Diabetes Therapy最新文献

{"title":"Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study.","authors":"Catherine B Johannes, Ryan Ziemiecki, Manel Pladevall-Vila, Natalie Ebert, Csaba P Kovesdy, Reimar W Thomsen, Brenda N Baak, Aníbal García-Sempere, Hiroshi Kanegae, Craig I Coleman, Michael Walsh, Ina Trolle Andersen, Clara Rodríguez Bernal, Celia Robles Cabaniñas, Christian Fynbo Christiansen, Alfredo E Farjat, Alain Gay, Patrick Gee, Ron M C Herings, Isabel Hurtado, Naoki Kashihara, Frederik Pagh Bredahl Kristensen, Fangfang Liu, Suguru Okami, Jetty A Overbeek, Fernie J A Penning-van Beest, Satoshi Yamashita, Yuichiro Yano, J Bradley Layton, David Vizcaya, Nikolaus G Oberprieler","doi":"10.1007/s13300-024-01671-x","DOIUrl":"10.1007/s13300-024-01671-x","url":null,"abstract":"<p><strong>Introduction: </strong>The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).</p><p><strong>Methods: </strong>This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics^® Data Mart Database (CDM) (US). Eligible patients had CKD (based on either diagnosis codes, eGFR values, and/or urine ACR) and initiated an SGLT2i between 2012 and 2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and drug utilization patterns were described.</p><p><strong>Results: </strong>The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.</p><p><strong>Conclusions: </strong>At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"205-226"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794911/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834434","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}

{"title":"The Impact of Age and Sex on Fasting Plasma Glucose and Glycated Haemoglobin (HbA1c) in the Non-diabetes Population.","authors":"Mike Stedman, Adrian H Heald, David Holland, Ian Halsall, Lewis Green, Pensee Wu, Kashyap Patel, Jonathan Scargill, Martin Gibson, Fahmy W F Hanna, Anthony A Fryer","doi":"10.1007/s13300-024-01680-w","DOIUrl":"10.1007/s13300-024-01680-w","url":null,"abstract":"<p><strong>Introduction: </strong>We previously reported sex differences in the distribution of glycated haemoglobin (HbA1c) for men/women aged < 50 years vs older individuals, with implications for delayed diabetes diagnosis. Here, we explored whether this pattern was also seen in matched fasting plasma glucose (FPG) levels.</p><p><strong>Methods: </strong>We extracted data on same-day, paired HbA1c and FPG levels from clinical biochemistry laboratory databases from Mersey and West Lancashire Teaching Hospitals NHS Trust (n = 10,153) and Cambridge University Hospitals NHS Foundation Trust (n = 10,022) between Jan 2019 and Dec 2023. Only cases with a single, general-practice HbA1c test were utilised to minimise the risk of including non-diagnostic tests and tests from specialist care (e.g. endocrinology, antenatal services; final dataset: n = 17,271). We examined the links of HbA1c and FPG levels to age and sex.</p><p><strong>Results: </strong>Median HbA1c levels were 1 mmol/mol lower in women aged < 45 years compared to men aged < 45 years but not in those aged ≥ 45 years. This pattern was not seen with FPG, where median levels in women were 0.1-0.2 mmol/L lower across all ages. The HbA1c:FPG ratio was significantly higher in women than men in the 45-54 and ≥ 55 years age groups (p = 0.004, Z-score = 2.9 and p =  < 0.001, Z-score = 8.9, respectively) but not in the < 45 years age group (p = 0.649, Z-score = 0.5). We confirmed our previous finding that median HbA1c levels in women aged ≥ 55 years and 45-55 years were the same as those in men (39 and 37 mmol/mol, respectively) and that for women aged < 45 years, the median HbA1c (34 mmol/mol) was 1 mol/mol lower than for men (35 mmol/mol). This is reflected in the Z-scores, which showed the largest deviation from zero in the < 45 years age group (- 9.1) and the smallest in the older age group (- 2.9).</p><p><strong>Conclusion: </strong>We showed differences in HbA1c and FPG patterns with age between men and women, with implications for the diabetes diagnostic threshold for HbA1c in pre-menopausal women, the underdiagnosis of type 2 diabetes in younger women, and missed opportunities for intervention. We propose that a suggested change to HbA1c reference ranges in this group warrants serious consideration and detailed evaluation.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"257-267"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863650","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}

{"title":"Characteristics and Dosing Patterns of Tirzepatide Users with Type 2 Diabetes in the United States.","authors":"Reema Mody, Karishma Desai, Chia-Chen Teng, Gally Reznor, Grace Stockbower, Michael Grabner, Brian D Benneyworth","doi":"10.1007/s13300-024-01684-6","DOIUrl":"10.1007/s13300-024-01684-6","url":null,"abstract":"<p><strong>Introduction: </strong>The study objective was to describe characteristics and utilization patterns of tirzepatide users with type 2 diabetes (T2D) using the Healthcare Integrated Research Database in the USA.</p><p><strong>Methods: </strong>Adults (≥18 years) included had T2D diagnosis; ≥1 tirzepatide claim (May 2022-January 2023; first claim date = index date); and continuous medical and pharmacy enrollment during the 6-month baseline and follow-up periods from the index date. Baseline demographics, clinical characteristics, and 6-month follow-up dosing and treatment patterns were summarized descriptively.</p><p><strong>Results: </strong>The study included 15,665 patients with T2D initiating tirzepatide (mean age: 53.2 years; 58.5% women; 76.7% non-Hispanic white). During the 6-month baseline period, hypertension (69.2%), dyslipidemia (69.2%), overweight/obesity (58.4%), and obstructive sleep apnea (22.8%) were commonly reported comorbidities. Over half of the patients (51.2%) had used glucagon-like peptide-1 (GLP-1) receptor agonist (RA) before initiating tirzepatide. The mean glycated hemoglobin (HbA1c) was 7.6% (n = 5175), and 58.4% of these patients had HbA1c ≥7%. The mean body mass index (BMI) was 38.7 kg/m² (n = 3459), and 87.8% of these patients either had Class 1, 2, or 3 obesity. Among patients with a single prescription on each fill date (N = 14,986), 84.1% initiated tirzepatide at ≤5 mg dose. During sixth prescription refill (n = 7304), 56.5% were receiving tirzepatide doses of <10 mg. During the 6-month follow-up period, 69.6% of patients had ≥1 dose escalation and 17.2% had ≥1 dose de-escalation. The mean time to first dose escalation was 59.1 days and first dose de-escalation was 104.8 days. Tirzepatide adherence (proportion of days covered [PDC] ≥80%) was 57.5% and persistence (45-day gap) was 73.3% at 6 months. Of patients who discontinued tirzepatide (n = 4177; 26.7%), 29.1% re-initiated tirzepatide (45-day gap).</p><p><strong>Conclusion: </strong>Patients with T2D initiating tirzepatide had multimorbidity; uncontrolled diabetes; and mean BMI was consistent with Class 2 obesity. Patients showed favorable tirzepatide adherence and persistence profiles, and the majority remained at <10 mg doses during the 6-month follow-up period.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"307-327"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794899/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964029","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}

{"title":"Cardiovascular Events in Adults with Type 2 Diabetes and ASCVD Initiating Once-Weekly Semaglutide vs DPP-4is in the USA.","authors":"Silvio E Inzucchi, Xi Tan, Yuanjie Liang, Larisa Yedigarova, Lin Xie, Adam de Havenon","doi":"10.1007/s13300-024-01678-4","DOIUrl":"10.1007/s13300-024-01678-4","url":null,"abstract":"<p><strong>Introduction: </strong>Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have demonstrated cardiovascular benefits in trials involving high-risk patients with type 2 diabetes (T2D), while dipeptidyl peptidase 4 inhibitors (DPP-4is) have not. However, DPP-4is are still commonly prescribed in patients with T2D and atherosclerotic cardiovascular disease (ASCVD). This study compared time to occurrence of cardiovascular events, health care resource utilization (HCRU), and medical costs in patients with T2D and ASCVD who initiated once-weekly semaglutide vs a DPP-4i.</p><p><strong>Methods: </strong>Two separate observational cohort analyses were conducted using Optum's de-identified Clinformatics^® Data Mart Database (CDM) and Komodo Healthcare Map™ (January 1, 2018 to September 30, 2022). Patients had T2D and ASCVD and received semaglutide or a DPP-4i. Baseline characteristics were balanced using inverse probability of treatment weighting.</p><p><strong>Results: </strong>After weighting, the CDM analysis included 14,461 semaglutide users and 38,630 DPP-4i users and the Komodo Healthcare Map analysis included 48,303 semaglutide users and 109,179 DPP-4i users. In CDM, semaglutide users had significantly decreased risk of stroke (hazard ratio [HR], 0.54), myocardial infarction (HR 0.64), and their composite (HR 0.59) vs DPP-4is. Semaglutide users also had fewer ASCVD-related and all-cause hospitalizations and outpatient visits and lower ASCVD-related and all-cause hospitalization and total medical costs. Results from Komodo Health were generally consistent with those from CDM.</p><p><strong>Conclusion: </strong>Semaglutide users had significantly reduced risk of cardiovascular outcomes, HCRU, and medical costs compared with DPP-4is. This corroborates results from prior studies of once-weekly GLP-1 RAs and reinforces the important role of semaglutide treatment for patients with T2D and ASCVD. Graphical abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"187-203"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794941/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834432","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}

{"title":"Association of Polypharmacy and Burden of Comorbidities on COVID-19 Adverse Outcomes in People with Type 1 or Type 2 Diabetes.","authors":"Juhi K Gupta, Rathi Ravindrarajah, George Tilston, William Ollier, Darren M Ashcroft, Adrian H Heald","doi":"10.1007/s13300-024-01681-9","DOIUrl":"10.1007/s13300-024-01681-9","url":null,"abstract":"<p><strong>Introduction: </strong>It is widely accepted that the higher the number of medications prescribed and taken by an individual, the higher the risk of poor health outcomes. We have investigated whether polypharmacy and comorbidities conveyed more risk of adverse health outcomes following COVID-19 infection (as a paradigm of serious viral infections in general) in people with type 1 diabetes (T1DM) or type 2 diabetes (T2DM).</p><p><strong>Methods: </strong>The Greater Manchester Care Record (GMCR) is an integrated database of electronic health records containing data collected from 433 general practices in Greater Manchester. Baseline demographic information (age, body mass index [BMI], gender, ethnicity, smoking status, deprivation index), hospital admission or death within 28 days of infection were extracted for adults (18+) diagnosed with either T1DM or T2DM.</p><p><strong>Results: </strong>The study cohort included individuals diagnosed as T1DM and T2DM separately. Across the Greater Manchester Region, a total of 145,907 individuals were diagnosed with T2DM and 9705 were diagnosed with T1DM. For the T2DM individuals, 45.2% were women and for the T1DM individuals, 42.7% were women. For T2DM, 16-20 medications (p = 0.005; odds ratio [OR] [95% confidence interval (CI) 2.375 [1.306-4.319]) and > 20 medications (p < 0.001; OR [95% CI] 3.141 [1.755-5.621]) were associated with increased risk of death following COVID-19 infection. Increased risk of hospital admissions in T2DM individuals was associated with 11 to 15 medications (p = 0.013; OR = 1.341 (95% CI) [1.063-1.692]). This was independent of comorbidities, metabolic and demographic factors. For T1DM, there was no association of polypharmacy with hospital admission. Additionally, respiratory, cardiovascular/cerebrovascular and gastrointestinal conditions were associated with increased risk of hospital admissions and deaths in T2DM (p < 0.001). Many comorbidities were common across both T1DM and T2DM.</p><p><strong>Conclusions: </strong>We have shown in T2DM an independent association of multiple medications taken from 11 upwards with adverse health consequences following COVID-19 infection. We also found that individuals with diabetes develop comorbidities that were common across both T1DM and T2DM. This study has laid the foundation for future investigations into the way that complex pharmacological interactions may influence clinical outcomes in people with T2DM.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"241-256"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794775/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142863646","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}

{"title":"Integrating Polygenic Risk Scores (PRS) for Personalized Diabetes Care: Advancing Clinical Practice with Tailored Pharmacological Approaches.","authors":"Omna Singh, Madhur Verma, Nikita Dahiya, Sabyasachi Senapati, Rakesh Kakkar, Sanjay Kalra","doi":"10.1007/s13300-024-01676-6","DOIUrl":"10.1007/s13300-024-01676-6","url":null,"abstract":"<p><p>The rising global prevalence of diabetes poses a serious threat to public health, national economies, and the healthcare system. Despite a high degree of disease heterogeneity and advancing techniques, there is still an unclear diagnosis of patients with diabetes compounded by the array of long-term microvascular and macrovascular complications associated with the disease. In addition to environmental variables, diabetes susceptibility is significantly influenced by genetic components. The risk stratification of genetically predisposed individuals may play an important role in disease diagnosis and management. Precision medicine methods are crucial to reducing this global burden by delivering a more personalised and patient-centric approach. Compared to the European population, genetic susceptibility variants of type 2 diabetes mellitus (T2DM) are still not fully understood in other major populations, including South Asians, Latinos, and people of African descent. Polygenic risk scores (PRS) can be used to identify individuals who are more susceptible to complex diseases such as diabetes. PRS is selective and effective in developing novel diagnostic interventions. This comprehensive predictive approach facilitates the understanding of distinct response profiles, resulting in the development of more effective management strategies. The targeted implementation of PRS is especially advantageous for people who fall into a higher-risk category for diabetes. Through early risk assessment and the creation of individualised diabetes treatment plans, the integration of PRS in clinical practice shows potential for reducing the prevalence of diabetes and its complications. Diabetes self-management depends significantly on patient empowerment, with behavioural monitoring emerging as a vital facilitator. The main aim of this review article is to formulate a more structured intervention strategy by advocating for increased awareness of the clinical utility of PRS and counseling among healthcare practitioners, patients, and individuals at risk of diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"149-168"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834452","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}

{"title":"A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.","authors":"Mette Søndergaard Nielsen, Lise Brøndsted, Martin Kankam, Gaetano Morelli, David Nguyen, Trine Vang Skjøth, Usha Rani Patted, Marloes van Hout","doi":"10.1007/s13300-024-01674-8","DOIUrl":"10.1007/s13300-024-01674-8","url":null,"abstract":"<p><strong>Introduction: </strong>The glucagon-like peptide-1 (GLP-1) analogue semaglutide is approved as an oral formulation for the treatment of type 2 diabetes. This study aimed to confirm bioequivalence between a new, second-generation (2G) oral semaglutide formulation (1.5, 4 and 9 mg) and the initially approved first-generation (1G) formulation (3, 7 and 14 mg).</p><p><strong>Methods: </strong>This was a randomised, multicentre, open-label, full replicate crossover study to confirm bioequivalence between 2G and 1G oral semaglutide formulations at steady-state (SS) in healthy participants (NCT05227196). Participants were recruited to three groups. In each group, participants were randomised to one of two alternating sequences comparing once-daily oral semaglutide treatment of 9 and 14 mg (group 1), 4 and 7 mg (group 2) or 1.5 and 3 mg (group 3) at SS. Treatment duration was 20 weeks, comprising four 5-week steady-state periods on alternating formulations. Repeated 24-h blood sampling at the end of each steady-state period supported pharmacokinetic analysis. Co-primary endpoints were area under the semaglutide plasma concentration-time curve during a dosing interval at SS (AUC_0-24h,SS) and maximum semaglutide plasma concentration at SS (C_{max, 0-24h,SS}). Bioequivalence for co-primary endpoints was assessed using European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA) criteria. Safety was monitored.</p><p><strong>Results: </strong>A total of 222, 201 and 123 participants were recruited into groups 1, 2 and 3, respectively. The prespecified EMA, FDA and PMDA bioequivalence criteria were met for 2G versus 1G oral semaglutide for all three dose levels (1.5 vs 3 mg, 4 vs 7 mg and 9 vs 14 mg). The safety profile of 2G oral semaglutide was consistent with 1G oral semaglutide.</p><p><strong>Conclusions: </strong>The 2G oral semaglutide formulation was confirmed as bioequivalent to 1G oral semaglutide, with no new safety concerns identified.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT05227196.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"269-287"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794934/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871658","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}

{"title":"Experience of People with Diabetes Treated with Insulin Delivery Systems in France: A Comparative Analysis of Multiple Daily Injections, Tubeless Pumps, Tubed Pumps, and Hybrid Closed Loops.","authors":"Jacques Beltrand, Pierre-Yves Benhamou, Carine Choleau, Ben Braithwaite, Alice Bonin, Jean-Pierre Riveline","doi":"10.1007/s13300-024-01682-8","DOIUrl":"10.1007/s13300-024-01682-8","url":null,"abstract":"<p><strong>Introduction: </strong>While people with diabetes (PWD)'s experiences with their insulin delivery systems (IDS) are frequently reported in clinical trials, few real-world data exist on the subject. This study aimed to assess the real-world experience and satisfaction with IDS in PWD.</p><p><strong>Methods: </strong>This cross-sectional survey of PWD treated with tubed or tubeless insulin pumps, hybrid closed loop (HCL) systems, or multiple daily injections (MDI) for at least 3 months ran from 4 to 16 May 2023. The questionnaire containing bespoke questions and the Insulin Delivery System Rating Questionnaire (IDSRQ) satisfaction and interference subscales was answered by subscribers of the Aide aux Jeunes Diabétiques patient association and users of the MyDiabby Healthcare web platform.</p><p><strong>Results: </strong>Of 896 analysable respondents (552 children [age 10.7 ± 3.8 years, 46.9% female, all type 1] and 344 adults [age 43.1 ± 19.3 years, 61.9% female, 87.2% type 1]), HCL and pump users reported greater satisfaction with their IDS on the IDSRQ satisfaction subscale (HCL, 70.9 ± 17.7 [n = 208]; tubeless, 66.6 ± 19.1 [n = 272]; tubed, 64.1 ± 21.6 [n = 215]) than MDI users (53.1 ± 23.0 [n = 201]; all p < 0.001). Regarding the interference subscale, tubeless pumps (31.1 ± 24.8) performed similarly to HCLs (37.0 ± 25.5; p = 0.07) and significantly better than tubed pumps (38.6 ± 26.0; p < 0.001) and MDI (42.2 ± 24.3; p < 0.001). Furthermore, 84.6% of tubeless pump users would retain their style of pump for their ideal HCL, almost twice as often as tubed pump users.</p><p><strong>Conclusion: </strong>These results demonstrate a more positive person-reported experience with HCLs or tubeless pumps than with tubed pumps or MDI, primarily due to less interference with daily life, which most tubeless pump users would like to retain when transitioning to a HCL system. Overall, this pioneering study underscores the importance of patient preferences, providing valuable information for physicians prescribing IDS, and facilitating discussions about treatment options.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"289-306"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794741/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881510","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}

{"title":"Treatment Patterns and Glycaemic Control Between 2015 and 2019 in Tianjin, China: A Real-World Study of Adults with Type 2 Diabetes.","authors":"Qiumei Zhang, Yaqing Fan, Xixi Liu, Minlu Zhang, Jiewen Zhang, Qin Du, Lei Kang, Liming Chen","doi":"10.1007/s13300-024-01661-z","DOIUrl":"10.1007/s13300-024-01661-z","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes is associated with a high economic burden in China; therefore, strategies to prevent diabetes, improve glycaemic control, delay disease-related complications and maintain quality of life are essential. This study was conducted to evaluate trends in treatment patterns and glycaemic control in people with type 2 diabetes (T2D) in real-world clinical practice in Tianjin, China.</p><p><strong>Methods: </strong>This retrospective, cross-sectional, multicentre study analysed data from adults with T2D living in Tianjin, China between 2015 and 2019, based on information obtained from a regional electronic medical record database. Temporal trends in treatment patterns and glycaemic control were assessed using linear regression (continuous variables), and Cochran-Armitage (two categories) or Cochran-Mantel-Haenszel (≥ 3 categories) tests.</p><p><strong>Results: </strong>Between 2015 and 2019, data from 312,203 individuals treated at 75 hospitals were included. Over this period, there was an upward trend in the prevalence of hypertension, hyperlipidaemia, obesity, cardiovascular disease, stroke and retinopathy each year (all P < 0.001). The use of metformin or dipeptidyl peptidase-4 inhibitors increased, while thiazolidinedione, alpha-glucosidase inhibitor and glinide use decreased; the use of basal insulin (BI), glucagon-like peptide-1 receptor agonists (GLP-1 RAs), GLP-1 RAs + BI, bolus insulin and BI + bolus insulin increased, whereas the use of premixed insulin showed a downward trend (all P < 0.001). From 2015 to 2019, an increased proportion of individuals achieved glycated haemoglobin (HbA1c) < 7% (< 53 mmol/mol; 28.1-33.7%), fasting plasma glucose (FPG) < 7 mmol/l (21.7-26.9%) and postprandial glucose (PPG) < 10 mmol/l (22.0-48.2%; all P < 0.001). There was no change in the proportion of individuals with an FPG ≥ 7 mmol/l and a PPG ≥ 10 mmol/l, while the prevalence of residual hyperglycaemia increased (P < 0.001).</p><p><strong>Conclusions: </strong>Glycaemic control improved between 2015 and 2019 in people with T2D in Tianjin, China; however, there is an unmet need for more effective glycaemic control.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1-14"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11759750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142564215","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}

{"title":"Oral Semaglutide Use in Type 2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.","authors":"Gottfried Rudofsky, Hanan Amadid, Uffe Christian Braae, Sergiu-Bogdan Catrina, Anastas Kick, Kabirdev Mandavya, Klaus Roslind, Ponnusamy Saravanan, William van Houtum, Akshay B Jain","doi":"10.1007/s13300-024-01668-6","DOIUrl":"10.1007/s13300-024-01668-6","url":null,"abstract":"<p><strong>Introduction: </strong>Oral semaglutide is a glucagon-like peptide 1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type 2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA_1C) and body weight changes in relevant subgroup analyses.</p><p><strong>Methods: </strong>This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase 4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA_1C from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA_1C, body weight, and body mass index.</p><p><strong>Results: </strong>Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA_1C and body weight from baseline to week 38 were - 1.0%-point (95% CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA_1C reduction and body weight loss. Interaction was also observed between higher baseline HbA_1C and more pronounced decrease in HbA_1C. No significant interactions were detected between clinical outcomes and age or physician setting.</p><p><strong>Conclusion: </strong>The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction.</p><p><strong>Clinical trial registrations: </strong>NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"73-87"},"PeriodicalIF":3.8,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616531","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}