DiabetologiaPub Date : 2025-01-18DOI: 10.1007/s00125-025-06358-x
Kenny Mendoza, Simón Barquera, Deirdre K. Tobias
{"title":"Targeting ultra-processed foods for prevention of type 2 diabetes: state of the evidence and future directions","authors":"Kenny Mendoza, Simón Barquera, Deirdre K. Tobias","doi":"10.1007/s00125-025-06358-x","DOIUrl":"https://doi.org/10.1007/s00125-025-06358-x","url":null,"abstract":"<p>The incidence of type 2 diabetes has risen globally, in parallel with the obesity epidemic and environments promoting a sedentary lifestyle and low-quality diet. There has been scrutiny of ultra-processed foods (UPFs) as a driver of type 2 diabetes, underscored by their increasing availability and intake worldwide, across countries of all incomes. This narrative review addresses the accumulated evidence from investigations of the trends in UPF consumption and the relationship with type 2 diabetes incidence. Hypotheses for why UPFs may be causally implicated in the initiation and progression of weight gain and suboptimal blood glucose levels are varied. There is also uncertainty and debate about whether detrimental effects of UPFs could be owing to additives and other features of industrial processing, independent of established dietary risk factors, namely added sugar, sodium, saturated fat and low fibre content. However, these current research gaps are addressable with rigorous research and coordinated efforts across nutrition-science domains; for example, the strengths of longitudinal cohort studies can be leveraged to refine the characterisation of key UPF subcategories within the enormous and diverse category of UPFs and ultra-processed beverages, and to identify high-risk patterns of intake that are related to the development of chronic-disease outcomes. The notable advantages of dietary intervention studies are the critical gains in the reliability of dietary assessments, and isolating the effects of individual UPF additives and features through carefully formulated diets. Research improving our understanding of the modifiable food environment, the diet’s causal drivers of weight gain and suboptimal cardiometabolic health, and the interactions among them, can be used to meaningfully shift the food supply for large-scale improvements in health. Thus, although the global market share of UPFs seems to outpace the research on its detrimental health effects, leaving the scientific community with the responsibility of generating proof, there may still be promising opportunities to reduce the burden of type 2 diabetes.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\u0000","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"20 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2025-01-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142988909","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-17DOI: 10.1007/s00125-024-06348-5
Ildiko Lingvay, Malik Benamar, Liming Chen, Ariel Fu, Esteban Jódar, Tomoyuki Nishida, Jean-Pierre Riveline, Daisuke Yabe, Thomas Zueger, Rosângela Réa
{"title":"Once-weekly IcoSema versus once-weekly semaglutide in adults with type 2 diabetes: the COMBINE 2 randomised clinical trial","authors":"Ildiko Lingvay, Malik Benamar, Liming Chen, Ariel Fu, Esteban Jódar, Tomoyuki Nishida, Jean-Pierre Riveline, Daisuke Yabe, Thomas Zueger, Rosângela Réa","doi":"10.1007/s00125-024-06348-5","DOIUrl":"https://doi.org/10.1007/s00125-024-06348-5","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Aims/hypothesis</h3><p>COMBINE 2 assessed the efficacy and safety of once-weekly IcoSema (a combination therapy of basal insulin icodec and semaglutide) vs once-weekly semaglutide (a glucagon-like peptide-1 analogue) 1.0 mg in individuals with type 2 diabetes inadequately managed with GLP-1 receptor agonist (GLP-1 RA) therapy, with or without additional oral glucose-lowering medications.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>This 52 week, randomised, multicentre, open-label, parallel group, Phase IIIa trial was conducted across 121 sites in 13 countries/regions. Adults with type 2 diabetes (HbA<sub>1c</sub> 53.0–85.8 mmol/mol [7.0–10.0%]) receiving GLP-1 RA therapy with or without additional oral glucose-lowering medications were randomly assigned 1:1 to once-weekly IcoSema or once-weekly semaglutide 1.0 mg. The primary endpoint was change in HbA<sub>1c</sub> from baseline to week 52; superiority of IcoSema to semaglutide 1.0 mg was assessed. Secondary endpoints included change in fasting plasma glucose and body weight (baseline to week 52), and combined clinically significant (level 2; <3.0 mmol/l) or severe (level 3; associated with severe cognitive impairment requiring external assistance for recovery) hypoglycaemia (baseline to week 57).</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Overall, 683 participants were randomised using a Randomisation and Trial Supply Management system to IcoSema (<i>n</i>=342) or semaglutide 1.0 mg (<i>n</i>=341). Mean ± SD baseline characteristics were as follows: HbA<sub>1c</sub> 64.0±8.2 mmol/mol (8.0±0.7%); diabetes duration 12.6±6.9 years; and BMI 31.1±4.7 kg/m<sup>2</sup>. From baseline to week 52, mean change in HbA<sub>1c</sub> was −14.7 mmol/mol (−1.35%-points) in the IcoSema group and −9.88 mmol/mol (−0.90%-points) in the semaglutide group; the estimated treatment difference (ETD) was –4.85 (95% CI −6.13, −3.57) mmol/mol (−0.44 [95% CI −0.56, −0.33]%-points), confirming superiority of IcoSema to semaglutide (<i>p</i><0.0001). The estimated mean change in fasting plasma glucose from baseline to week 52 was statistically significantly reduced with IcoSema vs semaglutide (−2.48 mmol/l vs −1.43 mmol/l, respectively; ETD −1.05 [95% CI −1.36, −0.75] mmol; <i>p</i><0.0001). Mean change in body weight from baseline to week 52 was statistically significantly different between groups: +0.84 kg for IcoSema vs −3.70 kg for semaglutide (ETD 4.54 kg [95% CI 3.84, 5.23]; <i>p</i><0.0001). There was no statistically significant difference in the rate of combined clinically significant or severe hypoglycaemia between IcoSema and semaglutide (0.042 vs 0.036 episodes per person-year of exposure; estimated rate ratio 1.20 [95% CI 0.53, 2.69]; <i>p</i>=0.66). The proportion of participants experiencing gastrointestinal adverse events was similar between treatment groups (IcoSema 31.4%; semaglutide 34.4%).</p><h3 data-test=\"abstract-sub-heading\">Conclu","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"20 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142987221","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-14DOI: 10.1007/s00125-024-06353-8
Zhangling Chen, Frank Qian, Binkai Liu, Geng Zong, Yanping Li, Frank B. Hu, Qi Sun
{"title":"Monounsaturated fatty acids from plant or animal sources and risk of type 2 diabetes in three large prospective cohorts of men and women","authors":"Zhangling Chen, Frank Qian, Binkai Liu, Geng Zong, Yanping Li, Frank B. Hu, Qi Sun","doi":"10.1007/s00125-024-06353-8","DOIUrl":"https://doi.org/10.1007/s00125-024-06353-8","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Aims/hypothesis</h3><p>Existing evidence on the relationship between intake of monounsaturated fatty acids (MUFAs) and type 2 diabetes is conflicting. Few studies have examined whether MUFAs from plant or animal sources (MUFA-Ps and MUFA-As, respectively) exhibit differential associations with type 2 diabetes. We examined associations of intakes of total MUFAs, MUFA-Ps and MUFA-As with type 2 diabetes risk.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We used data from 51,290 women in the Nurses’ Health Study (1990–2016), 61,703 women in the Nurses’ Health Study II (1991–2017) and 29,497 men in the Health Professionals Follow-up Study (1990–2016). Using food frequency questionnaires and food composition tables, we calculated MUFA-P and MUFA-A intakes every 4 years and modelled their associations with type 2 diabetes using Cox regression models.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>During 3,268,512 person-years of follow-up, we documented 13,211 incident type 2 diabetes cases. After multivariate adjustment, total MUFA intake was associated with higher type 2 diabetes risk, with HR for Q5 vs Q1 of 1.10 (95% CI 1.01, 1.22). MUFA-Ps and MUFA-As demonstrated divergent associations, with HRs of 0.87 (95% CI 0.81, 0.94) and 1.34 (1.23, 1.45), respectively. In substitution analyses, HRs were 0.92 (95% CI 0.86, 0.99) for replacing 2% of energy from trans fatty acids or 0.72 (0.66, 0.78) and 0.82 (0.77, 0.88) for replacing 5% from MUFA-As and 5% from the sum of saturated fatty acids and MUFA-As with MUFA-Ps, respectively. Substituting MUFA-As for saturated fatty acids and refined carbohydrates was associated with a 43% and 33% higher risk, respectively.</p><h3 data-test=\"abstract-sub-heading\">Conclusions/interpretation</h3><p>Higher intake of MUFA-Ps was associated with lower type 2 diabetes risk, whereas increased intake of MUFA-As was associated with higher risk. Replacing saturated fatty acids, trans fatty acids and MUFA-As with MUFA-Ps may be beneficial for type 2 diabetes prevention.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\u0000","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"36 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2025-01-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142974556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-08DOI: 10.1007/s00125-024-06351-w
Lorena S. Pacheco, Deirdre K. Tobias, Danielle E. Haslam, Jean-Philippe Drouin-Chartier, Yanping Li, Shilpa N. Bhupathiraju, Walter C. Willett, David S. Ludwig, Cara B. Ebbeling, Frank B. Hu, Marta Guasch-Ferré
{"title":"Sugar-sweetened or artificially sweetened beverage consumption, physical activity and risk of type 2 diabetes in US adults","authors":"Lorena S. Pacheco, Deirdre K. Tobias, Danielle E. Haslam, Jean-Philippe Drouin-Chartier, Yanping Li, Shilpa N. Bhupathiraju, Walter C. Willett, David S. Ludwig, Cara B. Ebbeling, Frank B. Hu, Marta Guasch-Ferré","doi":"10.1007/s00125-024-06351-w","DOIUrl":"https://doi.org/10.1007/s00125-024-06351-w","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Aims/hypothesis</h3><p>A positive association between sugar-sweetened beverages (SSBs) and diabetes risk has been shown, with inconsistent evidence between artificially sweetened beverages (ASBs) and diabetes. Moreover, it is uncertain if physical activity can mitigate the negative effects of these beverages on diabetes development. Therefore, we aimed to evaluate the independent and joint associations between SSB or ASB consumption and physical activity on the risk of type 2 diabetes.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We followed 64,029 women in the Nurses’ Health Study (1980–2016), 88,340 women in the Nurses’ Health Study II (1991–2017) and 39,436 men in the Health Professionals Follow-up Study (1986–2016). SSB and ASB consumption was calculated from food-frequency questionnaires administered every 4 years, while physical activity data were collected biennially. A validated supplementary questionnaire on diabetes symptoms, diagnostic tests and treatment confirmed type 2 diabetes cases. Multivariable Cox proportional hazards regression models were used to calculate HRs and 95% CIs for developing type 2 diabetes.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>During 5,105,351 person-years of follow-up, we recorded 19,940 new cases of type 2 diabetes. Compared with those who never or rarely consumed SSBs or ASBs, those who consumed ≥2 servings/day had a 41% (HR 1.41 [95% CI 1.33, 1.50]) and 11% (HR 1.11 [95% CI 1.07, 1.16]) higher risk of type 2 diabetes, respectively. For participants meeting physical activity guidelines (≥7.5 metabolic equivalent of task [MET] h/week) and consuming ≥2 servings/week of SSBs or ASBs, the risk was 22% (HR 1.22 [95% CI 1.15, 1.29]) and 7% (HR 1.07 [95% CI 1.02, 1.12]) higher, respectively, compared with those who met physical activity guidelines and never or rarely (<1 serving/month) consumed these beverages. For participants meeting the physical activity guidelines and consuming 1–4 servings/month of SSBs, there was a 9% (HR 1.09 [95% CI 1.02, 1.15]) higher risk of type 2 diabetes. Compared with the reference group (those who met physical activity guidelines and consumed <1 SSB serving/month), adults who did not meet physical activity guidelines (<7.5 MET h/week) and who never or rarely (<1 serving/month) consumed SSBs, had 1–4 SSB servings/month, or had ≥2 SSB servings/week, the HRs (95% CIs) were 1.22 (1.13, 1.31), 1.28 (1.20, 1.37), and 1.51 (1.43, 1.61), respectively. Similarly, for ASB consumption, adults who did not meet physical activity guidelines and who never or rarely (<1 serving/month) consumed ASBs, had 1–4 servings/month, or had ≥2 servings/week, the HRs (95% CIs) were 1.21 (1.14, 1.28), 1.21 (1.13, 1.30), and 1.30 (1.23, 1.37) compared with the reference group (who met physical activity guidelines and consumed <1 ASB serving/month).</p><h3 data-test=\"abstract-sub-heading\">Conclusions/interpretation</h3><p>Even when in","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"133 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2025-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142935822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-04DOI: 10.1007/s00125-024-06346-7
Leon Hirvelä, Jari Haukka, Anna Keski-Rahkonen, Pyry N. Sipilä
{"title":"Eating disorders among people with and without type 1 diabetes: incidence and treatment in a nationwide population-based cohort","authors":"Leon Hirvelä, Jari Haukka, Anna Keski-Rahkonen, Pyry N. Sipilä","doi":"10.1007/s00125-024-06346-7","DOIUrl":"https://doi.org/10.1007/s00125-024-06346-7","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Aims/hypothesis</h3><p>Eating disorders are over-represented in type 1 diabetes and are associated with an increased risk of complications, but it is unclear whether type 1 diabetes affects the treatment of eating disorders. We assessed incidence and treatment of eating disorders in a nationwide sample of individuals with type 1 diabetes and diabetes-free control individuals.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Our study comprised 11,055 individuals aged <30 who had been diagnosed with type 1 diabetes in 1998–2010, and 11,055 diabetes-free control individuals matched for age, sex and hospital district. We ascertained incidence of eating disorders from hospital records using Poisson regression. Eating disorder treatment was assessed by new prescriptions for psychotropic medications and hospital treatment for eating disorders.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>During a mean follow-up of 13.1 years, there were 175 incident cases of eating disorders among individuals with type 1 diabetes and 75 among the control individuals (adjusted incidence rate ratio 2.35; 95% CI 1.80, 3.09). The prescription of psychotropic medications was similar among eating disorder patients with and without type 1 diabetes. However, those with type 1 diabetes received outpatient hospital treatment for their eating disorder less often than those without diabetes (mean 3.32 vs 5.33 outpatient care visits per year [adjusted difference 1.24; 95% CI 0.39, 2.08]).</p><h3 data-test=\"abstract-sub-heading\">Conclusions/interpretation</h3><p>People with type 1 diabetes are more likely to be diagnosed with eating disorders than their diabetes-free peers. However, they receive less outpatient hospital treatment for their eating disorders despite their greater risk for major adverse health outcomes. These findings emphasise the need for targeted eating disorder treatment for people with type 1 diabetes.</p><h3 data-test=\"abstract-sub-heading\">Graphical Abstract</h3>\u0000","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":"24 1","pages":""},"PeriodicalIF":8.2,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142925120","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Addressing methodological considerations in the assessment of the effect of SGLT2 inhibitors and GLP-1 receptor agonists on risk of diabetic eye complications.","authors":"Yi-Hsuan Tsai, Nefertiti OjiNjideka Hemphill, Tobias Kurth","doi":"10.1007/s00125-024-06300-7","DOIUrl":"10.1007/s00125-024-06300-7","url":null,"abstract":"","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"247-248"},"PeriodicalIF":8.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-01Epub Date: 2024-10-29DOI: 10.1007/s00125-024-06311-4
Philip J G M Voets
{"title":"A modified total body water deficit formula for use in diabetes care.","authors":"Philip J G M Voets","doi":"10.1007/s00125-024-06311-4","DOIUrl":"10.1007/s00125-024-06311-4","url":null,"abstract":"","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"243-244"},"PeriodicalIF":8.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544320","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-01Epub Date: 2024-10-30DOI: 10.1007/s00125-024-06290-6
Pernille E Hostrup, Tobias Schmidt, Simon B Hellsten, Rebekka H Gerwig, Joachim Størling, Jesper Johannesen, Karolina Sulek, Morten Hostrup, Henrik U Andersen, Karsten Buschard, Yasmin Hamid, Flemming Pociot
{"title":"Effect of fenofibrate on residual beta cell function in adults and adolescents with newly diagnosed type 1 diabetes: a randomised clinical trial.","authors":"Pernille E Hostrup, Tobias Schmidt, Simon B Hellsten, Rebekka H Gerwig, Joachim Størling, Jesper Johannesen, Karolina Sulek, Morten Hostrup, Henrik U Andersen, Karsten Buschard, Yasmin Hamid, Flemming Pociot","doi":"10.1007/s00125-024-06290-6","DOIUrl":"10.1007/s00125-024-06290-6","url":null,"abstract":"<p><strong>Aims/hypothesis: </strong>Fenofibrate, a peroxisome proliferator-activated receptor alpha agonist, shows some promise in alleviating beta cell stress and preserving beta cell function in preclinical studies of type 1 diabetes. The aim of this phase 2, placebo-controlled, double-blinded, randomised clinical trial was to investigate the efficacy and safety of fenofibrate in adults and adolescents with newly diagnosed type 1 diabetes.</p><p><strong>Methods: </strong>We enrolled 58 individuals (aged 16 to 40 years old) with newly diagnosed type 1 diabetes and randomised them to daily oral treatment with fenofibrate 160 mg or placebo for 52 weeks (in a block design with a block size of 4, assigned in a 1:1 ratio). Our primary outcome was change in beta cell function after 52 weeks of treatment, assessed by AUC for C-peptide levels following a 2 h mixed-meal tolerance test. Secondary outcomes included glycaemic control (assessed by HbA<sub>1c</sub> and continuous glucose monitoring), daily insulin use, and proinsulin/C-peptide (PI/C) ratio as a marker of beta cell stress. We assessed outcome measures before and after 4, 12, 26 and 52 weeks of treatment. Blinding was maintained for participants, their healthcare providers and all staff involved in handling outcome samples and assessment.</p><p><strong>Results: </strong>The statistical analyses for the primary outcome included 56 participants (n=27 in the fenofibrate group, after two withdrawals, and n=29 in the placebo group). We found no significant differences between the groups in either 2 h C-peptide levels (mean difference of 0.08 nmol/l [95% CI -0.05, 0.23]), insulin use or glycaemic control after 52 weeks of treatment. On the contrary, the fenofibrate group showed a higher PI/C ratio at week 52 compared with placebo (mean difference of 0.024 [95% CI 0.000, 0.048], p<0.05). Blood lipidome analysis revealed that fenofibrate repressed pathways involved in sphingolipid metabolism and signalling at week 52 compared with placebo. The 52 week intervention evoked few adverse events and no serious adverse events. Follow-up in vitro experiments in human pancreatic islets demonstrated a stress-inducing effect of fenofibrate.</p><p><strong>Conclusions/interpretation: </strong>Contrary to the beneficial effects of fenofibrate found in preclinical studies, this longitudinal, randomised, placebo-controlled trial does not support the use of fenofibrate for preserving beta cell function in individuals with newly diagnosed type 1 diabetes.</p><p><strong>Trial registration: </strong>EudraCT number: 2019-004434-41 FUNDING: This study was funded by the Sehested Hansens Foundation.</p>","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"29-40"},"PeriodicalIF":8.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11663161/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142544323","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-01Epub Date: 2024-10-04DOI: 10.1007/s00125-024-06284-4
Antonio Ceriello, Francesco Prattichizzo, Cesare Berra
{"title":"Is glycaemic control still central in the hierarchy of priorities in type 2 diabetes management? The way forward is to combine glucose control and the prevention of cardiorenal complications.","authors":"Antonio Ceriello, Francesco Prattichizzo, Cesare Berra","doi":"10.1007/s00125-024-06284-4","DOIUrl":"10.1007/s00125-024-06284-4","url":null,"abstract":"","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"245-246"},"PeriodicalIF":8.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
DiabetologiaPub Date : 2025-01-01Epub Date: 2024-11-04DOI: 10.1007/s00125-024-06295-1
Gillian L Garden, Ka Siu Fan, Megan Paterson, Fariba Shojaee-Moradie, Monique Borg Inguanez, Antonios Manoli, Victoria Edwards, Vivienne Lee, Brian M Frier, Ewan J Hutchison, Declan Maher, Chantal Mathieu, Stuart J Mitchell, Simon R Heller, Graham A Roberts, Kenneth M Shaw, Gerd Koehler, Julia K Mader, Bruce R King, David L Russell-Jones
{"title":"Effects of atmospheric pressure change during flight on insulin pump delivery and glycaemic control of pilots with insulin-treated diabetes: an in vitro simulation and a retrospective observational real-world study.","authors":"Gillian L Garden, Ka Siu Fan, Megan Paterson, Fariba Shojaee-Moradie, Monique Borg Inguanez, Antonios Manoli, Victoria Edwards, Vivienne Lee, Brian M Frier, Ewan J Hutchison, Declan Maher, Chantal Mathieu, Stuart J Mitchell, Simon R Heller, Graham A Roberts, Kenneth M Shaw, Gerd Koehler, Julia K Mader, Bruce R King, David L Russell-Jones","doi":"10.1007/s00125-024-06295-1","DOIUrl":"10.1007/s00125-024-06295-1","url":null,"abstract":"<p><strong>Aims/hypothesis: </strong>Glycaemic control and clinical outcomes in diabetes are improved by continuous subcutaneous insulin infusion (CSII). Atmospheric pressure changes during flights may affect insulin delivery from pumps and cause unintended metabolic consequences, including hypoglycaemia, in people with type 1 diabetes. The present report evaluates both hypobaric flight simulation and real-world data in pilots using insulin pumps while flying.</p><p><strong>Methods: </strong>In the flight simulation part of this study, an in vitro study of insulin pumps was conducted in a hypobaric chamber, de-pressurised to 550 mmHg to mimic the atmospheric pressure changes in airliner cabins during commercial flights. Insulin delivery rates and bubble formation were recorded for standard flight protocol. Insulin infusion sets, without pumps, were tested in a simulated rapid decompression scenario. The real-world observational study was a 7.5-year retrospective cohort study in which pre- and in-flight self-monitored blood glucose (SMBG) values were monitored in pilots with insulin-treated diabetes. Commercial and private pilots granted a medical certificate to fly within the European Union Aviation Safety Agency approved protocol and receiving insulin either by pump or multiple daily injections (MDI) were included.</p><p><strong>Results: </strong>In the flight simulation study, full cartridges over-delivered 0.60 U of insulin during a 20 min ascent and under-delivered by 0.51 U during descent compared with ground-level performance. During emergency rapid decompression, 5.6 U of excess insulin was delivered. In the real-world study, seven pilots using CSII recorded 4656 SMBG values during 2345 h of flying across 1081 flights. Only 33 (0.7%) values were outside an acceptable safe range (5.0-15.0 mmol/l [90-270 mg/dl]). No clinically significant fall in the median SMBG concentration was observed after aircraft ascent and no in-flight SMBG values were within the hypoglycaemic range (<4.0 mmol/l [<72 mg/dl]). Compared with pilots receiving MDI therapy, pilots using CSII recorded more SMBG values within the acceptable range (99.3% vs 97.5%), fewer values in the low red range (0.02% vs 0.1%), fewer in-flight out-of-range values (0.2% vs 1.3%) and maintained stricter glycaemic control during flight.</p><p><strong>Conclusions/interpretation: </strong>Ambient pressure reduction during simulated flights results in bubble formation and expansion within insulin cartridges. This causes unintended delivery of small insulin doses independent of pre-determined delivery rates and represents the maximum amount of insulin that could be delivered and retracted. However, in vivo, pilots using CSII in-flight did not experience a fall in blood glucose or episodes of hypoglycaemia during these atmospheric pressure changes and the use of insulin pumps can be endorsed in view of their clinical benefits.</p>","PeriodicalId":11164,"journal":{"name":"Diabetologia","volume":" ","pages":"52-68"},"PeriodicalIF":8.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11663189/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142575195","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}