Pub Date : 2025-05-28DOI: 10.1136/bmjdrc-2025-005027
Neil Holden, Onyinye Diribe, Karen Palmer, Amar Puttanna, Aymeric Mahieu, Charlie Nicholls, Xiaocong Li Marston, Nick Denholm, Fatemeh Saberi Hosnijeh, Iskandar Idris
Introduction: The prevalence of people with type 2 diabetes (T2D) on basal insulin (BI) is rising to improve glucose control and minimize complications. However, limited evidence exists regarding the economic impact of second-generation BI analogs compared with first-generation BI in the United Kingdom.
Research design and methods: In this comparative retrospective, observational study, adults with T2D who initiated treatment with a first-generation BI (eg, glargine 100 U/mL, detemir) and switched to another first-generation or a second-generation BI (glargine 300 U/mL (Gla-300) or degludec) (index date) between 1 July 2014 and 31 March 2021 were analyzed using the Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics. Subjects were followed from the index date until the end of observation period, deregistration in CPRD or death. Propensity score weighting balanced baseline characteristics and healthcare resource utilization (HCRU) and costs were compared using standardized differences and zero-inflated regression models.
Results: A total of 13 975 people with T2D (mean (SD) age: 62.45 (13.59) years) treated with a first-generation BI who switched to another first-generation BI (n=5654), Gla-300 (n=4737) or degludec (n=3584) were included. Mean (SD) follow-up time was 4.98 (4.27), 1.96 (1.62) and 2.05 (1.92) years for the first-generation BI, Gla-300 and degludec groups, respectively. Overall, people who switched to Gla-300 had significantly lower HCRU. Fewer people in the Gla-300 group received hypoglycemia-related healthcare compared with those in the first-generation BI group (9.1% vs 16.4%, incident rate ratio (IRR)=0.41, p<0.001) and the degludec group (9.2% vs 11.7%, IRR=0.51, p<0.001). During follow-up, diabetes-related and diabetic ketoacidosis-related total direct costs were lower for the Gla-300 group compared with the first-generation BI group by 17% and the degludec group by 60%, respectively.
Conclusions: These findings suggest that Gla-300 may offer clinical and economic benefits by reducing hypoglycemia incidents and lowering healthcare costs compared with first-generation BI.
{"title":"Healthcare utilization and costs in adults with type 2 diabetes treated with first or second-generation basal insulins in England.","authors":"Neil Holden, Onyinye Diribe, Karen Palmer, Amar Puttanna, Aymeric Mahieu, Charlie Nicholls, Xiaocong Li Marston, Nick Denholm, Fatemeh Saberi Hosnijeh, Iskandar Idris","doi":"10.1136/bmjdrc-2025-005027","DOIUrl":"10.1136/bmjdrc-2025-005027","url":null,"abstract":"<p><strong>Introduction: </strong>The prevalence of people with type 2 diabetes (T2D) on basal insulin (BI) is rising to improve glucose control and minimize complications. However, limited evidence exists regarding the economic impact of second-generation BI analogs compared with first-generation BI in the United Kingdom.</p><p><strong>Research design and methods: </strong>In this comparative retrospective, observational study, adults with T2D who initiated treatment with a first-generation BI (eg, glargine 100 U/mL, detemir) and switched to another first-generation or a second-generation BI (glargine 300 U/mL (Gla-300) or degludec) (index date) between 1 July 2014 and 31 March 2021 were analyzed using the Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics. Subjects were followed from the index date until the end of observation period, deregistration in CPRD or death. Propensity score weighting balanced baseline characteristics and healthcare resource utilization (HCRU) and costs were compared using standardized differences and zero-inflated regression models.</p><p><strong>Results: </strong>A total of 13 975 people with T2D (mean (SD) age: 62.45 (13.59) years) treated with a first-generation BI who switched to another first-generation BI (n=5654), Gla-300 (n=4737) or degludec (n=3584) were included. Mean (SD) follow-up time was 4.98 (4.27), 1.96 (1.62) and 2.05 (1.92) years for the first-generation BI, Gla-300 and degludec groups, respectively. Overall, people who switched to Gla-300 had significantly lower HCRU. Fewer people in the Gla-300 group received hypoglycemia-related healthcare compared with those in the first-generation BI group (9.1% vs 16.4%, incident rate ratio (IRR)=0.41, p<0.001) and the degludec group (9.2% vs 11.7%, IRR=0.51, p<0.001). During follow-up, diabetes-related and diabetic ketoacidosis-related total direct costs were lower for the Gla-300 group compared with the first-generation BI group by 17% and the degludec group by 60%, respectively.</p><p><strong>Conclusions: </strong>These findings suggest that Gla-300 may offer clinical and economic benefits by reducing hypoglycemia incidents and lowering healthcare costs compared with first-generation BI.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12121600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144179664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-16DOI: 10.1136/bmjdrc-2025-004928
Raveendhara R Bannuru
Obesity is a chronic, relapsing, and progressive disease requiring long-term, interprofessional treatment strategies to improve health outcomes. With over 40% of US adults and nearly 20% of children affected, obesity remains a significant public health concern. Despite the American Medical Association's recognition of obesity as a chronic disease, gaps persist in education, training, and access to effective treatments. These gaps contribute to inadequate obesity management and reinforce stigma and weight bias in healthcare settings.The Standards of Care in Overweight and Obesity-2025, developed by The Obesity AssociationTM, a division of the American Diabetes Association(R), (ADA's Obesity Association), will provide evidence-based recommendations for screening, diagnosis, and management of obesity and related complications. These guidelines will emphasize a complication-centric, risk-reduction approach rather than solely focusing on weight loss. The recommendations will be intended for healthcare professionals, including but not limited to primary care physicians, endocrinologists, obesity medicine physicians, dietitians, and behavioral health specialists, as well as policymakers and insurers.The guideline development will follow a rigorous methodology, incorporating evidence from systematic literature reviews, expert consensus, and public feedback. Recommendations will be graded based on the quality and certainity of supporting evidence, with the goal of annual updates to ensure alignment with the latest research. A stringent conflict-of-interest policy will be maintained to uphold guideline integrity.By promoting personalized and equitable obesity care, these guidelines will aim to bridge existing gaps in clinical practice, enhance treatment accessibility, and improve long-term health outcomes for individuals with overweight or obesity.
{"title":"Introduction and methodology: Standards of Care in Overweight and Obesity-2025.","authors":"Raveendhara R Bannuru","doi":"10.1136/bmjdrc-2025-004928","DOIUrl":"https://doi.org/10.1136/bmjdrc-2025-004928","url":null,"abstract":"<p><p>Obesity is a chronic, relapsing, and progressive disease requiring long-term, interprofessional treatment strategies to improve health outcomes. With over 40% of US adults and nearly 20% of children affected, obesity remains a significant public health concern. Despite the American Medical Association's recognition of obesity as a chronic disease, gaps persist in education, training, and access to effective treatments. These gaps contribute to inadequate obesity management and reinforce stigma and weight bias in healthcare settings.The Standards of Care in Overweight and Obesity-2025, developed by The Obesity Association<sup>TM</sup>, a division of the American Diabetes Association<sup>(R)</sup>, (ADA's Obesity Association), will provide evidence-based recommendations for screening, diagnosis, and management of obesity and related complications. These guidelines will emphasize a complication-centric, risk-reduction approach rather than solely focusing on weight loss. The recommendations will be intended for healthcare professionals, including but not limited to primary care physicians, endocrinologists, obesity medicine physicians, dietitians, and behavioral health specialists, as well as policymakers and insurers.The guideline development will follow a rigorous methodology, incorporating evidence from systematic literature reviews, expert consensus, and public feedback. Recommendations will be graded based on the quality and certainity of supporting evidence, with the goal of annual updates to ensure alignment with the latest research. A stringent conflict-of-interest policy will be maintained to uphold guideline integrity.By promoting personalized and equitable obesity care, these guidelines will aim to bridge existing gaps in clinical practice, enhance treatment accessibility, and improve long-term health outcomes for individuals with overweight or obesity.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 Suppl 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144207661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-16DOI: 10.1136/bmjdrc-2025-004962
Raveendhara R Bannuru
Weight bias involves negative attitudes and stereotypes towards individuals based on their weight, which can be explicit or implicit. This bias contributes to weight stigma, or the mistreatment and social devaluation of individuals based on weight. Weight stigma is linked to adverse physical and mental health outcomes, leading to reduced access and quality of healthcare for individuals with obesity. The American Diabetes Association (ADA)'s Obesity Association developed guidelines on recognizing and addressing weight bias and stigma. All healthcare professionals and staff should receive training on weight bias and stigma to improve care for individuals with obesity. Training should start early and continue throughout medical education and practice. Multicomponent training that combines education with hands-on learning is recommended to reduce explicit and implicit weight bias. Clinical practices, a potential source of stigmatization for people living with obesity, should be equipped with appropriate furniture and equipment to establish an inclusive environment. Privacy and sensitivity during anthropometric measurements are essential to minimize stigmatization. Healthcare professionals should use person-centered, non-judgmental language and engage individuals in shared decision-making to consider their health and goals. Asking permission to discuss weight and respecting individual preferences is crucial. The ADA's Obesity Association encourages adopting these guidelines to reduce weight bias and stigma, emphasizing education, inclusive clinical environments, and effective communication to improve obesity care.
{"title":"Weight stigma and bias: standards of care in overweight and obesity-2025.","authors":"Raveendhara R Bannuru","doi":"10.1136/bmjdrc-2025-004962","DOIUrl":"10.1136/bmjdrc-2025-004962","url":null,"abstract":"<p><p>Weight bias involves negative attitudes and stereotypes towards individuals based on their weight, which can be explicit or implicit. This bias contributes to weight stigma, or the mistreatment and social devaluation of individuals based on weight. Weight stigma is linked to adverse physical and mental health outcomes, leading to reduced access and quality of healthcare for individuals with obesity. The American Diabetes Association (ADA)'s Obesity Association developed guidelines on recognizing and addressing weight bias and stigma. All healthcare professionals and staff should receive training on weight bias and stigma to improve care for individuals with obesity. Training should start early and continue throughout medical education and practice. Multicomponent training that combines education with hands-on learning is recommended to reduce explicit and implicit weight bias. Clinical practices, a potential source of stigmatization for people living with obesity, should be equipped with appropriate furniture and equipment to establish an inclusive environment. Privacy and sensitivity during anthropometric measurements are essential to minimize stigmatization. Healthcare professionals should use person-centered, non-judgmental language and engage individuals in shared decision-making to consider their health and goals. Asking permission to discuss weight and respecting individual preferences is crucial. The ADA's Obesity Association encourages adopting these guidelines to reduce weight bias and stigma, emphasizing education, inclusive clinical environments, and effective communication to improve obesity care.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 Suppl 1","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-13DOI: 10.1136/bmjdrc-2025-004962
Raveendhara R Bannuru
Weight bias involves negative attitudes and stereotypes towards individuals based on their weight, which can be explicit or implicit. This bias contributes to weight stigma, or the mistreatment and social devaluation of individuals based on weight. Weight stigma is linked to adverse physical and mental health outcomes, leading to reduced access and quality of healthcare for individuals with obesity. The American Diabetes Association (ADA)'s Obesity Association developed guidelines on recognizing and addressing weight bias and stigma. All healthcare professionals and staff should receive training on weight bias and stigma to improve care for individuals with obesity. Training should start early and continue throughout medical education and practice. Multicomponent training that combines education with hands-on learning is recommended to reduce explicit and implicit weight bias. Clinical practices, a potential source of stigmatization for people living with obesity, should be equipped with appropriate furniture and equipment to establish an inclusive environment. Privacy and sensitivity during anthropometric measurements are essential to minimize stigmatization. Healthcare professionals should use person-centered, non-judgmental language and engage individuals in shared decision-making to consider their health and goals. Asking permission to discuss weight and respecting individual preferences is crucial. The ADA's Obesity Association encourages adopting these guidelines to reduce weight bias and stigma, emphasizing education, inclusive clinical environments, and effective communication to improve obesity care.
{"title":"Weight stigma and bias: standards of care in overweight and obesity-2025.","authors":"Raveendhara R Bannuru","doi":"10.1136/bmjdrc-2025-004962","DOIUrl":"https://doi.org/10.1136/bmjdrc-2025-004962","url":null,"abstract":"<p><p>Weight bias involves negative attitudes and stereotypes towards individuals based on their weight, which can be explicit or implicit. This bias contributes to weight stigma, or the mistreatment and social devaluation of individuals based on weight. Weight stigma is linked to adverse physical and mental health outcomes, leading to reduced access and quality of healthcare for individuals with obesity. The American Diabetes Association (ADA)'s Obesity Association developed guidelines on recognizing and addressing weight bias and stigma. All healthcare professionals and staff should receive training on weight bias and stigma to improve care for individuals with obesity. Training should start early and continue throughout medical education and practice. Multicomponent training that combines education with hands-on learning is recommended to reduce explicit and implicit weight bias. Clinical practices, a potential source of stigmatization for people living with obesity, should be equipped with appropriate furniture and equipment to establish an inclusive environment. Privacy and sensitivity during anthropometric measurements are essential to minimize stigmatization. Healthcare professionals should use person-centered, non-judgmental language and engage individuals in shared decision-making to consider their health and goals. Asking permission to discuss weight and respecting individual preferences is crucial. The ADA's Obesity Association encourages adopting these guidelines to reduce weight bias and stigma, emphasizing education, inclusive clinical environments, and effective communication to improve obesity care.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143969258","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-13DOI: 10.1136/bmjdrc-2025-004928
Raveendhara R Bannuru
Obesity is a chronic, relapsing, and progressive disease requiring long-term, interprofessional treatment strategies to improve health outcomes. With over 40% of US adults and nearly 20% of children affected, obesity remains a significant public health concern. Despite the American Medical Association's recognition of obesity as a chronic disease, gaps persist in education, training, and access to effective treatments. These gaps contribute to inadequate obesity management and reinforce stigma and weight bias in healthcare settings.The Standards of Care in Overweight and Obesity-2025, developed by The Obesity AssociationTM, a division of the American Diabetes Association(R), (ADA's Obesity Association), will provide evidence-based recommendations for screening, diagnosis, and management of obesity and related complications. These guidelines will emphasize a complication-centric, risk-reduction approach rather than solely focusing on weight loss. The recommendations will be intended for healthcare professionals, including but not limited to primary care physicians, endocrinologists, obesity medicine physicians, dietitians, and behavioral health specialists, as well as policymakers and insurers.The guideline development will follow a rigorous methodology, incorporating evidence from systematic literature reviews, expert consensus, and public feedback. Recommendations will be graded based on the quality and certainity of supporting evidence, with the goal of annual updates to ensure alignment with the latest research. A stringent conflict-of-interest policy will be maintained to uphold guideline integrity.By promoting personalized and equitable obesity care, these guidelines will aim to bridge existing gaps in clinical practice, enhance treatment accessibility, and improve long-term health outcomes for individuals with overweight or obesity.
{"title":"Introduction and methodology: Standards of Care in Overweight and Obesity-2025.","authors":"Raveendhara R Bannuru","doi":"10.1136/bmjdrc-2025-004928","DOIUrl":"https://doi.org/10.1136/bmjdrc-2025-004928","url":null,"abstract":"<p><p>Obesity is a chronic, relapsing, and progressive disease requiring long-term, interprofessional treatment strategies to improve health outcomes. With over 40% of US adults and nearly 20% of children affected, obesity remains a significant public health concern. Despite the American Medical Association's recognition of obesity as a chronic disease, gaps persist in education, training, and access to effective treatments. These gaps contribute to inadequate obesity management and reinforce stigma and weight bias in healthcare settings.The Standards of Care in Overweight and Obesity-2025, developed by The Obesity Association<sup>TM</sup>, a division of the American Diabetes Association<sup>(R)</sup>, (ADA's Obesity Association), will provide evidence-based recommendations for screening, diagnosis, and management of obesity and related complications. These guidelines will emphasize a complication-centric, risk-reduction approach rather than solely focusing on weight loss. The recommendations will be intended for healthcare professionals, including but not limited to primary care physicians, endocrinologists, obesity medicine physicians, dietitians, and behavioral health specialists, as well as policymakers and insurers.The guideline development will follow a rigorous methodology, incorporating evidence from systematic literature reviews, expert consensus, and public feedback. Recommendations will be graded based on the quality and certainity of supporting evidence, with the goal of annual updates to ensure alignment with the latest research. A stringent conflict-of-interest policy will be maintained to uphold guideline integrity.By promoting personalized and equitable obesity care, these guidelines will aim to bridge existing gaps in clinical practice, enhance treatment accessibility, and improve long-term health outcomes for individuals with overweight or obesity.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143980287","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-06DOI: 10.1136/bmjdrc-2024-004713
Leah E Cahill, Rachel A Warren, Samantha K Lavallée, Andrew P Levy, Allie S Carew, John Sapp, Michelle Samuel, Elizabeth Selvin, Neil Poulter, Michel Marre, Stephen Harrap, Giuseppe Mancia, Katie Harris, John Chalmers, Mark Woodward, Eric Rimm
Introduction: This study sought to determine whether the association between attaining specific glycated hemoglobin (HbA1c) targets (<7.0% (<53 mmol/mol) and ≥8.0% (≥64 mmol/mol) compared with 7.0%-7.9%) over time and risk of incident coronary artery disease (CAD) was dependent on haptoglobin (Hp) phenotype in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study.
Research design and methods: Prospectively collected HbA1c data from the ADVANCE biomarker case-cohort study, updated at 6 months and every 12 months thereafter over a median of 5.0 (IQR 4.5-5.3) years, were analyzed in relation to incident CAD in the Hp2-2 (n=1323) and non-Hp2-2 (n=2069) phenotypes separately using weighted multivariable-adjusted Cox regression models. Additional a priori stratifications by sex, race, previous cardiovascular disease (CVD), and type 2 diabetes duration were performed.
Results: Mean HbA1c was similar in each phenotype group throughout the study. Compared with HbA1c of 7.0%-7.9%, HbA1c <7.0% was not associated with CAD risk for any phenotype group or subgroup. HbA1c ≥8.0% compared with 7.0%-7.9% over time was associated with higher CAD risk for the Hp2-2 phenotype only (HR 1.53, 95% CI 1.01 to 2.32; no significant association in the non-Hp2-2 type: 1.26, 0.89 to 1.77, p-interaction=0.71); this was pronounced when those with previous CVD at baseline were excluded (Hp2-2: 2.80, 1.41 to 5.53, p-interaction=0.03). Compared with HbA1c of <8.0%, having HbA1c ≥8.0% was associated with a 59% higher CAD risk among participants with the Hp2-2 phenotype (1.59, 1.12 to 2.26) and a 39% higher CAD risk among participants without the Hp2-2 phenotype (1.39, 1.03 to 1.88, p-interaction=0.97).
Conclusions: The present ADVANCE analysis suggests that not having HbA1c ≥8.0%, rather than achieving HbA1c <7.0%, was found to be particularly important for CAD prevention among people with type 2 diabetes and the common Hp2-2 phenotype. While the subgroup analyses were likely underpowered, their inclusion is hypothesis generating and can be used in future meta-analyses to improve power and generalizability.
{"title":"Relationship between time-varying achieved HbA<sub>1c</sub> and risk of coronary artery disease events among common haptoglobin phenotype groups with type 2 diabetes: the ADVANCE study.","authors":"Leah E Cahill, Rachel A Warren, Samantha K Lavallée, Andrew P Levy, Allie S Carew, John Sapp, Michelle Samuel, Elizabeth Selvin, Neil Poulter, Michel Marre, Stephen Harrap, Giuseppe Mancia, Katie Harris, John Chalmers, Mark Woodward, Eric Rimm","doi":"10.1136/bmjdrc-2024-004713","DOIUrl":"https://doi.org/10.1136/bmjdrc-2024-004713","url":null,"abstract":"<p><strong>Introduction: </strong>This study sought to determine whether the association between attaining specific glycated hemoglobin (HbA<sub>1c</sub>) targets (<7.0% (<53 mmol/mol) and ≥8.0% (≥64 mmol/mol) compared with 7.0%-7.9%) over time and risk of incident coronary artery disease (CAD) was dependent on haptoglobin (Hp) phenotype in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) study.</p><p><strong>Research design and methods: </strong>Prospectively collected HbA<sub>1c</sub> data from the ADVANCE biomarker case-cohort study, updated at 6 months and every 12 months thereafter over a median of 5.0 (IQR 4.5-5.3) years, were analyzed in relation to incident CAD in the Hp2-2 (n=1323) and non-Hp2-2 (n=2069) phenotypes separately using weighted multivariable-adjusted Cox regression models. Additional a priori stratifications by sex, race, previous cardiovascular disease (CVD), and type 2 diabetes duration were performed.</p><p><strong>Results: </strong>Mean HbA<sub>1c</sub> was similar in each phenotype group throughout the study. Compared with HbA<sub>1c</sub> of 7.0%-7.9%, HbA<sub>1c</sub> <7.0% was not associated with CAD risk for any phenotype group or subgroup. HbA<sub>1c</sub> ≥8.0% compared with 7.0%-7.9% over time was associated with higher CAD risk for the Hp2-2 phenotype only (HR 1.53, 95% CI 1.01 to 2.32; no significant association in the non-Hp2-2 type: 1.26, 0.89 to 1.77, p-interaction=0.71); this was pronounced when those with previous CVD at baseline were excluded (Hp2-2: 2.80, 1.41 to 5.53, p-interaction=0.03). Compared with HbA<sub>1c</sub> of <8.0%, having HbA<sub>1c</sub> ≥8.0% was associated with a 59% higher CAD risk among participants with the Hp2-2 phenotype (1.59, 1.12 to 2.26) and a 39% higher CAD risk among participants without the Hp2-2 phenotype (1.39, 1.03 to 1.88, p-interaction=0.97).</p><p><strong>Conclusions: </strong>The present ADVANCE analysis suggests that not having HbA<sub>1c</sub> ≥8.0%, rather than achieving HbA<sub>1c</sub> <7.0%, was found to be particularly important for CAD prevention among people with type 2 diabetes and the common Hp2-2 phenotype. While the subgroup analyses were likely underpowered, their inclusion is hypothesis generating and can be used in future meta-analyses to improve power and generalizability.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12056637/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143972108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-02DOI: 10.1136/bmjdrc-2025-005098
Sanjeev Sharma
{"title":"Editorial for CASPAR: a retrospective cohort study of the high-concentration capsaicin topical system in patients with painful diabetic peripheral neuropathy of the feet.","authors":"Sanjeev Sharma","doi":"10.1136/bmjdrc-2025-005098","DOIUrl":"https://doi.org/10.1136/bmjdrc-2025-005098","url":null,"abstract":"","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143963564","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-02DOI: 10.1136/bmjdrc-2024-004864
Michael Überall, Tamara Quandel, Sylvia Engelen, Lucia Garcia-Guerra, Tawfik Fajri, Samuel Allen, Rita Freitas, Zoltan Kender, Marielle Eerdekens
Introduction: Painful diabetic peripheral neuropathy (pDPN), a common complication of diabetes, is challenging to treat and negatively impacts quality of life (QoL). Many patients either fail to achieve adequate pain relief with current treatments or suffer from systemic side effects with oral options. This study used data from the German Pain e-Registry (GPeR) to evaluate the high-concentration capsaicin topical system (HCCTS) for treating pDPN of the feet.
Research design and methods: This retrospective, non-interventional cohort study (CASPAR) included patients with pDPN of the feet who received ≥1 HCCTS treatment (~3-month treatment intervals) and contributed data to the GPeR for ≥12 months. Data were collected on pain intensity, QoL, sleep, mood, concomitant medication, and tolerability.
Results: Overall, 365 patients with pDPN of the feet were included. Significant reductions in 24-hour average pain intensity (API) were observed from baseline to month 3 (following one HCCTS treatment). Further reductions in mean API score were seen over 12 months with ongoing treatments, whereas API increased in patients who discontinued treatment (baseline to month 12 mean API scores: 61.4 to 8.8 for four HCCTS [∆ -52.6], 59.3 to 16.7 for three HCCTS [∆ -42.6], 56.3 to 31.9 for two HCCTS [∆ -24.4], 57.5 to 51.4 for one HCCTS [∆ -6.1]). Similar trends were seen for sleep, mood, and QoL outcomes. There was a significant reduction in concomitant pain medication use in patients receiving ongoing HCCTS treatments. The most common adverse events were local application-site reactions.
Conclusions: This real-world study in patients with pDPN of the feet demonstrates that ongoing HCCTS treatments continue to improve pain intensity, mood, and QoL, while concomitant medication use decreases. Benefits from treatment were lost following HCCTS discontinuation. These findings emphasize the importance of ongoing treatments to achieve the potential of HCCTS in improving outcomes for patients with pDPN.
{"title":"CASPAR: a retrospective cohort study of the high-concentration capsaicin topical system in patients with painful diabetic peripheral neuropathy of the feet.","authors":"Michael Überall, Tamara Quandel, Sylvia Engelen, Lucia Garcia-Guerra, Tawfik Fajri, Samuel Allen, Rita Freitas, Zoltan Kender, Marielle Eerdekens","doi":"10.1136/bmjdrc-2024-004864","DOIUrl":"https://doi.org/10.1136/bmjdrc-2024-004864","url":null,"abstract":"<p><strong>Introduction: </strong>Painful diabetic peripheral neuropathy (pDPN), a common complication of diabetes, is challenging to treat and negatively impacts quality of life (QoL). Many patients either fail to achieve adequate pain relief with current treatments or suffer from systemic side effects with oral options. This study used data from the German Pain e-Registry (GPeR) to evaluate the high-concentration capsaicin topical system (HCCTS) for treating pDPN of the feet.</p><p><strong>Research design and methods: </strong>This retrospective, non-interventional cohort study (CASPAR) included patients with pDPN of the feet who received ≥1 HCCTS treatment (~3-month treatment intervals) and contributed data to the GPeR for ≥12 months. Data were collected on pain intensity, QoL, sleep, mood, concomitant medication, and tolerability.</p><p><strong>Results: </strong>Overall, 365 patients with pDPN of the feet were included. Significant reductions in 24-hour average pain intensity (API) were observed from baseline to month 3 (following one HCCTS treatment). Further reductions in mean API score were seen over 12 months with ongoing treatments, whereas API increased in patients who discontinued treatment (baseline to month 12 mean API scores: 61.4 to 8.8 for four HCCTS [∆ -52.6], 59.3 to 16.7 for three HCCTS [∆ -42.6], 56.3 to 31.9 for two HCCTS [∆ -24.4], 57.5 to 51.4 for one HCCTS [∆ -6.1]). Similar trends were seen for sleep, mood, and QoL outcomes. There was a significant reduction in concomitant pain medication use in patients receiving ongoing HCCTS treatments. The most common adverse events were local application-site reactions.</p><p><strong>Conclusions: </strong>This real-world study in patients with pDPN of the feet demonstrates that ongoing HCCTS treatments continue to improve pain intensity, mood, and QoL, while concomitant medication use decreases. Benefits from treatment were lost following HCCTS discontinuation. These findings emphasize the importance of ongoing treatments to achieve the potential of HCCTS in improving outcomes for patients with pDPN.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049874/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964169","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-05-02DOI: 10.1136/bmjdrc-2025-004935
Alaa Al Nofal, Doha Hassan, Tamim Rajjo, Herbert C Heien, Rozalina G McCoy
Background: Previous studies have demonstrated disparities in the utilization of diabetes technology among youth with type 1 diabetes (T1D) based on race and socioeconomic status (SES). Few studies have examined these differences on a national scale or among youth with commercial health insurance.
Aim: To investigate differences in the fill rates of insulin pumps and continuous glucose monitors (CGMs) among commercially insured children with T1D across diverse racial and SES groups.
Methods: Using medical and pharmacy claims included in the OptumLabs Data Warehouse, we calculated the proportion of youth <18 years with T1D who had a fill for an insulin pump or a CGM, overall and stratified by race/ethnicity and annual household income, between 2011 and 2021.
Results: Among 13,246 youth with T1D, 36.1% had CGM and 30.9% had pump fills. White youth had higher CGM and pump fills than black (CGMs: 35.8% vs 22.5%; pumps: 31.9% vs 21.2%, p<0.001) and Hispanic (CGMs: 35.8% vs 32.6%, p=0.047; pumps: 31.9% vs 25.0%, p<0.001). Youth from households with income
Conclusions: In a cohort of commercially insured youth with T1D, both race and income are important factors that can independently influence the use of diabetes technology. Racial disparities decrease with higher income and disappear at incomes ≥US$200,000. Black youth with income
背景:先前的研究表明,基于种族和社会经济地位(SES),青少年1型糖尿病(T1D)患者对糖尿病技术的使用存在差异。很少有研究在全国范围内或在有商业健康保险的青年中调查这些差异。目的:探讨不同种族和社会经济地位群体商业保险T1D儿童胰岛素泵和连续血糖监测仪(CGMs)填充率的差异。方法:利用OptumLabs数据仓库中包含的医疗和药学索赔数据,计算青少年的比例。结果:13246例T1D青少年中,36.1%的人有CGM, 30.9%的人有泵填充。白人青年的CGM和泵填充量高于黑人(CGM: 35.8% vs 22.5%;结论:在商业保险的青年T1D患者队列中,种族和收入是可以独立影响糖尿病技术使用的重要因素。种族差异随着收入的增加而减小,在收入≥20万美元时消失。有收入的黑人青年
{"title":"Disparities in technology utilization among youth with type 1 diabetes across diverse racial and socioeconomic backgrounds.","authors":"Alaa Al Nofal, Doha Hassan, Tamim Rajjo, Herbert C Heien, Rozalina G McCoy","doi":"10.1136/bmjdrc-2025-004935","DOIUrl":"https://doi.org/10.1136/bmjdrc-2025-004935","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have demonstrated disparities in the utilization of diabetes technology among youth with type 1 diabetes (T1D) based on race and socioeconomic status (SES). Few studies have examined these differences on a national scale or among youth with commercial health insurance.</p><p><strong>Aim: </strong>To investigate differences in the fill rates of insulin pumps and continuous glucose monitors (CGMs) among commercially insured children with T1D across diverse racial and SES groups.</p><p><strong>Methods: </strong>Using medical and pharmacy claims included in the OptumLabs Data Warehouse, we calculated the proportion of youth <18 years with T1D who had a fill for an insulin pump or a CGM, overall and stratified by race/ethnicity and annual household income, between 2011 and 2021.</p><p><strong>Results: </strong>Among 13,246 youth with T1D, 36.1% had CGM and 30.9% had pump fills. White youth had higher CGM and pump fills than black (CGMs: 35.8% vs 22.5%; pumps: 31.9% vs 21.2%, p<0.001) and Hispanic (CGMs: 35.8% vs 32.6%, p=0.047; pumps: 31.9% vs 25.0%, p<0.001). Youth from households with income <US$40,000 had lower CGM and pump fills than those with income ≥US$200,000 (CGM 25.4% vs 43.8%; pumps: 22.4% vs 38.8%, p<0.001). Within similar incomes <US$40,000, black youth had fewer CGM and pump fills than white youth (CGM: 15.2% vs 27.9%, p=0.006; pumps: 12.9% vs 25.5%, p=0.004). This racial difference disappeared with income ≥US$200,000 (CGMs: 47.5% for black vs 43.1% for white; pumps: 45.9% for black vs 38.3% for white, p=0.45 and p=0.57, respectively).</p><p><strong>Conclusions: </strong>In a cohort of commercially insured youth with T1D, both race and income are important factors that can independently influence the use of diabetes technology. Racial disparities decrease with higher income and disappear at incomes ≥US$200,000. Black youth with income <US$40,000 are at the highest exclusion risk from essential technologies. Greater effort is needed at both the system and individual levels to mitigate these disparities.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 3","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-05-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049953/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143981465","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-04-27DOI: 10.1136/bmjdrc-2025-004981
Muhammad Abdul-Ghani, Curtiss Puckett, Siham Abdelgani, Aurora Merovci, Olga Lavrynenko, John Adams, Curtis Triplitt, Ralph A DeFronzo
Introduction: To compare carotid intima-media thickness (cIMT) and liver fat content in subjects who maintained good glycemic control for 6 years on initial triple therapy with metformin/exenatide/pioglitazone versus sequential add-on therapy with metformin followed with glipizide and basal insulin in subjects with new-onset diabetes.
Research design and methods: Liver fat content and cIMT were compared among patients with T2DM who received initial triple therapy with metformin/pioglitazone/exenatide (n=29) versus metformin, followed by stepwise addition of glipizide and then insulin glargine (n=26) and who maintained HbA1c<6.5% for 6 years in Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes.
Results: After 6 years in subjects receiving initial triple therapy with metformin/pioglitazone/exenatide and subjects receiving sequential addition of metformin followed by glipizide and insulin glargine had a mean HbA1c of 5.7% vs 6.0%, respectively, p=NS. Nonetheless, subjects receiving sequential add-on therapy experienced a greater increase in cIMT and manifested greater liver fat content and fibrosis than subjects receiving initial triple therapy.
Conclusions: Including pioglitazone plus exenatide in the glucose-lowering regimen slows the progression of cIMT and was associated with lower hepatic fat content and fibrosis compared with subjects receiving sequential add-on therapy without pioglitazone and exenatide despite comparable optimal glycemic control.
{"title":"Glycemic and non-glycemic benefits of initial triple therapy versus sequential add-on therapy in patients with new-onset diabetes: results from the EDICT study.","authors":"Muhammad Abdul-Ghani, Curtiss Puckett, Siham Abdelgani, Aurora Merovci, Olga Lavrynenko, John Adams, Curtis Triplitt, Ralph A DeFronzo","doi":"10.1136/bmjdrc-2025-004981","DOIUrl":"https://doi.org/10.1136/bmjdrc-2025-004981","url":null,"abstract":"<p><strong>Introduction: </strong>To compare carotid intima-media thickness (cIMT) and liver fat content in subjects who maintained good glycemic control for 6 years on initial triple therapy with metformin/exenatide/pioglitazone versus sequential add-on therapy with metformin followed with glipizide and basal insulin in subjects with new-onset diabetes.</p><p><strong>Research design and methods: </strong>Liver fat content and cIMT were compared among patients with T2DM who received initial triple therapy with metformin/pioglitazone/exenatide (n=29) versus metformin, followed by stepwise addition of glipizide and then insulin glargine (n=26) and who maintained HbA1c<6.5% for 6 years in Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes.</p><p><strong>Results: </strong>After 6 years in subjects receiving initial triple therapy with metformin/pioglitazone/exenatide and subjects receiving sequential addition of metformin followed by glipizide and insulin glargine had a mean HbA1c of 5.7% vs 6.0%, respectively, p=NS. Nonetheless, subjects receiving sequential add-on therapy experienced a greater increase in cIMT and manifested greater liver fat content and fibrosis than subjects receiving initial triple therapy.</p><p><strong>Conclusions: </strong>Including pioglitazone plus exenatide in the glucose-lowering regimen slows the progression of cIMT and was associated with lower hepatic fat content and fibrosis compared with subjects receiving sequential add-on therapy without pioglitazone and exenatide despite comparable optimal glycemic control.</p><p><strong>Trial registration number: </strong>NCT01107717.</p>","PeriodicalId":9151,"journal":{"name":"BMJ Open Diabetes Research & Care","volume":"13 2","pages":""},"PeriodicalIF":3.7,"publicationDate":"2025-04-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12035423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143971126","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}