Diabetes Therapy最新文献

{"title":"Time to Initiation of Omnipod DASH® vs. Tubed Insulin Pump Therapy: A Time-and-Motion Study.","authors":"Charlotte A Gordon, Meike Graf, Colin D Hopley, Pete J Jennings, Melanie Littlewood","doi":"10.1007/s13300-024-01686-4","DOIUrl":"10.1007/s13300-024-01686-4","url":null,"abstract":"<p><strong>Introduction: </strong>There is currently a limited understanding of the process of initiating standard insulin pump therapy (IPT) and how this differs with pump type. A time-and-motion study was conducted in Germany and the United Kingdom (UK) to evaluate the time required for initiation with a tubeless insulin pump (a pod) versus other tubed pumps.</p><p><strong>Methods: </strong>The time taken to initiate patients onto tubeless IPT and tubed IPT (excluding automated insulin delivery systems, AID) was self-recorded by diabetes specialist nurses using a web-based tool. Pump users were adults with and without prior experience of IPT, and initiations were conducted face-to-face and remote.</p><p><strong>Results: </strong>In 276 recorded initiations (112 tubeless, 164 tubed, 89% type 1 diabetes), the mean time for initiating tubeless IPT was 13 min shorter compared with tubed IPT, 118 min [standard deviation (SD): 94] vs. 131 min [SD: 109]; p < 0.001. There was a particular benefit in people transferring from multiple daily injections (MDI) and for all initiations in a face-to-face setting. People transferring from MDI in a face-to-face setting had the highest time saving with tubeless IPT (24 min per nurse per initiation, p = 0.001), and this was also substantial for people in the face-to-face setting from both MDI and prior IPT (15 min per nurse per initiation, p = 0.002). According to survey responses, nurses reported initiations on tubeless IPT to be as effective as on tubed IPT despite taking less time.</p><p><strong>Conclusions: </strong>This novel time-and-motion study identified significant time reductions for initiating tubeless IPT vs. tubed IPT. Applying these time savings across pump services could increase efficiencies for initiating IPT and reduce workloads. Further time-and-motion studies for IPT and AID initiations are needed.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"629-644"},"PeriodicalIF":3.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448460","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":"Practical Approaches to Continuous Glucose Monitoring in Primary Care: A UK-Based Consensus Opinion.","authors":"Kevin Fernando, Vicki Alabraba, John B Welsh, Samuel Seidu, W David Strain, Heather Elizabeth Bell, Sarah Davies, Marc Evans","doi":"10.1007/s13300-025-01706-x","DOIUrl":"10.1007/s13300-025-01706-x","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes (T2D) imposes significant personal challenges and societal costs. Continuous glucose monitoring (CGM) is recognised as a state-of-the-art tool, but remains underutilised. Adoption of CGM in primary care should be informed by a broader understanding of the technology's capabilities and limitations.</p><p><strong>Methods: </strong>An expert panel was convened to review current literature and clinical experience to provide practical approaches to CGM for primary care practitioners and discuss the technology's value in the routine management of T2D. The goals were to review and reach consensus on the current state of CGM in non-specialist practice settings and on strategies for successfully initiating and maintaining people on CGM.</p><p><strong>Results: </strong>Initiation and maintenance of CGM therapy can be successfully conducted in primary care settings. CGM therapy should include proper patient selection, proper setting of expectations, and evidence-based adjustments to therapy. Most patients are likely to see quick, meaningful, and lasting improvements in their diabetes, along with a better understanding of their condition and greater motivation for successful management. Retrospective report interpretation is feasible and intuitive. Barriers to adoption and sustained use include cost, technological limitations, behavioural or psychological factors, and therapeutic inertia. Addressing these barriers is critical to enable better access to CGM. Continuous glucose monitoring can be leveraged by primary care teams to inform treatment decisions and also by patients to inform diabetes self-management.</p><p><strong>Conclusion: </strong>CGM should be considered for all people with T2D. The recommendations provided here should simplify adoption and maintenance use of CGM in primary care and maximise the glycaemic and psychosocial benefits of the technology.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"749-762"},"PeriodicalIF":3.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925819/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143522937","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":"Perspectives on Stringent Glycemic Control and Weight Loss Among Patients with Type 2 Diabetes in China: A Survey Study.","authors":"Jian Zhang, Ang Li, Jinxing Quan, Jun Wu, Hanqing Cai, Yuchen Ding, Jiani Tang, Xiao Ma, Junqing Zhang","doi":"10.1007/s13300-024-01690-8","DOIUrl":"10.1007/s13300-024-01690-8","url":null,"abstract":"<p><strong>Introduction: </strong>Although current guidelines for type 2 diabetes (T2D) underscored the importance of attaining glycemic control and weight management goals, the patient perspectives on achieving these goals remained unclear in China. This study aimed to understand Chinese patients' perspectives on stringent glycemic control (hemoglobin A1c [HbA1c] ≤ 6.5%) and weight loss (≥ 10%) and their treatment preferences.</p><p><strong>Methods: </strong>Adult Chinese patients diagnosed with T2D who were aware of their latest HbA1c were enrolled in this survey study. An electronic questionnaire was designed to collect patients' characteristics, perspectives on safely achieving stringent glycemic control and weight loss, and preferences for different T2D treatment profiles.</p><p><strong>Results: </strong>The study included 495 patients. Patients predominantly indicated that safely achieving stringent glycemic control was extremely (82.83%) or moderately (12.12%) important. Nearly half of the patients (n = 231) perceived ≥ 10% weight loss as beneficial, among whom 117 (50.65%) and 84 (36.36%) indicated it was extremely and moderately important, respectively. Both having HbA1c > 6.5% within the past 6 months and body mass index ≥ 24 kg/m² were associated with increased odds of choosing the T2D treatment with a higher chance of achieving stringent glycemic control and weight loss, given a similar safety profile. Conversely, age ≥ 60 years was associated with decreased odds of having the outcomes listed above.</p><p><strong>Conclusion: </strong>This study demonstrated that most surveyed patients with T2D in China recognized the importance of safely achieving stringent glycemic control and weight loss. The identified factors associated with patients' perspectives and preferences could benefit clinical decision-making.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"591-612"},"PeriodicalIF":3.8,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11925834/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406174","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 Therapeutic Potential of Dipeptidyl Peptidase 4 Inhibitors and Glucagon-Like Peptide-1 Receptor Agonists in Diabetic Peripheral Neuropathy.","authors":"Theodoros Panou, Evanthia Gouveri, Djordje S Popovic, Dimitrios Papazoglou, Nikolaos Papanas","doi":"10.1007/s13300-025-01712-z","DOIUrl":"https://doi.org/10.1007/s13300-025-01712-z","url":null,"abstract":"<p><p>Diabetic peripheral neuropathy (DPN) is one of the commonest complications of diabetes mellitus (DM). Current therapeutic approaches largely focus on pain management. However, less evidence is available on the clinical potential of two widely prescribed drug categories in DM management: dipeptidyl peptidase 4 inhibitors (DPP-4is) and glucagon-like peptide-1 receptor agonists (GLP-1RAs). In this review, we discuss evidence from both experimental and clinical studies on the potential utility of these drugs in the management of DPN. Immunohistochemical data indicate that agents in both categories promote neurite outgrowth, ion conduction, neuronal survival and Schwann cell function. Furthermore, intra-epidermal nerve fibre density has been reported to increase with DPP-4is or GLP-1RAs treatment. Moreover, electrophysiological studies have indicated a diverse, but mostly beneficial, effect on motor or sensory nerve conduction velocity. Clinical tests, such as the muscular grip or paw jumping control resembling neuropathic symptoms, have also confirmed the advantageous effect of DPP-4is and GLP-1RAs. Finally, limited but promising clinical data have shown improved somatosensory-evoked potentials and vibration perception threshold, as well as restored excitability and nerve size parameters. Nevertheless, further clinical studies are required to elucidate the exact role of DPP-4is and GLP-1RAs in DPN.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735784","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preferences, Expectations and Attitudes on Basal Insulin from Patient-Physician-Payer Perspective: A Multi-stakeholder Survey by the Italian Diabetes Society (ITA4P Study).","authors":"Gian Paolo Fadini, Stefano Ciardullo, Gianluca Perseghin, Carla Giordano, Ernesto Maddaloni, Raffaella Buzzetti, Mariangela Ghiani, Angelo Avogaro","doi":"10.1007/s13300-025-01729-4","DOIUrl":"https://doi.org/10.1007/s13300-025-01729-4","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes management often involves complex insulin regimens, posing significant challenges for patients and healthcare systems. Weekly basal insulin formulations aim to simplify treatment, reduce injection frequency, and improve adherence and quality of life. This study explored the beliefs, preferences and attitudes of patients, physicians and payers regarding current basal insulin therapy and weekly insulin formulations.</p><p><strong>Methods: </strong>An online survey with structured questionnaires was developed for multiple stakeholders: patients with type 1 or type 2 diabetes, physicians and payers. Participants provided self-reported insights into basal insulin therapy and perceptions of weekly formulations. Results are presented in a descriptive non-analytical way.</p><p><strong>Results: </strong>A total of 1094 patients, 468 physicians and 100 payers participated. Patients reported moderate satisfaction with current insulin therapy, with lower satisfaction in type 2 diabetes (T2D). The major burdens identified were daily injections and fear of hypoglycaemia, with weekly insulin seen as a promising alternative. Physicians prioritized glycaemic control goals, while patients emphasized independence and quality of life. Payers valued adherence and hypoglycaemia avoidance but raised concerns about costs and education needs.</p><p><strong>Conclusions: </strong>According to this multi-stakeholder survey, weekly basal insulin offers a promising approach to reduce treatment burden and improve adherence and quality of life. Addressing concerns about safety, efficacy and cost will be critical to its successful adoption in clinical practice.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association of Blood Heavy Metals with Diabetic Foot Ulcers in U.S. Adults with Diabetes: Insights from the 1999-2004 NHANES Data.","authors":"Jia-Hao Xing, Yang Yu, Lin Teng, Xue-Ying Hui, Wei-Guang Guo","doi":"10.1007/s13300-025-01730-x","DOIUrl":"https://doi.org/10.1007/s13300-025-01730-x","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetic foot ulcers (DFU) are serious complications of diabetes. These ulcers significantly increase the risk of amputations. Many studies have examined how blood heavy metals affect insulin secretion in diabetes. However, research linking blood heavy metal exposure to DFU is limited. This study aims to explore the connection between blood heavy metal exposure and DFU in people with diabetes.</p><p><strong>Methods: </strong>This cross-sectional study used data from the 1999-2004 cycle of the National Health and Nutrition Examination Survey (NHANES). Researchers measured blood levels of lead (Pb) and cadmium (Cd) using inductively coupled plasma mass spectrometry (ICP-MS). Four logistic regression models assessed the relationship between blood heavy metals and the prevalence of DFU. The models adjusted for potential confounding factors. Additionally, smooth curve fitting and piecewise regression analyses were conducted to investigate the correlation further. Subgroup analyses and interaction tests helped evaluate consistency across the general population.</p><p><strong>Results: </strong>A total of 1664 participants aged 40 years or older with diabetes were included in the final analysis. The average age is 64.66 ± 11.79 years, with 52.52% being male and 47.48% being female. Among these individuals, 135 (8.11%) were diagnosed with DFU. Statistical modeling revealed a significant positive correlation between blood cadmium (Cd) levels and the prevalence of DFU. Specifically, model 4, which was the fully adjusted model, indicated that for each unit increase in blood Cd level, there was a corresponding 64% increase in DFU prevalence [OR = 1.64; 95% CI (1.42-1.89), p = 0.004]. Further analysis through smooth curve fitting demonstrated a significant linear relationship between blood Cd levels and DFU prevalence.</p><p><strong>Conclusions: </strong>This study identified a positive correlation between blood cadmium (Cd) levels and the prevalence of DFU. These results suggest that monitoring blood Cd levels in patients with diabetes during follow-up may be important for preventing the development of DFU. However, further prospective studies are necessary to provide additional evidence.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143735769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Systematic Literature Review of the Impact of Type 2 Diabetes and Heart Failure Guideline Adherence on Clinical and Economic Outcomes.","authors":"Elena Vianini, Anuja Pandey, Catherine Rolland, Nomxolisi Ngubane, Dirk Mueller-Wieland, Jeremy Gilbert, Alhussein Ahmad","doi":"10.1007/s13300-025-01725-8","DOIUrl":"https://doi.org/10.1007/s13300-025-01725-8","url":null,"abstract":"<p><strong>Introduction: </strong>Type 2 diabetes mellitus (T2DM) is associated with comorbidities, particularly in the cardiovascular, renal, and metabolic (CVRM) spectrum. Given the complexity of CVRM spectrum diseases and the treatment landscape, treatment guidelines have been established to assist physicians in selecting the most appropriate treatment based on not only patients' primary disease but also their comorbidities. However, the impact of adherence to treatment guidelines on associated outcomes remains unclear.</p><p><strong>Methods: </strong>A systematic literature review was conducted to evaluate the impact of guideline-based treatment on clinical, economic, and quality-of-life (QoL) outcomes and related comorbidities in the CVRM spectrum or heart failure (HF) alone in individuals with T2DM. The MEDLINE, MEDLINE In-Process, Embase, Cochrane Central Register of Controlled Trials, and EconLit electronic databases were searched to identify relevant peer-reviewed studies published in the United States, Canada, or Germany. The studies were screened and selected for inclusion or exclusion based on populations, interventions, comparators, and study design (PICOS) criteria.</p><p><strong>Results: </strong>Of the 622 records identified, 28 publications met the inclusion criteria. In total, 11 and 16 studies reported adherence to clinical guidelines for T2DM and HF management, respectively. Adherence to T2DM and HF treatment guidelines decreased all-cause mortality and all-cause hospitalizations; furthermore, adherence to T2DM guidelines decreased hospitalizations due to HF, myocardial infarction, and stroke, and reduced T2DM-related long-term complications, while adherence to HF guidelines reduced hospitalizations due to HF. Evidence gaps were identified, including the need to assess the impact of guideline adherence on economic outcomes, the impact of adherence to diagnosis and monitoring guidelines, and the impact of guideline adherence on QoL outcomes.</p><p><strong>Conclusions: </strong>Adherence to disease management guidelines improves the outcomes of patients with T2DM or HF and reduces disease-related complications and hospitalizations; however, key evidence gaps exist, particularly regarding patients with T2DM along with comorbidities in the CVRM spectrum.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Once-Weekly Semaglutide Versus Sodium-Glucose Co-transporter 2 Inhibitors: Real-World Impact on Weight, HbA1c, and Healthcare Resource Utilization in Type 2 Diabetes (PAUSE).","authors":"James Amamoo, Riddhi Doshi, Joshua Noone, Lin Xie, Cory Gamble, Mico Guevarra, Victoria Divino, Justin Chen, Aaron King","doi":"10.1007/s13300-025-01721-y","DOIUrl":"https://doi.org/10.1007/s13300-025-01721-y","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical trials have demonstrated greater glycemic control and weight loss with once-weekly (OW) semaglutide versus other anti-diabetes medications, including sodium-glucose co-transporter 2 inhibitors (SGLT2is) in adults with type 2 diabetes (T2D), yet real-world evidence is limited.</p><p><strong>Methods: </strong>This observational study of adults with uncontrolled T2D (HbA1c ≥ 7.0%) initiating semaglutide OW or SGLT2is (January 2018-February 2022; first prescription = index) utilized linked data from IQVIA PharMetrics® Plus adjudicated claims and Ambulatory Electronic Medical Records databases. Among the all semaglutide OW cohort and subgroups (1: persistent [≤ 60-day gap in semaglutide OW supply]; 2: receiving maximum dose ≥ 1 mg; and 3: persistent and ≥ 1 mg dose), changes in weight, body mass index (BMI), and glycated hemoglobin (HbA1c) outcomes from baseline to 1 year post index were descriptively compared. For the main analysis, changes in weight, BMI, HbA1c, and all-cause healthcare resource utilization (HCRU) after 1 year were compared among adjusted semaglutide OW and comparator SGLT2i cohorts, following inverse probability of treatment weighting (IPTW).</p><p><strong>Results: </strong>The all semaglutide OW cohort included 772 patients, and IPTW adjusted cohorts included 416 semaglutide OW patients and 1093 SGLT2i patients. Significant (P < 0.0001) mean changes from baseline were observed in the all semaglutide OW cohort and all subgroups, in weight (kg [all: - 4.4; 1: - 5.0; 2: - 4.9; 3: - 5.2]), BMI (kg/m² [all: - 1.5; 1: - 1.8; 2: - 1.8; 3: - 1.9]), and HbA1c (% [all: - 1.5; 1: - 1.7; 2: - 1.5; 3: - 1.6]). Post-IPTW adjustment, the semaglutide OW cohort had significantly greater mean reductions versus the SGLT2i cohort in weight (- 4.4 versus - 3.4 kg, P = 0.0061), BMI (- 1.5 versus - 1.1 kg/m², P = 0.0013), and HbA1c (- 1.6 versus - 1.2%, P < 0.0001), with similar all-cause HCRU.</p><p><strong>Conclusion: </strong>Adults with T2D initiating semaglutide OW in the real-world had significant decreases in weight, BMI, and HbA1c after 1 year, with greater improvements versus SGLT2i, and similar HCRU.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718282","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Association Between HbA1c Levels and the Risk of Myocardial Infarction and Stroke in People with Type 2 Diabetes: A Post Hoc Analysis of the REPRESENT Study.","authors":"Irene Cristina Romera, Jennifer Redondo-Antón, Miriam Rubio-de Santos, Silvia Díaz-Cerezo, Esther Artime, Albert Rafels-Ybern, Emilio Ortega, Ignacio Conget","doi":"10.1007/s13300-025-01727-6","DOIUrl":"https://doi.org/10.1007/s13300-025-01727-6","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of this work was to analyze the association between baseline glycated hemoglobin (HbA1c) levels and other factors on the risk of first myocardial infarction (MI) and on the risk of first stroke in people with type 2 diabetes (T2D) in Spain.</p><p><strong>Methods: </strong>This post hoc analysis of the REPRESENT study used the IQVIA electronic medical records database. Cumulative incidences were estimated using the Kaplan-Meier method, and Cox regression models were used to identify associated risk factors, including gender, age, HbA1c, or prior cardiovascular disease (other than MI/stroke).</p><p><strong>Results: </strong>Median follow-up was 7 years. In people without prior MI/stroke, the incidence (95% confidence interval [CI]) of first MI/stroke was 0.31 (0.28-0.34) and 0.18 (0.15-0.20) events per 100 patient-years, respectively. Baseline HbA1c levels < 6.5% were independently associated with lower risk of first MI (hazard ratio [HR] 0.76 [95% CI 0.61-0.94]) and of first stroke (HR 0.74 [95% CI 0.56-0.98]). Male sex, age ≥ 50 years, and previous cardiovascular disease were independently associated with a higher risk of MI/stroke.</p><p><strong>Conclusions: </strong>This analysis found an association between baseline HbA1c levels < 6.5% and lower risk of a first MI or stroke in a T2D cohort in Spain, suggesting a role of stringent glycemic control in the prevention of cardiovascular complications.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143718310","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PIONEER REAL Italy: Real-World Usage of Once-Daily Oral Semaglutide in Adults with Type 2 Diabetes.","authors":"Roberta Manti, Salvatore De Cosmo, Paolo Desenzani, Lidia Ferrara, Angela Girelli, Giuseppe Memoli, Alessandro Bisio, Uffe Christian Braae, Alisa Deinega, Cesare Berra","doi":"10.1007/s13300-025-01719-6","DOIUrl":"https://doi.org/10.1007/s13300-025-01719-6","url":null,"abstract":"<p><strong>Introduction: </strong>The PIONEER REAL Italy study examined the clinical outcomes associated with oral semaglutide in real-world settings.</p><p><strong>Methods: </strong>This was a multicenter, prospective, non-interventional, single-arm study in adults with type 2 diabetes (T2D) who were treatment-naive to injectable glucose-lowering medications. Participants initiated oral semaglutide at doses of 3, 7, or 14 mg, and were followed for 34-44 weeks. The primary endpoint was the change in glycated hemoglobin (HbA_1c) from baseline to the end of study (EoS). Secondary endpoints were the change in body weight (BW), the percentage of participants attaining HbA_1c < 7%, composite endpoints of HbA_1c reduction ≥ 1%-point plus BW reduction (≥ 3%/ ≥ 5%), and treatment satisfaction measured using Diabetes Treatment Satisfaction Questionnaires (DTSQ) status. Safety was assessed in participants who received ≥ 1 dose of oral semaglutide.</p><p><strong>Results: </strong>Of 445 eligible participants, 398 completed the study; 351 (78.9%) remained on oral semaglutide at EoS. The median time of treatment follow-up was 40 weeks for each participant. At baseline, participants had a mean (standard deviation [SD]) age of 62.9 (10.2) years, HbA_1c of 7.8% (1.3), T2D duration of 8.0 (6.9) years, and BW of 87.8 (19.0) kg. The estimated changes (95% confidence interval) from baseline to EoS in HbA_1c and BW were - 0.9%-points (- 1.01 to - 0.82; p < 0.0001) and - 3.8 kg (- 4.45 to - 3.24; p < 0.0001), respectively. At EoS, 65.1% achieved HbA_1c < 7%; 25.5% and 19.1% reached HbA_1c reduction ≥ 1%-point plus ≥ 3% and ≥ 5% reduction in BW, respectively. DTSQ status improved significantly at EoS (estimated change + 5.24; 95% CI, 5.24 to 6.61, p < 0.0001). Of participants who remained on oral semaglutide at EoS, 72.6% received a 7-mg dose. No new safety signals were observed.</p><p><strong>Conclusions: </strong>In Italy, the real-world clinical outcomes associated with oral semaglutide in adults with T2D complemented the findings from clinical trials. This reassures oral semaglutide usage in routine clinical practice.</p><p><strong>Trial registration: </strong>NCT05230615.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2025-03-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143699975","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}