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The Association Between Hemoglobin A1c and Complications Among Individuals With Diabetes and Severe Chronic Kidney Disease Diabetes Care (IF 14.8) Pub Date : 2025-06-07 Dea H. Kofod, Nicholas Carlson, Thomas P. Almdal, Tobias Bomholt, Christian Torp-Pedersen, Kirsten Nørgaard, Jesper H. Svendsen, Bo Feldt-Rasmussen, Mads Hornum
OBJECTIVE The optimal glycemic target for individuals with severe chronic kidney disease (CKD) remains unclear. We investigated the association between HbA1c and complications in individuals with diabetes and severe CKD. RESEARCH DESIGN AND METHODS In a Danish nationwide registry-based cohort study, we included 27,113 individuals ≥18 years old with diabetes and severe CKD (estimated glomerular filtration
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Kidney Disease: The Forgotten Legacy of Type 1 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-06-06 Merlin C. Thomas, Sophia Zoungas, Nordin M.J. Hanssen, Sybil A. McAuley, Mark E. Cooper
Type 1 diabetes is associated with a progressive decline in kidney function. With improved survival, more individuals with type 1 diabetes are reaching an age where irreversible loss of kidney function can impact health and clinical outcomes. Although current standard of care has markedly reduced the incidence of fast-progressing kidney disease characterized by heavy albuminuria, and improved patient
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Daily Carbohydrate Entries and Glycemic Outcomes Following Automated Insulin Delivery System Initiation in Youth With Type 1 Diabetes: A Real-World Multinational Longitudinal Study Diabetes Care (IF 14.8) Pub Date : 2025-06-06 Bruno Bombaci, Tim Hropot, Natasa Bratina, Darja Smigoc Schweiger, Stefano Passanisi, Giuseppina Salzano, Francesca Di Candia, Fortunato Lombardo, Tadej Battelino, Klemen Dovc
OBJECTIVE To assess the association between daily carbohydrate (CHO) entries and glycemic outcomes in youth with type 1 diabetes after automated insulin delivery (AID) initiation in real-life settings. RESEARCH DESIGN AND METHODS In this longitudinal, multinational observational study, 347 young individuals (7–21 years old) with type 1 diabetes for >1 year were followed for >6 months after AID initiation
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Risk of Thyroid Tumors With GLP-1 Receptor Agonists: A Retrospective Cohort Study Diabetes Care (IF 14.8) Pub Date : 2025-06-04 Daniel R. Morales, Fan Bu, Benjamin Viernes, Scott L. DuVall, Michael E. Matheny, Katherine R. Simon, Thomas Falconer, Lauren R. Richter, Anna Ostropolets, Wallis C. Y. Lau, Kenneth K. C. Man, Shounak Chattopadhyay, Nestoras Mathioudakis, Evan Minty, Akihiko Nishimura, Feng Sun, Can Yin, Sarah L. Seager, Yi Chai, Jin J. Zhou, Yuan Lu, Carlen Reyes, Andrea Pistillo, Talita Duarte-Salles, Clair Blacketer
OBJECTIVE To assess the association between glucagon-like peptide 1 receptor agonist (GLP-1RA) use and risk of incident thyroid tumors. RESEARCH DESIGN AND METHODS The retrospective, active-comparator new-user cohort study used international administrative claims and electronic health record databases. Participants included patients with type 2 diabetes mellitus (T2DM) with prior metformin therapy
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Effects of a Province-Wide Change in Gestational Diabetes Mellitus Screening Policy on Treatment and Newborn Birth Weight Diabetes Care (IF 14.8) Pub Date : 2025-06-04 Elizabeth Nethery, Jennifer A. Hutcheon, Julie Lee, Patricia A. Janssen, Laura Schummers
OBJECTIVE To evaluate changes in gestational diabetes mellitus (GDM) treatment and newborn birth weight after a 2010 change in GDM screening recommendations from a two-step (50-g glucose challenge test + 3-h, 100-g oral glucose tolerance test [OGTT] with Carpenter-Coustan criteria) to a mix of one-step and two-step (2-h, 75-g OGTT with International Association for Diabetes in Pregnancy Study Group
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Overall Uptake and Racial, Ethnic, and Socioeconomic Disparities in the Use of Continuous Glucose Monitoring Devices Among Insulin-Treated Older Adults With Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-05-30 Wajd Alkabbani, Sara J. Cromer, Dae Hyun Kim, Julie M. Paik, Katsiaryna Bykov, Medha Munshi, Deborah J. Wexler, Elisabetta Patorno
OBJECTIVE To assess time trends of and examine which sociodemographic and clinical characteristics are associated with continuous glucose monitoring (CGM) initiation in insulin-treated older adults with type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS Using data from Medicare Fee-for-Service (2013–2020) and Optum’s deidentified Clinformatics Data Mart Database (Clinformatics) (2013–2022), we identified
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GLP-1R Polymorphisms Modify the Relationship Between Exposure to Gestational Diabetes and Offspring BMI Growth: The EPOCH Study Diabetes Care (IF 14.8) Pub Date : 2025-05-30 Kylie K. Harrall, Deborah H. Glueck, Leslie A. Lange, Elizabeth M. Litkowski, Lauren A. Vanderlinden, Iain R. Konigsberg, Melanie G. Cree, Wei Perng, Dana Dabelea
OBJECTIVE Exposure to maternal gestational diabetes mellitus (GDM) is associated with childhood BMI. Among youth, we explored whether three different glucagon-like peptide 1 receptor gene (GLP-1R) polymorphisms modified the associations between 1) GDM and BMI trajectories and 2) GDM and markers of glucose-insulin homeostasis. RESEARCH DESIGN AND METHODS For 464 participants from the Exploring Perinatal
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SGLT2i Versus Metformin for Delirium Prevention in Type 2 Diabetes: A Real-World, Head- to-Head Comparative Study Diabetes Care (IF 14.8) Pub Date : 2025-05-28 Mingyang Sun, Xiaoling Wang, Zhongyuan Lu, Yitian Yang, Shuang Lv, Mengrong Miao, Wan-Ming Chen, Szu-Yuan Wu, Jiaqiang Zhang
OBJECTIVE To compare the effectiveness of sodium–glucose cotransporter 2 inhibitors (SGLT2is) versus metformin in preventing delirium among patients with type 2 diabetes (T2D), using real-world data. RESEARCH DESIGN AND METHODS We conducted a retrospective cohort study using the TriNetX global health research network, including 857,171 adults with T2D who initiated either an SGLT2i (n = 88,012) or
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Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD) in People With Diabetes: The Need for Screening and Early Intervention. A Consensus Report of the American Diabetes Association Diabetes Care (IF 14.8) Pub Date : 2025-05-28 Kenneth Cusi, Manal F. Abdelmalek, Caroline M. Apovian, Kirthikaa Balapattabi, Raveendhara R. Bannuru, Diana Barb, Joan K. Bardsley, Elizabeth A. Beverly, Karen D. Corbin, Nuha A. ElSayed, Scott Isaacs, Fasiha Kanwal, Elizabeth J. Pekas, Caroline R. Richardson, Michael Roden, Arun J. Sanyal, Jay H. Shubrook, Zobair M. Younossi, Mandeep Bajaj
Metabolic dysfunction–associated steatotic liver disease (MASLD), formerly referred to as nonalcoholic fatty liver disease (NAFLD), is a growing but often unrecognized medical problem for people with diabetes (particularly type 2 diabetes, especially when associated with obesity). Liver health has not been at the forefront of complications tracked for disease prevention, as traditionally done for diabetic
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β-Cell Function Derived From Routine Clinical Measures Reports and Predicts Treatment Response to Immunotherapy in Recent-Onset Type 1 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-05-27 Michelle So, Sara Vogrin, Michaela Waibel, Thomas W.H. Kay, John M. Wentworth
OBJECTIVE Baricitinib preserves β-cell function in people with recently diagnosed type 1 diabetes. We aimed to determine whether simple routine clinical measures could be used to assess β-cell preservation and predict treatment response. RESEARCH DESIGNS AND METHOD Measures of β-cell function derived from clinical and biochemical measures were calculated using data from the BAricitinib in Newly DIagnosed
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Trends and Disparities in Rates of Hypoglycemia Among Hospitalized Patients With Type II Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-05-22 Paul A. Heidenreich, Shoutzu Lin, Robert J. Gallo, Anju Sahay, Mary Burkhardt, Peter Glassman, Daniel Fang, Von Moore
OBJECTIVE Hypoglycemia is a common complication of inpatient care for patients with diabetes. We sought to determine recent trends and demographic disparities in the rate of inpatient hypoglycemia. RESEARCH DESIGN AND METHODS We used data from the Veterans Affairs (VA) health care system to identify all patients with type 2 diabetes hospitalized from 2016 to 2022. We determined rates of inpatient hypoglycemia
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Associations of Concurrent Hypertension and Type 2 Diabetes With Mortality Outcomes: A Prospective Study of U.S. Adults Diabetes Care (IF 14.8) Pub Date : 2025-05-21 Ye Yuan, Carmen R. Isasi, Tala Al-Rousan, Arnab K. Ghosh, Pricila H. Mullachery, Priya Palta, Nour Makarem
OBJECTIVE To investigate associations of concurrent hypertension and type 2 diabetes (T2D) with mortality in U.S. adults and elucidate differences by sex, race, and ethnicity. RESEARCH DESIGN AND METHODS The study population included 48,727 adults from the 1999–2018 National Health and Nutrition Examination Surveys. Participants were categorized into four mutually exclusive categories: 1) no hypertension
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Sodium–Glucose Cotransporter 2 Inhibitor Use and Risk of Liver-Related Events in Patients With Type 2 Diabetes: A Meta-analysis of Observational Cohort Studies Diabetes Care (IF 14.8) Pub Date : 2025-05-20 Alessandro Mantovani, Riccardo Morandin, Maria Giovanna Lando, Veronica Fiorio, Grazia Pennisi, Salvatore Petta, Norbert Stefan, Herbert Tilg, Christopher D. Byrne, Giovanni Targher
BACKGROUND There is uncertainty regarding effect of sodium–glucose cotransporter 2 (SGLT2) inhibitors on the risk of major adverse liver-related outcomes (MALOs). PURPOSE We performed a meta-analysis of observational cohort studies to quantify the magnitude of the association between SGLT2 inhibitor use and risk of developing MALOs for people with type 2 diabetes mellitus (T2DM). DATA SOURCES We systematically
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Cost-effectiveness of Semaglutide Compared With Other Glucose-Lowering Medications in Treating Type 2 Diabetes: A Comprehensive Systematic Review and Meta-analysis Diabetes Care (IF 14.8) Pub Date : 2025-05-20 Ziyun Liu, Baoqi Zeng, Feng Sun, Qing Xia
BACKGROUND Significant clinical efficacy has been shown for semaglutide in managing type 2 diabetes (T2D); however, its cost-effectiveness remains uncertain. PURPOSE To systematically review existing evidence on cost-effectiveness of semaglutide versus other T2D medications. DATA SOURCES PubMed, Embase, and the Cost-Effectiveness Analysis Registry (by 11 June 2024). STUDY SELECTION A total of 45 articles
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Effectiveness of Low Intensity Mental Health Support via a Telehealth Enabled Network (LISTEN) for Adults With Diabetes Distress: A Parallel Group, Pragmatic Randomized Controlled Trial Diabetes Care (IF 14.8) Pub Date : 2025-05-20 Edith E. Holloway, Laura Jenkins, Paul A. Agius, Sarah Manallack, Roslyn Le Gautier, Cathrine Mihalopoulos, Mary Lou Chatterton, Vincent L. Versace, Jennifer Halliday, Virginia Hagger, Shikha Gray, Kim Henshaw, Ben Harrap, Natasha Van Bruggen, Taryn Black, Glen Noonan, Carolyn Hines, Adrienne O’Neil, Timothy C. Skinner, Jane Speight, Christel Hendrieckx
OBJECTIVE To assess the effectiveness of Low Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals, for reducing diabetes distress among adults with type 1 or type 2 diabetes. RESEARCH DESIGN AND METHODS A two-arm, parallel group, pragmatic randomized controlled trial. Adults with diabetes distress (20-item Problem Areas in Diabetes
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Human Physiologic Responses to Insulin in Indigenous Americans Identify a Metabolic Susceptibility Profile Linked to Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-05-20 Venkatesh L. Murthy, Paolo Piaggi, Phillip Lin, Shilin Zhao, Lindsey K. Stolze, Andrew S. Perry, Robert L. Hanson, John Jeffrey Carr, James G. Terry, Leslie J. Baier, Clifton Bogardus, Clary Clish, Eric R. Gamazon, Jonathan Krakoff, Ravi V. Shah
OBJECTIVE To identify metabolic signatures of insulin action/secretion in Indigenous Americans (IAs) and their association with diabetes. RESEARCH DESIGN AND METHODS We defined circulating metabolomic signatures of insulin action/secretion in 446 IAs, including glucose disposal rate during low-dose insulin clamp (Mlow) and endogenous glucose production (EGP) during insulin infusion (suppression of
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In Utero Exposure to Maternal Hyperglycemia and Offspring Type 2 Diabetes Genetic Risk Score Are Independently Associated With Risk of Impaired Glucose Tolerance in Youth Diabetes Care (IF 14.8) Pub Date : 2025-05-19 Abigayil C. Dieguez, Alan Kuang, Jami L. Josefson, Denise M. Scholtens, William L. Lowe, M. Geoffrey Hayes, Marie-France Hivert
OBJECTIVE We tested associations of type 2 diabetes genetic risk score (T2D-GRS) and exposure to maternal hyperglycemia with childhood impaired glucose tolerance (IGT) and T2D and glycemic outcomes in youth from the Hyperglycemia and Adverse Pregnancy Outcome Follow-Up Study. RESEARCH DESIGN AND METHODS We calculated T2D-GRS using 1,150 known genetic variants associated with T2D in adults. In utero
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One-Hour Plasma Glucose Predicts the Progression From Normal Glucose Tolerance to Prediabetes Diabetes Care (IF 14.8) Pub Date : 2025-05-16 Muhammad Abdul-Ghani, Mohamed Abu-Farha, Tamam Abdul-Ghani, Alberto Chavez-Velazquez, Auora Merovci, Ralph A. DeFronzo, Fahad Alajmi, Michael Stern, Fahd Al-Mulla
OBJECTIVE To examine the ability of the 1-h plasma glucose (PG) concentration during the oral glucose tolerance test (OGTT) to predict the risk of progression to prediabetes in individuals with normal glucose tolerance (NGT). RESEARCH DESIGN AND METHODS A total of 1,557 participants from the San Antonio Heart Study who were free of type 2 diabetes at baseline, had a baseline OGTT, and had a repeat
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Stroke Incidence Evolution in People With Newly Diagnosed Diabetes and Impaired Glucose Tolerance: A 34-Year Follow-up of the Da Qing Diabetes Study Diabetes Care (IF 14.8) Pub Date : 2025-05-15 Yanyan Chen, Jinping Wang, Xinxin Feng, Xin Qian, Siyao He, Qier An, Xiang Yin, Xuan Wang, Yali An, Qiuhong Gong, Shuhan Zhou, Hui Li, Xiuwei Zhai, Xiaoping Chen, Guangwei Li
OBJECTIVE To examine the incidence of stroke in Chinese adults with newly diagnosed type 2 diabetes (NDD), impaired glucose tolerance (IGT), and normal glucose tolerance (NGT) over a 34-year follow-up period. RESEARCH DESIGN AND METHODS This cohort study included participants with NDD, IGT, and NGT initially identified in 1986 in the Da Qing Diabetes Prevention Study who were followed up for 34 years
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Trends in Cystic Fibrosis–Related Diabetes Epidemiology Between 2003 and 2018 From the U.S. Cystic Fibrosis Foundation Patient Registry Diabetes Care (IF 14.8) Pub Date : 2025-05-15 Celia L. Kohler, Tim Vigers, Laura Pyle, Kristen Miller, Edith T. Zemanick, Antoinette Moran, Scott D. Sagel, Christine L. Chan
OBJECTIVE A number of disease-modifying therapies have been introduced for people with cystic fibrosis (CF) over the past two decades. The cumulative effects of this changing landscape on CF–related diabetes (CFRD) are unclear. We examined trends in CFRD epidemiology over time using data from the U.S. Cystic Fibrosis Foundation Patient Registry (CFFPR). RESEARCH DESIGN AND METHODS CFFPR data from 2003
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Diet, Gut Microbiota, and Histidine Metabolism Toward Imidazole Propionate Production in Relation to Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-05-09 Hongbo Yang, Kai Luo, Brandilyn A. Peters, Yi Wang, Yanbo Zhang, Martha Daviglus, Amber Pirzada, Christina Cordero, Bing Yu, Robert D. Burk, Robert Kaplan, Qibin Qi
OBJECTIVE To examine associations of serum imidazole propionate (ImP), histidine, and their ratio with incident type 2 diabetes (T2D) and related dietary and gut microbial factors in U.S. Hispanic/Latino people. RESEARCH DESIGN AND METHODS In the Hispanic Community Health Study/Study of Latinos, we evaluated serum ImP, histidine, and ImP-to-histidine ratio at baseline (2008–2011) and their cross-sectional
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Cellular Versus Acellular Matrix Products for Diabetic Foot Ulcer Treatment: The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE)—A Randomized Clinical Trial Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Harrison Shawa, Ramanjot Kaur, Catherine Tchanque-Fossuo, Hadar Lev-Tov, Kaitlyn West, Pallas Sulgi Lim, Nuen Tsang Yang, Mirabel Dafinone, Rawlings Everett Lyle, Chin-Shang Li, David Rocke, Sara Dahle, Roslyn Rivkah Isseroff
OBJECTIVE To determine whether cellular matrix (CM) products result in better healing rates than acellular matrix (ACM) products for nonhealing diabetic foot ulcers. RESEARCH DESIGN AND METHODS The Dermagraft and Oasis Longitudinal Comparative Efficacy Study (DOLCE) was a randomized, single-blinded, three-arm controlled trial. Patients (aged ≥18 years) with a full-thickness nonhealing diabetic foot
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Persistent Hyperglycemia and Insulin Resistance With the Risk of Worsening Cardiac Damage in Adolescents: A 7-Year Longitudinal Study of the ALSPAC Birth Cohort Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Andrew O. Agbaje, Justin P. Zachariah, Alan R. Barker, Craig A. Williams, Dimitris Vlachopoulos, Christoph Saner, Tomi-Pekka Tuomainen
OBJECTIVE Insulin resistance (IR) and dysglycemia can induce cardiac remodeling in adulthood, but little evidence exists with respect to cardiac remodeling in youth with and without evidence of new-onset glucose metabolic alterations. This study investigated whether changes in metabolic status from adolescence to young adulthood are associated with the risk of progressive cardiac remodeling and examined
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Comparison of Insulin Titration Strategies for Glycemic Control in Type 2 Diabetes: A Systematic Review and Network Meta-analysis Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Kansak Boonpattharatthiti, Kirana Wechkunanukul, Noramon Mayang, E Lyn Lee, Anjana Fuangchan, Alice Y.Y. Cheng, Nathorn Chaiyakunapruk, Teerapon Dhippayom
BACKGROUND Adjusting basal insulin doses is essential for lowering blood glucose while minimizing the risk of hypoglycemia. Despite various basal insulin titration strategies being available, their comparative effectiveness remains unclear. PURPOSE To compare the effectiveness of different basal insulin titration strategies on glycemic control in patients with type 2 diabetes. DATA SOURCES PubMed,
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Type 1 Diabetes TrialNet: Leading the Charge in Disease Prediction, Prevention, and Immunotherapeutic Mechanistic Understanding Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Laura M. Jacobsen, Jamie L. Felton, Brandon M. Nathan, Cate Speake, Jeffrey Krischer, Kevan C. Herold
Established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2001, Type 1 Diabetes TrialNet (TrialNet) is an international consortium of clinical research centers that studies the development of type 1 diabetes and performs clinical studies aimed at delaying or preventing the disease. In recognition of NIDDK’s 75th anniversary, this review will summarize the major
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Is the Current Lifestyle Modification Approach to Diabetes Prevention in the U.S. a Success? Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Justin B. Echouffo-Tcheugui, Rosette J. Chakkalakal, Mohammed K. Ali
Prediabetes is an intermediate stage between normal glycemia and diabetes and is highly prevalent, especially in adults, but is also increasingly common in young individuals. Randomized clinical trials have demonstrated that lifestyle modification is cost-effective in preventing diabetes. Implementation studies showed the feasibility of delivering real-world structured lifestyle modification programs
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Capillary Ketone Level and Future Ketoacidosis Risk in Patients With Type 1 Diabetes Using Sodium–Glucose Cotransporter Inhibitors Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Priya Bapat, Sharon Dhaliwal, Cimon Song, Yucheng Zhang, Daniel Scarr, Abdulmohsen Bakhsh, Dalton Budhram, Natasha J. Verhoeff, Alanna Weisman, Michael Fralick, Noah M. Ivers, David Z.I. Cherney, George Tomlinson, Doug Mumford, Leif Erik Lovblom, Bruce A. Perkins
OBJECTIVE We aimed to determine if routine capillary blood ketone testing on well days predicts future diabetic ketoacidosis (DKA) in type 1 diabetes (T1D) using sodium–glucose cotransporter inhibitors (SGLTi). RESEARCH DESIGN AND METHODS We examined previously collected data from empagliflozin-assigned participants in a T1D trial that included weekly fasted ketone levels. Over 6–12 months, ketone
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Lipidomic Markers of Processed Meat and Unprocessed Red Meat Intake and Risk of Diabetes in American Indians Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Xiaoxiao Wen, Guanhong Miao, Amanda M. Fretts, Mingjing Chen, Ying Zhang, Jason G. Umans, Shelley A. Cole, Lyle G. Best, Oliver Fiehn, Jinying Zhao
OBJECTIVE To identify lipidomic markers of habitual unprocessed red meat and processed meat intake and evaluate their associations with diabetes risk in American Indians. RESEARCH DESIGN AND METHODS We studied 1,816 participants from the Strong Heart Family Study. Using untargeted liquid chromatography-mass spectrometry, we quantified 1,542 lipids (518 known) in fasting plasma at baseline and follow-up
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Premeal Whey Protein Lowers Postprandial Blood Glucose in Women With Gestational Diabetes Mellitus: A Randomized, Crossover Clinical Trial Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Stine Smedegaard, Ulla Kampmann, Per G. Ovesen, Louise B. Suder, Janni H. Knudsen, Gregers Wegener, Lise H. Brunsgaard, Nikolaj Rittig
OBJECTIVE To examine how whey protein served as a premeal affects postprandial glucose excursions in women with gestational diabetes mellitus (GDM). RESEARCH DESIGN AND METHODS A placebo-controlled, single-blinded, crossover, randomized trial including women with and without GDM (20–36 weeks’ gestation) was performed. Participants were studied in the laboratory and at home. In the laboratory, women
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Energy Restriction, Weight Loss, Glycemia, and Breastfeeding Outcomes in Gestational Diabetes: A DiGest Trial Secondary Analysis Diabetes Care (IF 14.8) Pub Date : 2025-05-07 Sarah Dib, Laura C. Kusinski, Danielle L. Jones, Nooria Atta, Suzanne Smith, Emanuella De Lucia Rolfe, Helen R. Murphy, Roy Taylor, Claire L. Meek
OBJECTIVE We aimed to assess whether energy restriction, weight loss, or maternal glycemia in late pregnancy were associated with breastfeeding outcomes. RESEARCH DESIGN AND METHODS This is a secondary analysis of the Dietary Intervention in Gestational Diabetes (DiGest) randomized controlled trial, which included 425 participants with gestational diabetes who were randomly assigned to receive a standard-energy
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Influence of Maternal Glycemia on Breast Milk Composition and Volume Ingested by Infants of Mothers With Type 1 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-04-15 Lois E. Donovan, Rhonda C. Bell, Jennifer M. Yamamoto, Patricia Lemieux, Josephine Ho, Denice S. Feig, Heidi Virtanen, Susan Crawford, Raylene A. Reimer
OBJECTIVE To examine relationships between maternal glucose and breast milk composition and volume ingested by infants of mothers with type 1 diabetes (T1D), and to compare breast milk composition in women with and without T1D. RESEARCH DESIGN AND METHODS Midfeed breast milk samples were collected from 11 mothers with T1D. Maternal continuous glucose monitoring data were correlated with breast milk
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Empagliflozin in Patients With Type 2 Diabetes Undergoing On-Pump CABG: The POST-CABGDM Randomized Clinical Trial Diabetes Care (IF 14.8) Pub Date : 2025-04-15 Fabio Grunspun Pitta, Eduardo Gomes Lima, Caio Assis Moura Tavares, Eduardo Bello Martins, Fabiana Hanna Rached, Eduardo Martelli Moreira, Bruno Mahler Mioto, Simão Augusto Lottenberg, Paula Mathias Paulino Bolta, Larissa Gonçalves Justino, Desiderio Favarato, Letícia Neves Solon Carvalho, Henrique Trombini Pinesi, Camila Talita Machado Barbosa, Luís Alberto Oliveira Dallan, Luís Roberto Palma Dallan
OBJECTIVE To evaluate the efficacy and safety of empagliflozin in patients with type 2 diabetes mellitus (T2DM) undergoing elective on-pump coronary artery bypass grafting (CABG). RESEARCH DESIGN AND METHODS Investigator-initiated, pragmatic, single-center, randomized, open-label trial with blinded outcome adjudication conducted in Brazil. A total of 145 patients with T2DM scheduled for elective on-pump
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Islet Autoantibodies and Their Association With β-Cell Function and Diabetes Measures in Children With Acute Recurrent and Chronic Pancreatitis Diabetes Care (IF 14.8) Pub Date : 2025-04-15 Gila Ginzburg, Lindsey Hornung, Lee Denson, Amy S. Shah, Sarah Swauger, Jonathan Tatum, Siobhan Tellez, Deborah Elder, Melena D. Bellin, Maisam Abu-El-Haija
OBJECTIVE In children with acute recurrent pancreatitis (ARP) and chronic pancreatitis (CP), circulating islet autoantibodies (auto-Ab) may influence β-cell function. This study reports Ab prevalence in youth with ARP/CP, and investigates effects on indices of insulin secretion during mixed meal tolerance testing (MMTT) and diabetes status. RESEARCH DESIGN AND METHODS This was a retrospective cross-sectional
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Visit-to-Visit Variability in Lipid Levels and Risk of Incident Heart Failure in Adults With Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-04-14 Arnaud D. Kaze, Chiadi E. Ndumele, Seth S. Martin, Prasanna Santhanam, Beeletsega T. Yeneneh, Mookadam Farouk, Roderick Tung, Gregg C. Fonarow, Justin B. Echouffo-Tcheugui
OBJECTIVE Limited data exist on the relation between long-term variability in blood lipid fractions and incident heart failure (HF) in the setting of type 2 diabetes mellitus (T2DM). RESEARCH DESIGN AND METHODS Among 9,443 T2DM participants from the Action to Control Cardiovascular Risk in Diabetes (ACCORD) study, with lipid measurements available at six time points (baseline, 4, 8, 12, 24, and 36
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Subphenotype-Dependent Benefits of Bariatric Surgery for Individuals at Risk for Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-04-11 Leontine Sandforth, Violeta Raverdy, Arvid Sandforth, Pierre Bauvin, Estelle Chatelain, Helene Verkindt, Geltrude Mingrone, Caterina Guidone, Ornella Verrastro, Karin Zhou, Rami Archid, André Mihaljevic, Robert Caiazzo, Gregory Baud, Camille Marciniak, Mikael Chetboun, Marlene Ganslmeier, Vitória Minelli Faiao, Martin Heni, Louise Fritsche, Anja Moller, Konstantinos Kantartzis, Andreas Peter, Rainer
OBJECTIVE Bariatric surgery is an effective treatment option for individuals with obesity and type 2 diabetes (T2D). However, whether outcomes in subtypes of individuals at risk for T2D and/or comorbidities (Tübingen Clusters) differ, is unknown. Of these, cluster 5 (C5) and cluster 6 (C6) are high-risk clusters for developing T2D and/or comorbidities, while cluster 4 (C4) is a low-risk cluster. We
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M120 Risk Score Improves Identification of Children at High Risk of Developing Clinical Type 1 Diabetes and Reports Short-Term Response to Preventive Immunotherapy Diabetes Care (IF 14.8) Pub Date : 2025-04-10 Minh V. Le, Leonard C. Harrison, Tim Spelman, John M. Wentworth
OBJECTIVE Approval of teplizumab as disease-modifying therapy for type 1 diabetes heralds a new therapeutic era. To facilitate prevention trials, we determined if the M120 risk score could enrich for type 1 diabetes risk and define early treatment effects. RESEARCH DESIGN AND METHODS M120, based on age, sex, BMI, IA-2 antibody status, HbA1c, blood glucose, and C-peptide 120 min after oral glucose,
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Risk of Adverse Pregnancy Outcomes Among Asian Individuals With Gestational Diabetes Mellitus in the U.S., 2016–2021 Diabetes Care (IF 14.8) Pub Date : 2025-04-10 Kartik K. Venkatesh, Xiaoning Huang, Nilay S. Shah,, Mark B. Landon, William A. Grobman, Sadiya S. Khan
OBJECTIVE The risk of adverse pregnancy outcomes (APOs) differs among race and ethnic groups with gestational diabetes mellitus (GDM). Heterogeneity in APOs may be masked by aggregating these groups. We assessed whether the frequency and risk of APOs differed among Asian groups with GDM. RESEARCH DESIGN AND METHODS This is a serial cross-sectional analysis of U.S. birth certificate data (2016–2021)
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Effect of Marked Weight Loss on Adipose Tissue Biology in People With Obesity and Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-04-10 Dmitri Samovski, Gordon I. Smith, Hector Palacios, Terri Pietka, Anja Fuchs, Gary J. Patti, Allah Nawaz, C. Ronald Kahn, Samuel Klein
OBJECTIVE Weight loss improves insulin sensitivity in people with obesity and type 2 diabetes. However, the mechanisms responsible for this effect are unclear. We hypothesized that alterations in adipose tissue biology and adipose tissue-related factors in plasma are involved in mediating the systemic metabolic benefits of weight loss. RESEARCH DESIGN AND METHODS We evaluated blood and adipose tissue
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Association of Patient Cost-Sharing With Adherence to GLP-1a and Adverse Health Outcomes Diabetes Care (IF 14.8) Pub Date : 2025-04-09 Donglan Zhang, Nihan Gencerliler, Amrita Mukhopadhyay, Saul Blecker, Morgan E. Grams, Davene R. Wright, Vivian Hsing-Chun Wang, Anand Rajan, Eisha Butt, Jung-Im Shin, Yunwen Xu, Karan R. Chhabra, Jasmin Divers
OBJECTIVE To examine the associations between patient out-of-pocket (OOP) costs and nonadherence to glucagon-like peptide 1 receptor agonists (GLP-1a), and the consequent impact on adverse outcomes, including hospitalizations and emergency department (ED) visits. RESEARCH DESIGN AND METHODS This retrospective cohort study used MarketScan Commercial data (2016–2021). The cohort included nonpregnant
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A Comparative Analysis of Glycemic Metrics Derived From Three Continuous Glucose Monitoring Systems Diabetes Care (IF 14.8) Pub Date : 2025-04-08 Guido Freckmann, Stephanie Wehrstedt, Manuel Eichenlaub, Stefan Pleus, Manuela Link, Nina Jendrike, Sükrü Öter, Derek Brandt, Cornelia Haug, Delia Waldenmaier
OBJECTIVE This study analyzed the differences in continuous glucose monitoring (CGM)-derived metrics among three current-generation systems and evaluated their impact on therapeutic decision-making. RESEARCH DESIGN AND METHODS Twenty-three participants wore the FreeStyle Libre 3, Dexcom G7, and Medtronic Simplera CGM systems for 14 days in parallel. CGM metrics were calculated for each participant
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Comparison of Serum Creatinine- and Cystatin C–Based eGFR at Baseline and Their Prediction of Incident Moderate Albuminuria in Individuals With Type 1 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-04-07 Valma Harjutsalo, Lena M. Thorn, Per-Henrik Groop
OBJECTIVE To assess the concordance between serum creatinine (SCr)- and serum cystatin C (SCysC)–based estimated glomerular filtration rate (eGFR) in individuals with type 1 diabetes (T1D) at different stages of albuminuria; identify the factors associated with the discordance; and study the association of SCysC, eGFR of creatinine (eGFRcr), and eGFR of cystatin C (eGFRcys) with incident moderate albuminuria
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Large-Scale Proteomics Improve Risk Prediction for Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-04-03 Ruijie Xie, Tomislav Vlaski, Kira Trares, Christian Herder, Bernd Holleczek, Hermann Brenner, Ben Schöttker
OBJECTIVE This study evaluated the incremental predictive value of proteomic biomarkers in assessing 10-year type 2 diabetes risk when added to the clinical Cambridge Diabetes Risk Score (CDRS). RESEARCH DESIGN AND METHODS Data from 21,898 UK Biobank participants were used for model derivation and internal validation, and 4,454 Epidemiologische Studie zu Chancen der Verhütung, Früherkennung und optimierten
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Risk of Urogenital Infections in People With Type 2 Diabetes Initiating SGLT2i Versus GLP-1RA in Routine Clinical Care: A Danish Cohort Study Diabetes Care (IF 14.8) Pub Date : 2025-04-02 Christine Ljungberg, Frederik Pagh Bredahl Kristensen, Michael Dalager-Pedersen, Christina Vandenbroucke-Grauls, Henrik Toft Sørensen, Mette Nørgaard, Reimar Wernich Thomsen
OBJECTIVE Anticipated risks of urinary tract infections (UTI) and genital tract infections (GTI) associated with sodium–glucose cotransporter 2 inhibitors (SGLT2i) may prevent their use in clinical practice. We investigated whether initiation of SGLT2i, compared with glucagon-like peptide 1 receptor agonists (GLP-1RAs), was associated with an elevated risk of UTI and GTI in people with type 2 diabetes
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Symptoms of Autonomic Nervous System Dysregulation and Diabetes Distress in Adults With Type 1 and Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-03-31 Mary de Groot, Barbara A. Myers, Timothy E. Stump, Deb Dana, Greg Lewis, Jacek Kolacz, Lauren Baker, Kelly A. Fox, Stephen W. Porges
OBJECTIVE To test the association of autonomic nervous system (ANS) dysregulation symptoms and diabetes distress (DD) in adults with type 1 diabetes (T1D; study 1) and type 2 diabetes (T2D; study 2). RESEARCH DESIGN AND METHODS A total of 556 adults with T1D and 299 with T2D completed the Body Perception Questionnaire (BPQ) to assess ANS reactivity symptoms, diabetes distress (via Diabetes Distress
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Community-Based Peer Support for Diabetes Management: 24-Month Changes Relative to Comparison Communities Diabetes Care (IF 14.8) Pub Date : 2025-03-31 Yuexing Liu, Chun Cai, Jiahe Tian, Li Shen, Patrick Y. Tang, Muchieh Maggy Coufal, Hongli Chen, Megan S. Evans, Yiqing Qian, Wenya Yu, Xiaoyu Wu, Xiaobing Wu, Edwin B. Fisher, Weiping Jia
OBJECTIVE To evaluate the effectiveness of community-based peer support for diabetes self-management with HbA1c and other clinical and psychosocial outcomes over 24 months. RESEARCH DESIGN AND METHODS This study used an intervention comparison design with 12 intervention communities and 4 comparison communities matched according to location in urban or suburban areas. A community organization approach
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Dynamic Relationships Among Continuous Glucose Metrics and Momentary Cognitive Performance in Diverse Adults With Type 1 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-03-31 Claire J. Hoogendoorn, Raymond Hernandez, Stefan Schneider, Anne Peters, Meredith Hawkins, Elizabeth A. Pyatak, Jeffrey S. Gonzalez
OBJECTIVE Despite established relationships between glycemia and cognition, few studies have evaluated within-person changes over time. We paired continuous glucose monitoring (CGM) with ambulatory cognitive testing to examine bidirectional associations among adults with type 1 diabetes (T1D). RESEARCH DESIGN AND METHODS Participants wore blinded CGM and completed ambulatory tests of perceptual speed
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Association Between Use of Sodium–Glucose Cotransporter 2 Inhibitors and Epilepsy: A Population-Based Study Using Target Trial Emulation Diabetes Care (IF 14.8) Pub Date : 2025-03-25 Houyu Zhao, Baixue Zhang, Lin Zhuo, Yueqi Yin, Yexiang Sun, Peng Shen, Zhiqin Jiang, Siyan Zhan
OBJECTIVE Preclinical studies in animals have suggested potential neuroprotective effects of sodium–glucose cotransporter 2 inhibitors (SGLT-2is), but no epidemiological study has investigated the potential effects of SGLT-2is on epilepsy risk. We aimed to assess the association between use of SGLT-2is and epilepsy incidence. RESEARCH DESIGN AND METHODS We emulated a target trial comparing SGLT-2is
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Association Between Diabetes and Anemia: Evidence From NHANES and the UK Biobank Diabetes Care (IF 14.8) Pub Date : 2025-03-21 Danyang Wang, Jedidiah I. Morton, Agus Salim, Jonathan E. Shaw, Dianna J. Magliano
OBJECTIVE To explore the association between diabetes and anemia. RESEARCH DESIGN AND METHODS We included 9,026 and 389,616 participants from the U.S. National Health and Nutrition Examination Surveys and the UK Biobank study (UKB), respectively. Multivariable logistic regression was used to examine the cross-sectional association of diabetes with anemia, as defined by hemoglobin measurement. For the
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Management of Diabetes and Hyperglycemia in the Hospital: A Systematic Review of Clinical Practice Guidelines Diabetes Care (IF 14.8) Pub Date : 2025-03-21 Linnea M. Wilson, Shoshana J. Herzig, Edward R. Marcantonio, Michael A. Steinman, Mara A. Schonberg, Brianna X. Wang, Ella Hileman-Kaplan, Timothy S. Anderson
BACKGROUND Inpatient hyperglycemia is common among adults, and management varies. PURPOSE To systematically identify guidelines on inpatient hyperglycemia management. DATA SOURCES MEDLINE, Guidelines International Network, and specialty society websites were searched from 1 January 2010 to 14 August 2024. STUDY SELECTION Clinical practice guidelines pertaining to blood glucose management in hospitalized
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ATLANTIC DIP, Changing the Landscape for Better Maternal and Infant Health: The 2024 Norbert Freinkel Award Lecture Diabetes Care (IF 14.8) Pub Date : 2025-03-21 Fidelma Dunne
The Norbert Freinkel Award recognizes contribution of research, clinical practice, and advocacy to improving pregnancy outcomes for women with diabetes. This award honors a man of outstanding achievements. Norbert was a forward-thinking investigator, a concise and precise writer, and a gifted clinical practitioner. His philosophy stated that a research question should be framed around an unsolved patient
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The Modern Role of Basal Insulin in Advancing Therapy in People With Type 2 Diabetes Diabetes Care (IF 14.8) Pub Date : 2025-03-21 Geremia B. Bolli, Philip D. Home, Francesca Porcellati, Matthew C. Riddle, Hertzel C. Gerstein, Paola Lucidi, Carmine G. Fanelli, David R. Owens
Insulin deficiency, often aggravated by insulin resistance, results in type 2 diabetes mellitus (T2DM). With the availability of glucagon-like peptide 1 receptor agonists and sodium–glucose cotransporter 2 inhibitors, basal insulin (BI) therapy is no longer the first-line option after lifestyle modification plus oral agents is insufficient. In contrast to BI, the newer medications require minor titration
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Early Fasting Serum Glucose or Weight Reduction With Tirzepatide and Metabolic Outcomes in People With Type 2 Diabetes: A Post Hoc Analysis of the SURPASS Trials Diabetes Care (IF 14.8) Pub Date : 2025-03-18 Francesco Giorgino, Ildiko Lingvay, Luc F. Van Gaal, Palash Sharma, Ángel Rodríguez, Jacek Kiljański, Amelia Torcello-Gómez, Joshua A. Levine
OBJECTIVE To evaluate late (week 40 or 42; hereafter, week 40/42) metabolic outcomes by early glycemic response (<20% or ≥20% fasting serum glucose [FSG] reduction at week 4) or weight response (<5% or ≥5% weight reduction at week 8), respectively, in tirzepatide-treated participants with type 2 diabetes in the SURPASS trials. RESEARCH DESIGN AND METHODS This post hoc analysis used pooled data across
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Quantifying Environmental Waste From Diabetes Devices in the U.S. Diabetes Care (IF 14.8) Pub Date : 2025-03-12 Tiffany Tian, Cindy N. Ho, Alessandra T. Ayers, Rachel E. Aaron, David C. Klonoff, David T. Ahn, David Kerr, Anne L. Peters, Athena Philis-Tsimikas, Viral N. Shah, Emily G. Herndon, Yijiong Yang, Chengdong Li, Jing Wang
OBJECTIVE Diabetes devices, including continuous glucose monitors (CGMs) and insulin pumps, may significantly affect environmental sustainability and long-term resilience. RESEARCH DESIGN AND METHODS This observational study enrolled 49 adults with diabetes using CGMs, insulin pumps, or multiple daily injections (MDIs; three or more per day). Participants completed daily surveys detailing the types
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Metabolic Improvements With Tirzepatide in Lipodystrophy: A Novel Option? Diabetes Care (IF 14.8) Pub Date : 2025-03-10 Rasimcan Meral, Merve Celik Guler, Diarratou Kaba, Jeevitha Prativadi, Eric D. Frontera, Maria Cristina Foss-Freitas, Noura Nachawi, David T. Broome, Marissa Lightbourne, Rebecca J. Brown, Simeon I. Taylor, Elif A. Oral
OBJECTIVE Lipodystrophy encompasses a group of rare disorders associated with severe metabolic disease. These disorders are defined by abnormal fat distribution, with near-total (generalized lipodystrophy [GL]) or partial (partial lipodystrophy [PL]; e.g. familial partial lipodystrophy [FPLD]) absence of adipocyte mass, leading to a decreased ability to store lipids safely. Excess lipids are more likely
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One-Hour Oral Glucose Tolerance Test for the Postpartum Reclassification of Women With Hyperglycemia in Pregnancy Diabetes Care (IF 14.8) Pub Date : 2025-03-03 Ravi Retnakaran, Chang Ye, Caroline K. Kramer, Anthony J. Hanley, Philip W. Connelly, Mathew Sermer, Bernard Zinman
OBJECTIVE The International Diabetes Federation recently endorsed a 1-h oral glucose tolerance test (OGTT) as more convenient than the conventional 2-h OGTT. In practice, women with hyperglycemia in pregnancy are advised to undergo a 2-h OGTT within 6 months after delivery, but this test is often not completed, partly owing to its inconvenience for busy mothers. Recognizing the potential advantage
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Efficacy and Safety of Finerenone in Type 2 Diabetes: A Pooled Analysis of Trials of Heart Failure and Chronic Kidney Disease Diabetes Care (IF 14.8) Pub Date : 2025-03-03 John W. Ostrominski, Brian L. Claggett, Zi Michael Miao, Gerasimos Filippatos, Akshay S. Desai, Pardeep S. Jhund, Alasdair Henderson, Meike Brinker, Patrick Schloemer, Prabhakar Viswanathan, Andrea Lage, Katja Rohwedder, Carolyn S.P. Lam, Michele Senni, Sanjiv J. Shah, Adriaan A. Voors, Faiez Zannad, Peter Rossing, Luis M. Ruilope, Stefan D. Anker, Bertram Pitt, Rajiv Agarwal, John J.V. McMurray, Scott
OBJECTIVE To evaluate the efficacy and safety of finerenone, a nonsteroidal mineralocorticoid receptor antagonist, in individuals with type 2 diabetes (T2D) and either chronic kidney disease (CKD) or heart failure (HF) with mildly reduced ejection fraction (HFmrEF) or preserved ejection fraction (HFpEF). RESEARCH DESIGN AND METHODS In this prespecified participant-level pooled analysis of all phase
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Early Continuous Glucose Monitor Use in Children and Adolescents With Type 1 Diabetes: Rates of Initiation and Impact on Glycemic Outcomes Diabetes Care (IF 14.8) Pub Date : 2025-02-26 Elizabeth A. Mann, Saketh Rompicherla, Brian Miyazaki, Nicole Rioles, Holly Hardison, Lauren Golden, Jennifer Sarhis, Halis K. Akturk, Joyce Lee, Daniel J. DeSalvo, Patricia Gomez, Osagie Ebekozien, Priya Prahalad
OBJECTIVE Early initiation of continuous glucose monitor (CGM) after type 1 diabetes (T1D) diagnosis has been associated with lower hemoglobin A1C (HbA1c) in single-institution studies. This multicenter study evaluated the association between the timing of CGM initiation and HbA1c at 3 years postdiagnosis. RESEARCH DESIGN AND METHODS Data were obtained from the T1D Exchange Quality Improvement Collaborative
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Isolated Glucosuria in Adolescence and Early-Onset Diabetes: A Nationwide Cohort Study of 1.6 Million Adolescents Diabetes Care (IF 14.8) Pub Date : 2025-02-26 Adi Vinograd, Tsahi T. Lerman, Orit Pinhas-Hamiel, Aya Bardugo, Cole D. Bendor, Estela Derazne, Josef Coresh, Ofir Vinograd, Miri Lutski, Inbar Zucker, Michal Bromberg, Tamar Fishman, Gabriel Chodick, Hertzel C. Gerstein, Tali Cukierman-Yaffe, Asaf Vivante, Adi Leiba, Arnon Afek, Amir Tirosh, Boris Fishman, Gilad Twig
OBJECTIVE We assess diabetes risk in adulthood among adolescents with isolated glucosuria. RESEARCH DESIGN AND METHODS Included were adolescents (16–19 years) examined before military service between 1993 and 2015. Data were linked with the Israeli National Diabetes Registry. Glucosuria was confirmed following normal renal function and glucose tolerance tests. Cox models were applied. RESULTS The study
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Development and Validation of the Patient-Level Chinese Diabetes Outcome Model on Long-term Complications in Type 2 Diabetes: An Application of the Hong Kong Diabetes Register Diabetes Care (IF 14.8) Pub Date : 2025-02-25 Eric S.H. Lau, Andrea O.Y. Luk, Lee-Ling Lim, Hongjiang Wu, Aimin Yang, Alice P.S. Kong, Ronald C.W. Ma, Risa Ozaki, Elaine Y.K. Chow, Chiu-Chi Tsang, Chun-Kwun O, Amy Fu, Edward W. Gregg, Philip Clarke, Wing-Yee So, Juliana N.M. Lui, Juliana C.N. Chan
OBJECTIVE Patient-level simulation models, mainly developed in Western populations, capture complex interactions between risk factors and complications to predict the long-term effectiveness and cost-effectiveness of novel treatments and identify high-risk subgroups for personalized care. However, incidence of outcomes varies significantly by ethnicity and region. We used high-quality, patient-level
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Comparative Efficacy of Glucagon-Like Peptide 1 Receptor Agonists for Cardiovascular Outcomes in Asian Versus White Populations: Systematic Review and Meta-analysis of Randomized Trials of Populations With or Without Type 2 Diabetes and/or Overweight or Obesity Diabetes Care (IF 14.8) Pub Date : 2025-02-20 Matthew M.Y. Lee, Nazim Ghouri, Anoop Misra, Yu Mi Kang, Martin K. Rutter, Hertzel C. Gerstein, Darren K. McGuire, Naveed Sattar
BACKGROUND Cardiovascular outcome trials (CVOTs) suggest glucagon-like peptide 1 receptor agonists (GLP-1RAs) provide greater cardiovascular (CV) benefits in Asian compared with White individuals. PURPOSE Compare CV efficacy of GLP-1RAs between Asian and White individuals. DATA SOURCES Systematic review of PubMed and ClinicalTrials.gov (1 January 2015 to 1 November 2024). STUDY SELECTION Randomized