Pub Date : 2024-10-01Epub Date: 2024-08-17DOI: 10.1007/s13300-024-01640-4
Georgia Thomason, Catherine Gooday, Ian Nunney, Ketan Dhatariya
Introduction: This study aimed to determine the relationship between HbA1c variability and foot ulcer healing at 12 weeks and 12 months.
Methods: Using National Diabetic Foot Care Audit (NDFA) and hospital records, demographics, baseline ulcer characteristics and healing outcomes for subjects presenting with a foot ulcer between 2017-2022 were collected at 12 weeks and 12 months. Subjects had diabetes duration > 3 years and ≥ 3 HbA1c recordings in the 5 years prior to presentation.
Results: At 12 weeks, factors associated with an active ulcer were presence on hind foot (adjusted odds ratios) (2.1 [95% CI 1.3-3.7]), ischaemia (2.1 [95% CI:1.4-3.2]), area > 1 cm2 (2.7 [95% CI:1.7-4.2]) and diabetes duration > 24 years vs 3-10 (AOR 2.0 [95% CI 1.2-3.5]). After adjustment, HbA1c variability 6-10 mmol/mol and > 14.5 mmol/mol had AOR of 1.76 (95% CI 1.1-2.8; p = 0.0192) and 1.5 (95% CI 0.9-2.6; p = 0.1148) of an active ulcer at 12 weeks vs variability < 6 mmol/mol. At 12 months, ischaemia (AOR 2.4 [95% CI 1.5-3.8]) and diabetes duration > 24 years vs 3-10 years (AOR 3.3 [95% CI 1.7-6.4] were significant factors. HbA1c variability was not significant at 12 months.
Conclusion: In keeping with the national NDFA data, in our cohort ulcer characteristics, but not HbA1c variability, were the key factors associated with ulcer healing at 12 weeks and 12 months.
简介本研究旨在确定12周和12个月时HbA1c变异性与足部溃疡愈合之间的关系:利用国家糖尿病足护理审计(NDFA)和医院记录,收集2017-2022年间出现足部溃疡的受试者在12周和12个月时的人口统计学、基线溃疡特征和愈合结果。受试者糖尿病病程>3年,发病前5年内HbA1c记录≥3次:12周时,与活动性溃疡相关的因素有:后足(调整后的几率比)(2.1 [95% CI 1.3-3.7])、缺血(2.1 [95% CI:1.4-3.2])、面积大于1平方厘米(2.7 [95% CI:1.7-4.2])和糖尿病病程大于24年与3-10年(AOR 2.0 [95% CI 1.2-3.5])。经调整后,HbA1c 变异性 6-10 mmol/mol 和 > 14.5 mmol/mol 在 12 周时出现活动性溃疡的 AOR 为 1.76 (95% CI 1.1-2.8; p = 0.0192) 和 1.5 (95% CI 0.9-2.6; p = 0.1148) vs 变异性 24 年 vs 3-10 年(AOR 3.3 [95% CI 1.7-6.4] 是显著因素。12个月时的 HbA1c 变异性不显著:结论:与全国 NDFA 数据一致,在我们的队列中,溃疡特征而非 HbA1c 变异是 12 周和 12 个月时溃疡愈合的关键因素。
{"title":"The Association of HbA<sub>1c</sub> Variability with 12 Week and 12 Month Outcomes on Diabetes Related Foot Ulcer Healing.","authors":"Georgia Thomason, Catherine Gooday, Ian Nunney, Ketan Dhatariya","doi":"10.1007/s13300-024-01640-4","DOIUrl":"10.1007/s13300-024-01640-4","url":null,"abstract":"<p><strong>Introduction: </strong>This study aimed to determine the relationship between HbA<sub>1c</sub> variability and foot ulcer healing at 12 weeks and 12 months.</p><p><strong>Methods: </strong>Using National Diabetic Foot Care Audit (NDFA) and hospital records, demographics, baseline ulcer characteristics and healing outcomes for subjects presenting with a foot ulcer between 2017-2022 were collected at 12 weeks and 12 months. Subjects had diabetes duration > 3 years and ≥ 3 HbA<sub>1c</sub> recordings in the 5 years prior to presentation.</p><p><strong>Results: </strong>At 12 weeks, factors associated with an active ulcer were presence on hind foot (adjusted odds ratios) (2.1 [95% CI 1.3-3.7]), ischaemia (2.1 [95% CI:1.4-3.2]), area > 1 cm<sup>2</sup> (2.7 [95% CI:1.7-4.2]) and diabetes duration > 24 years vs 3-10 (AOR 2.0 [95% CI 1.2-3.5]). After adjustment, HbA<sub>1c</sub> variability 6-10 mmol/mol and > 14.5 mmol/mol had AOR of 1.76 (95% CI 1.1-2.8; p = 0.0192) and 1.5 (95% CI 0.9-2.6; p = 0.1148) of an active ulcer at 12 weeks vs variability < 6 mmol/mol. At 12 months, ischaemia (AOR 2.4 [95% CI 1.5-3.8]) and diabetes duration > 24 years vs 3-10 years (AOR 3.3 [95% CI 1.7-6.4] were significant factors. HbA<sub>1c</sub> variability was not significant at 12 months.</p><p><strong>Conclusion: </strong>In keeping with the national NDFA data, in our cohort ulcer characteristics, but not HbA<sub>1c</sub> variability, were the key factors associated with ulcer healing at 12 weeks and 12 months.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2223-2232"},"PeriodicalIF":3.8,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11411040/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995486","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}
Pub Date : 2024-09-18DOI: 10.1007/s13300-024-01653-z
Raffaella Panza, Valentina Cattivera, Jacopo Colella, Maria Elisabetta Baldassarre, Manuela Capozza, Luca Zagaroli, Maria Laura Iezzi, Nicola Laforgia, Maurizio Delvecchio
Neonatal diabetes mellitus is a rare disorder of glucose metabolism with onset within the first 6 months of life. The initial treatment is based on insulin infusion. The technologies for diabetes treatment can be very helpful, even if guidelines are still lacking. The current study aimed to provide a comprehensive review of the literature about the safety and efficacy of insulin treatment with technology for diabetes to support clinicians in the management of infants with neonatal diabetes mellitus. A total of 22 papers were included, most of them case reports or case series. The first infants with neonatal diabetes mellitus treated with insulin pumps were described nearly two decades ago. Over the years, continuous glucose monitoring systems were added to treat these individuals, allowing for a better customization of insulin administration. Insulin was diluted in some cases to further minimize the doses. Improvement in technology for diabetes prompted clinicians to use new devices and algorithms for insulin delivery in infants with neonatal diabetes as well. These systems are safe and effective, may shorten hospital stay, and help clinicians weaning insulin during the remission phase in the transient forms or switching from insulin to sulfonylurea when suggested by the molecular diagnosis. New technologies for insulin delivery in infants with neonatal diabetes can be used safely and closed-loop algorithms can work properly in these situations, optimizing blood glucose control.
{"title":"Insulin Delivery Technology for Treatment of Infants with Neonatal Diabetes Mellitus: A Systematic Review","authors":"Raffaella Panza, Valentina Cattivera, Jacopo Colella, Maria Elisabetta Baldassarre, Manuela Capozza, Luca Zagaroli, Maria Laura Iezzi, Nicola Laforgia, Maurizio Delvecchio","doi":"10.1007/s13300-024-01653-z","DOIUrl":"https://doi.org/10.1007/s13300-024-01653-z","url":null,"abstract":"<p>Neonatal diabetes mellitus is a rare disorder of glucose metabolism with onset within the first 6 months of life. The initial treatment is based on insulin infusion. The technologies for diabetes treatment can be very helpful, even if guidelines are still lacking. The current study aimed to provide a comprehensive review of the literature about the safety and efficacy of insulin treatment with technology for diabetes to support clinicians in the management of infants with neonatal diabetes mellitus. A total of 22 papers were included, most of them case reports or case series. The first infants with neonatal diabetes mellitus treated with insulin pumps were described nearly two decades ago. Over the years, continuous glucose monitoring systems were added to treat these individuals, allowing for a better customization of insulin administration. Insulin was diluted in some cases to further minimize the doses. Improvement in technology for diabetes prompted clinicians to use new devices and algorithms for insulin delivery in infants with neonatal diabetes as well. These systems are safe and effective, may shorten hospital stay, and help clinicians weaning insulin during the remission phase in the transient forms or switching from insulin to sulfonylurea when suggested by the molecular diagnosis. New technologies for insulin delivery in infants with neonatal diabetes can be used safely and closed-loop algorithms can work properly in these situations, optimizing blood glucose control.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":"39 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251862","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}
We aim to evaluate the efficacy and safety of pioglitazone/metformin fixed-dose combination (FDC) versus uptitrated metformin in patients with type 2 diabetes mellitus (T2DM) without adequate glycemic control.
Methods
A total of 304 patients were recruited from 15 hospitals in China and randomly assigned (1:1) to the test group (pioglitazone/metformin FDC, 15/500 mg) or the control group (uptitrated metformin, 2000–2500 mg/day). The primary endpoint was the proportion of patients with glycated hemoglobin A1c (HbA1c) ≤ 6.5% and ≤ 7.0% at week 16. The secondary outcomes included the change from baseline in glucose, serum lipids, and liver function. Full analysis set (FAS) and per-protocol set (PPS) were used for analyses.
Results
In the test group, 103 (69.59%) patients reached HbA1c ≤ 7.0% (FAS, P = 0.009), with 68 (45.95%) patients achieved HbA1c ≤ 6.5 (FAS, P = 0.043). More reduction in HbA1c, homeostatic model assessment for insulin resistance, and diastolic pressure was found. Bodyweight, body mass index, and high-density lipoprotein cholesterol increased markedly. The changes of triglycerides, alanine transaminase, aspartate aminotransferase, and high-sensitivity C-reactive protein decreased noticeably. There were no significant differences in rates of adverse events between the two groups.
Conclusions
Pioglitazone/metformin FDC was superior to uptitrated metformin among patients with T2DM without adequate glycemic control.
Trial Registration Number
This trial is registered with the Chinese Clinical Trial Registry (ChiCTR1900028606).
{"title":"Efficacy and Safety of Pioglitazone/Metformin Fixed-Dose Combination Versus Uptitrated Metformin in Patients with Type 2 Diabetes without Adequate Glycemic Control: A Randomized Clinical Trial","authors":"Li-xin Guo, Lian-wei Wang, De-zeng Tian, Feng-mei Xu, Wei Huang, Xiao-hong Wu, Wei Zhu, Jun-Qiu Chen, Xin Zheng, Hai-Yan Zhou, Hong-Mei Li, Zhong-Chen He, Wen-Bo Wang, Li-Zhen Ma, Jun-Ting Duan","doi":"10.1007/s13300-024-01638-y","DOIUrl":"https://doi.org/10.1007/s13300-024-01638-y","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>We aim to evaluate the efficacy and safety of pioglitazone/metformin fixed-dose combination (FDC) versus uptitrated metformin in patients with type 2 diabetes mellitus (T2DM) without adequate glycemic control.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A total of 304 patients were recruited from 15 hospitals in China and randomly assigned (1:1) to the test group (pioglitazone/metformin FDC, 15/500 mg) or the control group (uptitrated metformin, 2000–2500 mg/day). The primary endpoint was the proportion of patients with glycated hemoglobin A1c (HbA1c) ≤ 6.5% and ≤ 7.0% at week 16. The secondary outcomes included the change from baseline in glucose, serum lipids, and liver function. Full analysis set (FAS) and per-protocol set (PPS) were used for analyses.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>In the test group, 103 (69.59%) patients reached HbA1c ≤ 7.0% (FAS, <i>P</i> = 0.009), with 68 (45.95%) patients achieved HbA1c ≤ 6.5 (FAS, <i>P</i> = 0.043). More reduction in HbA1c, homeostatic model assessment for insulin resistance, and diastolic pressure was found. Bodyweight, body mass index, and high-density lipoprotein cholesterol increased markedly. The changes of triglycerides, alanine transaminase, aspartate aminotransferase, and high-sensitivity C-reactive protein decreased noticeably. There were no significant differences in rates of adverse events between the two groups.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Pioglitazone/metformin FDC was superior to uptitrated metformin among patients with T2DM without adequate glycemic control.</p><h3 data-test=\"abstract-sub-heading\">Trial Registration Number</h3><p>This trial is registered with the Chinese Clinical Trial Registry (ChiCTR1900028606).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":"25 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251861","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}
Pub Date : 2024-09-14DOI: 10.1007/s13300-024-01644-0
Janos T. Kis, Jochen Seufert, Martin Haluzík, Mireille Bonnemaire, Carine Vera, Mathilde Tournay, Nick Freemantle, Cristian Guja
Introduction
This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice.
Methods
We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m2 and 510 (36%) a BMI < 30 kg/m2; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%.
Results
After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups.
Conclusions
Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.
{"title":"Real-Life Effectiveness of iGlarLixi (Insulin Glargine 100 U/ml and Lixisenatide) in People with Type 2 Diabetes (T2D) According to Baseline HbA1c and BMI","authors":"Janos T. Kis, Jochen Seufert, Martin Haluzík, Mireille Bonnemaire, Carine Vera, Mathilde Tournay, Nick Freemantle, Cristian Guja","doi":"10.1007/s13300-024-01644-0","DOIUrl":"https://doi.org/10.1007/s13300-024-01644-0","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>This study aimed to evaluate the effect of baseline body mass index (BMI) and glycated hemoglobin (HbA1c) on the effectiveness and safety of initiating iGlarLixi (insulin glargine 100 U/ml and lixisenatide) in people with type 2 diabetes (T2D) in routine clinical practice.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We pooled patient-level data from 1406 people with inadequately controlled T2D, initiating a 24-week iGlarLixi treatment. Analysis sets were based on baseline BMI and HbA1c. In the BMI set, 894 (64%) people had a BMI ≥ 30 kg/m<sup>2</sup> and 510 (36%) a BMI < 30 kg/m<sup>2</sup>; in the HbA1c set, 615 (44%) people had an HbA1c >9%, 491 (35%) between 8 and 9%, and 298 (21%) < 8%.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>After initiating iGlarLixi, HbA1c decreased in all participants, with the greatest least-squares mean reduction at 2.15% from baseline to week 24 in those with baseline HbA1c > 9% (using a mixed model for repeated measures). Overall, mean ± standard deviation body weight decreased by 1.9 ± 4.8 kg, with the most prominent loss of 2.6 ± 4.9 kg recorded in people presenting with obesity. Reported hypoglycemia rates were low across all groups.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Initiation of iGlarLixi in people with uncontrolled T2D is effective and safe in clinical practice, across different baseline HbA1c and BMI categories.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":"15 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251859","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}
Pub Date : 2024-09-14DOI: 10.1007/s13300-024-01646-y
Federico Losada-Díaz, Santiago Lizarazo-Bocanegra, Juan J. Perdomo-Lugo, Sebastián A. Gutiérrez-Romero, Isabella Correa-Osio, Carlos O. Mendivil
Obesity is both a major risk factor for diabetes and a serious comorbidity of the condition. The twin epidemics of obesity and diabetes have spread globally over the past few decades. Treatment of obesity in patients with diabetes provides a host of clinical benefits that encompass virtually all body systems. Despite this, multiple lines of evidence suggest that the efficacy of most therapies for weight loss is significantly reduced among patients with diabetes. With this background, we summarize the evidence of a differential effect of lifestyle, pharmacological, and surgical treatments for obesity in patients with existing diabetes, and explore the potential mechanisms involved in this phenomenon. This information is then used to formulate strategies to improve weight loss outcomes for patients with diabetes.
{"title":"Differential Efficacy of Weight Loss Interventions in Patients with Versus Without Diabetes","authors":"Federico Losada-Díaz, Santiago Lizarazo-Bocanegra, Juan J. Perdomo-Lugo, Sebastián A. Gutiérrez-Romero, Isabella Correa-Osio, Carlos O. Mendivil","doi":"10.1007/s13300-024-01646-y","DOIUrl":"https://doi.org/10.1007/s13300-024-01646-y","url":null,"abstract":"<p>Obesity is both a major risk factor for diabetes and a serious comorbidity of the condition. The twin epidemics of obesity and diabetes have spread globally over the past few decades. Treatment of obesity in patients with diabetes provides a host of clinical benefits that encompass virtually all body systems. Despite this, multiple lines of evidence suggest that the efficacy of most therapies for weight loss is significantly reduced among patients with diabetes. With this background, we summarize the evidence of a differential effect of lifestyle, pharmacological, and surgical treatments for obesity in patients with existing diabetes, and explore the potential mechanisms involved in this phenomenon. This information is then used to formulate strategies to improve weight loss outcomes for patients with diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":"211 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251860","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}
Pub Date : 2024-09-14DOI: 10.1007/s13300-024-01651-1
Anastasia-Stefania Alexopoulos, Susanne Danus, Alice Parish, Maren K. Olsen, Bryan C. Batch, Connie R. Thacker, Cynthia A. Moylan, Matthew J. Crowley
Introduction
Patients with type 2 diabetes (T2D), particularly those from historically marginalized racial and ethnic groups, are at high risk of poor outcomes from metabolic dysfunction-associated steatotic liver disease (MASLD). Evidence-based management (EBM) of MASLD can prevent its progression to cirrhosis and poor outcomes, yet rates of EBM of MASLD are low in T2D.
Methods
In this pilot study of ten participants, we examined the feasibility and acceptability of a telehealth intervention that delivered EBM of MASLD in Latino/a and Black patients with T2D in the Duke Healthcare System. The intervention included: (a) MASLD education; (b) diet/lifestyle counseling; (c) T2D medication adjustment (i.e., to promote liver health) and (d) ordering of clinically indicated tests and referrals. This 3-month intervention was delivered by an endocrinologist over three virtual study visits. Phone interviews were conducted at study conclusion. We examined rates of recruitment, retention, T2D medication adjustment, and ordering of clinically indicated tests/referrals.
Results
The median age of our cohort was 54.0 (44.0, 59.0); six and four participants self-identified as Latino/a ethnicity and Black race, respectively. Retention rate in this study was 100% (n = 10/10), and all scheduled visits were completed (n = 30/30). Recruitment occurred over one month, and the rate was 25.8% (n = 8/31) by telephone call and 10% (n = 2/20) by electronic health record message. The intervention was highly acceptable based on a median Treatment Acceptability and Preferences score of 4.0 (4.0, 4.0). In exit interviews, all participants reported improved understanding of MASLD and its link to diabetes. All participants received T2D medication adjustment (n = 5/10) and/or clinically indicated testing/referral (n = 10/10) for the purpose of improving MASLD.
Conclusions
We demonstrated that a telehealth intervention designed to proactively deliver EBM of MASLD was feasible and acceptable in a cohort of Latino/a and Black patients with T2D. Opportunities existed to better align each participants’ care with guideline-based care of MASLD.
{"title":"Intervening on Metabolic Dysfunction-Associated Steatotic Liver Disease in Latino/a and Black Patients with Diabetes: A Feasibility Pilot","authors":"Anastasia-Stefania Alexopoulos, Susanne Danus, Alice Parish, Maren K. Olsen, Bryan C. Batch, Connie R. Thacker, Cynthia A. Moylan, Matthew J. Crowley","doi":"10.1007/s13300-024-01651-1","DOIUrl":"https://doi.org/10.1007/s13300-024-01651-1","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Introduction</h3><p>Patients with type 2 diabetes (T2D), particularly those from historically marginalized racial and ethnic groups, are at high risk of poor outcomes from metabolic dysfunction-associated steatotic liver disease (MASLD). Evidence-based management (EBM) of MASLD can prevent its progression to cirrhosis and poor outcomes, yet rates of EBM of MASLD are low in T2D.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>In this pilot study of ten participants, we examined the feasibility and acceptability of a telehealth intervention that delivered EBM of MASLD in Latino/a and Black patients with T2D in the Duke Healthcare System. The intervention included: (a) MASLD education; (b) diet/lifestyle counseling; (c) T2D medication adjustment (i.e., to promote liver health) and (d) ordering of clinically indicated tests and referrals. This 3-month intervention was delivered by an endocrinologist over three virtual study visits. Phone interviews were conducted at study conclusion. We examined rates of recruitment, retention, T2D medication adjustment, and ordering of clinically indicated tests/referrals.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>The median age of our cohort was 54.0 (44.0, 59.0); six and four participants self-identified as Latino/a ethnicity and Black race, respectively. Retention rate in this study was 100% (<i>n</i> = 10/10), and all scheduled visits were completed (<i>n</i> = 30/30). Recruitment occurred over one month, and the rate was 25.8% (<i>n</i> = 8/31) by telephone call and 10% (<i>n</i> = 2/20) by electronic health record message. The intervention was highly acceptable based on a median Treatment Acceptability and Preferences score of 4.0 (4.0, 4.0). In exit interviews, all participants reported improved understanding of MASLD and its link to diabetes. All participants received T2D medication adjustment (<i>n</i> = 5/10) and/or clinically indicated testing/referral (<i>n</i> = 10/10) for the purpose of improving MASLD.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>We demonstrated that a telehealth intervention designed to proactively deliver EBM of MASLD was feasible and acceptable in a cohort of Latino/a and Black patients with T2D. Opportunities existed to better align each participants’ care with guideline-based care of MASLD.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":"20 1","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142251863","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}
Pub Date : 2024-09-01Epub Date: 2024-07-22DOI: 10.1007/s13300-024-01625-3
Riccardo Candido, Chiara Di Loreto, Paolo Desenzani, Paola Pantanetti, Cristina Romano, Silvio Settembrini, Sebastiano Bruno Solerte, Gian Paolo Fadini
From clinical trials and observational data, oral semaglutide has proven to be the most effective second-line oral therapy for the management of patients with type 2 diabetes. This review aims to describe the perspective of an Italian expert panel that addressed the potential challenges arising during the use of oral semaglutide in the free-living conditions of routine clinical care. A group of Italian experts discussed and generated insights into the use of oral semaglutide in clinical practice. Key topics included the effectiveness of oral semaglutide in clinical practice, the positioning of the agent to optimize the treatment benefits, the possibility to adopt flexibility in the administration schedule, critical issues encountered, the role of patient communication and information in the importance of dose escalation and management of adverse events. Available data on efficacy and effectiveness of oral semaglutide from randomized clinical trials and real-world studies were reported, along with factors that determine tolerability and persistence on treatment. The debate over a fixed versus a flexible dosing schedule was critically addressed, providing anecdotical clues from a small case series and a real-world database. Additionally, a set of recommendations for clinicians to consider when prescribing oral semaglutide and during the process of patient monitoring were provided.
{"title":"Suitability and Usefulness of a Flexible Dosing Timing of Oral Semaglutide to Maximize Benefit in Clinical Practice: An Expert Panel.","authors":"Riccardo Candido, Chiara Di Loreto, Paolo Desenzani, Paola Pantanetti, Cristina Romano, Silvio Settembrini, Sebastiano Bruno Solerte, Gian Paolo Fadini","doi":"10.1007/s13300-024-01625-3","DOIUrl":"10.1007/s13300-024-01625-3","url":null,"abstract":"<p><p>From clinical trials and observational data, oral semaglutide has proven to be the most effective second-line oral therapy for the management of patients with type 2 diabetes. This review aims to describe the perspective of an Italian expert panel that addressed the potential challenges arising during the use of oral semaglutide in the free-living conditions of routine clinical care. A group of Italian experts discussed and generated insights into the use of oral semaglutide in clinical practice. Key topics included the effectiveness of oral semaglutide in clinical practice, the positioning of the agent to optimize the treatment benefits, the possibility to adopt flexibility in the administration schedule, critical issues encountered, the role of patient communication and information in the importance of dose escalation and management of adverse events. Available data on efficacy and effectiveness of oral semaglutide from randomized clinical trials and real-world studies were reported, along with factors that determine tolerability and persistence on treatment. The debate over a fixed versus a flexible dosing schedule was critically addressed, providing anecdotical clues from a small case series and a real-world database. Additionally, a set of recommendations for clinicians to consider when prescribing oral semaglutide and during the process of patient monitoring were provided.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1963-1977"},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330423/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747696","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}
Introduction: Country-specific evidence-based research is crucial for understanding the role of nonnutritive sweeteners (NNS) in managing type 2 diabetes (T2D). The main aim of this study was to explore the effect of replacing sucrose with sucralose in coffee/tea in Asian Indians with type 2 diabetes (T2D).
Methods: This 12-week, parallel-arm randomized controlled trial included 210 participants with T2D, assigned to the intervention group, where sugar/sucrose in coffee or tea was substituted with sucralose, or the control group, where sugar/sucrose was continued. Lifestyle factors remained unchanged. The primary outcome was change in HbA1c. Secondary outcomes were changes in body weight (BW), body mass index (BMI), waist circumference (WC), lipid profiles, and inflammatory markers.
Results: At the end of 12 weeks, no change was observed in HbA1c, fasting plasma glucose, lipid profile, and inflammatory markers between or within groups. There was a small but significant reduction in BW (- 0.5 kg [95% CI - 1.0, - 0.1]; p = 0.02), BMI (- 0.2 kg/m2 [- 0.4, 0.0]; p = 0.03), and WC (- 0.8 cm [- 1.4, - 0.3]; p = 0.002) in the intervention group. Improvements were also observed in lipid accumulation product (p = 0.01), visceral adiposity index (p = 0.04), triglyceride/glucose index (p = 0.04), total energy intake (p = 0.04), and carbohydrate intake (p < 0.0001).
Conclusions: In Asian Indians with T2D, replacing about 60 kcal of added sucrose with sucralose in coffee/ tea had no benefit on glycemia but resulted in a small reduction in body weight, body mass index, and waist circumference.
Trial registration: Clinical Trials Registry of India (CTRI/2021/04/032686).
{"title":"Effect of Replacing Sucrose in Beverages with Nonnutritive Sweetener Sucralose on Cardiometabolic Risk Factors Among Asian Indian Adults with Type 2 Diabetes: A 12-Week Randomized Controlled Trial.","authors":"Viswanathan Mohan, Valangaiman Sriram Manasa, Kuzhandaivelu Abirami, Ranjit Unnikrishnan, Rajagopal Gayathri, Gunasekaran Geetha, Mookambika RamyaBai, Soundararajan Padmavathi, Marimuthu Rajalakshmi, Rajendra Pradeepa, Ranjit Mohan Anjana, Kamala Krishnaswamy, Vasudevan Sudha","doi":"10.1007/s13300-024-01622-6","DOIUrl":"10.1007/s13300-024-01622-6","url":null,"abstract":"<p><strong>Introduction: </strong>Country-specific evidence-based research is crucial for understanding the role of nonnutritive sweeteners (NNS) in managing type 2 diabetes (T2D). The main aim of this study was to explore the effect of replacing sucrose with sucralose in coffee/tea in Asian Indians with type 2 diabetes (T2D).</p><p><strong>Methods: </strong>This 12-week, parallel-arm randomized controlled trial included 210 participants with T2D, assigned to the intervention group, where sugar/sucrose in coffee or tea was substituted with sucralose, or the control group, where sugar/sucrose was continued. Lifestyle factors remained unchanged. The primary outcome was change in HbA1c. Secondary outcomes were changes in body weight (BW), body mass index (BMI), waist circumference (WC), lipid profiles, and inflammatory markers.</p><p><strong>Results: </strong>At the end of 12 weeks, no change was observed in HbA1c, fasting plasma glucose, lipid profile, and inflammatory markers between or within groups. There was a small but significant reduction in BW (- 0.5 kg [95% CI - 1.0, - 0.1]; p = 0.02), BMI (- 0.2 kg/m<sup>2</sup> [- 0.4, 0.0]; p = 0.03), and WC (- 0.8 cm [- 1.4, - 0.3]; p = 0.002) in the intervention group. Improvements were also observed in lipid accumulation product (p = 0.01), visceral adiposity index (p = 0.04), triglyceride/glucose index (p = 0.04), total energy intake (p = 0.04), and carbohydrate intake (p < 0.0001).</p><p><strong>Conclusions: </strong>In Asian Indians with T2D, replacing about 60 kcal of added sucrose with sucralose in coffee/ tea had no benefit on glycemia but resulted in a small reduction in body weight, body mass index, and waist circumference.</p><p><strong>Trial registration: </strong>Clinical Trials Registry of India (CTRI/2021/04/032686).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2061-2077"},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330421/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141751251","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}
Pub Date : 2024-09-01Epub Date: 2024-07-30DOI: 10.1007/s13300-024-01626-2
Rafael Zubirán, Ivette Cruz-Bautista, Carlos A Aguilar-Salinas
There is a gap of knowledge about the clinical and pathophysiological implications resulting from the interaction between primary hyperlipidemias and type 2 diabetes (T2D). Most of the existing evidence comes from sub-analyses of cohorts; scant information derives from randomized clinical trials. The expected clinical implications of T2D in patients with primary hyperlipidemias is an escalation of their already high cardiovascular risk. There is a need to accurately identify patients with this dual burden and to adequately prescribe lipid-lowering therapies, with the current advancements in newer therapeutic options. This review provides an update on the interactions of primary hyperlipidemias, such as familial combined hyperlipidemia, familial hypercholesterolemia, multifactorial chylomicronemia, lipoprotein (a), and type 2 diabetes.
{"title":"Interaction Between Primary Hyperlipidemias and Type 2 Diabetes: Therapeutic Implications.","authors":"Rafael Zubirán, Ivette Cruz-Bautista, Carlos A Aguilar-Salinas","doi":"10.1007/s13300-024-01626-2","DOIUrl":"10.1007/s13300-024-01626-2","url":null,"abstract":"<p><p>There is a gap of knowledge about the clinical and pathophysiological implications resulting from the interaction between primary hyperlipidemias and type 2 diabetes (T2D). Most of the existing evidence comes from sub-analyses of cohorts; scant information derives from randomized clinical trials. The expected clinical implications of T2D in patients with primary hyperlipidemias is an escalation of their already high cardiovascular risk. There is a need to accurately identify patients with this dual burden and to adequately prescribe lipid-lowering therapies, with the current advancements in newer therapeutic options. This review provides an update on the interactions of primary hyperlipidemias, such as familial combined hyperlipidemia, familial hypercholesterolemia, multifactorial chylomicronemia, lipoprotein (a), and type 2 diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"1979-2000"},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330433/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141855071","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}
Pub Date : 2024-09-01Epub Date: 2024-07-27DOI: 10.1007/s13300-024-01627-1
Adrian Heald, Fahmida Mannan, Ryan Wiltshire, Parisa Ghaffari, Unaiza Waheed, Dragan Zdravkovic, Bilal Bashir, Akheel Syed, Rachelle Donn, Handrean Soran
Introduction: Bariatric surgery (BS) has emerged an effective intervention in achieving significant and sustained weight loss in patients with type 2 diabetes (T2D). However, comprehensive data on the long-term impact of BS on hypertension is scarce. We aimed to investigate the long-term impact of BS on blood pressure management in individuals within a T2D cohort.
Methods: This retrospective cohort study was conducted on 119 patients who underwent BS between 2009 and 2012. Baseline and follow-up observations, including blood pressure, HbA1c, BMI, and antihypertensive medication use were obtained from electronic patient records at regular intervals up to and beyond 10-year follow-up.
Results: The median follow-up period for the 119 patients was 11.5 years. Mean fall in BMI 4-8 weeks post-surgery was 12%. A sustained reduction in systolic BP was observed up to 10 years post-surgery (154.5 mmHg pre-op vs. 132.8 mmHg at 10 years; p < 0.0001. From 5 years onwards, there were increases in mean glycated hemoglobin (HbA1c) and body mass index (BMI). At latest follow-up (> 5 years after bariatric surgery), the number of individuals prescribed an antihypertensive agent started to increase. This is in the context of the number of the number of individuals on 2-3 antihypertensive agents declining up until 5 years post-BS. Specifically, there was a reduction in the number of prescriptions of an antihypertensive agent over time from 164 prescriptions pre-operatively to 81 at 8 weeks post-operatively, 78 at 6 months, 72 at 1 year, 66 at 5 years before rising at 10 years to 95 prescriptions.
Conclusions: Our study shows an overall benefit in the years after bariatric surgery in terms of blood pressure and requirement for antihypertensive medication. However, at 5 years and beyond after surgery, the beneficial effect of bariatric surgery diminishes with respect to an increase in number of antihypertensive medication prescriptions, BMI, and HbA1c.
{"title":"The Effects of Bariatric Surgery on the Requirement for Antihypertensive Treatment in Type 2 Diabetes: Insights from a Long-Term Follow-Up Study.","authors":"Adrian Heald, Fahmida Mannan, Ryan Wiltshire, Parisa Ghaffari, Unaiza Waheed, Dragan Zdravkovic, Bilal Bashir, Akheel Syed, Rachelle Donn, Handrean Soran","doi":"10.1007/s13300-024-01627-1","DOIUrl":"10.1007/s13300-024-01627-1","url":null,"abstract":"<p><strong>Introduction: </strong>Bariatric surgery (BS) has emerged an effective intervention in achieving significant and sustained weight loss in patients with type 2 diabetes (T2D). However, comprehensive data on the long-term impact of BS on hypertension is scarce. We aimed to investigate the long-term impact of BS on blood pressure management in individuals within a T2D cohort.</p><p><strong>Methods: </strong>This retrospective cohort study was conducted on 119 patients who underwent BS between 2009 and 2012. Baseline and follow-up observations, including blood pressure, HbA1c, BMI, and antihypertensive medication use were obtained from electronic patient records at regular intervals up to and beyond 10-year follow-up.</p><p><strong>Results: </strong>The median follow-up period for the 119 patients was 11.5 years. Mean fall in BMI 4-8 weeks post-surgery was 12%. A sustained reduction in systolic BP was observed up to 10 years post-surgery (154.5 mmHg pre-op vs. 132.8 mmHg at 10 years; p < 0.0001. From 5 years onwards, there were increases in mean glycated hemoglobin (HbA1c) and body mass index (BMI). At latest follow-up (> 5 years after bariatric surgery), the number of individuals prescribed an antihypertensive agent started to increase. This is in the context of the number of the number of individuals on 2-3 antihypertensive agents declining up until 5 years post-BS. Specifically, there was a reduction in the number of prescriptions of an antihypertensive agent over time from 164 prescriptions pre-operatively to 81 at 8 weeks post-operatively, 78 at 6 months, 72 at 1 year, 66 at 5 years before rising at 10 years to 95 prescriptions.</p><p><strong>Conclusions: </strong>Our study shows an overall benefit in the years after bariatric surgery in terms of blood pressure and requirement for antihypertensive medication. However, at 5 years and beyond after surgery, the beneficial effect of bariatric surgery diminishes with respect to an increase in number of antihypertensive medication prescriptions, BMI, and HbA1c.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2097-2107"},"PeriodicalIF":3.8,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11330420/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141792154","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}