Deliverables
Using the classifications and research priorities developed in other tasks: development and implementation of a Statistical Analysis Plan (SAP) to 1) examine risk factors for severe hypoglycaemia, and 2) establish the clinical consequences of hypoglycaemic events at different glucose levels. Consequences will include biomedical (e.g. acute and chronic cognitive impairment, cardiac arrhythmias and mortality), psychological (fear of hypoglycaemia, quality of life), social (limitation of employment, loss of driving license), economic (costs to the individual and society).
We will improve the description of hypoglycaemia in the model-based framework developed at UNIPD . The new in-silico model-based framework will be validated by comparing the incidence, frequency and duration of hypoglycaemia seen in the model with data from the validation datasets.
Identification of behavioural risk factors for hypoglycaemia and modelling of the potential benefit of addressing each of those risk factors.
A systematic review will be undertaken of the literature to establish the strength of the existing evidence base for the cut-off level, in terms of associated and predicted clinical consequences, and define what questions need to be answered in analysing the database sets. Definitions of hypoglycaemia will be extended to include continuous glucose monitoring data where these have been collected robustly with input from WP5.
A position paper will be authored by the coordinator (RUMC) to inform about the project. It is aimed to be published in a high-ranked journal.
We will register the study on clinicaltrials.net with inclusion and exclusion criteria.
A validated search strategy will be applied to collect the existing guidelines and documents. Completeness of the guidelines will be cross-checked with the agencies and organisations, and relevant literature will be added to the document. A consensus process of the group will be applied, and a report as deliverable will be available to all consortium members.
A multi-disciplinary expert group will be established to guide, comment and inform the analysis of clinical trial data as it is generated by the statistics groups.
An external project website will be developed and launched online.
Searching for OpenAIRE data...
Publications
Author(s): Andrea Groselj-Strele, Hesham Elsayed, Monika Cigler, Haris Ziko, Daniel A Hochfellner, Julia Kopanz, Tina Pöttler, Katharina Secco, Amra Simic, Slave Trajanoski, Julia K Mader
Published in: Wiener Klinische Wochenschrift, WKW 133. Jahrgang 2021 Supplement, 2021
Publisher: Austrian Society of Internal Medicine, the Austrian Society of Cardiology, the Austrian Society of Pneumology
Author(s): Monika Cigler, Hesham Elsayed, Haris Ziko, Daniel A Hochfellner, Julia Kopanz, Tina Pöttler, Katharina Secco, Amra Simic, Slave Trajanoski, Andrea Groselj-Strele, Julia K Mader
Published in: Wiener Klinische Wochenschrift, WKW 133. Jahrgang 2021 Supplement, 2021
Publisher: Austrian Society of Internal Medicine, the Austrian Society of Cardiology, the Austrian Society of Pneumology
Author(s): Nunzio Camerlingo, Martina Vettoretti, Simone Del Favero, Andrea Facchinetti, Giovanni Sparacino
Published in: Journal of Diabetes Science and Technology, 15/2, 2021, Page(s) 346-359, ISSN 1932-2968
Publisher: Diabetes Technology Society
DOI: 10.1177/1932296820952123
Author(s): Omar Diouri, Monika Cigler, Martina Vettoretti, Julia K. Mader, Pratik Choudhary, Eric Renard
Published in: Diabetes/Metabolism Research and Reviews, e3449, ahead of print, 2021, ISSN 1520-7552
Publisher: John Wiley & Sons Inc.
DOI: 10.1002/dmrr.3449
Author(s): AlexandrePicard1XavierBerney1JuditCastillo-Armengol12DavidTarussio1MaximeJan1Ana RodriguezSanchez-Archidona1SophieCroizier1BernardThorens1
Published in: Molecular Metabolism, Volume 61, July 2022, 2022, Page(s) 101479, ISSN 2212-8778
Publisher: Elsevier GmbH
DOI: 10.1016/j.molmet.2022.101479
Author(s): Alexandre Picard; Salima Metref; David Tarussio; Wanda Dolci; Xavier Berney; Sophie Croizier; Gwenaël Labouebe; Bernard Thorens
Published in: Diabetes, vol. 70, Issue 7, 2021, Page(s) 1443-1457, ISSN 0012-1797
Publisher: American Diabetes Association
DOI: 10.2337/db20-1121
Author(s): Kevin A. Matlock, Melanie Broadley, Christel Hendrieckx, Mark Clowes, Anthea Sutton, Simon R. Heller, Bastiaan E. de Galan, Frans Pouwer, Jane Speight, for the Hypo- RESOLVE consortium
Published in: Diabetic Medicine, 2022;39:e14706, 2021, ISSN 1464-5491
Publisher: Wiley Online Library
DOI: 10.1111/dme.14706
Author(s): Patrick Divilly, Natalie Zaremba, Zeinab Mahmoudi, Uffe Søholm, Daniel J. Pollard, Melanie Broadley, Evertine J. Abbink, Bastiaan de Galan, Ulrik Pedersen-Bjergaard, Eric Renard, Mark Evans, Jane Speight, Alan Brennan, Rory J. McCrimmon, Matthias Müllenborn, Simon Heller, Alexander Seibold, Julia K. Mader, Stephanie A. Amiel, Frans Pouwer, Pratik Choudhary, Hypo-RESOLVE Consortium
Published in: Diabetic Medicine, Online Version of Record before inclusion in an issue, 2022, Page(s) e14892, ISSN 1464-5491
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/dme.14892
Author(s): Mette Valdersdorf Jensen, Melanie Broadley, Jane Speight, Alison Scope, Louise Preston, Simon Heller, Bastiaan E. de Galan, Frans Pouwer, Christel Hendrieckx, the Hypo-RESOLVE Consortium
Published in: Diabetic Medicine, vol. 38, issue 10, 2021, ISSN 1464-5491
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/dme.14666
Author(s): Nunzio Camerlingo, Martina Vettoretti, Giovanni Sparacino, Andrea Facchinetti, Julia K. Mader, Pratik Choudhary, Simone Del Favero, the Hypo-RESOLVE Consortium
Published in: Diabetic Medicine, May 2022, 2021, Page(s) e14758, ISSN 1464-5491
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/dme.14758
Author(s): Mette Valdersdorf Jensen, Melanie Broadley, Jane Speight, Hannah Chatwin, Alison Scope, Anna Cantrell, Simon Heller, Bastiaan E. de Galan, Christel Hendrieckx, Frans Pouwer, on behalf of the Hypo-RESOLVE consortium
Published in: Pediatrics Diabetes, Volume23, Issue3, 2022, Page(s) 390-405, ISSN 1464-5491
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/pedi.13308
Author(s): Emily O.Staricoff, Mark L.Evans
Published in: Current Opinion in Endocrine and Metabolic Research, Volume 24, 2022, 2021, Page(s) 100353, ISSN 2451-9650
Publisher: Elsevier
DOI: 10.1016/j.coemr.2022.100353
Author(s): Manon Coolen, Melanie Broadley, Christel Hendrieckx, Hannah Chatwin, Mark Clowes, Simon Heller, Bastiaan E. de Galan, Jane Speight, Frans Pouwer, for the Hypo-RESOLVE Consortium
Published in: Plos One, 6(12): e0260896, 2021, ISSN 1932-6203
Publisher: Public Library of Science
DOI: 10.1371/journal.pone.0260896
Author(s): Suresh Rama Chandran, Peter Jacob, Pratik Choudhary, and on behalf of the Hypo-RESOLVE Consortium
Published in: Diabetes Technology & Therapeutics, Vol. 22, No.12, 2020, Page(s) 937-942, ISSN 1520-9156
Publisher: Mary Ann Liebert Inc.
DOI: 10.1089/dia.2020.0011
Author(s): Nunzio Camerlingo, Martina Vettoretti, Andrea Facchinetti, Giovanni Sparacino, Julia K. Mader, Pratik Choudhary, Simone Del Favero
Published in: Scientific Reports, 10/1, 2020, Page(s) Article number: 18180, ISSN 2045-2322
Publisher: Nature Publishing Group
DOI: 10.1038/s41598-020-75079-5
Author(s): Heather J Merchant and Alison D McNeilly
Published in: Diabetic Medicine, 2021 Dec;38(12):e14721, 2021, ISSN 1464-5491
Publisher: John Wiley & Sonst Ltd
DOI: 10.1111/dme.14721
Author(s): Simon Quenneville; Gwenaël Labouèbe; Davide Basco; Salima Metref; Benoit Viollet; Marc Foretz; Bernard Thorens
Published in: Diabetes/ Metabolism, Vol. 69, issue 11, 2020, Page(s) 2253-2266, ISSN 0012-1797
Publisher: American Diabetes Association
DOI: 10.2337/db20-0577
Author(s): Keeran Vickneson, Jessica Blackburn, Jennifer R. Gallagher, Mark L. Evans, Bastiaan E. de Galan, Ulrik Pedersen-Bjergaard, Bernard Thorens, Alison D. McNeilly, Rory J. McCrimmon
Published in: Diabetologia, 64/6, 2021, Page(s) 1436-1441, ISSN 0012-186X
Publisher: Springer Verlag
DOI: 10.1007/s00125-021-05425-3
Author(s): B. E. Galan, R. J. McCrimmon, M. Ibberson, S. R. Heller, P. Choudhary, F. Pouwer, J. Speight, J. Carlton, T. R. Pieber, M. Rosilio, C. J. Tack, M. Müllenborn
Published in: Diabetic Medicine, 37/6, 2020, Page(s) 1066-1073, ISSN 0742-3071
Publisher: Blackwell Publishing Inc.
DOI: 10.1111/dme.14240
Author(s): Chiara Roversi, Martina Vettoretti, Simone Del Favero, Andrea Facchinetti, Giovanni Sparacino
Published in: Diabetes Technology & Therapeutics, 2020, ISSN 1520-9156
Publisher: Mary Ann Liebert Inc.
DOI: 10.1089/dia.2019.0502
Author(s): Suresh Rama Chandran, Peter Jacob, Pratik Choudhary
Published in: Diabetes Technology & Therapeutics, 2020, ISSN 1520-9156
Publisher: Mary Ann Liebert Inc.
DOI: 10.1089/dia.2020.0011
Author(s): Chiara Roversi, MS, Martina Vettoretti, PhD, Simone Del Favero, PhD, Andrea Facchinetti, PhD, Pratik Choudhary, MD, Giovanni Sparacino, PhDon behalf of the Hypo-RESOLVE Consortium
Published in: Journal of Diabetes Science and Technology, I-9, 2021, ISSN 1932-2968
Publisher: Diabetes Technology Society
DOI: 10.1177/19322968211012392
Author(s): Jill Carlton, Joanna Leaviss, Frans Pouwer, Christel Hendrieckx, Melanie M. Broadley, Mark Clowes, Rory J. McCrimmon, Simon R. Heller, Jane Speight
Published in: Diabetologia, 64/6, 2021, Page(s) 1213-1225, ISSN 0012-186X
Publisher: Springer Verlag
DOI: 10.1007/s00125-021-05382-x
Author(s): Hannah Chatwin, Melanie Broadley, Christel Hendrieckx, Jill Carlton, Simon Heller, Stephanie A. Amiel, Bastiaan E. de Galan, Norbert Hermanns, Katharina Finke-Groene, Jane Speight, Frans Pouwer, the Hypo-RESOLVE Consortium
Published in: Diabetic Medicine, Vol. 39, Issue 1, 2021, Page(s) e14727, ISSN 1464-5491
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/dme.14727
Author(s): Hannah Chatwin, Melanie Broadley, Christel Hendrieckx, Jill Carlton, Simon Heller, Stephanie A. Amiel, Bastiaan de Galan, Rory J. McCrimmon, Ulrik Pedersen-Bjergaard, FransP ouwer, Jane Speight, On behalf of the Hypo-RESOLVE Consortium
Published in: Journal of Diabetes and its Complications, Volume 36, Issue 7, 2022, Page(s) available online 21 June 2022, 108232, ISSN 1056-8727
Publisher: Elsevier BV
DOI: 10.1016/j.jdiacomp.2022.108232
Author(s): Nunzio Camerlingo, Martina Vettoretti, Simone Del Favero, Andrea Facchinetti, Pratik Choudhary, Giovanni Sparacino, on behalf of the Hypo-RESOLVE Consortium
Published in: Computer Methods and Programs in Biomedicine, Vol. 221(2022), 2022, Page(s) 106862, ISSN 0169-2607
Publisher: Elsevier BV
DOI: 10.1016/j.cmpb.2022.106862
Author(s): Hannah Chatwin, Dr Melanie Broadley, Mette Valdersdorf Jensen, Dr Christel Hendrieckx, Dr Jill Carlton, Prof Simon Heller, Prof Stephanie Amiel, MD, Prof Bastiaan de Galan, MD, Prof Norbert Hermanns, Katharina Finke-Grone, Prof Jane Speight, Prof Frans Pouwer
Published in: BMJ Open Diabetes Research & Care, 9:e002322, 2021, ISSN 1756-1833
Publisher: BMJ
DOI: 10.1136/bmjdrc-2021-002322
Author(s): Therese W. Fabricius, Clementine E. M. Verhulst, Peter L. Kristensen, Cees J. Tack, Rory J. McCrimmon, Simon Heller, Mark L. Evans, Stephanie A. Amiel, Thomas R. Pieber, Bastiaan E. de Galan, Ulrik Pedersen-Bjergaard
Published in: Diabetologia, 64/4, 2021, Page(s) 727-736, ISSN 0012-186X
Publisher: Springer Verlag
DOI: 10.1007/s00125-020-05361-8
Author(s): Hannah Chatwin, Melanie Broadley, Jane Speight, Anna Cantrell, Anthea Sutton, Simon Heller, Bastiaan de Galan, Christel Hendrieckx, Frans Pouwer
Published in: Diabetes Research and Clinical Practice, 174, 2021, Page(s) 108752, ISSN 0168-8227
Publisher: Elsevier BV
DOI: 10.1016/j.diabres.2021.108752
Author(s): Nunzio Camerlingo MSc, Martina Vettoretti PhD, Giovanni Sparacino PhD, Andrea Facchinetti PhD, Julia K. Mader MD, Pratik Choudhary MD, Simone Del Favero PhD, on behalf of the Hypo-RESOLVE Consortium
Published in: Diabetes, Obesity and Metabolism, vol. 23, issue 11, 2021, Page(s) 2446-2454, ISSN 1463-1326
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/dom.14483
Author(s): Othmar Moser, Haris Ziko, Hesham Elsayed, Daniel Hochfellner, Tina Pöttler, Alexander Mueller, Max L Eckstein, Harald Sourij, Julia K Mader, on behalf of the Hypo-RESOLVE Consortium
Published in: Diabetic Medicine, Volume37, Issue12, 2020, Page(s) 2153-2159, ISSN 1464-5491
Publisher: John Wiley & Sons Ltd
DOI: 10.1111/dme.14362
Author(s): Uffe Søholm, Melanie Broadley, Natalie Zaremba, Patrick Divilly, Giesje Nefs, Zeinab Mahmoudi, Bastiaan de Galan,Ulrik Pedersen-Bjergaard, Alan Brennan, Daniel John Pollard, Rory J McCrimmon, Stephanie A. Amiel ,Christel Hendrieckx, Jane Speight, Pratik Choudhary, Frans Pouwer, for the Hypo-RESOLVE Consortium
Published in: BMJ Open, Volume 12, Issue 2, 2022, Page(s) e051651, ISSN 1756-1833
Publisher: BMJ
DOI: 10.1136/bmjopen-2021-051651
Author(s): Zeinab Mahmoudia, Simone Del Favero, PeterJacob, Pratik Choudhary, on behalf of the Hypo-RESOLVE Consortium
Published in: Computer Methods and Programs in Biomedicine, Volume 209, September 2021, 106303, 2021, Page(s) e106303, ISSN 0169-2607
Publisher: Elsevier BV
DOI: 10.1016/j.cmpb.2021.106303
Author(s): Mette Valdersdorf Jensen
Published in: SDU Library, 2022
Publisher: University of Southern Denmark
DOI: 10.21996/5v07-3t82
Author(s): Hannah Chatwin
Published in: SDU Library, 2022
Publisher: University of Southern Denmark
DOI: 10.21996/xcqk-ps10
Author(s): Manon Coolen
Published in: SDU Library, 2022
Publisher: University of Southern Denmark
DOI: 10.21996/jb1p-ed62