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AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes.
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-19 DOI: 10.1007/s13300-024-01679-3
Liana K Billings, Marisse Asong, Martin Bøg, Simon Clancy, Christian Kruse, Elisabeth de Laguiche, Ernesto Maddaloni

Introduction: ONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).

Methods: ONWARDS 5 data were augmented with RWD collected from the US Ambulatory Electronic Medical Records database. Randomized and augmented comparisons (propensity-score-matched) between icodec with app and glargine U300 were weighted to provide a fully augmented estimate of the primary outcome (change in glycated hemoglobin [HbA1c] after 52 weeks). Data were adjusted for trial effects. Sensitivity analyses were conducted.

Results: The nonaugmented randomized estimated treatment difference (ETD; 95% CI) between icodec with app and glargine U300 (trial stratum) for change in HbA1c was - 0.21 (- 0.70 to 0.28) percentage points. After adjusting for trial effects, the overall fully augmented ETD (95% CI) was - 0.33 (- 0.68 to 0.01) percentage points numerically in favor of icodec with app, although not statistically significant. Sensitivity analyses supported the findings.

Conclusions: Using augmented data, the precision of the change in HbA1c estimate was increased compared with the trial stratum analysis alone. These findings help to validate the principle of utilizing augmentation to strengthen trial outcomes.

Trial registration number: The ONWARDS 5 trial is registered with ClinicalTrials.gov (NCT04760626).

{"title":"AUGMENTed Real-World Data Enhances Comparative Efficacy Between Once-Weekly Insulin Icodec with Dosing Guide App Versus Once-Daily Insulin Glargine U300 in Insulin-Naive Type 2 Diabetes.","authors":"Liana K Billings, Marisse Asong, Martin Bøg, Simon Clancy, Christian Kruse, Elisabeth de Laguiche, Ernesto Maddaloni","doi":"10.1007/s13300-024-01679-3","DOIUrl":"https://doi.org/10.1007/s13300-024-01679-3","url":null,"abstract":"<p><strong>Introduction: </strong>ONWARDS 5 evaluated the effectiveness and safety of insulin icodec (icodec) titrated with a dosing guide app (icodec with app) versus once-daily insulin analogs in insulin-naive adults with type 2 diabetes. The insulin glargine U300 (glargine U300) stratum was too small to enable a robust post hoc efficacy comparison. Augmentation methodology was applied to increase the glargine U300 group size using real-world data (RWD), to facilitate efficacy comparisons of icodec with app versus glargine U300, and to demonstrate the potential of the augmentation methodology to strengthen underpowered treatment comparisons (AUGMENT study).</p><p><strong>Methods: </strong>ONWARDS 5 data were augmented with RWD collected from the US Ambulatory Electronic Medical Records database. Randomized and augmented comparisons (propensity-score-matched) between icodec with app and glargine U300 were weighted to provide a fully augmented estimate of the primary outcome (change in glycated hemoglobin [HbA<sub>1c</sub>] after 52 weeks). Data were adjusted for trial effects. Sensitivity analyses were conducted.</p><p><strong>Results: </strong>The nonaugmented randomized estimated treatment difference (ETD; 95% CI) between icodec with app and glargine U300 (trial stratum) for change in HbA<sub>1c</sub> was - 0.21 (- 0.70 to 0.28) percentage points. After adjusting for trial effects, the overall fully augmented ETD (95% CI) was - 0.33 (- 0.68 to 0.01) percentage points numerically in favor of icodec with app, although not statistically significant. Sensitivity analyses supported the findings.</p><p><strong>Conclusions: </strong>Using augmented data, the precision of the change in HbA<sub>1c</sub> estimate was increased compared with the trial stratum analysis alone. These findings help to validate the principle of utilizing augmentation to strengthen trial outcomes.</p><p><strong>Trial registration number: </strong>The ONWARDS 5 trial is registered with ClinicalTrials.gov (NCT04760626).</p>","PeriodicalId":11192,"journal":{"name":"Diabetes Therapy","volume":" ","pages":""},"PeriodicalIF":3.8,"publicationDate":"2024-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142853395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study. 先进的混合闭环算法在 1 型糖尿病中的应用:法国 MiniMed™ 血糖控制和生活质量研究。
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-17 DOI: 10.1007/s13300-024-01673-9
Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen

Introduction: The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.

Methods: Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.

Results: Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.

Conclusion: In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.

Trial registration: ClinicalTrials.gov identifier, NCT04308291.

{"title":"Advanced Hybrid Closed Loop Algorithm Use in Type 1 Diabetes: The French MiniMed™ Glycemic Control and Quality of Life Study.","authors":"Laurence Kessler, Charles Thivolet, Alfred Penfornis, Didier Gouet, Christine Coffin, Myriam Moret, Sophie Borot, Saïd Bekka, Emmanuel Sonnet, Michael Joubert, Sandrine Lablanche, Geoffrey Burtin, Fabio Di Piazza, Tim van den Heuvel, Ohad Cohen","doi":"10.1007/s13300-024-01673-9","DOIUrl":"https://doi.org/10.1007/s13300-024-01673-9","url":null,"abstract":"<p><strong>Introduction: </strong>The MiniMed™ 780G system uses an advanced hybrid closed loop algorithm to improve outcomes in people with type 1 diabetes (T1D). The MiniMed™ 780G Glycemic Control and Quality of Life (EQOL) study aimed to provide routine clinical practice data on system effectiveness and associated patient-reported outcomes (PROs) in France.</p><p><strong>Methods: </strong>Individuals aged ≥ 7 years with T1D were enrolled. A 14-day run-in phase in Manual mode preceded a 12-month study phase using Auto mode. The primary endpoint was absolute change in time in range (TIR) from baseline to 6 months. Secondary endpoints included changes in glycemic targets, glycated hemoglobin (HbA1c), and hypoglycemia. PROs included treatment satisfaction, quality of life (QoL), and fear of hypoglycemia.</p><p><strong>Results: </strong>Two-hundred seventy participants formed the intent-to-treat population at 6 months. TIR increased by 11.8 percentage points (standard deviation [SD] 8.96, 95% confidence interval 10.7 to 12.9, p < 0.0001), from 61.9% (SD 11.0) to 73.7% (SD 7.4), equivalent to 2.8 h per day more in range. Time < 70 mg/dL decreased by 1.5 percentage points (p < 0.0001), from 4.0% to 2.5%. All glycemic parameters significantly improved. HbA1c decreased by 0.52% and 0.42% at 6 and 12 months, respectively. More patients met glycemic targets, while severe hypoglycemia was reduced. At 12 months, treatment satisfaction increased across age groups, and QoL improved in adults. Fear of hypoglycemia decreased in adults and children.</p><p><strong>Conclusion: </strong>In France, people with T1D initiating the MiniMed™ 780G system demonstrated sustained TIR and HbA1c improvements. System usage reduced hypoglycemia and fear of hypoglycemia, and increased treatment satisfaction.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov identifier, NCT04308291.</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":"142834430","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}
引用次数: 0
Cost-Effectiveness of FreeStyle Libre for Glucose Self-Management Among People with Diabetes Mellitus: A Canadian Private Payer Perspective.
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-17 DOI: 10.1007/s13300-024-01677-5
Stewart Harris, Sal Cimino, Yen Nguyen, Kirk Szafranski, Yeesha Poon

Introduction: For people living with diabetes, effective glucose monitoring is a key component in diabetes care, helping to reduce disease burden, complications, and healthcare utilization. Sensor-based glucose monitoring systems, which can provide more comprehensive information about glucose levels than capillary-based self-monitoring of blood glucose (SMBG), are becoming established among people living with diabetes. The objective of this study was to assess the cost-effectiveness of glucose monitoring with FreeStyle Libre systems, compared with SMBG, from the perspective of a Canadian private payer.

Methods: The analysis used the validated, person-level microsimulation model DEDUCE (Determination of Diabetes Utilities, Costs, and Effects). Analyses were conducted separately for populations of people with type 1 and type 2 diabetes mellitus (T1DM; T2DM), with time horizons of 40 and 25 years, respectively. T2DM treatment was assumed to be 84% non-insulin, 10% basal insulin, and 6% multiple daily injections of insulin. The effect of FreeStyle Libre was modeled as reductions versus SMBG in glycated hemoglobin level (T1DM, - 0.42%; insulin-treated T2DM, - 0.59%; non-insulin-treated T2DM, - 0.3%) and in acute diabetic events (hypoglycemia and diabetic ketoacidosis). Costs (in 2023 Canadian dollars (Can$)) and utilities were discounted at 1.5%. Outcomes were assessed as costs and quality-adjusted life years (QALYs).

Results: In both populations, FreeStyle Libre was dominant to SMBG, providing more QALYs at a lower cost (T1DM: + 1.25 QALYs, - Can$32,287 costs; T2DM: + 0.48 QALYs, - Can$8091 costs). Reductions were seen in the cumulative incidence of all complications (except blindness in the T1DM analysis). FreeStyle Libre was dominant to SMBG in all scenarios tested. Probabilistic sensitivity analysis showed that FreeStyle Libre had a 100% probability of being dominant to SMBG for T1DM and a 91% probability of being dominant for T2DM.

Conclusion: This economic analysis shows that, from a Canadian private payer perspective, FreeStyle Libre is cost-effective compared with SMBG for all people living with diabetes.

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引用次数: 0
Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study. 开始服用 SGLT2 抑制剂的 2 型糖尿病和慢性肾病患者的临床概况和治疗依从性:一项多队列研究
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-17 DOI: 10.1007/s13300-024-01671-x
Catherine B Johannes, Ryan Ziemiecki, Manel Pladevall-Vila, Natalie Ebert, Csaba P Kovesdy, Reimar W Thomsen, Brenda N Baak, Aníbal García-Sempere, Hiroshi Kanegae, Craig I Coleman, Michael Walsh, Ina Trolle Andersen, Clara Rodríguez Bernal, Celia Robles Cabaniñas, Christian Fynbo Christiansen, Alfredo E Farjat, Alain Gay, Patrick Gee, Ron M C Herings, Isabel Hurtado, Naoki Kashihara, Frederik Pagh Bredahl Kristensen, Fangfang Liu, Suguru Okami, Jetty A Overbeek, Fernie J A Penning-van Beest, Satoshi Yamashita, Yuichiro Yano, J Bradley Layton, David Vizcaya, Nikolaus G Oberprieler

Introduction: The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).

Methods: This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics® Data Mart Database (CDM) (US). Eligible patients had CKD (based on either diagnosis codes, eGFR values, and/or urine ACR) and initiated an SGLT2i between 2012 and 2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and drug utilization patterns were described.

Results: The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.

Conclusions: At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources.

{"title":"Clinical Profile and Treatment Adherence in Patients with Type 2 Diabetes and Chronic Kidney Disease Who Initiate an SGLT2 Inhibitor: A Multi-cohort Study.","authors":"Catherine B Johannes, Ryan Ziemiecki, Manel Pladevall-Vila, Natalie Ebert, Csaba P Kovesdy, Reimar W Thomsen, Brenda N Baak, Aníbal García-Sempere, Hiroshi Kanegae, Craig I Coleman, Michael Walsh, Ina Trolle Andersen, Clara Rodríguez Bernal, Celia Robles Cabaniñas, Christian Fynbo Christiansen, Alfredo E Farjat, Alain Gay, Patrick Gee, Ron M C Herings, Isabel Hurtado, Naoki Kashihara, Frederik Pagh Bredahl Kristensen, Fangfang Liu, Suguru Okami, Jetty A Overbeek, Fernie J A Penning-van Beest, Satoshi Yamashita, Yuichiro Yano, J Bradley Layton, David Vizcaya, Nikolaus G Oberprieler","doi":"10.1007/s13300-024-01671-x","DOIUrl":"https://doi.org/10.1007/s13300-024-01671-x","url":null,"abstract":"<p><strong>Introduction: </strong>The clinical landscape for the treatment of patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) is rapidly evolving. As part of the FOUNTAIN platform (NCT05526157; EUPAS48148), we described and compared cohorts of adult patients with CKD and T2D initiating a sodium-glucose cotransporter 2 inhibitor (SGLT2i) before the launch of finerenone in Europe, Japan, and the United States (US).</p><p><strong>Methods: </strong>This was a multinational, multi-cohort study of patients with T2D in five data sources: the Danish National Health Registers (DNHR) (Denmark), PHARMO Data Network (The Netherlands), Valencia Health System Integrated Database (VID) (Spain), Japan Chronic Kidney Disease Database Extension (J-CKD-DB-Ex) (Japan), and Optum's de-identified Clinformatics<sup>®</sup> Data Mart Database (CDM) (US). Eligible patients had CKD (based on either diagnosis codes, eGFR values, and/or urine ACR) and initiated an SGLT2i between 2012 and 2021. Baseline demographic, lifestyle, and clinical characteristics were analyzed, and drug utilization patterns were described.</p><p><strong>Results: </strong>The final cohorts included 21,739 patients in DNHR, 381 in PHARMO, 31,785 in VID, 1157 in J-CKD-DB-Ex, and 56,219 in CDM. Across data sources, approximately 41-70% had CKD stage 1 or 2 at baseline; severe CKD (stage 4) was uncommon (1.6-6.7%). The median duration of SGLT2i therapy ranged from 7.5 months in PHARMO to 17.0 months in VID. At least 50% of patients were currently receiving SGLT2i treatment at 1 year after initiation.</p><p><strong>Conclusions: </strong>At a 1-year follow-up, at least half of the patients with CKD and T2D were receiving SGLT2i treatment across the data sources. In patients initiating SGLT2i, treatment options for T2D and CKD were heterogeneous and dynamic within and among data sources.</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":"142834434","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}
引用次数: 0
Cardiovascular Events in Adults with Type 2 Diabetes and ASCVD Initiating Once-Weekly Semaglutide vs DPP-4is in the USA.
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-17 DOI: 10.1007/s13300-024-01678-4
Silvio E Inzucchi, Xi Tan, Yuanjie Liang, Larisa Yedigarova, Lin Xie, Adam de Havenon

Introduction: Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have demonstrated cardiovascular benefits in trials involving high-risk patients with type 2 diabetes (T2D), while dipeptidyl peptidase 4 inhibitors (DPP-4is) have not. However, DPP-4is are still commonly prescribed in patients with T2D and atherosclerotic cardiovascular disease (ASCVD). This study compared time to occurrence of cardiovascular events, health care resource utilization (HCRU), and medical costs in patients with T2D and ASCVD who initiated once-weekly semaglutide vs a DPP-4i.

Methods: Two separate observational cohort analyses were conducted using Optum's de-identified Clinformatics® Data Mart Database (CDM) and Komodo Healthcare Map™ (January 1, 2018 to September 30, 2022). Patients had T2D and ASCVD and received semaglutide or a DPP-4i. Baseline characteristics were balanced using inverse probability of treatment weighting.

Results: After weighting, the CDM analysis included 14,461 semaglutide users and 38,630 DPP-4i users and the Komodo Healthcare Map analysis included 48,303 semaglutide users and 109,179 DPP-4i users. In CDM, semaglutide users had significantly decreased risk of stroke (hazard ratio [HR], 0.54), myocardial infarction (HR 0.64), and their composite (HR 0.59) vs DPP-4is. Semaglutide users also had fewer ASCVD-related and all-cause hospitalizations and outpatient visits and lower ASCVD-related and all-cause hospitalization and total medical costs. Results from Komodo Health were generally consistent with those from CDM.

Conclusion: Semaglutide users had significantly reduced risk of cardiovascular outcomes, HCRU, and medical costs compared with DPP-4is. This corroborates results from prior studies of once-weekly GLP-1 RAs and reinforces the important role of semaglutide treatment for patients with T2D and ASCVD. Graphical abstract available for this article.

{"title":"Cardiovascular Events in Adults with Type 2 Diabetes and ASCVD Initiating Once-Weekly Semaglutide vs DPP-4is in the USA.","authors":"Silvio E Inzucchi, Xi Tan, Yuanjie Liang, Larisa Yedigarova, Lin Xie, Adam de Havenon","doi":"10.1007/s13300-024-01678-4","DOIUrl":"https://doi.org/10.1007/s13300-024-01678-4","url":null,"abstract":"<p><strong>Introduction: </strong>Glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have demonstrated cardiovascular benefits in trials involving high-risk patients with type 2 diabetes (T2D), while dipeptidyl peptidase 4 inhibitors (DPP-4is) have not. However, DPP-4is are still commonly prescribed in patients with T2D and atherosclerotic cardiovascular disease (ASCVD). This study compared time to occurrence of cardiovascular events, health care resource utilization (HCRU), and medical costs in patients with T2D and ASCVD who initiated once-weekly semaglutide vs a DPP-4i.</p><p><strong>Methods: </strong>Two separate observational cohort analyses were conducted using Optum's de-identified Clinformatics<sup>®</sup> Data Mart Database (CDM) and Komodo Healthcare Map™ (January 1, 2018 to September 30, 2022). Patients had T2D and ASCVD and received semaglutide or a DPP-4i. Baseline characteristics were balanced using inverse probability of treatment weighting.</p><p><strong>Results: </strong>After weighting, the CDM analysis included 14,461 semaglutide users and 38,630 DPP-4i users and the Komodo Healthcare Map analysis included 48,303 semaglutide users and 109,179 DPP-4i users. In CDM, semaglutide users had significantly decreased risk of stroke (hazard ratio [HR], 0.54), myocardial infarction (HR 0.64), and their composite (HR 0.59) vs DPP-4is. Semaglutide users also had fewer ASCVD-related and all-cause hospitalizations and outpatient visits and lower ASCVD-related and all-cause hospitalization and total medical costs. Results from Komodo Health were generally consistent with those from CDM.</p><p><strong>Conclusion: </strong>Semaglutide users had significantly reduced risk of cardiovascular outcomes, HCRU, and medical costs compared with DPP-4is. This corroborates results from prior studies of once-weekly GLP-1 RAs and reinforces the important role of semaglutide treatment for patients with T2D and ASCVD. Graphical abstract available for this article.</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":"142834432","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}
引用次数: 0
Integrating Polygenic Risk Scores (PRS) for Personalized Diabetes Care: Advancing Clinical Practice with Tailored Pharmacological Approaches.
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-17 DOI: 10.1007/s13300-024-01676-6
Omna Singh, Madhur Verma, Nikita Dahiya, Sabyasachi Senapati, Rakesh Kakkar, Sanjay Kalra

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.

{"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}
引用次数: 0
Safety and Effectiveness of Glargine 300 U/ml After Switching from Basal Insulins in Patients with Type 1 Diabetes: COMET-T Study.
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-02 DOI: 10.1007/s13300-024-01670-y
Stefan Gölz, Julia K Mader, Stefan Bilz, Julia Kenzler, Thomas Danne

Introduction: 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.

Methods: 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 HbA1c, fasting plasma glucose (FPG), coefficient of variation (CV%) of plasma glucose, body weight (BW) and insulin dose.

Results: 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/m2 (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 HbA1c 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.

Conclusions: Although switching to Gla-300 in poorly controlled PwT1D did not significantly reduce TIR, it significantly decreased HbA1c values and glycemic variability without changes in BW and basal insulin dose.

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引用次数: 0
12-Month Time in Tight Range Improvement with Advanced Hybrid-Closed Loop System in Adults with Type 1 Diabetes. 在 1 型糖尿病成人患者中使用先进的混合闭环系统,12 个月后拮抗范围有所改善。
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-01 Epub Date: 2024-09-30 DOI: 10.1007/s13300-024-01656-w
Laura Nigi, Maria De Los Angeles Simon Batzibal, Dorica Cataldo, Francesco Dotta

Introduction: 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.

Methods: 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.

Results: 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.

Conclusion: The AHCL Minimed™ 780G system significantly enhances TITR, demonstrating continuous improvement throughout a 12-month follow-up period.

导言胰岛素紧控时间(TITR)是评估血糖正常与否的一个新兴且有价值的指标。胰岛素自动给药系统(AID)的最新进展--高级混合闭环系统(AHCL)在管理 1 型糖尿病(T1D)和加强血糖控制方面尤其值得关注:在真实的临床环境中,我们使用 AHCL Minimed™ 780G 系统对 42 名患有 T1D 的成年受试者进行了为期 12 个月的 TITR 回顾性评估:结果:在激活自动模式的短短 14 天内,AHCL Minimed™ 780G 系统的 TITR 和其他连续血糖监测 (CGM) 指标都有了迅速改善。这种改善持续了 12 个月,达到了建议的 45-50% 有效血糖控制范围:结论:AHCL Minimed™ 780G 系统显著提高了 TITR,在 12 个月的随访期间持续改善。
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引用次数: 0
Monitoring of the Analytical Performance of Four Different Blood Glucose Monitoring Systems: A Post-market Performance Follow-Up Study. 监测四种不同血糖监测系统的分析性能:上市后性能跟踪研究。
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-01 Epub Date: 2024-10-28 DOI: 10.1007/s13300-024-01665-9
Julia K Mader, Annette Baumstark, Johannes Tüting, Günter Sokol, Ruth Schuebel, Yuhong Tong, Julia Roetschke, Robbert J Slingerland

Introduction: 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.

Methods: 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).

Results: 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.

Conclusion: 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.

导言:相当一部分市售血糖监测系统(BGM)在获得批准后无法满足 ISO 15197:2013 等法规对准确度的要求。本研究通过调查血糖监测系统在非标准化环境中的准确性,评估所测试的血糖监测系统能否始终满足 ISO 的这些要求:在这项为期 18 个月的上市后性能研究中,医护人员采用 ISO 标准对四款获得 CE 认证的 BGM 系统(罗氏糖尿病护理公司,德国曼海姆)的准确性进行了测试,测试对象为欧洲成年糖尿病患者。ISO 标准包括 95% 的血糖 (BG) 值在 BG 参考测量值的± 15 mg/dl 范围内:1650 名参与者获得了血糖仪读数,每个血糖仪系统的读数在 1712 到 2376 之间。符合 ISO 15197:2013 限制的血糖仪读数百分比从 99.4% 到 99.9% 不等。对于所有类型的仪表,100% 的数据点都位于 A 区或 B 区,每种仪表的大多数数据点(≥ 99.9%)都位于 A 区:结论:所有四种获得 CE 认证的 BGM 型号在非标准化环境下显示的结果都在 ISO 15197 规定的准确度范围内,因此始终符合法规对准确度的要求。
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引用次数: 0
The Efficacy and Safety of Liraglutide in Patients Remaining Obese 6 Months after Metabolic Surgery. 利拉鲁肽对代谢手术后 6 个月仍肥胖患者的疗效和安全性。
IF 3.8 3区 医学 Q2 Medicine Pub Date : 2024-12-01 Epub Date: 2024-10-23 DOI: 10.1007/s13300-024-01643-1
Yuanyuan Shen, Yuanhao Huang, Yuqin Ouyang, Xinyue Xiang, Xuehui Chu, Bingqing Zhang, Tao Han, Wenjuan Tang, Wenhuan Feng

Introduction: 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.

Methods: This retrospective cohort study included 61 patients who remained obese (body mass index [BMI] ≥ 28.0 kg/m2) 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.

Results: 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/m2 (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.

Conclusions: 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.

简介:利拉鲁肽作为一种减肥干预措施,对代谢手术后1年内仍肥胖的患者的安全性和有效性仍不清楚。本研究旨在评估利拉鲁肽(1.8 毫克)对术后 6 个月内持续肥胖患者的效果和安全性:这项回顾性队列研究纳入了 61 名术后 6 个月仍肥胖(体重指数 [BMI] ≥ 28.0 kg/m2)的患者。在这些患者中,27人接受了为期12周的1.8毫克利拉鲁肽治疗,34人作为对照组。主要终点是 24 周后总体重减轻率(%TWL)的变化。此外,还评估了体重、体重指数、并发症和不良事件的变化:结果:与对照组相比,利拉鲁肽组的总减重百分比下降幅度更大(11.6% ± 1.1% vs. 4.9% ± 1.0%),估计治疗差异为 6.6%(95% 置信区间 [CI],3.7-9.6%,P 2(95% CI - 4.2 to - 1.7,P 结论:利拉鲁肽组的总减重百分比下降幅度比对照组更大(11.6% ± 1.1% vs. 4.9% ± 1.0%):对于术后 6 个月仍肥胖的患者,12 周的利拉鲁肽治疗可增加体重下降,改善代谢控制,24 周后肥胖相关代谢疾病的缓解率很高。术后一年内根据体重指数进行更早、更及时的辅助减重药物干预,可提高代谢手术后的减重效果。本文图文摘要。
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引用次数: 0
期刊
Diabetes Therapy
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