Epub Date: 2024-09-09 DOI: 10.1007/s13300-024-01642-2
Mohamed Hassanein, Rachid Malek, Saud Al Sifri, Rakesh Kumar Sahay, Mehmet Akif Buyukbese, Khier Djaballah, Lydie Melas-Melt, Inass Shaltout
{"title":"Safety and Effectiveness of Concomitant iGlarLixi and SGLT-2i Use in People with T2D During Ramadan Fasting: A SoliRam Study Sub-analysis.","authors":"Mohamed Hassanein, Rachid Malek, Saud Al Sifri, Rakesh Kumar Sahay, Mehmet Akif Buyukbese, Khier Djaballah, Lydie Melas-Melt, Inass Shaltout","doi":"10.1007/s13300-024-01642-2","DOIUrl":"10.1007/s13300-024-01642-2","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this work was to assess the safety and effectiveness of concomitant iGlarLixi and sodium-glucose co-transporter-2 inhibitors (SGLT-2i) use in adults with type 2 diabetes (T2D) who fasted during Ramadan.</p><p><strong>Methods: </strong>Of the 420 eligible participants from the SoliRam study, 174 were using SGLT-2i in addition to iGlarLixi and 246 were not using SGLT-2i, referred to as SGLT-2i user and non-user, respectively. The primary endpoint was the proportion of participants experiencing ≥ 1 severe and/or symptomatic documented (< 70 mg/dl [< 3.9 mmol/l]) hypoglycemia.</p><p><strong>Results: </strong>More than 50% of participants in both groups were male. The mean weight, glycated hemoglobin (HbA1c), and fasting plasma glucose (FPG) were similar in both groups. Approximately half of participants in the SGLT-2i-user group and ~ 25% participants in the SGLT-2i-non-user group were on two oral anti-hyperglycemic drugs (OADs), whereas ~ 20% in the SGLT-2i-user group and ~ 1% of participants in the SGLT-2i-non-user group were on three OADs in addition to iGlarLixi. Around 35% and 55% of participants in the SGLT-2i-user and SGLT-2i-non-user groups, respectively, were taking concurrent sulphonylureas. About 97% of participants in both groups were able to fast for ≥ 25 days. The incidence of primary endpoint was low in both groups; SGLT-2i user: 0.6%, 4.2%, and 0.6% and SGLT-2i-non-user: 1.3%, 0.9% and 0% during pre-Ramadan, Ramadan, and post-Ramadan period, respectively. The incidence of severe and/or symptomatic documented (< 54 mg/dl [< 3.0 mmol/l]) hypoglycemia events was also low throughout the study, including during Ramadan. No severe hypoglycemia occurred during Ramadan in either group. Improvements in HbA1c and FPG, with a small reduction in weight, were observed from pre- to post-Ramadan in both groups. No serious adverse event was reported in either group.</p><p><strong>Conclusions: </strong>Concomitant iGlarLixi and SGLT-2i therapy with or without other OADs was demonstrated to be safe in adults with T2D during Ramadan fast, with a low risk of hypoglycemia and improvements in glycemic outcomes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2309-2322"},"PeriodicalIF":3.8,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11467161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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