{"title":"The Long-Term Cost-Effectiveness of Tirzepatide 5 mg versus Dulaglutide 0.75 mg for the Treatment of People with Type 2 Diabetes in Japan.","authors":"Toshihiko Aranishi, Ataru Igarashi, Kazuo Hara, Beatrice Osumili, Zhihong Cai, Aska Mizogaki, Manaka Sato, Masakazu Takeuchi, Alice Minghetti, Barnaby Hunt, Takashi Kadowaki","doi":"10.1007/s13300-024-01675-7","DOIUrl":"10.1007/s13300-024-01675-7","url":null,"abstract":"<p><strong>Introduction: </strong>This analysis aimed to evaluate the long-term cost-effectiveness of tirzepatide 5 mg versus dulaglutide 0.75 mg (both administered once weekly) in people not achieving glycemic control on metformin, based on the results of the head-to-head SURPASS J-mono trial from a Japanese healthcare payer perspective.</p><p><strong>Methods: </strong>A cost-utility analysis was performed over a 50-year time horizon using an implementation of the UKPDS Outcomes Model 2 developed in Microsoft Excel. Baseline cohort characteristics, treatment effects and adverse event rates were sourced from the SURPASS J-mono trial. Simulated patients were assumed to receive either tirzepatide 5 mg or dulaglutide 0.75 mg until HbA1c exceeded 8.0%, at which point treatment was discontinued and basal insulin was initiated. Direct costs were derived from the Japan Medical Data Center claims database. Future costs and clinical benefits were discounted at 2% annually.</p><p><strong>Results: </strong>In this cost-utility modeling analysis, tirzepatide 5 mg was associated with lower diabetes-related complication rates, improved life expectancy, improved quality-adjusted life expectancy and higher direct costs versus dulaglutide 0.75 mg. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY (Japanese yen) 1,302,240 per quality-adjusted life year (QALY) gained for tirzepatide 5 mg versus dulaglutide 0.75 mg (JPY 140 = USD 1). Tirzepatide remained cost-effective versus dulaglutide over a range of sensitivity analyses.</p><p><strong>Conclusions: </strong>In this analysis, tirzepatide 5 mg was associated with an ICER below the commonly quoted willingness-to-pay threshold of JPY 5,000,000 per QALY gained, suggesting that tirzepatide is a cost-effective treatment option for adult patients with type 2 diabetes mellitus, compared with dulaglutide 0.75 mg.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"431-445"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868005/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142871662","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-02-10DOI: 10.1007/s13300-025-01692-0
Daphne S L Gardner, Banshi Saboo, Jothydev Kesavadev, Norlaila Mustafa, Michael Villa, Edward Mahoney, Shailendra Bajpai
{"title":"Digital Health Technology in Diabetes Management in the Asia-Pacific Region: A Narrative Review of the Current Scenario and Future Outlook.","authors":"Daphne S L Gardner, Banshi Saboo, Jothydev Kesavadev, Norlaila Mustafa, Michael Villa, Edward Mahoney, Shailendra Bajpai","doi":"10.1007/s13300-025-01692-0","DOIUrl":"10.1007/s13300-025-01692-0","url":null,"abstract":"<p><p>Diabetes is a growing global health concern with a high prevalence in the Asian and Western Pacific regions. Effective diabetes management mainly relies on self-care practices. However, glycemic control remains poor, especially in developing nations where healthcare access is limited. Low physician density and minimal healthcare funding exacerbate the challenges faced by people with diabetes in Asia. Digital health technologies offer promising solutions to bridge these gaps. These technologies enhance patient engagement, improve medication adherence, and promote healthier lifestyles. Mobile apps provide tools for self-management, such as monitoring physical activity and dietary intake, while telemedicine platforms and electronic medical records facilitate patient data management and remote consultations. Despite the advantages provided by digital health technologies in managing diabetes, barriers to their adoption include infrastructure limitations, regulatory challenges, and issues with data security. Some Asian countries have made major strides in the adoption of digital health tools with national strategies and regulatory bodies to manage digital health options; however, disparities in digital health readiness persist. Effective implementation of these technologies requires addressing these barriers, including enhancing infrastructure, improving app usability, and ensuring regulatory compliance. While digital health solutions present significant opportunities, their impact depends on overcoming current challenges and ensuring equitable access and effective use in managing diabetes. Future directions should focus on prioritizing app acceptance and efficacy, as well as integrating machine learning and artificial intelligence-powered digital solutions.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"349-369"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381835","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":"Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes.","authors":"Risa Nasu, Tomonori Oura, Kenji Ohwaki, Makoto Imori, Kenichi Furihata","doi":"10.1007/s13300-025-01695-x","DOIUrl":"10.1007/s13300-025-01695-x","url":null,"abstract":"<p><strong>Introduction: </strong>This analysis aimed to assess the safety and tolerability of insulin efsitora alfa (efsitora, basal insulin Fc, LY3209590) and characterize the pharmacokinetic and pharmacodynamic profiles of efsitora in Japanese patients with type 2 diabetes.</p><p><strong>Methods: </strong>The single-dose escalation study assessed once-weekly efsitora administration in three patient cohorts: 5 mg for cohort 1; 10 mg for cohort 2 or placebo under double-blind conditions; and 20 mg for cohort 3 under open-label conditions. In the 6-week, multiple-dose study, patients started or continued using insulin degludec during the lead-in period, followed by randomization to efsitora (individualized fixed weekly dose) or insulin degludec (individualized fixed daily dose). Pharmacokinetics, pharmacodynamics, and safety were examined.</p><p><strong>Results: </strong>The mean age was 58.3 and 58.4 years, and mean body mass index was 25.6 and 26.8 kg/m<sup>2</sup> in the single-dose escalation (n = 31) and multiple-dose studies (n = 28), respectively. The pharmacokinetic profile showed a prolonged half-life of 15 to 16 days, with a low peak-to-trough ratio of 1.13 after the last dose with little fluctuation. All doses of efsitora (5, 10, and 20 mg) decreased mean fasting glucose levels from baseline to day 15 (single-dose study), with no notable changes observed after switching from insulin degludec (multiple-dose study). All treatment-emergent adverse events were mild and unrelated to the study drug. No severe hypoglycemic events were reported.</p><p><strong>Conclusions: </strong>Efsitora was well tolerated, and the pharmacokinetic and pharmacodynamic profiles were consistent with findings in prior global studies, supporting the participation of Japanese patients in phase 3 studies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT03603704; NCT04276428.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"513-526"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381837","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-01-30DOI: 10.1007/s13300-025-01696-w
Hong Wang, Quannan Zu, Ming Lu, Rongfa Chen, Zhangui Tang, Zhiren Yang
{"title":"Cardiovascular Outcomes in Patients with Complex Type 2 Diabetes Mellitus Treated with the Dual SGLT Inhibitor Sotagliflozin: A Meta-analysis.","authors":"Hong Wang, Quannan Zu, Ming Lu, Rongfa Chen, Zhangui Tang, Zhiren Yang","doi":"10.1007/s13300-025-01696-w","DOIUrl":"10.1007/s13300-025-01696-w","url":null,"abstract":"<p><strong>Introduction: </strong>Scientific publications have shown sodium-glucose co-transporter-2 (SGLT2) inhibitors to have several beneficial effects in patients with complex type 2 diabetes mellitus (T2DM). However, sodium-glucose co-transporter-1 (SGLT-1) inhibitor is still under investigation in clinical trials. Recently, a dual inhibitor of sodium-glucose co-transporter (SGLT1/2), sotagliflozin, has been approved for use in patients with T2DM. In this analysis, we aimed to systematically compare the cardiovascular outcomes in patients with complex T2DM who were treated with the newly approved dual (SGLT 1 and 2) inhibitor sotagliflozin.</p><p><strong>Methods: </strong>Electronic databases, including Embase, MEDLINE, http://www.</p><p><strong>Clinicaltrials: </strong>gov , Web of Science, Google Scholar, the Cochrane database, and reference lists of relevant publications, were searched for publications comparing the novel SGLT1/2 inhibitor versus placebo for the treatment of patients with complex T2DM. The primary endpoint, including total number of deaths from cardiovascular causes, hospitalization for heart failure, and urgent visits for heart failure, death from cardiovascular causes, cardiac mortality, hospitalization for heart failure, non-fatal myocardial infarction, and total number of cardiac events, were considered as the endpoints in this analysis. The RevMan software version 5.4 was used to carry out the statistical analysis. Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data following analysis.</p><p><strong>Results: </strong>A total of 13,054 participants enrolled between 2017 and 2020 were included in this analysis, with 6734 participants assigned to sotagliflozin and 6320 assigned to placebo. The results of this analysis showed that the primary endpoint was significantly in favor of sotagliflozin with (RR: 0.73, 95% CI 0.67-0.80; P = 0.00001). Hospitalization for heart failure (RR: 0.67, 95% CI 0.60-0.75; P = 0.00001) and the total number of cardiac events (RR: 0.73, 95% CI 0.67-0.79; P = 0.00001) were also significantly lower with sotagliflozin when compared to placebo in these patients with complex T2DM. However, the risk for cardiovascular mortality and non-fatal myocardial infarction were not significantly different with (RR: 0.91, 95% CI 0.76-1.09; P = 0.31) and (RR: 0.92, 95% CI 0.27-3.12; P = 0.89), respectively.</p><p><strong>Conclusions: </strong>Cardiovascular outcomes, including the total number of adverse cardiac events and hospitalization for heart failure, were significantly reduced with the newly approved SGLT1/2 inhibitor sotagliflozin apparently showing its cardiovascular efficacy in patients with complex T2DM. Future trials with larger sample sizes and a longer follow-up time could possibly confirm this hypothesis.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"485-498"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867987/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143064410","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-02-06DOI: 10.1007/s13300-025-01698-8
Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen
{"title":"Correction to: Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study.","authors":"Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen","doi":"10.1007/s13300-025-01698-8","DOIUrl":"10.1007/s13300-025-01698-8","url":null,"abstract":"","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"429-430"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867991/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255210","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}
Diabetes TherapyPub Date : 2025-03-01Epub Date: 2025-01-11DOI: 10.1007/s13300-024-01689-1
Tianzuo Wang, Yuying Cui, Lin Liao
{"title":"Comparative Efficacy and Safety of Oral Semaglutide in Asians and Non-Asians Patients with Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis.","authors":"Tianzuo Wang, Yuying Cui, Lin Liao","doi":"10.1007/s13300-024-01689-1","DOIUrl":"10.1007/s13300-024-01689-1","url":null,"abstract":"<p><strong>Introduction: </strong>More than half of diabetes patients are Asians, and their tolerance to antidiabetic drugs may differ from that of non-Asians. Oral semaglutide has recently gained attention for its advantages in glycemic and body weight control. However, its effects across different ethnic groups remain unknown.</p><p><strong>Methods: </strong>All available databases of randomized controlled trials (RCTs) on oral semaglutide in patients with type 2 diabetes mellitus were included. These databases provided detailed patient information, including HbA1c levels, body weight, and adverse events (AEs and serious adverse events [SAEs]).</p><p><strong>Results: </strong>Ten randomized controlled trials involving 7817 patients were included: six conducted in European and American populations and four in East Asian populations. In both the Asian and non-Asian patients' subgroups, oral semaglutide 3, 7, and 14 mg was more effective in reducing HbA1c than placebo, and between-subgroups analysis showed that semaglutide 3, 7, and 14 mg was more effective in reducing HbA1c in the Asian patients' subgroup than in the non-Asian patients' subgroup. There were no significant differences between subgroups in the number of patients achieving HbA1c < 5%. Non-Asian patients with type 2 diabetes showed significant weight reduction with 7 mg and 14 mg oral semaglutide, and Asian patients reduced body weight only with 14 mg oral semaglutide. Between-subgroups analysis showed that 7 mg oral semaglutide was more effective for weight reduction in non-Asian patients than in Asian patients. In the analysis of the efficacy of oral semaglutide at weeks 26 and 52 in Asian and non-Asian patients, in Asian patients, the hypoglycemic efficacy of oral semaglutide at 3-, 7-, and 14-mg doses at week 52 was significantly lower than that at week 26. In non-Asian patients, there was no significant difference in the reducing HbA1c efficacy of these doses of oral semaglutide at weeks 26 and 52. The weight-reduction efficacy of all doses of oral semaglutide did not change significantly with treatment duration in either Asian or non-Asian patients. Compared with sitagliptin, oral semaglutide was more effective in HbA1c reduction and weight reduction in both Asian and non-Asian patients. Subgroup analysis showed that compared with sitagliptin, Asian patients received oral semaglutide to achieve greater efficacy (HbA1c and weight reduction) than non-Asian patients. In the analysis of adverse events, oral semaglutide, as compared with placebo, was not associated with serious adverse events in either subgroup. The incidence of other (not including series) adverse events was significantly higher in non-Asian patients receiving 7 mg and 14 mg oral semaglutide.</p><p><strong>Conclusions: </strong>Oral semaglutide demonstrates superior efficacy in reducing HbA1c levels and a rapid onset of action in Asian patients. However, its efficacy appears to diminish with prolonged treatment in ","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"449-470"},"PeriodicalIF":3.8,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11868037/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142964030","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}
Diabetes TherapyPub Date : 2025-02-01Epub Date: 2024-12-28DOI: 10.1007/s13300-024-01669-5
Jonathan D Rich, Hyvelle Ferguson-Davis
{"title":"A Podcast on Patient and Physician Perspectives in the Holistic Care of Heart-Related Challenges of Type 2 Diabetes.","authors":"Jonathan D Rich, Hyvelle Ferguson-Davis","doi":"10.1007/s13300-024-01669-5","DOIUrl":"10.1007/s13300-024-01669-5","url":null,"abstract":"<p><p>Type 2 diabetes (T2D) frequently coexists with cardiorenal complications. Therefore, a holistic approach to patient management is required, with specialists such as primary care physicians, cardiologists, endocrinologists, and nephrologists working together to provide patient care. Although glycemic control is important in the management of T2D, patients with T2D and acceptable glycemic control are still at risk from cardiovascular (CV) events such as stroke, heart attack, and heart failure (HF). Therefore, management of other risk factors, such as high blood pressure, high cholesterol, smoking cessation, and excess bodyweight, are imperative for reducing the risk of CV disease and HF in patients with T2D. In addition to pharmacological interventions, patient self-care, including beneficial dietary changes, regular exercise, and smoking cessation are critical for improving heart health and reducing the risk of CV events and progression of HF. In this podcast, a patient with lived experience of the heart-related challenges of T2D and a cardiologist discuss the link between T2D and heart-related complications, the pharmacological interventions and lifestyle modifications that can be used to reduce the risk of CV events and prevent HF, and the complexities of engaging with the healthcare system when managing multiple comorbidities. The discussion highlights the importance of patient education and empowerment for the management of heart-related challenges of T2D, and the central role of collaborative care between physicians of multiple specialties to reduce CV risk for patients with T2D.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"137-144"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794770/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142892937","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}
Diabetes TherapyPub Date : 2025-02-01Epub Date: 2025-01-06DOI: 10.1007/s13300-024-01687-3
Jerry R Greenfield, Ruth Frampton, Kellie Millard, Jennifer R Snaith
{"title":"Use of Cardioprotective Adjuncts in Type 1 Diabetes.","authors":"Jerry R Greenfield, Ruth Frampton, Kellie Millard, Jennifer R Snaith","doi":"10.1007/s13300-024-01687-3","DOIUrl":"10.1007/s13300-024-01687-3","url":null,"abstract":"<p><p>Type 1 diabetes is associated with excess cardiovascular risk, even after accounting for traditional cardiovascular risk factors, including glycaemia. Hence, there is an urgent need to document the metabolic abnormalities that contribute to the cardiovascular mortality gap in type 1 diabetes, and to examine whether cardioprotective type 2 diabetes medications prevent premature morbidity and mortality in this population.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"145-148"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794932/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930878","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}
Diabetes TherapyPub Date : 2025-02-01Epub Date: 2024-12-19DOI: 10.1007/s13300-024-01679-3
Liana K Billings, Marisse Asong, Martin Bøg, Simon Clancy, Christian Kruse, Elisabeth de Laguiche, Ernesto Maddaloni
{"title":"AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes.","authors":"Liana K Billings, Marisse Asong, Martin Bøg, Simon Clancy, Christian Kruse, Elisabeth de Laguiche, Ernesto Maddaloni","doi":"10.1007/s13300-024-01679-3","DOIUrl":"10.1007/s13300-024-01679-3","url":null,"abstract":"<p><strong>Introduction: </strong>ONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).</p><p><strong>Methods: </strong>ONWARDS 5 data were augmented with RWD collected from the US Ambulatory Electronic Medical Records database. Randomized and augmented comparisons (propensity-score-matched) between icodec with app and glargine U300 were weighted to provide a fully augmented estimate of the primary outcome (change in glycated hemoglobin [HbA<sub>1c</sub>] after 52 weeks). Data were adjusted for trial effects. Sensitivity analyses were conducted.</p><p><strong>Results: </strong>The nonaugmented randomized estimated treatment difference (ETD; 95% CI) between icodec with app and glargine U300 (trial stratum) for change in HbA<sub>1c</sub> was - 0.21 (- 0.70 to 0.28) percentage points. After adjusting for trial effects, the overall fully augmented ETD (95% CI) was - 0.33 (- 0.68 to 0.01) percentage points numerically in favor of icodec with app, although not statistically significant. Sensitivity analyses supported the findings.</p><p><strong>Conclusions: </strong>Using augmented data, the precision of the change in HbA<sub>1c</sub> estimate was increased compared with the trial stratum analysis alone. These findings help to validate the principle of utilizing augmentation to strengthen trial outcomes.</p><p><strong>Trial registration number: </strong>The ONWARDS 5 trial is registered with ClinicalTrials.gov (NCT04760626).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"227-239"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794749/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853395","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}
Diabetes TherapyPub Date : 2025-02-01Epub Date: 2024-12-17DOI: 10.1007/s13300-024-01677-5
Stewart Harris, Sal Cimino, Yen Nguyen, Kirk Szafranski, Yeesha Poon
{"title":"Cost-Effectiveness of FreeStyle Libre for Glucose Self-Management Among People with Diabetes Mellitus: A Canadian Private Payer Perspective.","authors":"Stewart Harris, Sal Cimino, Yen Nguyen, Kirk Szafranski, Yeesha Poon","doi":"10.1007/s13300-024-01677-5","DOIUrl":"10.1007/s13300-024-01677-5","url":null,"abstract":"<p><strong>Introduction: </strong>For people living with diabetes, effective glucose monitoring is a key component in diabetes care, helping to reduce disease burden, complications, and healthcare utilization. Sensor-based glucose monitoring systems, which can provide more comprehensive information about glucose levels than capillary-based self-monitoring of blood glucose (SMBG), are becoming established among people living with diabetes. The objective of this study was to assess the cost-effectiveness of glucose monitoring with FreeStyle Libre systems, compared with SMBG, from the perspective of a Canadian private payer.</p><p><strong>Methods: </strong>The analysis used the validated, person-level microsimulation model DEDUCE (Determination of Diabetes Utilities, Costs, and Effects). Analyses were conducted separately for populations of people with type 1 and type 2 diabetes mellitus (T1DM; T2DM), with time horizons of 40 and 25 years, respectively. T2DM treatment was assumed to be 84% non-insulin, 10% basal insulin, and 6% multiple daily injections of insulin. The effect of FreeStyle Libre was modeled as reductions versus SMBG in glycated hemoglobin level (T1DM, - 0.42%; insulin-treated T2DM, - 0.59%; non-insulin-treated T2DM, - 0.3%) and in acute diabetic events (hypoglycemia and diabetic ketoacidosis). Costs (in 2023 Canadian dollars (Can$)) and utilities were discounted at 1.5%. Outcomes were assessed as costs and quality-adjusted life years (QALYs).</p><p><strong>Results: </strong>In both populations, FreeStyle Libre was dominant to SMBG, providing more QALYs at a lower cost (T1DM: + 1.25 QALYs, - Can$32,287 costs; T2DM: + 0.48 QALYs, - Can$8091 costs). Reductions were seen in the cumulative incidence of all complications (except blindness in the T1DM analysis). FreeStyle Libre was dominant to SMBG in all scenarios tested. Probabilistic sensitivity analysis showed that FreeStyle Libre had a 100% probability of being dominant to SMBG for T1DM and a 91% probability of being dominant for T2DM.</p><p><strong>Conclusion: </strong>This economic analysis shows that, from a Canadian private payer perspective, FreeStyle Libre is cost-effective compared with SMBG for all people living with diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"169-186"},"PeriodicalIF":3.8,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11794756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834437","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}