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1. Skin manifestations in rare types of diabetes and other endocrine conditions

Author

Felix Reschke, Torben Biester, Thekla von dem Berge, Dagmar Jamiolkowski, Laura Hasse, Francesca Dassie, Pietro Maffei, Katharina Klee, Olga Kordonouri, Hagen Ott, and Thomas Danne

Subjects
rare types of diabetes, rare endocrinopathies, cutaneous effects of rare diabetes, rare dermatologic changes in endocrine disorders, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

As the most visible and vulnerable organ of the human organism, the skin can provide an impression of its state of health. Rare forms of diabetes and endocrinopathies are often diagnosed late or primarily misinterpreted due to their rarity. Skin peculiarities associated with these rare diseases may be indicative of the underlying endocrinopathy or form of diabetes. At the same time, rare skin changes in diabetes or endocrinopathies can also be a major challenge for dermatologists, diabetologists and endocrinologists in optimal patient and therapy management. Active collaboration between these different specialist groups can therefore lead to increased patient safety, better therapeutic success and more targeted diagnostics.

Published
2023
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2. An analysis of DPV and DIVE registry patients with chronic kidney disease according to the finerenone phase III clinical trial selection criteria

Author

Peter Bramlage, Stefanie Lanzinger, Steffen Mühldorfer, Karsten Milek, Anton Gillessen, Roman Veith, Tobias Ohde, Thomas Danne, Reinhard W. Holl, and Jochen Seufert

Subjects
Diabetes, Diabetic kidney disease, Hypertension, Chronic kidney disease, Glomerular filtration rate, Albuminuria, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background The FIDELIO-DKD and FIGARO-DKD randomized clinical trials (RCTs) showed finerenone, a novel non-steroidal mineralocorticoid receptor antagonist (MRA), reduced the risk of renal and cardiovascular events in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). Using RCT inclusion and exclusion criteria, we analyzed the RCT coverage for patients with T2DM and CKD in routine clinical practice in Germany. Methods German patients from the DPV/DIVE registries who were ≥ 18 years, had T2DM and CKD (an estimated glomerular filtration rate [eGFR]

Published
2023
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3. Gene expression signature predicts rate of type 1 diabetes progressionResearch in context

Author

Tomi Suomi, Inna Starskaia, Ubaid Ullah Kalim, Omid Rasool, Maria K. Jaakkola, Toni Grönroos, Tommi Välikangas, Caroline Brorsson, Gianluca Mazzoni, Sylvaine Bruggraber, Lut Overbergh, David Dunger, Mark Peakman, Piotr Chmura, Søren Brunak, Anke M. Schulte, Chantal Mathieu, Mikael Knip, Riitta Lahesmaa, Laura L. Elo, Pieter Gillard, Kristina Casteels, Lutgart Overbergh, Chris Wallace, Mark Evans, Ajay Thankamony, Emile Hendriks, Loredana Marcoveccchio, Timothy Tree, Noel G. Morgan, Sarah Richardson, John A. Todd, Linda Wicker, Adrian Mander, Colin Dayan, Mohammad Alhadj Ali, Thomas Pieber, Decio L. Eizirik, Myriam Cnop, Flemming Pociot, Jesper Johannesen, Peter Rossing, Cristina Legido Quigley, Roberto Mallone, Raphael Scharfmann, Christian Boitard, Timo Otonkoski, Riitta Veijola, Matej Oresic, Jorma Toppari, Thomas Danne, Anette G. Ziegler, Peter Achenbach, Teresa Rodriguez-Calvo, Michele Solimena, Ezio E. Bonifacio, Stephan Speier, Reinhard Holl, Francesco Dotta, Francesco Chiarelli, Piero Marchetti, Emanuele Bosi, Stefano Cianfarani, Paolo Ciampalini, Carine De Beaufort, Knut Dahl-Jørgensen, Torild Skrivarhaug, Geir Joner, Lars Krogvold, Przemka Jarosz-Chobot, Tadej Battelino, Bernard Thorens, Martin Gotthardt, Bart O. Roep, Tanja Nikolic, Arnaud Zaldumbide, Ake Lernmark, Marcus Lundgren, Guillaume Costacalde, Thorsten Strube, Almut Nitsche, Jose Vela, Matthias Von Herrath, Johnna Wesley, Antonella Napolitano-Rosen, Melissa Thomas, Nanette Schloot, Allison Goldfine, Frank Waldron-Lynch, Jill Kompa, Aruna Vedala, Nicole Hartmann, Gwenaelle Nicolas, Jean van Rampelbergh, Nicolas Bovy, Sanjoy Dutta, Jeannette Soderberg, Simi Ahmed, Frank Martin, Esther Latres, Gina Agiostratidou, Anne Koralova, Ruben Willemsen, Anne Smith, Binu Anand, Vipan Datta, Vijith Puthi, Sagen Zac-Varghese, Renuka Dias, Premkumar Sundaram, Bijay Vaidya, Catherine Patterson, Katharine Owen, Barbara Piel, Simon Heller, Tabitha Randell, Tasso Gazis, Elise Bismuth Reismen, Jean-Claude Carel, Jean-Pierre Riveline, Jean-Francoise Gautier, Fabrizion Andreelli, Florence Travert, Emmanuel Cosson, Alfred Penfornis, Catherine Petit, Bruno Feve, Nadine Lucidarme, Jean-Paul Beressi, Catherina Ajzenman, Alina Radu, Stephanie Greteau-Hamoumou, Cecile Bibal, Thomas Meissner, Bettina Heidtmann, Sonia Toni, Birgit Rami-Merhar, Bart Eeckhout, Bernard Peene, N. Vantongerloo, Toon Maes, and Leen Gommers

Subjects
Type 1 diabetes, Autoantibodies, RNA-seq, Gene expression signature, Predictive model, Medicine, Medicine (General), R5-920
Abstract

Summary: Background: Type 1 diabetes is a complex heterogenous autoimmune disease without therapeutic interventions available to prevent or reverse the disease. This study aimed to identify transcriptional changes associated with the disease progression in patients with recent-onset type 1 diabetes. Methods: Whole-blood samples were collected as part of the INNODIA study at baseline and 12 months after diagnosis of type 1 diabetes. We used linear mixed-effects modelling on RNA-seq data to identify genes associated with age, sex, or disease progression. Cell-type proportions were estimated from the RNA-seq data using computational deconvolution. Associations to clinical variables were estimated using Pearson's or point-biserial correlation for continuous and dichotomous variables, respectively, using only complete pairs of observations. Findings: We found that genes and pathways related to innate immunity were downregulated during the first year after diagnosis. Significant associations of the gene expression changes were found with ZnT8A autoantibody positivity. Rate of change in the expression of 16 genes between baseline and 12 months was found to predict the decline in C-peptide at 24 months. Interestingly and consistent with earlier reports, increased B cell levels and decreased neutrophil levels were associated with the rapid progression. Interpretation: There is considerable individual variation in the rate of progression from appearance of type 1 diabetes-specific autoantibodies to clinical disease. Patient stratification and prediction of disease progression can help in developing more personalised therapeutic strategies for different disease endotypes. Funding: A full list of funding bodies can be found under Acknowledgments.

Published
2023
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4. Mini conference: Current and potential future treatment options for children in different stages of type 1 diabetes. Update on new therapies for pediatric diabetes

Author

Thomas Danne

Subjects
diabetes, pediatría, Nutritional diseases. Deficiency diseases, RC620-627, Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

There is considerable heterogeneity within the clinical phenotype of type 1 diabetes: genetic susceptibility is complex, progression rates differ markedly, as does the efficacy of therapeutic interventions. New prevention strategies should use biomarkers to lead to personalized combination therapies analogous to the approach used in pediatric oncology. It is well known that type 1 diabetes starts with autoimmunity, the detection of 2 or more persistent diabetes-associated antibodies (stage 1). Additional subclinical dysglycemia is termed stage 2, and manifest type 1 diabetes is termed stage 3. Both genetic and immunologic parameters allow early detection in children and adolescents. Because 9 out of 10 affected children come from families without other family members with type 1 diabetes, screening approaches provide an opportunity for preservation of residual insulin-producing beta cell function. Studies of the psychological burden of screening procedures and results showed that the vast majority of families were able to live relatively unburdened by the knowledge of their child's increased diabetes risk after a short period of time. The GPPAD research network is investigating primary prevention with oral insulin (POINT study) or probiotics (S1NTIA study). The European research network INNODIA is developing a standardized study protocol ("master protocol") to accelerate the investigation of new single agents and combination therapies from the age of 5 years. Secondary prevention approaches are showing promising results in initial pilot studies to prolong the remission phase or delay disease onset in at-risk populations. Intensified insulin therapy with differential substitution of basal- and bolus insulin is the gold standard also for children with type 1 diabetes. The different absorption profiles and half-lives of insulin preparations allow insulin therapy to be tailored for the individual patient. Ultra-rapid insulin analogues show improved postprandial glucose levels, while second-generation basal analogues are associated with less hypoglycemia and reduced events of hyperglycemia and ketosis as a surrogate marker of a high risk for DKA. New parameters like time in range and time below range suitable for identifying high glycemic variability as risk factor for severe hypoglycemia complement the HbA1c targets and the ambulatory glucose profile in a shared decision making on therapeutic adjustments between the diabetes team and families with a child with diabetes. Automated insulin delivery as a hybrid closed loop or dosing advice using artificial intelligence are becoming a clinical reality. However, diabetes education as a team approach, defining clear targets with outcomes evaluated in multinational registries like SWEET remain important for shaping the future of pediatric diabetology.

Published
2021
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5. Alterations in Dietary Behavior, Appetite Regulation, and Health-Related Quality of Life in Youth with Obesity in Germany during the COVID-19 Pandemic

Author

Nora Struckmeyer, Torben Biester, Olga Kordonouri, Chantal Weiner, Evelin Sadeghian, Cathrin Guntermann, Kerstin Kapitzke, Jantje Weiskorn, Laura Galuschka, Kisa von Stuelpnagel, Daniela Meister, Karin Lange, Thomas Danne, and Felix Reschke

Subjects
nutritional content, hunger control, children with overweight, life quality, eating habits, SARS-CoV-2, Nutrition. Foods and food supply, TX341-641
Abstract

Background: This study aimed to evaluate the impact of the COVID-19 pandemic on the nutritional patterns, eating behavior, dietary content, and health-related quality of life (HrQoL) of adolescents with preexisting obesity. Methods: Anthropometric and metabolic parameters were measured, and validated questionnaires on eating habits, nutritional content, and HrQoL were administered to 264 adolescents with obesity during the COVID-19 pandemic (June 2020–June 2022) and 265 adolescents with obesity before the pandemic (from June 2017 to June 2019). Results: Both study cohorts were comparable in age and sex distribution. Significant differences were found between the COVID-19 and pre-COVID-19 cohorts in HOMA-index (3.8 (interquartile range [IQR])): 3.3; 4.1) vs. 3.2 (IQR: 2.8; 3.5, p < 0.001), total cholesterol (208.8 mg/dL (IQR: 189.9; 214.5) vs. 198.5 mg/dL (IQR: 189.5; 207.4), p < 0.001), and GPT (93.4 (IQR 88.7; 96.5) vs. 72.8 U/L (IQR 68.9; 75.7), p < 0.001). The COVID-19 cohort reported significantly higher consumption of obesity-promoting food components, such as soft drinks, meat, sausages, fast food and delivery food, chocolate, and sweets. There was also a significant decrease in cognitive hunger control (p = 0.002) and an increase in distractibility potential (p = 0.001) while eating. HrQoL was significantly lower in the COVID-19 cohort (p = 0.001). Conclusions: This study reveals the adverse associations of exposure to the public health measures during the COVID-19 pandemic with nutrition, dietary content, and HrQoL in adolescents with preexisting obesity. These findings underscore the importance of tailored preventive and treatment strategies for addressing the specific challenges of disruptive events such as pandemics, especially in population-based context.

Published
2023
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6. Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300)

Author

Peter Bramlage, Thomas Danne, Julia K Mader, Stefan Gölz, and Stefan Bilz

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Short-term glycemic variability is associated with the risk of hypoglycemia and hyperglycemia in people living with type 1 diabetes and can potentially affect clinical outcomes. Continuous glucose monitoring (CGM) is of increasing importance to evaluate glycemic variability in greater detail. Specific metrics for assessing glycemic variability were proposed, such as the SD of mean glucose level and associated coefficient of variation, and time in target glucose range to guide study designs, therapy and allow people with diabetes more transparency in interpreting their own CGM data. Randomized controlled trials (RCT) and real-world evidence provide complementary information about the efficacy/effectiveness and safety of interventions. Insulin glargine 300 U/mL (Gla-300) has a longer lasting and less variable action than insulin glargine U100 (Gla-100) with a lower risk of hypoglycemia. While insulin degludec U100 (iDeg-100) was associated with lower glucose values but more time below range in one randomized study compared with Gla-300, Gla-300 was associated with a higher per cent time in range, but also above the therapeutic range. However, a real-world study did not find differences during the day between Gla-300 and iDeg-100. The upcoming InRange RCT is the first head-to-head comparison of Gla-300 with iDeg-100 using CGM in an international population using CGM metrics as the primary endpoint. The non-interventional COMET-T real-world study will determine the real-world effectiveness of Gla-300 using CGM metrics and cover a broad spectrum of clinical practice decisions irrespective of the prior basal insulin.

Published
2022
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7. Guidelines adherence in the prevention and management of chronic kidney disease in patients with diabetes mellitus on the background of recent European recommendations – a registry-based analysis

Author

Peter Bramlage, Stefanie Lanzinger, Sascha R. Tittel, Eva Hess, Simon Fahrner, Christoph H. J. Heyer, Mathias Friebe, Ivo Buschmann, Thomas Danne, Jochen Seufert, and Reinhard W. Holl

Subjects
diabetes, hypertension, chronic kidney disease, glomerular filtration rate, albuminuria, diagnostics, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Background Recent European Society of Cardiology (ESC)/European Association for the Study of Diabetes (EASD) guidelines provide recommendations for detecting and treating chronic kidney disease (CKD) in diabetic patients. We compared clinical practice with guidelines to determine areas for improvement. Methods German database analysis of 675,628 patients with type 1 or type 2 diabetes, with 134,395 included in this analysis. Data were compared with ESC/EASD recommendations. Results This analysis included 17,649 and 116,747 patients with type 1 and type 2 diabetes, respectively. The analysis showed that 44.1 and 49.1 % patients with type 1 and type 2 diabetes, respectively, were annually screened for CKD. Despite anti-diabetic treatment, only 27.2 % patients with type 1 and 43.5 % patients with type 2 achieved a target HbA1c of 65 years). Renin angiotensin aldosterone inhibitors were used in 24.0 and 40.9 % patients with type 1 diabetes (micro- vs. macroalbuminuria) and 39.9 and 47.7 %, respectively, in type 2 diabetes. Conclusions Data indicate there is room for improvement in caring for diabetic patients with respect to renal disease diagnosis and treatment. While specific and potentially clinically justified reasons for non-compliance exist, the data may serve well for a critical appraisal of clinical practice decisions.

Published
2021
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8. Renal function deterioration in adult patients with type-2 diabetes

Author

Peter Bramlage, Stefanie Lanzinger, Eva Hess, Simon Fahrner, Christoph H. J. Heyer, Mathias Friebe, Ivo Buschmann, Thomas Danne, Reinhard W. Holl, and Jochen Seufert

Subjects
Type 2 diabetes, Chronic kidney disease, eGFR slope, Hypertension, Dyslipidemia, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Abstract Background To explore, in a large group of patients with type-2 diabetes (T2DM), renal function decline in terms of the slope of the estimated glomerular filtration rate (eGFR) over time, and to find out how classical risk factors, such as the presence of hypertension, dyslipidemia and microalbuminuria, affect the renal function. Methods The analysis included 32,492 adult T2DM patients from the DIVE/DPV registries who had serial eGFR determinations and information on the presence of microalbuminuria, hypertension and dyslipidemia available. Results Patients had a mean age of 66.3 years, 52.6% were male with a mean BMI of 31.7 kg/m2. The mean eGFR was 78.4 ± 21.4 mL/min/1.73m2. The results showed that the prevalence of renal function impairment understood as chronic kidney disease (CKD) is considerable (53.0%) in a population of patients with T2DM and has a high incidence rate of 6.6% within a year. Serial determinations of the eGFR are, however, infrequent (7.8% of all patients) and these patients are characterised by the presence of a high-risk profile for CKD, such as hypertension (88.1%) and dyslipidemia (66.1%). Over a three-year time period, 30.9% of the patients had an eGFR slope of -12 mL/min/1.73m2 or more; and more than a doubled proportion of patients with an eGFR

Published
2020
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9. Supplementation with Bifidobacterium longum subspecies infantis EVC001 for mitigation of type 1 diabetes autoimmunity: the GPPAD-SINT1A randomised controlled trial protocol

Author

Matthew D Snape, Melanie Gündert, Anette-Gabriele Ziegler, Peter Achenbach, Reinhard Berner, Kristina Casteels, Thomas Danne, Joerg Hasford, Olga Kordonouri, Karin Lange, Helena Elding Larsson, Markus Lundgren, Agnieszka Szypowska, John A Todd, Ezio Bonifacio, Nicole Zubizarreta, Christiane Winkler, Åke Lernmark, Daniel Agardh, Cigdem Gezginci, Claudia Ramminger, Marlon Scholz, Katharina Warncke, Carin Andrén Aronsson, Rasmus Bennet, Lina Fransson, Zeliha Mestan, Caroline Nilsson, Anita Ramelius, Carina Törn, Sarah Hogg, Catherine Owen, Lidia Groele, Florian Haupt, Claudia Matzke, Robin Assfalg, Matthew Snape, Felix Reschke, Marcin L Pekalski, Andreas Weiss, Andrew Johnston, Manja Jolink, Loredana Marcovecchio, Mariusz Ołtarzewski, Stefanie Arnolds, Annika Kölln, Markus Pfirrmann, Corinna Barz, Karina Blasius, Nadine Friedl, Adriano Gomez-Bantel, Martin Heigermoser, Bianca Höfelschweiger, Nadine Klein, Ramona Lickert, Rebecca Niewöhner, Katharina Schütte-Borkovec, Mira Taulien, Lara Vogel, Franziska Voß, José Maria Zapardiel Gonzalo, Philipp Sifft, Heidi Kapfelsberger, Merve Vurucu, Katharina Sarcletti, Stefanie Jacobson, Yulia Grinin, John A. Todd, Anette-G. Ziegler, Marcin L. Pekalski, Anette G. Ziegler, Annre Rochtus, An Jacobs, Hilde Morobé, Jasmin Paulus, Brontë Vrancken, Natalie Van den Driessche, Renka Van Heyste, Janne Houben, Veerle Vanhuyse, Sevina Dietz, Gita Gemulla, Manja Gottschalk-Schwarz, Sophie Heinke, Angela Hommel, Susann Kowal, Fabian Lander, Robert Morgenstern, Marc Weigelt, Sari Arabi, Raphael Hoffmann, Ruth Blechschmidt, Franziska Ehrlich, Anja Loff, Laura Galuschka, Ute Holtkamp, Nils Janzen, Sarah Landsberg, Erika Marquardt, Frank Roloff, Kerstin Semler, Thekla von dem Berge, Melanie Bunk, Simone Färber-Meisterjahn, Willi Grätz, Ines Greif, Melanie Herbst, Anna Hofelich, Benjamin Marcus, Annette Munzinger, Jasmin Ohli, Franziska Reinmüller, Tiziana Welzhofer, Sylwia Dybkowska, Katarzyna Dżygało, Dorota Owczarek, Katarzyna Popko, Agnieszka Skrobot, Anna Taczanowska, Beata Zduńczyk, Charlotte Brundin, Ida Jönsson, Sara Maroufkhani, Evelyn Tekum Amboh, Katarzyna Gajewska-Knapik, Elena Romero, Suzannah Twiss, Helen Gallon, Laura Gebbie, Fiona Jenkinson, Steven Pratt, Steve Robson, Claire Simmister, Evelyn Thomson, and Eileen Walton

Subjects
Medicine
Abstract

Introduction The Global Platform for the Prevention of Autoimmune Diabetes-SINT1A Study is designed as a randomised, placebo-controlled, double-blind, multicentre, multinational, primary prevention study aiming to assess whether daily administration of Bifidobacterium infantis from age 7 days to 6 weeks until age 12 months to children with elevated genetic risk for type 1 diabetes reduces the cumulative incidence of beta-cell autoantibodies in childhood.Methods and analysis Infants aged 7 days to 6 weeks from Germany, Poland, Belgium, UK and Sweden are eligible for study participation if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies by age 6 years as determined by genetic risk score or family history and HLA genotype. Infants are randomised 1:1 to daily administration of B. infantis EVC001 or placebo until age 12 months and followed for a maximum of 5.5 years thereafter. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies. Secondary outcomes are (1) Any persistent confirmed beta-cell autoantibody, defined as at least one confirmed autoantibody in two consecutive samples, including insulin autoantibodies, glutamic acid decarboxylase, islet tyrosine phosphatase 2 or zinc transporter 8, (2) Diabetes, (3) Transglutaminase autoantibodies associated with coeliac disease, (4) Respiratory infection rate in first year of life during supplementation and (5) Safety. Exploratory outcomes include allergy, antibody response to vaccines, alterations of the gut microbiome or blood metabolome, stool pH and calprotectin.Ethics and dissemination The study was approved by the local ethical committees of the Technical University Munich, Medical Faculty, the Technische Universität Dresden, the Medizinische Hochschule Hannover, the Medical University of Warsaw, EC Research UZ Leuven and the Swedish ethical review authority. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the study.Trial registration number NCT04769037.

Published
2021
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10. Patient and disease characteristics of type-2 diabetes patients with or without chronic kidney disease: an analysis of the German DPV and DIVE databases

Author

Peter Bramlage, Stefanie Lanzinger, Gesine van Mark, Eva Hess, Simon Fahrner, Christoph H. J. Heyer, Mathias Friebe, Jochen Seufert, Thomas Danne, and Reinhard W. Holl

Subjects
Type-2-diabetes, Chronic kidney disease, DPV, DIVE, Patient characteristics, Disease characteristics, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Abstract Background To evaluate the characteristics of type 2 diabetes (T2DM) patients with or without chronic kidney disease (CKD) in Germany. Methods Using combined DPV/DIVE registry data, the analysis included patients with T2DM at least ≥ 18 years old who had an estimated glomerular filtration rate (eGFR) value available. CKD was defined as an eGFR 5.5 mmol/L: 3.7% vs. 1.0%). Comorbidities were more common among CKD patients (p

Published
2019
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11. Efficacy and safety of the SGLT2 inhibitor empagliflozin versus placebo and the DPP-4 inhibitor linagliptin versus placebo in young people with type 2 diabetes (DINAMO): a multicentre, randomised, double-blind, parallel group, phase 3 trial

Author

Lori M Laffel, Thomas Danne, Georgeanna J Klingensmith, William V Tamborlane, Steven Willi, Philip Zeitler, Dietmar Neubacher, Jan Marquard, Tatiana Bardymova, Margarita Barrientos Perez, Kathleen Bethin, Petter Bjornstad, Irina Bondar, Mimi Chen, Jin-Ho Choi, Mark A Clements, Javier Ricardo Colomar, Mark Daniels, Chaicharn Deerochanawong, Vivek S Desai, Jean-Claude G Desmangles, Robert G Dillon, Naznin M Dixit, Hongwei Du, Rachel Edelen, Diego Espinoza Peralta, María Verónica Felipe Gacioppo, Tania Maria Bulcão Lousada Ferraz, Galina Galkina, Mary Patricia Gallagher, Minu George, Edgar Gonzalez, Michael Everett Gottschalk, Giancarlo Guido, Amir Ali Hassan, Eli Hershkovitz, Lina P Huerta-Saenz, Jin Soon Hwang, Jaime Orlando Ibarra Gomez, Lydia Irizarry Gonzalez, Nina Jain, David H Jelley, Ho-Seong Kim, Tatiana Kovalenko, Lori Michelle B Laffel, Steven B Leichter, Raphael Del Roio Liberatore Jr, Jane Lynch, Farid Hussain Mahmud, Oleg Arturovich Malievskiy, Andrew Muir, Bryce A Nelson, Luis Alejandro Nevarez Ruiz, Micah L Olson, Emilia Susana Pelayo Orozco, Valentina Peterkova, Fernando Ramón Ramírez Mendoza, Konda Mohan Reddy, Henry Rodriguez, Javier Andres Saenz, Julia Samoilova, Karl-Otfried Schwab, Sejal H Shah, Naim Shehadeh, Ashley H Shoemaker, Yulia Skorodok, Aleksandr Sobolev, Silvana Ernestina Solís, Shylaja Srinivasan, Eva Tsalikian, Farida Valeeva, Carl D Vance, Pedro A Velasquez-Mieyer, Rafael Margarito Violante Ortiz, Olga Votyakova, Haiyan Wei, Ruth S Weinstock, Mark D Wheeler, Brandy Alexandra Wicklow, Steven M Willi, Kupper A Wintergerst, Risa M Wolf, Jamie Ruth Wood, Chandan Yaliwal, and Hernán Yupanqui Lozno

Subjects
Endocrinology, Endocrinology, Diabetes and Metabolism, Internal Medicine
Published
2023

13. Validation of a risk prediction model for early chronic kidney disease in patients with type 2 diabetes: Data from the German/Austrian Diabetes Prospective Follow‐up registry

Author

Stephan Kress, Peter Bramlage, Reinhard W. Holl, Christian Dominik Möller, Steffen Mühldorfer, Jörg Reindel, Jochen Seufert, Rüdiger Landgraf, Ludwig Merker, Sebastian M. Meyhöfer, Thomas Danne, Peter Fasching, Peter R. Mertens, Christoph Wanner, and Stefanie Lanzinger

Subjects
Endocrinology, Endocrinology, Diabetes and Metabolism, Internal Medicine
Abstract

To validate a recently proposed risk prediction model for chronic kidney disease (CKD) in type 2 diabetes (T2D).Subjects from the German/Austrian Diabetes Prospective Follow-up (DPV) registry with T2D, normoalbuminuria, an estimated glomerular filtration rate of 60 ml/min/1.73mSubjects (n = 10 922) had a mean age of 61 years, diabetes duration of 6 years, BMI of 31.7 kg/mThe predictive model achieved moderate discrimination but good calibration in a German/Austrian T2D population, suggesting that the model may be relevant for determining CKD risk.

Published
2022

15. The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany

Author

Thomas Danne, Jochen Seufert, Christian Wagner, Kerstin König, Dirk Raddatz, Rosmarie Weber-Lauffer, Diether Erath, Jost Hilgenberg, Carsten Spies, Maximilian Gabler, Johannes Foersch, and Ludwin Ley

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Introduction Empagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin.Research design and methods Data from the Diabetes Patienten Verlaufsdokumentation (DPV)/Diabetes Versorgungsevaluation (DIVE) registries on 9571 adults with T2DM (registered in 2014–2019) receiving empagliflozin were used. Patients were grouped according to the following: early users (group 1; n=505) received empagliflozin before the EMPA-REG OUTCOME study publication (mid-September 2015); intermediate users (group 2; n=2961) started empagliflozin after the EMPA-REG OUTCOME publication but before the European Medicines Agency label change (from mid-September 2015 to mid-January 2017); and late users (group 3; n=6105) started empagliflozin after mid-January 2017. Data on clinical and treatment characteristics were collected.Results Over time, the proportion of recipients aged

Published
2020
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17. <scp>C</scp> ontinuous glucose monitoring‐based <scp>time‐in‐range</scp> using insulin glargine 300 units/ <scp>ml</scp> versus insulin degludec 100 units/ <scp>ml</scp> in type 1 diabetes: The <scp>head‐to‐head</scp> randomized controlled <scp>InRange</scp> trial

Author

Tadej Battelino, Thomas Danne, Steve V. Edelman, Pratik Choudhary, Eric Renard, Jukka Westerbacka, Bhaswati Mukherjee, Valerie Pilorget, Mathieu Coudert, and Richard M. Bergenstal

Subjects
Endocrinology, Endocrinology, Diabetes and Metabolism, Internal Medicine
Published
2022

18. Dynamics of Hemoglobin A1c, Body Mass Index, and Rates of Severe Hypoglycemia in 4434 Adults with Type 1 or Type 2 Diabetes After Initiation of Continuous Glucose Monitoring

Author

Stefanie Lanzinger, Frank Best, Tanja Bergmann, Markus Laimer, Boris Lipovsky, Thomas Danne, Stefan Zimny, Peter Bramlage, Svenja Meyhöfer, and Reinhard W. Holl

Subjects
Adult, Blood Glucose, Glycated Hemoglobin, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Endocrinology, Diabetes Mellitus, Type 2, Blood Glucose Self-Monitoring, Endocrinology, Diabetes and Metabolism, Humans, Prospective Studies, Hypoglycemia, Body Mass Index
Published
2022

19. Alterations in Dietary Behavior, Appetite Regulation, and Health-Related Quality of Life in Youth with Obesity in Germany during the COVID-19 Pandemic

Author

Reschke, Nora Struckmeyer, Torben Biester, Olga Kordonouri, Chantal Weiner, Evelin Sadeghian, Cathrin Guntermann, Kerstin Kapitzke, Jantje Weiskorn, Laura Galuschka, Kisa von Stuelpnagel, Daniela Meister, Karin Lange, Thomas Danne, and Felix

Subjects
nutritional content, hunger control, children with overweight, life quality, eating habits, SARS-CoV-2
Abstract

Background: This study aimed to evaluate the impact of the COVID-19 pandemic on the nutritional patterns, eating behavior, dietary content, and health-related quality of life (HrQoL) of adolescents with preexisting obesity. Methods: Anthropometric and metabolic parameters were measured, and validated questionnaires on eating habits, nutritional content, and HrQoL were administered to 264 adolescents with obesity during the COVID-19 pandemic (June 2020–June 2022) and 265 adolescents with obesity before the pandemic (from June 2017 to June 2019). Results: Both study cohorts were comparable in age and sex distribution. Significant differences were found between the COVID-19 and pre-COVID-19 cohorts in HOMA-index (3.8 (interquartile range [IQR])): 3.3; 4.1) vs. 3.2 (IQR: 2.8; 3.5, p < 0.001), total cholesterol (208.8 mg/dL (IQR: 189.9; 214.5) vs. 198.5 mg/dL (IQR: 189.5; 207.4), p < 0.001), and GPT (93.4 (IQR 88.7; 96.5) vs. 72.8 U/L (IQR 68.9; 75.7), p < 0.001). The COVID-19 cohort reported significantly higher consumption of obesity-promoting food components, such as soft drinks, meat, sausages, fast food and delivery food, chocolate, and sweets. There was also a significant decrease in cognitive hunger control (p = 0.002) and an increase in distractibility potential (p = 0.001) while eating. HrQoL was significantly lower in the COVID-19 cohort (p = 0.001). Conclusions: This study reveals the adverse associations of exposure to the public health measures during the COVID-19 pandemic with nutrition, dietary content, and HrQoL in adolescents with preexisting obesity. These findings underscore the importance of tailored preventive and treatment strategies for addressing the specific challenges of disruptive events such as pandemics, especially in population-based context.

Published
2023
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20. Diabetes registries and high-quality diabetes care

Author

Kamlesh Khunti, Chantal Mathieu, Bart Torbeyns, Stefano Del Prato, Robert Heine, Helen Colhoun, Thomas Danne, Mette Due-Christensen, Katarina Eeg-Olofsson, Guy Fagherazzi, Robert Haustein, Rogier Klok, Fleur Levrat-Guillen, Massimo Massi Benedetti, Manel Mata, Jaivir Pall, Jeannette Soderberg, Ola Vedin, and Petra Wilson

Subjects
Endocrinology, Endocrinology, Diabetes and Metabolism, Internal Medicine
Published
2023

22. Patient and disease characteristics of adult patients with type 1 diabetes in Germany: an analysis of the DPV and DIVE databases

Author

Gesine van Mark, Stefanie Lanzinger, Ralf Barion, Michael Degenhardt, Simone Badis, Horst Noll, Thomas Danne, Peter Bramlage, Jochen Seufert, and Reinhard W. Holl

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

Background: An understanding of the current status of patients with type 1 diabetes mellitus (T1DM) can help to provide appropriate treatment. Methods: This was a retrospective analysis of the DIabetes Versorgungs-Evaluation (DIVE) and the Diabetes-Patienten-Verlaufsdokumentation (DPV) databases for Germany. Results: The analysis included 56,250 people with T1DM (54.2% male), a median age of 36.8 years, and a median diabetes duration of 12.4 years. 15.3% were obese (body mass index ≥ 30kg/m 2 ). Long-acting insulin analogs were used by 53.3%, short-acting analogs by 72.1%, and oral antidiabetic drugs by 4.7%. Patients had a median glycosylated hemoglobin (HbA1c) of 7.8%. There was a drop in HbA1c and an increase in the rate of hypertension, oral antidiabetic drug use, and in the rate of severe hypoglycemia (all p < 0.01) with age. Flash glucose monitoring (FGM) showed the best glucose values with fewer complications compared to other monitoring systems. HbA1c and FBG were lower in patients using a pump versus multiple daily injections (MDIs; 7.7 versus 7.9% and 7.8 versus 8.7 mmol/l; all adjusted p < 0.01). Patients had a lower risk of at least one severe hypoglycemic or DKA episode during the most recent treatment year with pump treatment compared to MDI (9.4% versus 10.5% and 4.7% versus 6.1%, both adjusted p < 0.01). Conclusion: The data demonstrated less-than-optimal glycemic control in the young, an increasing metabolic pattern in T1DM with increasing age, a benefit of FGM to improve HbA1c control and adverse effects, as well as benefits of pump treatment over MDIs.

Published
2019
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23. Diagnosis, therapy and follow-up of diabetes mellitus in children and adolescents

Author

Verena M. Wagner, Rainer Stachow, Axel Dost, Thomas Kapellen, Thomas Danne, Martin Holder, Olga Kordonouri, Karin Lange, Andreas Neu, Susanna Wiegand, Klemens Raile, Susanne Müller, Paul-Martin Holterhus, Simone von Sengbusch, Jutta Bürger-Büsing, Beate Karges, Ralph Ziegler, R. W. Holl, and Roland Schweizer

Subjects
Male, Pediatrics, medicine.medical_specialty, Ambulatory blood pressure, Adolescent, Endocrinology, Diabetes and Metabolism, MEDLINE, law.invention, Text mining, Endocrinology, Randomized controlled trial, Quality of life, law, Diabetes mellitus, medicine, Internal Medicine, Humans, Child, business.industry, General Medicine, medicine.disease, Diabetes Mellitus, Type 1, Child, Preschool, Practice Guidelines as Topic, Female, business, Follow-Up Studies
Published
2023

30. Das europäische Netzwerk INNODIA

Author

Karsten Bode, Felix Reschke, Jantje Weiskorn, Nicole Pisarek, Mareike Polier Polier, Sarah Landsberg, Olga Kordonouri, and Thomas Danne

Subjects
Endocrinology, Diabetes and Metabolism, Internal Medicine
Abstract

ZUSAMMENFASSUNGHinter dem typischen klinischen Erscheinungsbild des Typ-1-Diabetes (T1D) können sich sehr unterschiedliche Krankheitsverläufe verbergen. Bei vielen Menschen ist zum Zeitpunkt der Manifestation noch eine nicht unerhebliche Restfunktion der Betazellen nachweisbar. In Europa hat sich, finanziert durch die Projekte INNODIA und INNODIA HARVEST der europäischen „Innovative Medicines Initiative“, ein neues Netzwerk zur T1D-Forschung gebildet. Es besteht einerseits aus Grundlagenforschern zur Entdeckung neuartiger Biomarker und Therapien. Anderseits sind darin akkreditierte klinische Zentren mit höchsten Qualitätsstandards organisiert. Das Konsortium führt gegenwärtig 4 klinische Studien an Menschen mit neu diagnostiziertem T1D durch. In Zusammenarbeit mit der Regulationsbehörde EMA entwickelte INNODIA ein einheitliches Studienprotokoll („Masterprotokoll“), um ab dem Alter von 5 Jahren die Untersuchung neuer Einzelsubstanzen und Kombinationstherapien zu beschleunigen.

Published
2022

31. Erste Anwendungserfahrung eines neuen, Glukosesensor-unterstützten Pumpensystems mit vorausschauender Insulin-Abschaltung zum Hypoglykämieschutz bei pädiatrischen Patienten in Deutschland

Author

Thekla von dem Berge, Kerstin Remus, Sarah Biester, Felix Reschke, Nicolin Datz, Thomas Danne, Olga Kordonouri, and Torben Biester

Subjects
Endocrinology, Diabetes and Metabolism
Abstract

Zusammenfassung Einleitung Die prädiktive Insulinabschaltung ist als System zur Prävention von Hypoglykämien in Deutschland etabliert (Smartguard). Seit 2020 ist in Deutschland ein zweites System verfügbar (Basal-IQ). Unterschiede betreffen eine nicht veränderbare prädiktive Abschaltgrenze von 80 mg/dl (vs. 50–90 mg/dl), eine Abschaltzeit von minimal 5 Minuten (vs. 30 Minuten) sowie die Festlegung der Wiedereinschaltung des Insulin bei einem höheren Wert als zuvor (vs. einem Abstand von 20 mg/dl über der Abschaltgrenze und höherer Prädiktion). Die Systeme wurden in einer Altersgruppe, die besonders von Unterzuckerungen bedroht ist, verglichen. Methodik Pädiatrische Patienten (Alter 6–13 Jahre), mit Pumpen- und Sensorerfahrung (kein AID) wurde die Erprobung von Basal-IQ für eine Dauer von 3 Monaten angeboten. Betrachtet wurden die CGM-Parameter Zeit unter Zielbereich (TBR < 70mg/dl), im Zielbereich (TIR 70–180 mg/dl), glykämische Variabilität (Varianzkoeffizient CV%) und HbA1c. Patienten-bezogene Outcomes (PROʼs) wurden mit dem Diabskids-Elternfragebogen und einem Gerätefragebogen erfasst. Ergebnisse Neun Teilnehmer (alle männlich, Mittelwerte: 9.7 Jahre, Diabetesdauer 6.1 Jahre, HbA1c 6.8%, Time in Range (TIR) 61.9%, Time below Range (TBR) 4.5%, mittlere Glukose (MW) 164 mg/dl, (CV) 40) wurden gefunden. Nach 3 Monaten konnten Verbesserungen der glykämischen Parameter beobachtet werden (HbA1c 6.5%, TIR 69.2%, TBR 2.8%, MW 159, CV 40; Kontrollen HbA1c 7.2%, TIR 64.9%, TBR 4.3%, MW 158, CV 39), die sich von einer zeitgleich mit Smartguard behandelten Kindern nicht unterschieden. Die Erfassung der PROʼs zeigte einen Rückgang der Diabetes- und Therapiebelastung, sowie eine Zufriedenheit mit dem System. Diskussion Das neue System mit prädiktiver Abschaltung zeigte nach 3 Monaten eine Verbesserung der glykämischen Parameter und PROʼs. Ein statistischer Vergleich vorher/nachher ist aufgrund der geringen Patientenzahl nicht erfolgt, aber die Daten zeigen zumindest die Nichtunterlegenheit gegenüber dem Baseline-Zeitpunkt und den Daten, die aus einer Gruppe von Patienten mit kontinuierlicher Systemnutzung stammen. Somit stehen in Deutschland aktuell zwei verschiedene effiziente Systeme mit prädiktiver Insulinabschaltung für Kinder und Jugendliche mit Diabetes zur Verfügung, so dass diese nach fundierter Beratung auswählen können.

Published
2022

33. Twenty years of the International Society for Pediatric and Adolescent Diabetes Science Schools programs: Assessment of their impact on the participants' personal careers and networking development

Author

Tiago Jeronimo, Dos Santos, Agata, Chobot, Wafaa, Laimon, Sheridan, Waldron, Claudia, Piona, Elisa, Giani, Klemen, Dovc, Maddalena, Macedoni, Chiara, Mameli, Roque, Cardona-Hernandez, Bärbel, Aschemeier-Fuchs, Margaret, McGill, Alan M, Delamater, Jamie, Wood, Luís Eduardo, Calliari, Andrea, Scaramuzza, Carine, De Beaufort, Sylvia, Lion, Thomas, Danne, and Kim C, Donaghue

Subjects
Schools, diabetes career, Adolescent, Health Personnel, Endocrinology, Diabetes and Metabolism, diabetes education, networking, Pediatrics, Perinatology and Child Health, social opportunities, Diabetes Mellitus, Internal Medicine, Humans, diabetes research, Child
Abstract

Objective: The following report describes the evaluation of the ISPAD Science School for Physicians (ISSP) and for Healthcare Professionals (ISSHP) in terms of their efficiency and success. Methods: All past attendees from 2000–2019 ISSP and 2004–2019 ISSHP programs were invited to respond to an online survey to assess perceived outcomes of the programs on career development, scientific enhancement, scientific networking, and social opportunities. Results: One-third of the past ISSP (129/428), and approximately 43% of the past ISSHP attendees (105/245) responded to the surveys. Most of ISSP attendees reported that the programs supported their career (82%) by helping to achieve a research position (59%), being engaged with diabetes care (68%) or research (63%) or starting a research fellowship (59%). Responders indicated that ISSP was effective in increasing interest in diabetes research (87%) and enhancing the number (66%) and quality (83%) of scientific productions, and promotion of international collaborations (86%). After the ISSP, 34% of responders received research grants. From the first round of the ISSHP survey (2004–2013), responders reported have improved knowledge (60%), gained more confidence in research (69%), undertaken a research project (63%), and achieved a higher academic degree (27%). From the second round (2014–2019), participants indicated that the program was valuable/ useful in workplace (94%) through understanding (89%) and conducting (68%) research and establishing communication from other participants (64%) or from faculty (42%). After the ISSHP, 17% had received awards. Conclusions: From the participants' viewpoint, both programs were effective in improving engagement with diabetes research, supporting career opportunities, increasing scientific skills, and enhancing networking and research activities.

Published
2022

35. Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

Author

Thekla von dem Berge, Sarah Biester, Torben Biester, Anne-Kathrin Buchmann, Nicolin Datz, Ute Grosser, Kerstin Kapitzke, Britta Klusmeier, Kerstin Remus, Felix Reschke, Inken Tiedemann, Jantje Weiskorn, Martina Würsig, Andreas Thomas, Olga Kordonouri, and Thomas Danne

Subjects
Endocrinology, Diabetes and Metabolism
Abstract

ZusammenfassungDas Prinzip der automatischen Insulindosierung, kurz „AID“ genannt, zeigt in Zulassungsstudien und Real-World-Erfahrungen ausgezeichnete Behandlungsergebnisse. Beim AID wird eine Insulinpumpe mit einem System zur kontinuierlichen Glukosemessung zusammengeschaltet, während ein Rechenprogramm, der sogenannte Algorithmus, die Steuerung der Insulingabe nach Bedarf übernimmt. Idealerweise wäre das System ein geschlossener Kreis, bei dem die Menschen mit Diabetes keine Eingabe mehr machen müssten. Jedoch sind bei den heute verfügbaren Systemen verschiedene Grundeinstellungen und Eingaben erforderlich (insbesondere von Kohlenhydratmengen der Mahlzeiten oder körperlicher Aktivität), die sich von den bisherigen Empfehlungen der sensorunterstützten Pumpentherapie in einzelnen Aspekten unterscheiden. So werden die traditionellen Konzepte von „Basal“ und „Bolus“ mit AID weniger nützlich, da der Algorithmus beide Arten der Insulinabgabe verwendet, um die Glukosewerte dem eingestellten Zielwert zu nähern. Daher sollte bei diesen Systemen statt der Erfassung von „Basal“ und „Bolus“, zwischen einer „nutzerinitiierten“ und einer „automatischen“ Insulindosis unterschieden werden. Gemeinsame Therapieprinzipien der verschiedenen AID-Systeme umfassen die passgenaue Einstellung des Kohlenhydratverhältnisses, die Bedeutung des Timings der vom Anwender initiierten Insulinbolusgaben vor der Mahlzeit, den korrekten Umgang mit einem verzögerten oder versäumten Mahlzeitenbolus, neue Prinzipien im Umgang mit Sport oder Alkoholgenuss sowie den rechtzeitigen Umstieg von AID zu manuellem Modus bei Auftreten erhöhter Ketonwerte. Das Team vom Diabetes-Zentrum AUF DER BULT in Hannover hat aus eigenen Studienerfahrungen und der zugrunde liegenden internationalen Literatur praktische Empfehlungen zur Anwendung und Schulung der gegenwärtig und demnächst in Deutschland kommerziell erhältlichen Systeme zusammengestellt. Für den Erfolg der AID-Behandlung scheint das richtige Erwartungsmanagement sowohl beim Behandlungsteam und als auch beim Anwender von großer Bedeutung zu sein.

Published
2021

36. 'The Times They Are A-Changin'' at Diabetes Care

Author

Steven E. Kahn, Cheryl A.M. Anderson, John B. Buse, Elizabeth Selvin, Sonia Y. Angell, Vanita R. Aroda, Jessica R. Castle, Alice Y.Y. Cheng, Thomas Danne, Justin B. Echouffo-Tcheugui, Jose C. Florez, Meghana D. Gadgil, Amalia Gastaldelli, Jennifer B. Green, Ania M. Jastreboff, Alka M. Kanaya, Namratha R. Kandula, Csaba P. Kovesdy, Neda Laiteerapong, Kristen J. Nadeau, Rodica Pop-Busui, Camille E. Powe, Casey M. Rebholz, Michael R. Rickels, Naveed Sattar, Jonathan E. Shaw, Emily K. Sims, Kristina M. Utzschneider, Adrian Vella, and Cuilin Zhang

Subjects
Advanced and Specialized Nursing, Endocrinology, Diabetes and Metabolism, Internal Medicine
Published
2022

37. ISPAD Clinical Practice Consensus Guidelines 2022: Insulin treatment in children and adolescents with diabetes

Author

Eda Cengiz, Thomas Danne, Tariq Ahmad, Ahila Ayyavoo, David Beran, Sarah Ehtisham, Jan Fairchild, Przemyslawa Jarosz‐Chobot, Sze May Ng, Megan Paterson, and Ethel Codner

Subjects
Diabetes Mellitus, Type 1, Consensus, Adolescent, Endocrinology, Diabetes and Metabolism, Pediatrics, Perinatology and Child Health, Internal Medicine, Insulins, Humans, Hypoglycemic Agents, Practice Patterns, Physicians', Child, Societies, Medical
Published
2022

39. Pharmacotherapy of type1 diabetes in children and adolescents: more than insulin?

Author

Torben Biester, Olga Kordonouri, and Thomas Danne

Subjects
Diseases of the endocrine glands. Clinical endocrinology, RC648-665
Abstract

For paediatric patients with type 1 diabetes, intensified insulin therapy with either multiple daily injection or insulin pump therapy is currently the only method of treatment. To optimize this therapy, insulin analogues are fixed parts of all therapy regimens. New ultra-rapid insulins seem to be beneficial not only in adults but also in this age group. New developments in long-acting analogues have demonstrated safety and will be regular in paediatrics, we hope, soon. Furthermore, the psychosocial approach for consideration of real-life aspects becomes more the focus of therapeutic regimens and is implemented into international guidelines. Technical improvements, such as continuous glucose monitoring, particularly in combination with pump therapy, support the great success of rapid-acting analogues by reducing hypoglycaemias. Non-insulin agents such as SGLT2-inhibitors show beneficial aspects in people with type 1 diabetes. For outpatient care with these currently off-label-used drugs, special training for measurement of ketones should be imperative.

Published
2018
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40. The automated pancreas: A review of technologies and clinical practice

Author

Torben Biester, Thomas Kapellen, Olga Kordonouri, Martin Tauschmann, Thomas Danne, Agata Chobot, and Klemen Dovc

Subjects
Pancreas, Artificial, Insulin pump, Telemedicine, business.industry, Blood Glucose Self-Monitoring, Endocrinology, Diabetes and Metabolism, Interoperability, HCL, artificial pancreas, automated delivery, closed loop, insulin, insulin AID, Cloud computing, Diabetes Therapy, Artificial pancreas, Clinical trial, Insulin Infusion Systems, Endocrinology, Risk analysis (engineering), Diabetes Mellitus, Internal Medicine, Humans, Medicine, Metric (unit), Child, business
Abstract

Insulin pumps and glucose sensors are effective in improving diabetes therapy and reducing acute complications. The combination of both devices using an algorithm-driven interoperable controller makes automated insulin delivery (AID) systems possible. Many AID systems have been tested in clinical trials and have proven safety and effectiveness. However, currently, none of these systems are available for routine use in children younger than 6 years in Europe. For continued use, both users and prescribers must have sound knowledge of the features of the individual AID systems. Presently, all systems require various user interactions (e.g. meal announcements) because fully automated systems are not yet developed. Open-source systems are non-regulated variants to circumvent existing regulatory conditions. There are risks here for both users and prescribers. To evaluate AID therapy, the metric data of the glucose sensors, 'time in target range' and 'glucose management index', are novel recognized and suitable parameters allowing a consultation based on real glucose and insulin pump download data from the daily life of people with diabetes. Read out via cloud-based software or automatic download of such individual treatment data provides the ideal technical basis for shared decision-making through telemedicine, which must be further evaluated for general use.

Published
2021

41. Wenn Menschen mit Typ-1-Diabetes erwachsen werden

Author

Olga Kordonouri, Nicolin Datz, and Thomas Danne

Subjects
Gerontology, Telemedicine, Type 1 diabetes, business.industry, International comparisons, Specialty, General Medicine, Type 2 diabetes, medicine.disease, Diabetes Therapy, Diabetes mellitus, Health care, medicine, business
Abstract

Approximately 40 % of adolescents with type 1 diabetes lose contact with specialty care at transfer to adult care, with a marked increase in risk for poor outcomes. Adolescents showed a 2,5-fold increased risk of an HbA1c level > 9 % after transfer, compared with adolescents who remained in pediatric care. While the use of modern technologies is rapidly increasing in pediatric diabetology, fewer resources are available to address the rapidly changing digital transformation of type 1 diabetes therapy in adult diabetology, not least because of the large number of patients with type 2 diabetes who require care. Therefore, in the transition from children with type 1 diabetes to adult medicine, disparities in resource provision for training and interpretation of new diabetes technologies now add to the problems that have been known for many years. One possible solution would be the creation of regional treatment centers with pediatric and internal medicine care for people with intensive diabetes therapy and use of diabetes technology, as well as the use of telemedicine capabilities. International comparisons show that in centers where pediatric and internal medicine diabetes teams provide age-appropriate care within the same treatment facility, the transition is much less complicated and people with type 1 diabetes benefit from shared experience in the use of diabetes technologies across the lifespan. However, the implementation of such concepts under the framework of the German health care system requires a rethinking among the involved stakeholders and does not seem promising without pressure from the affected people with type 1 diabetes.

Published
2021

42. Author response for 'Validation of a Risk Prediction Model for Early Chronic Kidney Disease in Patients with Type 2 Diabetes: Data from the German/Austrian DPV Registry'

Author

null Stephan Kress, null Peter Bramlage, null Reinhard W. Holl, null Christian Dominik Möller, null Steffen Mühldorfer, null Jörg Reindel, null Jochen Seufert, null Rüdiger Landgraf, null Ludwig Merker, null Sebastian M. Meyhöfer, null Thomas Danne, null Peter Fasching, null Peter R. Mertens, null Christoph Wanner, and null Stefanie Lanzinger

Published
2022

44. Continuous glucose monitoring-based time-in-range using insulin glargine 300 units/ml versus insulin degludec 100 units/ml in type 1 diabetes: The head-to-head randomized controlled InRange trial

Author

Tadej, Battelino, Thomas, Danne, Steve V, Edelman, Pratik, Choudhary, Eric, Renard, Jukka, Westerbacka, Bhaswati, Mukherjee, Valerie, Pilorget, Mathieu, Coudert, and Richard M, Bergenstal

Abstract

To use continuous glucose monitoring (CGM)-based time-in-range (TIR) as a primary efficacy endpoint to compare the second-generation basal insulin (BI) analogues insulin glargine 300 U/ml (Gla-300) and insulin degludec 100 U/ml (IDeg-100) in adults with type 1 diabetes (T1D).InRange was a 12-week, multicentre, randomized, active-controlled, parallel-group, open-label study comparing glucose TIR and variability between Gla-300 and IDeg-100 using blinded 20-day CGM profiles. The inclusion criteria consisted of adults with T1D treated with multiple daily injections, using BI once daily and rapid-acting insulin analogues for at least 1 year, with an HbA1c of 7% or higher and of 10% or less at screening.Overall, 343 participants were randomized: 172 received Gla-300 and 171 IDeg-100. Non-inferiority (10% relative margin) of Gla-300 versus IDeg-100 was shown for the primary endpoint (percentage TIR ≥ 70 to ≤ 180 mg/dl): least squares (LS) mean (95% confidence interval) 52.74% (51.06%, 54.42%) for Gla-300 and 55.09% (53.34%, 56.84%) for IDeg-100; LS mean difference (non-inferiority): 3.16% (0.88%, 5.44%) (non-inferiority P = .0067). Non-inferiority was shown on glucose total coefficient of variation (main secondary endpoint): LS mean 39.91% (39.20%, 40.61%) and 41.22% (40.49%, 41.95%), respectively; LS mean difference (non-inferiority) -5.44% (-6.50%, -4.38%) (non-inferiority P .0001). Superiority of Gla-300 over IDeg-100 was not shown on TIR. Occurrences of self-measured and CGM-derived hypoglycaemia were comparable between treatment groups. Safety profiles were consistent with known profiles, with no unexpected findings.Using clinically relevant CGM metrics, InRange shows that Gla-300 is non-inferior to IDeg-100 in people with T1D, with comparable hypoglycaemia and safety profiles.

Published
2022

45. The Use of Insulin Preparations—an Evaluation of the DPV Registry

Author

Alexander J. Eckert, Peter Bramlage, Thomas Danne, Andrea Näke, Michael Hummel, Karl Otfried Schwab, Steffen Mühldorfer, Gebhard Buchal, Antonia Müller, and Reinhard W. Holl

Subjects
Research Letter, Humans, Insulin, Hypoglycemic Agents, General Medicine, Registries
Published
2022

46. Neue Wege zur Prävention des Typ-1-Diabetes bei Kindern

Author

Thomas Danne, Olga Kordonouri, and Karin Lange

Subjects
Gynecology, medicine.medical_specialty, business.industry, Pediatrics, Perinatology and Child Health, medicine, Surgery, business
Abstract

Innerhalb des klinischen Phanotyps Typ-1-Diabetes besteht eine betrachtliche Heterogenitat: Die genetische Anfalligkeit ist komplex, die Progressionsraten unterscheiden sich deutlich, ebenso wie die Wirksamkeit therapeutischer Masnahmen. Neue Praventionsstrategien sollen mithilfe von Biomarkern zu personalisierten Kombinationstherapien in Analogie zum Vorgehen in der Kinderonkologie fuhren. Bekanntlich beginnt der Typ-1-Diabetes mit der Autoimmunitat, dem Nachweis von 2 oder mehr persistierenden diabetesassoziierten Antikorpern (Stadium 1). Eine zusatzliche subklinische Dysglykamie wird als Stadium 2 bezeichnet, der manifeste Typ-1-Diabetes als Stadium 3. Sowohl genetische wie immunologische Parameter ermoglichen eine Fruherkennung von Kindern und Jugendlichen. Da 9 von 10 betroffenen Kindern aus Familien ohne andere Familienmitglieder mit Typ-1-Diabetes stammen, sind bevolkerungsbezogene Screeningstrategien zur Pravention des Typ-1-Diabetes erforderlich. Untersuchungen zur psychologischen Belastung durch Screeningprozeduren zeigten, dass die grose Mehrheit der Familien mit dem Wissen um das erhohte Diabetesrisiko ihres Kindes nach kurzer Zeit relativ unbelastet leben konnte. Im Forschungsnetzwerk Globale Plattform zur Pravention des Autoimmunen Diabetes (GPPAD) werden Primarpravention mit oralem Insulin (POINT-Studie) oder Probiotika (S1NTIA-Studie) untersucht. Das europaische Forschungsnetzwerk „An innovative approach towards understanding and arresting Type 1 diabetes“ (INNODIA) entwickelt ein einheitliches Studienprotokoll („Masterprotokoll“), um ab dem Patientenalter von 5 Jahren die Untersuchung neuer Einzelsubstanzen und Kombinationstherapien zu beschleunigen. Sekundare Praventionsansatze zeigen in ersten Pilotstudien vielversprechende Ergebnisse zu Verlangerung der Remissionsphase oder Verzogerung des Krankheitsbeginns bei Risikopopulationen.

Published
2021

47. Declining Frequency of Acute Complications Associated with Tubeless Insulin Pump Use: Data from 2,911 Patients in the German/Austrian Diabetes Patienten Verlaufsdokumentation Registry

Author

Torben, Biester, Anke, Schwandt, Bettina, Heidtmann, Birgit, Rami-Merhar, Thomas, Haak, Andreas, Festa, Susanne, Kostow, Antonia, Müller, Kirsten, Mönkemöller, Thomas, Danne, and Jennifer E, Layne

Subjects
Insulin pump, Adult, medicine.medical_specialty, patch pump, Diabetic ketoacidosis, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, DPV, Hypoglycemia, Endocrinology, Insulin Infusion Systems, Internal medicine, Diabetes mellitus, Medicine, Humans, Hypoglycemic Agents, Insulin, Registries, Omnipod, Retrospective Studies, Glycated Hemoglobin, business.industry, CSII, Original Articles, medicine.disease, Medical Laboratory Technology, Diabetes Mellitus, Type 1, Austria, business, Corrigendum
Abstract

Objective: To characterize patients with diabetes treated with a tubeless insulin pump (Omnipod® Insulin Management System; Insulet Corp., Acton, MA), and to evaluate the frequency of acute complications with long-term use of the system. Methods: This retrospective analysis of the German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) registry included data from 3657 patients with diabetes (n = 3582 type 1, n = 25 type 2, n = 50 latent autoimmune diabetes in adults/other) treated with a tubeless insulin pump. Hemoglobin A1c (HbA1c) levels and frequency of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) were compared between 1 year pre- and 1 year (n = 2911) or up to 3 years (n = 1311) post-tubeless insulin pump initiation and compared with a contemporary cohort on multiple daily injections (MDI) with 3-year data (n = 1874). Results: Patients using tubeless insulin pump therapy had a median age of 13.7 years [interquartile range 10.8, 17.3], diabetes duration 3.7 years [1.7, 8.0], and HbA1c 7.5% [6.9, 8.2]. In patients with 3 years of follow-up data (n = 1311), the percentage with ≥1 episode of DKA, SH (Level 3, requiring assistance), and SH (coma) event with prior treatment was 6.3%, 5.5%, and 1.7%, respectively. After 3 years of tubeless insulin pump therapy, the frequency of DKA, SH (Level 3), and SH (coma) decreased to 2.2%, 4.1%, and 0.5%, respectively. Both DKA and SH remained significantly lower compared with MDI after adjustment in multiple regression analysis. High treatment retention rates (>90%) were observed. Conclusion: Real-world registry data document that tubeless insulin pump therapy is associated with good glycemic control and a low frequency of DKA and SH in an age group prone to acute complications.

Published
2021

48. Diagnostik, Therapie und Verlaufskontrolle des Diabetes mellitus im Kindes- und Jugendalter

Author

Paul-Martin Holterhus, Beate Karges, Susanna Wiegand, Klemens Raile, Susanne Müller, Martin Holder, Axel Dost, Andreas Neu, Ralph Ziegler, Olga Kordonouri, Karin Lange, Simone von Sengbusch, Verena M. Wagner, Thomas Kapellen, Thomas Danne, Jutta Bürger-Büsing, Rainer Stachow, R. W. Holl, and Roland Schweizer

Subjects
Pediatrics, medicine.medical_specialty, Glucose control, business.industry, Endocrinology, Diabetes and Metabolism, 030209 endocrinology & metabolism, medicine.disease, Cystic fibrosis, Gastroenterology, Cerebral edema, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Metabolic control analysis, Diabetes mellitus, medicine, 030212 general & internal medicine, business, Depressive symptoms, Insulin detemir, medicine.drug, Angiology
Published
2021

49. COVID-19 ('coronavirus disease 2019') und Typ-1-Diabetes

Author

Olga Kordonouri and Thomas Danne

Subjects
Gynecology, 03 medical and health sciences, medicine.medical_specialty, 2019-20 coronavirus outbreak, 0302 clinical medicine, Coronavirus disease 2019 (COVID-19), business.industry, Endocrinology, Diabetes and Metabolism, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Medicine, 030209 endocrinology & metabolism, 030204 cardiovascular system & hematology, business
Abstract

Verlauf und Prognose vieler chronischer Erkrankungen werden durch COVID-19 („coronavirus disease 2019“) negativ beeinflusst. Der Einfluss von COVID-19 auf Kinder und Erwachsene mit Typ-1-Diabetes sollte untersucht werden. Die publizierte Literatur zur Risikoeinschatzung von COVID-19 bei Vorliegen eines Typ-1-Diabetes sowie zur Rolle der SARS-CoV-2-Infektion (SARS-CoV-2: „severe acute respiratory syndrome coronavirus 2“) fur die Typ-1-Diabetes-Manifestation wurde ausgewertet. Bei Erwachsenen uber 50 Jahren mit Typ-1- oder Typ-2-Diabetes ist das Risiko einer schweren Erkrankung oder eines Todes durch COVID-19 in Abhangigkeit von der Stoffwechseleinstellung im Vergleich zu den Risiken Gleichaltriger in der Hintergrundbevolkerung deutlich erhoht. Demgegenuber sind schwere Verlaufe bei Kindern mit Typ-1-Diabetes nicht beschrieben. Allerdings nahmen wahrend der Pandemie die Falle diabetischer Ketoazidosen (DKA) sowohl bei Manifestation als auch im Verlauf der Erkrankung zu und fuhren zu einem erhohten Hospitalisierungsrisiko. Obwohl SARS-CoV‑2 beim Menschen nachweislich die Inselzellen infizieren kann, ist epidemiologisch bislang ein Zusammenhang mit einer gestiegenen Typ-1-Diabetes-Inzidenz nicht nachgewiesen. Typ-1- und Typ-2-Diabetes im hoheren Lebensalter sind mit einem todlichen Ausgang von COVID-19 verbunden. Kinder und Jugendliche mit Diabetes haben kein Risiko fur eine erhohte COVID-19-Mortalitat. Besonderes Augenmerk muss auf die Pravention der DKA sowohl bei Beginn des Typ-1-Diabetes als auch wahrend der Langzeitbehandlung gelegt werden. Wie in vielen anderen Bereichen des Gesundheitswesens konnte die COVID-19-Krise die Moglichkeit bieten, eine virtuelle Diabetesklinik als telemedizinische Erganzung zur ambulanten Standardversorgung einzurichten.

Published
2021

50. Dasiglucagon, a next‐generation ready‐to‐use glucagon analog, for treatment of severe hypoglycemia in children and adolescents with type 1 diabetes: Results of a phase 3, randomized controlled trial

Author

Thomas Danne, Jenine Y Stone, Timothy S. Bailey, Linda A. DiMeglio, Thekla von dem Berge, Klemen Dovc, Ramin Tehranchi, Tadej Battelino, Anita E. Melgaard, and Stephanie Woerner

Subjects
Blood Glucose, Male, Clinical Care and Technology, Adolescent, Nausea, type 1 diabetes, Endocrinology, Diabetes and Metabolism, Injections, Subcutaneous, Slovenia, 030209 endocrinology & metabolism, Hypoglycemia, Placebo, Glucagon, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Diabetes mellitus, Germany, Internal Medicine, medicine, Clinical endpoint, double‐blind trial, Humans, Insulin, 030212 general & internal medicine, Child, Type 1 diabetes, business.industry, hypoglycemic agent, Patient Acuity, medicine.disease, United States, Diabetes Mellitus, Type 1, Treatment Outcome, Anesthesia, Pediatrics, Perinatology and Child Health, Female, medicine.symptom, business
Abstract

Background Dasiglucagon, a next‐generation, ready‐to‐use aqueous glucagon analog formulation, has been developed to treat severe hypoglycemia in individuals with diabetes. Objective The aim of this trial was to evaluate the safety and efficacy of dasiglucagon in pediatric individuals with type 1 diabetes (T1DM). Participants were children and adolescents (6–17 years) with T1DM. Methods In this randomized double‐blind trial, 42 participants were randomly allocated (2:1:1) to a single subcutaneous (SC) injection of dasiglucagon (0.6 mg), placebo, or reconstituted glucagon (GlucaGen; dosed per label) during insulin‐induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery (first PG increase ≥20 mg/dL after treatment initiation without rescue intravenous glucose). The primary comparison was dasiglucagon vs. placebo; glucagon acted as a reference. Results The median time (95% confidence interval) to PG recovery following SC injection was 10 min (8–12) for dasiglucagon vs. 30 min (20 to –) for placebo (P

Published
2021

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