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17. Hypoglykämie

Author

Kordonouri, O., Danne, T., Lange, K., Danne, Thomas, Kordonouri, Olga, and Lange, Karin

Published
2016
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22. Electronic reporting of rare endocrine conditions within a clinical network:results from the EuRRECa project

Author

Ali, S. R., Bryce, J., Priego-Zurita, A. L., Cherenko, M., Smythe, C., de Rooij, T. M., Cools, M., Danne, T., Katugampola, H., Dekkers, O. M., Hiort, O., Linglart, A., Netchine, I., Nordenstrom, A., Attila, P., Persani, L., Reisch, N., Smyth, A., Sumnik, Z., Taruscio, D., Visser, W. E., Pereira, A. M., Appelman-Dijkstra, N. M., Ahmed, S. F., Ali, S. R., Bryce, J., Priego-Zurita, A. L., Cherenko, M., Smythe, C., de Rooij, T. M., Cools, M., Danne, T., Katugampola, H., Dekkers, O. M., Hiort, O., Linglart, A., Netchine, I., Nordenstrom, A., Attila, P., Persani, L., Reisch, N., Smyth, A., Sumnik, Z., Taruscio, D., Visser, W. E., Pereira, A. M., Appelman-Dijkstra, N. M., and Ahmed, S. F.

Abstract

Objective: The European Registries for Rare Endocrine Conditions (EuRRECa, eurreb. eu) includes an e-reporting registry (e-REC) used to perform surveillance of conditions within the European Reference Network (ERN) for rare endocrine conditions (Endo-ERN). The aim of this study was to report the experience of e-REC over the 3.5 years since its launch in 2018. Methods: Electronic reporting capturing new encounters of Endo-ERN conditions was performed monthly through a bespoke platform by clinicians registered to participate in e-REC from July 2018 to December 2021. Results: The number of centres reporting on e-REC increased to a total of 61 centres from 22 countries. A median of 29 (range 11, 45) paediatric and 32 (14, 51) adult centres had reported cases monthly. A total of 9715 and 4243 new cases were reported in adults (age ≥18 years) and children, respectively. In children, sex development conditions comprised 40% of all reported conditions and transgender cases were most frequently reported, comprising 58% of sex development conditions. The median number of sex development cases reported per centre per month was 0.6 (0, 38). Amongst adults, pituitary conditions comprised 44% of reported conditions and pituitary adenomas (69% of cases) were most commonly reported. The median number of pituitary cases reported per centre per month was 4 (0.4, 33). Conclusions: e-REC has gained increasing acceptability over the last 3.5 years for capturing brief information on new encounters of rare conditions and shows wide variations in the rate of presentation of these conditions to centres within a reference network. Significance statement Endocrinology includes a very wide range of rare conditions and their occurrence is often difficult to measure. By using an electronic platform that allowed monthly reporting of new clinical encounters of several rare endocrine conditions within a defined network that consisted of several reference centres in Europe, the EuRRECa project sh

Published
2023

24. Typ-1-Diabetes

Author

Danne, T., Freckmann, G., Kautzky-Willer, A., Lang, U., Lehmann, R., Pfohl, M., Schloot, N. C., Schumm-Draeger, P. M., Schatz, Helmut, editor, and Pfeiffer, Andreas F. H., editor

Published
2014
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28. INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Author

Dunger, David B., Bruggraber, Sylvaine F. A., Mander, Adrian P., Marcovecchio, M. Loredana, Tree, Timothy, Chmura, Piotr Jaroslaw, Knip, Mikael, Schulte, Anke M., Mathieu, Chantal, Mathieu, C., Gillard, P., Casteels, K., Overbergh, L., Dunger, D., Wallace, C., Evans, M., Thankamony, A., Hendriks, E., Bruggraber, S., Peakman, M., Tree, T., Morgan, N., Richardson, S., Todd, J., Wicker, L., Mander, A., Dayan, C., Alhadj Ali, M., Pieber, T., Eizirik, D., Cnop, M., Brunak, S., Pociot, F., Johannesen, J., Rossing, P., Legido Quigley, C., Mallone, R., Scharfmann, R., Boitard, C., Knip, M., Otonkoski, T., Veijola, R., Lahesmaa, R., Oresic, M., Toppari, J., Danne, T., Ziegler, A. G., Achenbach, P., Rodriguez-Calvo, T., Solimena, M., Bonifacio, E., Speier, S., Holl, R., Dotta, F., Chiarelli, F., Marchetti, P., Bosi, E., Cianfarani, S., Ciampalini, P., de Beaufort, C., Dahl-Jørgensen, K., Skrivarhaug, T., Joner, G., Krogvold, L., Jarosz-Chobot, P., Battelino, T., Thorens, B., Gotthardt, M., Roep, B., Nikolic, T., Zaldumbide, A., Lernmark, A., Lundgren, M., Costecalde, G., Strube, T., Schulte, A., Nitsche, A., von Herrath, M., Wesley, J., Napolitano-Rosen, A., Thomas, M., Schloot, N., Goldfine, A., Waldron-Lynch, F., Kompa, J., Vedala, A., Hartmann, N., Nicolas, G., van Rampelbergh, J., Bovy, N., Dutta, S., Soderberg, J., Ahmed, S., Martin, F., Agiostratidou, G., Koralova, A., Willemsen, R., Smith, A., Anand, B., Puthi, V., Zac-Varghese, S., Datta, V., Dias, R., Sundaram, P., Vaidya, B., Patterson, C., Owen, K., Piel, B., Heller, S., Randell, T., Gazis, T., Bismuth Reismen, E., Carel, J-C, Riveline, J-P, Gautier, J-F, Andreelli, F., Travert, F., Cosson, E., Penfornis, A., Petit, C., Feve, B., Lucidarme, N., Beressi, J-P, Ajzenman, C., Radu, A., Greteau-Hamoumou, S., Bibal, C., Meissner, T., Heidtmann, B., Toni, S., Rami-Merhar, B., Eeckhout, B., Peene, B., Vantongerloo, N., Maes, T., Gommers, L., Marcovecchio, M.L., Vela, J., Latres, E., Children's Hospital, and HUS Children and Adolescents

Subjects
Trials, Adult, Adolescent, SARS-CoV-2, Prevention, Beta-cell function, COVID-19, Medicine (miscellaneous), Beta-cell Function, C-peptide, Master Protocol, Phase 2, Type 1 Diabetes, Type 1 diabetes, Diabetes Mellitus, Type 1, Treatment Outcome, 3121 General medicine, internal medicine and other clinical medicine, Diabetes Mellitus, Type 1/diagnosis, Master protocol, Humans, Pharmacology (medical), Child, Biomarkers
Abstract

Background The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials. Methods In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow. Discussion The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers.

Published
2022

33. Efficacy and safety of adding sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline BMI =27 kg/m2

Author

Danne T, Edelman S, Frias J, Ampudia-Blasco F, Banks P, Jiang W, Davies M, and Sawhney S

Subjects
glycaemic control, type 1 diabetes, insulin therapy, nutritional and metabolic diseases, SGLT2 inhibitor, weight control
Abstract

Sotagliflozin, a dual SGLT1/SGLT2 inhibitor, is currently approved in Europe as an adjunct to optimal insulin therapy in adults with type 1 diabetes (T1D) and a body mass index (BMI) =27 kg/m2. In this post hoc analysis, efficacy at 24weeks and safety at 52weeks from pooled phase 3 clinical trials were evaluated in patients with baseline BMI =27 kg/m2. Sotagliflozin 200 and 400 mg added to insulin reduced HbA1c and increased time-in-range by continuous glucose monitoring vs placebo and also reduced body weight and systolic blood pressure. Differences in efficacy endpoints between sotagliflozin and placebo tended to be greater among patients with BMI =27 kg/m2 compared to those with baseline BMI

Published
2021

34. The Use Of e-REC For Capturing The Occurrence Of COVID-19 Infections In People With Rare Endocrine Conditions

Author

Bryce, J, Di Guisto, V, Ali, SR, Alexandraki, K, Badiu, C, Baronio, F, Biermasz, NR, Brandi, ML, Castinetti, F, Ceccato, F, Chifu, IO, Cools, M, Danne, T, Druce, M, Esposito, D, Falhammar, H, Fugazzola, L, Gan, HW, Giordano, R, Isidori, AM, Johannsson, G, Karavitaki, N, Linglart, A, Luger, A, Maffei, P, Marazuela, M, Jaksic, VP, Paschou, SA, Persani, L, Domingo, MP, Reisch, N, Schalin-Jantti, C, van den Akker, ELT, Vassiliadi, D, Young, J, Appelman-Dijkstra, N, Grozinsky-Glasberg, S, Pereira, AM, and Ahmed, SF

Published
2021

41. Establishing glycaemic control with continuous subcutaneous insulin infusion in children and adolescents with type 1 diabetes: experience of the PedPump Study in 17 countries

Author

Danne, T., Battelino, T., Jarosz-Chobot, P., Kordonouri, O., Pánkowska, E., Ludvigsson, J., Schober, E., Kaprio, E., Saukkonen, T., Nicolino, M., Tubiana-Rufi, N., Klinkert, C., Haberland, H., Vazeou, A., Madacsy, L., Zangen, D., Cherubini, V., Rabbone, I., Toni, S., de Beaufort, C., Bakker-van Waarde, W., van den Berg, N., Volkov, I., Barrio, R., Hanas, R., Zumsteg, U., Kuhlmann, B., Aebi, C., Schumacher, U., Gschwend, S., Hindmarsh, P., Torres, M., Shehadeh, N., Phillip, M., and and the PedPump Study Group

Published
2008
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