{"title":"Integrating Polygenic Risk Scores (PRS) for Personalized Diabetes Care: Advancing Clinical Practice with Tailored Pharmacological Approaches.","authors":"Omna Singh, Madhur Verma, Nikita Dahiya, Sabyasachi Senapati, Rakesh Kakkar, Sanjay Kalra","doi":"10.1007/s13300-024-01676-6","DOIUrl":"https://doi.org/10.1007/s13300-024-01676-6","url":null,"abstract":"<p><p>The rising global prevalence of diabetes poses a serious threat to public health, national economies, and the healthcare system. Despite a high degree of disease heterogeneity and advancing techniques, there is still an unclear diagnosis of patients with diabetes compounded by the array of long-term microvascular and macrovascular complications associated with the disease. In addition to environmental variables, diabetes susceptibility is significantly influenced by genetic components. The risk stratification of genetically predisposed individuals may play an important role in disease diagnosis and management. Precision medicine methods are crucial to reducing this global burden by delivering a more personalised and patient-centric approach. Compared to the European population, genetic susceptibility variants of type 2 diabetes mellitus (T2DM) are still not fully understood in other major populations, including South Asians, Latinos, and people of African descent. Polygenic risk scores (PRS) can be used to identify individuals who are more susceptible to complex diseases such as diabetes. PRS is selective and effective in developing novel diagnostic interventions. This comprehensive predictive approach facilitates the understanding of distinct response profiles, resulting in the development of more effective management strategies. The targeted implementation of PRS is especially advantageous for people who fall into a higher-risk category for diabetes. Through early risk assessment and the creation of individualised diabetes treatment plans, the integration of PRS in clinical practice shows potential for reducing the prevalence of diabetes and its complications. Diabetes self-management depends significantly on patient empowerment, with behavioural monitoring emerging as a vital facilitator. The main aim of this review article is to formulate a more structured intervention strategy by advocating for increased awareness of the clinical utility of PRS and counseling among healthcare practitioners, patients, and individuals at risk of diabetes.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142834452","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Diabetes TherapyPub Date : 2024-12-02DOI: 10.1007/s13300-024-01670-y
Stefan Gölz, Julia K Mader, Stefan Bilz, Julia Kenzler, Thomas Danne
{"title":"Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study.","authors":"Stefan Gölz, Julia K Mader, Stefan Bilz, Julia Kenzler, Thomas Danne","doi":"10.1007/s13300-024-01670-y","DOIUrl":"https://doi.org/10.1007/s13300-024-01670-y","url":null,"abstract":"<p><strong>Introduction: </strong>Appropriate glycemic control is paramount for people with type 1 diabetes (PwT1D) by the effective delivery of exogenous insulin. However, glycemic variability and the risk of severe hypoglycemia must be reliably controlled.</p><p><strong>Methods: </strong>COMET-T is a prospective, multicenter, observational study conducted in Germany, Austria, and Switzerland during 2021-2022 to assess the effectiveness and safety of insulin glargine 300 U/ml (Gla-300) after switching from other basal insulins. Out of 135 PwT1D, data of 94 patients were analyzed. The primary endpoint was the change in time in range (TIR) approximately 12 and 24 weeks after switching to Gla-300. Secondary endpoints were: change in HbA<sub>1c</sub>, fasting plasma glucose (FPG), coefficient of variation (CV%) of plasma glucose, body weight (BW) and insulin dose.</p><p><strong>Results: </strong>Patients had mean age of 48.6 ± 16.5 years, included 39.4% males and had 18.2 ± 15.5 years T1D duration. From baseline (54.3%), TIR changed at week 12 (mean change 0.3% [± 14.3]; p = 0.8383) and at week 24 (+ 4.5% [± 14.9], p = 0.078). At week 24, TIR significantly increased in patients with body mass index > 30 kg/m<sup>2</sup> (8.4% [± 12.8] p = 0.0057) and patients who previously received insulin detemir (10.5%; [± 12.93]; p = 0.0005). At week 24, there was a significant reduction in the HbA<sub>1c</sub> value (8.1 ± 0.6% vs. 7.7 ± 0.9%; p < 0.001), a reduction in the CV% of plasma glucose (36.1 ± 12.4% vs. 32.8 ± 9.6%, p = 0.056), and increase in bolus insulin dose (26.5 ± 16.3 vs. 27.9 ± 16.6 U/day; p = 0.042). FPG, BW, and basal insulin doses were not significantly changed.</p><p><strong>Conclusions: </strong>Although switching to Gla-300 in poorly controlled PwT1D did not significantly reduce TIR, it significantly decreased HbA<sub>1c</sub> values and glycemic variability without changes in BW and basal insulin dose.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142767081","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}
Diabetes TherapyPub Date : 2024-12-01Epub Date: 2024-09-30DOI: 10.1007/s13300-024-01656-w
Laura Nigi, Maria De Los Angeles Simon Batzibal, Dorica Cataldo, Francesco Dotta
{"title":"12-Month Time in Tight Range Improvement with Advanced Hybrid-Closed Loop System in Adults with Type 1 Diabetes.","authors":"Laura Nigi, Maria De Los Angeles Simon Batzibal, Dorica Cataldo, Francesco Dotta","doi":"10.1007/s13300-024-01656-w","DOIUrl":"10.1007/s13300-024-01656-w","url":null,"abstract":"<p><strong>Introduction: </strong>Time in tight range (TITR) is an emerging and valuable metric for assessing normoglycemia. The latest advancement in automated insulin delivery (AID) systems, the advanced hybrid closed-loop (AHCL) systems, are particularly noteworthy for managing type 1 diabetes (T1D) and enhancing glycemic control.</p><p><strong>Methods: </strong>In a real-world clinical setting, we carried out a retrospective evaluation of TITR in 42 adult subjects with T1D using the AHCL Minimed™ 780G system over a 12-month period.</p><p><strong>Results: </strong>Within just 14 days of activating the automatic mode, the AHCL Minimed™ 780G system showed rapid improvement in TITR, and in the other continuous glucose monitoring (CGM) metrics. This improvement persisted over 12 months, achieving the proposed 45-50% range for effective glycemic control.</p><p><strong>Conclusion: </strong>The AHCL Minimed™ 780G system significantly enhances TITR, demonstrating continuous improvement throughout a 12-month follow-up period.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2557-2568"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561210/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343443","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 : 2024-12-01Epub Date: 2024-10-28DOI: 10.1007/s13300-024-01665-9
Julia K Mader, Annette Baumstark, Johannes Tüting, Günter Sokol, Ruth Schuebel, Yuhong Tong, Julia Roetschke, Robbert J Slingerland
{"title":"Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study.","authors":"Julia K Mader, Annette Baumstark, Johannes Tüting, Günter Sokol, Ruth Schuebel, Yuhong Tong, Julia Roetschke, Robbert J Slingerland","doi":"10.1007/s13300-024-01665-9","DOIUrl":"10.1007/s13300-024-01665-9","url":null,"abstract":"<p><strong>Introduction: </strong>A sizeable minority of commercially available blood glucose monitoring (BGM) systems fail to satisfy regulatory accuracy requirements, such as ISO 15197:2013, after approval. This study assessed whether the BGMs tested could consistently meet these ISO requirements by investigating their accuracy in a non-standardized setting.</p><p><strong>Methods: </strong>In this 18-month post-market performance study, using the ISO criteria, healthcare professionals tested the accuracy of four CE-marked BGM systems (Roche Diabetes Care, Mannheim, Germany) on European adults with diabetes mellitus. ISO criteria included 95% of blood glucose (BG) values being within ± 15 mg/dl of a reference measurement for BG < 100 mg/dl or ± 15% for BG ≥ 100 mg/dl and, in the Parkes Consensus Error grid for type 1 diabetes comparing capillary BGM measurements versus reference method, 99% of BG values falling within zone A (no effect on clinical action or outcome) and zone B (altered clinical action with little or no effect on clinical outcome).</p><p><strong>Results: </strong>BGM readings were obtained from 1650 participants, and the number of readings per BGM system was between 1712 and 2376. The percentage of BGM readings that fell within ISO 15197:2013 limits ranged from 99.4 to 99.9%. For all meter types, 100% of data points fell within zone A or zone B, and most data points for each meter (≥ 99.9%) were in zone A.</p><p><strong>Conclusion: </strong>All four CE-marked BGM models showed results within the accuracy limits defined by ISO 15197 in a non-standardized setting and thus consistently met regulatory accuracy requirements.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2525-2535"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561228/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521340","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The Efficacy and Safety of Liraglutide in Patients Remaining Obese 6 Months after Metabolic Surgery.","authors":"Yuanyuan Shen, Yuanhao Huang, Yuqin Ouyang, Xinyue Xiang, Xuehui Chu, Bingqing Zhang, Tao Han, Wenjuan Tang, Wenhuan Feng","doi":"10.1007/s13300-024-01643-1","DOIUrl":"10.1007/s13300-024-01643-1","url":null,"abstract":"<p><strong>Introduction: </strong>The safety and efficacy of liraglutide as a weight loss intervention in individuals who remain obese within 1 year post-metabolic surgery remain unclear. This study aimed to evaluate the effects and safety of liraglutide (1.8 mg) in patients with persistent obesity at 6 months postoperatively.</p><p><strong>Methods: </strong>This retrospective cohort study included 61 patients who remained obese (body mass index [BMI] ≥ 28.0 kg/m<sup>2</sup>) at 6 months postoperatively. Among these patients, 27 were treated with 1.8 mg of liraglutide for 12 weeks, whereas 34 served as controls. The primary endpoint was the change in total weight loss (%TWL) after 24 weeks. Changes in weight, BMI, complications, and adverse events were also assessed.</p><p><strong>Results: </strong>The liraglutide group showed a greater reduction in %TWL than the control group (11.6% ± 1.1% vs. 4.9% ± 1.0%), with an estimated treatment difference of 6.6% (95% confidence interval [CI], 3.7-9.6%, P < 0.01). The adjusted mean differences in the reduction of weight and BMI between the liraglutide and control groups were - 6.2 kg (95% CI - 8.9 to - 3.4, P < 0.01) and - 3.0 kg/m<sup>2</sup> (95% CI - 4.2 to - 1.7, P < 0.01), respectively. The liraglutide group exhibited increased rates of remission in non-alcoholic fatty liver disease and hypertension. No serious adverse reactions were observed.</p><p><strong>Conclusions: </strong>For patients who remained obese at 6 months postoperatively, 12-week liraglutide treatment resulted in increased weight loss, improved metabolic control, and high rate of remission for obesity-related metabolic diseases after 24 weeks. Earlier and more timely adjuvant weight loss medication intervention based on BMI within 1 year postoperatively may enhance weight loss after metabolic surgery. Graphical abstract available for this article.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2499-2513"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496858","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":"Burden of Current Insulin Therapy and Expectations for Future Insulin Therapy: Results from INBEING, a Web-Based Survey in Japan.","authors":"Yasuaki Hayashino, Satoshi Tsuboi, Yuiko Yamamoto, Hitoshi Ishii","doi":"10.1007/s13300-024-01664-w","DOIUrl":"10.1007/s13300-024-01664-w","url":null,"abstract":"<p><strong>Introduction: </strong>This survey assessed the perspectives of physicians, people with diabetes (PWD), and caregivers in Japan regarding initiation barriers and treatment burden associated with insulin therapy, and expectations for new insulin therapies.</p><p><strong>Methods: </strong>An online survey, conducted May-June 2023, was completed by physicians (n = 411), PWD (type 1 diabetes, n = 108; type 2 diabetes [T2D]: insulin-naive, n = 114; insulin-treated, n = 108), and caregivers (family members, n = 107; nurses, n = 117; care workers, n = 104). Agreement with statements regarding initiation barriers, current feelings, and burden of insulin therapy was assessed. Physicians' views on ideal glycated hemoglobin (HbA<sub>1c</sub>) levels and actual levels in PWD at insulin initiation were captured.</p><p><strong>Results: </strong>Most PWD agreed with the statements \"I don't want to be bothered with doing injections\" (77.8-92.1%) and \"I don't want to inject myself for the rest of my life\" (78.7-91.2%). Physicians also considered these factors to be of high importance for PWD; however, physician and PWD (insulin-naive T2D) responses were significantly different for 11 statements. The greatest underestimation by physicians was for the statement \"my family will be worried\" (41.8% vs. 66.7%), whereas social factors (e.g., \"my friendships may suffer,\" \"if I take insulin I will be discriminated against\") were overestimated by physicians (49.1% vs. 33.3% and 46.5% vs. 24.6%, respectively). Although > 70% of physicians considered HbA<sub>1c</sub> < 9.0% (< 75 mmol/mol) ideal for insulin initiation, only ~ 30% of PWD started insulin at HbA<sub>1c</sub> < 9.0% (< 75 mmol/mol). Nurses rated the burden of assisting with insulin injections significantly lower than family members or care workers. Respondents agreed the need for less frequent injections and improved glycemic control were important attributes expected from future insulin therapies.</p><p><strong>Conclusion: </strong>Differences in perceptions between physicians and PWD in Japan regarding insulin therapy persist, but this gap may be narrowing. Both groups agreed that future insulin therapies should be simpler and provide better glycemic control.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2537-2555"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561213/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142562759","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":"Sodium-Glucose Co-transporter-2 Inhibitors in Type 1 Diabetes Mellitus: The Framework for Recommendations for Their Potential Use.","authors":"Djordje S Popovic, Dimitrios Patoulias, Theocharis Koufakis, Paschalis Karakasis, Nikolaos Papanas","doi":"10.1007/s13300-024-01657-9","DOIUrl":"10.1007/s13300-024-01657-9","url":null,"abstract":"<p><p>The growing prevalence of overweight/obesity, the persistence of inadequate glycemic control among the majority of affected individuals, and the still unacceptably high risk of cardiovascular morbidity and mortality among population with type 1 diabetes mellitus (T1D), impose an urgent need for the introduction of non-insulin glucose-lowering agents in the therapeutic armamentarium. Given that their antihyperglycemic mechanism of action is independent of endogenous insulin secretion and that the observed cardio-renal benefits are unrelated to their glucose-lowering properties, one can speculate that the use of sodium-glucose co-transporter-2 inhibitors (SGLT2is) could provide benefits in T1D, similar to the ones observed among individuals with type 2 diabetes mellitus, chronic kidney disease (CKD), and heart failure. Available evidence from randomized controlled trials suggests that treatment with SGLT2is as adjunct to insulin in T1D results in modest reductions in glycated hemoglobin and body weight. Additionally, SGLT2is ameliorate albuminuria, and thus delay or prevent the development of CKD in T1D. However, use of SGLT2is is associated with an increased risk of diabetic ketoacidosis (DKA) in T1D. This commentary aims at providing a framework for practical recommendations regarding the potential use of SGLT2is in adults with T1D, based on the individual's risk level for DKA development, the presence of inadequate glycemic control and related cardio-renal complications.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2445-2453"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460204","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 : 2024-12-01Epub Date: 2024-10-23DOI: 10.1007/s13300-024-01648-w
Adrian H Heald, Mike Stedman, John Warner Levy, Lleyton Belston, Angela Paisley, Reena Patel, Alison White, Edward Jude, JMartin Gibson, Hellena Habte-Asres, Martin Whyte, Angus Forbes
{"title":"The Relation of Diabetes Complications to a New Interpretation of Glycaemic Variability from Continuous Glucose Monitoring in People with Type 1 Diabetes.","authors":"Adrian H Heald, Mike Stedman, John Warner Levy, Lleyton Belston, Angela Paisley, Reena Patel, Alison White, Edward Jude, JMartin Gibson, Hellena Habte-Asres, Martin Whyte, Angus Forbes","doi":"10.1007/s13300-024-01648-w","DOIUrl":"10.1007/s13300-024-01648-w","url":null,"abstract":"<p><strong>Introduction: </strong>Microvascular and macrovascular complications in type 1 diabetes (T1D) may be linked to endothelial stress due to glycaemic variability. Continuous glucose monitoring systems (CGMs) provide new opportunities to quantify this variability, utilising the amplitude of glucose change summated over time. The aim of this study was to examine whether this determination of glucose variability (GV) is associated with microvascular clinical sequelae.</p><p><strong>Methods: </strong>Continuous glucose monitoring values were downloaded for 89 type 1 diabetes mellitus (T1D) individuals for up to 18 months from 2021 to 2023. Data for patient demographics was also taken from the patient record which included Sex, Date of Birth, and Date of Diagnosis. The recorded laboratory glycated haemoglobin (HbA1c) test results were also recorded. The glucose management index (GMI) was calculated from average glucose readings for 18 months using the formula GMI (%) = (0.82-(Average glucose/100)). This was then adjusted to give GMI (mmol/mol) = 10.929 * (GMI (%) - 2.15). Average Glucose Fluctuation (AGF) was calculated by adding up the total absolute change value between all recorded results over 18 months and dividing by the number of results minus one. The % Above Critical Threshold (ACT) was calculated by summing the total number of occurrences for each result value. A cumulative 95% limit was then applied to identify the glucose value that only 5% of results exceeded in the overall population. Using this value, we estimated the percentage of total tests that were above the Critical Threshold (ACT).</p><p><strong>Results: </strong>Results for the 89 individuals (44 men and 45 women) were analysed over 18 months. The mean age of participants was 43 years and the mean duration of diabetes was 18 years. A total of 3.22 million readings were analysed, giving an average of 10.3 mmol/L blood glucose. Those with the largest change in glucose from reading to reading, summated over time, showed the greatest change in eGFR of 3.12 ml/min/1.73 m<sup>2</sup> (p = 0.007). People with a higher proportion of glucose readings > 18 mmol/L showed a fall in eGFR of 2.8 ml/min/1.73 m<sup>2</sup> (p = 0.009) and experienced higher rates of sight-threatening retinopathy (44% of these individuals) (p = 0.01) as did 39% of individuals in the highest tertile of glucose levels (p = 0.008).</p><p><strong>Conclusion: </strong>Those individuals with T1D in the highest tertile of reading-to-reading glucose change showed the greatest change in eGFR. Those with a higher proportion of glucose readings > 18 mmol/L also showed a fall in eGFR and experienced higher rates of sight-threatening retinopathy, as did people with higher mean glucose. Discussions with T1D individuals could reflect on how the percentage recorded glucose above a critical level and degree of change in glucose are important in avoiding future tissue complications.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2489-2498"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561217/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496859","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":"Rationale and Design of the Study to Investigate the Metabolic Action of Imeglimin on Patients with Type 2 Diabetes Mellitus (SISIMAI).","authors":"Tsubasa Tajima, Hideyoshi Kaga, Naoaki Ito, Toshiki Kogai, Hitoshi Naito, Saori Kakehi, Satoshi Kadowaki, Yuya Nishida, Ryuzo Kawamori, Yoshifumi Tamura, Hirotaka Watada","doi":"10.1007/s13300-024-01655-x","DOIUrl":"10.1007/s13300-024-01655-x","url":null,"abstract":"<p><strong>Introduction: </strong>Imeglimin is a first-in-class, novel, oral glucose-lowering agent for the treatment of type 2 diabetes mellitus. The efficacy and safety of imeglimin as an antidiabetic agent have been investigated in clinical trials. However, its metabolic effects in humans have not yet been fully elucidated.</p><p><strong>Methods: </strong>The Study to InveStIgate the Metabolic Action of Imeglimin on patients with type 2 diabetes mellitus (SISIMAI) is a single-arm intervention study. In this study, we have recruited 25 patients with type 2 diabetes to receive 2000 mg/day imeglimin for 20 weeks. We perform a 75-g oral glucose tolerance test (OGTT) with double-glucose tracers, a two-step hyperinsulinemic-euglycemic clamp with glucose tracer, ectopic fat measurement by proton magnetic resonance spectroscopy, visceral/subcutaneous fat area measurement by magnetic resonance imaging, muscle biopsy, and evaluation of fitness level by cycle ergometer before and after imeglimin administration.</p><p><strong>Planned outcomes: </strong>The primary outcome is the change in area under the curve of glucose levels during the OGTT after 20 weeks of imeglimin treatment. We also calculate the endogenous glucose production, rate of oral glucose appearance, and rate of glucose disappearance from the data during the 75-g OGTT and compare them between pre- and post-treatment. Additionally, we will compare other parameters, such as the changes in tissue-specific insulin sensitivity, ectopic fat accumulation, visceral/subcutaneous fat area accumulation, and fitness level between each point. This is the first study to investigate the organ-specific metabolic action of imeglimin in patients with type 2 diabetes mellitus using the 75-g OGTT with the double tracer method. The results of this study are expected to provide useful information for drug selection based on the pathophysiology of individual patients with type 2 diabetes mellitus.</p><p><strong>Trial registration: </strong>jRCTs031210600.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2569-2580"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561198/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142343459","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 : 2024-12-01Epub Date: 2024-10-26DOI: 10.1007/s13300-024-01658-8
Salem A Beshyah, Amin Jayyousi, Ali Saif Al-Mamari, Ashraf Shaaban, Ebaa Al Ozairi, Jalal Nafach, Mahir Khalil Ibrahim Jallo, Said Khader, Marc Evans
{"title":"Current Perspectives in Pre- and Diabetic Peripheral Neuropathy Diagnosis and Management: An Expert Statement for the Gulf Region.","authors":"Salem A Beshyah, Amin Jayyousi, Ali Saif Al-Mamari, Ashraf Shaaban, Ebaa Al Ozairi, Jalal Nafach, Mahir Khalil Ibrahim Jallo, Said Khader, Marc Evans","doi":"10.1007/s13300-024-01658-8","DOIUrl":"10.1007/s13300-024-01658-8","url":null,"abstract":"<p><p>Peripheral neuropathy (PN) significantly impacts the quality of life, causing substantial morbidity and increased mortality, as well as escalating healthcare costs. While PN can have various causes, the most common form, diabetic peripheral neuropathy, poses considerable risks for potential complications. Diabetic peripheral neuropathy (DPN) affects over 50% of people with prediabetes and diabetes. Despite its prevalence, a global gap in diagnosis and management exists, exacerbated by the COVID-19 pandemic. This expert consensus was formulated through a comprehensive evaluation by a panel of experts, informed by a focused literature review, aiming to establish a clinically robust approach to diagnosing and managing pre- and diabetic PN with the early utilization of neurotropic B vitamins. This document offers a consensus perspective on the existing challenges in diagnosing and managing PN, focusing on DPN. The expert panel proposes measures to address this underdiagnosed burden, highlighting the importance of early intervention through innovative screening methods, integrated care approaches, and therapeutic strategies. The document advocates for increased awareness, targeted campaigns, and proactive care strategies to bridge gaps in the patient care of individuals with diabetes, emphasizing the importance of early detection and timely management to improve overall health outcomes. Specific recommendations include incorporating simplified questionnaires and innovative screening methods into routine care, prioritizing neurotropic B vitamin supplementation, optimizing glucagon-like peptide 1 (GLP-1) receptor agonist treatments, and adopting a holistic approach to neuropathy management. The consensus underscores the urgent need to address the underdiagnosis and undertreatment of PN, offering practical measures to enhance early detection and improve health outcomes for individuals with DPN.</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":"2455-2474"},"PeriodicalIF":3.8,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11561195/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142496856","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}