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Hypoglycaemia - REdefining SOLutions for better liVEs

Deliverables

Final Statistical Analysis plan

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).

Improvement and validation of the in-silico model of T1D patient (related to Task 5.3.2)

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 parameters affecting hypoglycaemia occurrence and effect of their optimization (related to Task 5.3.3)

Identification of behavioural risk factors for hypoglycaemia and modelling of the potential benefit of addressing each of those risk factors.

Updated review of the evidence surrounding our proposed classification

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.

Hypo-RESOLVE Position Paper

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.

First study subject approvals package (WP5)

We will register the study on clinicaltrials.net with inclusion and exclusion criteria.

Systematic review and report on guidelines

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.

Summary of expert group meetings I

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.

External Project Website

An external project website will be developed and launched online.

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Publications

Einfluss der Jahreszeiten auf die glykämischen Kontrolle gemessen mit CGM-Metriken bei Personen mit Typ 1 Diabetes

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

Kürzere Diabetesdauer und Betazellrestfunktion sind assoziiert mit einer besseren glykämischen Kontrolle gemessen mittels kontinuierlicher Glukosemessung bei Personen mit Typ 1 Diabetes

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

Mathematical Models of Meal Amount and Timing Variability With Implementation in the Type-1 Diabetes Patient Decision Simulator

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

Hypoglycaemia detection and prediction techniques: A systematic review on the latest developments

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

Hypothalamic Irak4 is a genetically controlled regulator of hypoglycemia-induced glucagon secretion

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

Fgf15 Neurons of the Dorsomedial Hypothalamus Control Glucagon Secretion and Hepatic Gluconeogenesis

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

Changes in quality of life following hypoglycaemia in adults with type 2 diabetes: A systematic review of longitudinal studies

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

Hypo-METRICS: Hypoglycaemia—MEasurement, ThResholds and ImpaCtS—A multi-country clinical study to define the optimal threshold and duration of sensor-detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol

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

The impact of hypoglycaemia on the quality of life of family members of adults with type 1 or type 2 diabetes: A qualitative systematic review

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

Choosing the duration of continuous glucose monitoring for reliable assessment of time in range: A new analytical approach to overcome the limitations of correlation-based methods

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

The impact of hypoglycaemia in children and adolescents with type 1 diabetes on parental quality of life and related outcomes: A systematic review

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

Recent advances in understanding hypothalamic control of defensive responses to hypoglycaemia

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

The impact of hypoglycemia on quality of life and related outcomes in children and adolescents with type 1 diabetes: A systematic review

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

Baseline Glucose Variability and Interweek Variability Affects the Time to Stability of Continuous Glucose Monitoring-Derived Glycemic Indices

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

An analytical approach to determine the optimal duration of continuous glucose monitoring data required to reliably estimate time in hypoglycemia

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

"Hypoglycaemia: Still the main drawback of insulin 100 years on : ""From man to mouse"""

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

Hypoglycemia-Sensing Neurons of the Ventromedial Hypothalamus Require AMPK-Induced Txn2 Expression but Are Dispensable for Physiological Counterregulation

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

Cold-induced dishabituation in rodents exposed to recurrent hypoglycaemia

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

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo‐RESOLVE) project

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

Modeling carbohydrate counting error in type 1 diabetes management

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

Baseline Glucose Variability and Interweek Variability Affects the Time to Stability of Continuous Glucose Monitoring-Derived Glycemic Indices

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

Impact of Carbohydrate Counting Error on Glycemic Control in Open-Loop Management of Type 1 Diabetes: Quantitative Assessment Through an in silico Trial

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

The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

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

Unmet support needs relating to hypoglycaemia among adults with type 1 diabetes: Results of a multi-country web-based qualitative study

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

The impact of hypoglycaemia on quality of life among adults with type 1 diabetes: Results from “YourSAY: Hypoglycaemia”

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

Generation of post-meal insulin correction boluses in type 1 diabetes simulation models for in-silico clinical trials: more realistic scenarios obtained using a decision tree approach

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

‘Never again will I be carefree’: a qualitative study of the impact of hypoglycemia on quality of life among adults with type 1 diabetes

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

Hyperinsulinaemic–hypoglycaemic glucose clamps in human research: a systematic review of the literature

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

The impact of hypoglycaemia on quality of life outcomes among adults with type 1 diabetes: A systematic review

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

Design of clinical trials to assess diabetes treatment: Minimum duration of continuous glucose monitoring data to estimate time-in-ranges with the desired precision

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

People with type 1 diabetes and impaired awareness of hypoglycaemia have a delayed reaction to perform a glucose scan during hypoglycaemia – a prospective observational study

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

Investigating the day-to-day impact of hypoglycaemia in adults with type 1 or type 2 diabetes: design and validation protocol of the Hypo-METRICS application

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

Toward an Optimal Definition of Hypoglycemia with Continuous Glucose Monitoring

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

The Impact of Hypoglycaemia on the Quality of Life of Family Members of Persons with Type 1 or Type 2 Diabetes

Author(s): Mette Valdersdorf Jensen
Published in: SDU Library, 2022
Publisher: University of Southern Denmark
DOI: 10.21996/5v07-3t82

The Impact of Hypoglycaemia on Quality of Life Among Adults with Type 1 Diabetes

Author(s): Hannah Chatwin
Published in: SDU Library, 2022
Publisher: University of Southern Denmark
DOI: 10.21996/xcqk-ps10

The impact of hypoglycaemia on quality of life in children and adolescents with type 1 diabetes

Author(s): Manon Coolen
Published in: SDU Library, 2022
Publisher: University of Southern Denmark
DOI: 10.21996/jb1p-ed62