TY - JOUR
T1 - The impact of hypoglycaemia on daily functioning among adults with diabetes
T2 - a prospective observational study using the Hypo-METRICS app
AU - Søholm, Uffe
AU - Broadley, Melanie
AU - Zaremba, Natalie
AU - Divilly, Patrick
AU - Baumann, Petra Martina
AU - Mahmoudi, Zeinab
AU - Martine-Edith, Gilberte
AU - Mader, Julia K.
AU - Cigler, Monika
AU - Brøsen, Julie Maria Bøggild
AU - Vaag, Allan
AU - Heller, Simon
AU - Pedersen-Bjergaard, Ulrik
AU - McCrimmon, Rory J.
AU - Renard, Eric
AU - Evans, Mark
AU - de Galan, Bastiaan
AU - Abbink, Evertine
AU - Amiel, Stephanie A.
AU - Hendrieckx, Christel
AU - Speight, Jane
AU - Choudhary, Pratik
AU - Pouwer, Frans
AU - Hypo-RESOLVE Consortium
N1 - Funding Information:
Open access funding provided by University of Southern Denmark. This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement no 777460. The JU receives support from the European Union\u2019s Horizon 2020 research and innovation programme and EFPIA and type 1 diabetes Exchange, JDRF, IDF and The Leona M. and Harry B. Helmsley Charitable Trust. The industry partners supporting the JU include Abbott Diabetes Care, Eli Lilly, Medtronic, Novo Nordisk and Sanofi-Aventis. The funder had no role in the design of the project or its work packages, the collection or analysis of data, the writing of the manuscript or the decision to submit for publication. This paper reflects the authors views and the JU is not responsible for any use that may be made of the information it contains. JS and CH are supported by core funding to the Australian Centre for Behavioural Research in Diabetes provided by the collaboration between Diabetes Victoria and Deakin University. GME\u2019s position at King\u2019s College London is funded by a grant from Novo Nordisk. The University of Cambridge has received salary support for MLE through the National Health Service in the East of England, through the Clinical Academic Reserve and work supported by the NIHR Cambridge Biomedical Research Centre and carried out in the NIHR Cambridge Clinical Research Facility/Translational Research Facility. This study represents independent research supported by the National Institute for Health and Care Research (NIHR) King\u2019s Clinical Research Facility and the NIHR Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King\u2019s College London. The views expressed are those of the authors and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care.
Funding Information:
US worked for Novo Nordisk A/S during the development of this manuscript. SAA has served on advisory boards for Novo Nordisk and Medtronic and has spoken at educational events sponsored by Novo Nordisk and Sanofi. SH has received research funding from Dexcom Inc. and served on advisory boards for Eli Lilly, Zealand Pharma and Zucara. He has spoken at educational events sponsored by NovoNordisk and is currently an Independent Chair of a Data Monitoring and Safety Committee on behalf of Eli Lilly. FP has received unrestricted funding for research from Novo Nordisk, Eli Lilly and Sanofi. JS has served on advisory boards for Insulet, Janssen, Medtronic, Roche Diabetes Care and Sanofi Diabetes, has received unrestricted educational grants and in-kind support from Abbott Diabetes Care, AstraZeneca, Medtronic, Roche Diabetes Care and Sanofi Diabetes, has received sponsorship to attend educational meetings from Medtronic, Roche Diabetes Care and Sanofi Diabetes, and has received consultancy income or speaker fees from Abbott Diabetes Care, AstraZeneca, Medtronic, Novo Nordisk, Roche Diabetes Care and Sanofi Diabetes. In all cases, her research group (the Australian Centre for Behavioural Research in Diabetes [ACBRD]) has been the beneficiary of these funds. JKM is a member in the advisory board of Abbott Diabetes Care, Becton-Dickinson/embecta, Biomea Fusion, Boehringer Ingelheim, Eli Lilly, Medtronic, Novo Nordisk, Roche Diabetes Care, Pharmasens, Prediktor SA, Sanofi and Viatris and has received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Becton-Dickinson/embecta, Eli Lilly, Dexcom, Medtronic, Medtrust, Menarini, Novo Nordisk, Roche Diabetes Care, Sanofi, Servier, Viatris and Ypsomed. She is a shareholder of decide Clinical Software GmbH and elyte Diagnostics GmbH. ER reports serving on advisory boards for Abbott, AstraZeneca, Boehringer Ingelheim, Dexcom Inc, Insulet, Sanofi, Roche Diabetes Care, Novo Nordisk and Eli Lilly, and has received research support from Dexcom Inc and Tandem. ME has served on advisory boards/received speakers fees from NovoNordisk, Eli Lilly, Abbott Diabetes Care, Medtronic, Dexcom, Pila Pharma and Zucara. RJM has served on advisory boards/received speakers fees from Sanofi and Novo Nordisk. UP-B has served on advisory boards for Sanofi-Aventis, Novo Nordisk and Vertex and has received lecture fees from Abbott, Sanofi-Aventis and Novo Nordisk. BdG and SH have received research funding from Novo Nordisk. UP-B and BdG are members of the editorial board of Diabetologia. The other authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.
Publisher Copyright:
© The Author(s) 2024.
PY - 2024/10
Y1 - 2024/10
N2 - Aims/hypothesis: The aim of this work was to examine the impact of hypoglycaemia on daily functioning among adults with type 1 diabetes or insulin-treated type 2 diabetes, using the novel Hypo-METRICS app. Methods: For 70 consecutive days, 594 adults (type 1 diabetes, n=274; type 2 diabetes, n=320) completed brief morning and evening Hypo-METRICS ‘check-ins’ about their experienced hypoglycaemia and daily functioning. Participants wore a blinded glucose sensor (i.e. data unavailable to the participants) for the study duration. Days and nights with or without person-reported hypoglycaemia (PRH) and/or sensor-detected hypoglycaemia (SDH) were compared using multilevel regression models. Results: Participants submitted a mean ± SD of 86.3±12.5% morning and 90.8±10.7% evening check-ins. For both types of diabetes, SDH alone had no significant associations with the changes in daily functioning scores. However, daytime and night-time PRH (with or without SDH) were significantly associated with worsening of energy levels, mood, cognitive functioning, negative affect and fear of hypoglycaemia later that day or while asleep. In addition, night-time PRH (with or without SDH) was significantly associated with worsening of sleep quality (type 1 and type 2 diabetes) and memory (type 2 diabetes). Further, daytime PRH (with or without SDH), was associated with worsening of fear of hyperglycaemia while asleep (type 1 diabetes), memory (type 1 and type 2 diabetes) and social functioning (type 2 diabetes). Conclusions/interpretation: This prospective, real-world study reveals impact on several domains of daily functioning following PRH but not following SDH alone. These data suggest that the observed negative impact is mainly driven by subjective awareness of hypoglycaemia (i.e. PRH), through either symptoms or sensor alerts/readings and/or the need to take action to prevent or treat episodes. Graphical Abstract: (Figure presented.)
AB - Aims/hypothesis: The aim of this work was to examine the impact of hypoglycaemia on daily functioning among adults with type 1 diabetes or insulin-treated type 2 diabetes, using the novel Hypo-METRICS app. Methods: For 70 consecutive days, 594 adults (type 1 diabetes, n=274; type 2 diabetes, n=320) completed brief morning and evening Hypo-METRICS ‘check-ins’ about their experienced hypoglycaemia and daily functioning. Participants wore a blinded glucose sensor (i.e. data unavailable to the participants) for the study duration. Days and nights with or without person-reported hypoglycaemia (PRH) and/or sensor-detected hypoglycaemia (SDH) were compared using multilevel regression models. Results: Participants submitted a mean ± SD of 86.3±12.5% morning and 90.8±10.7% evening check-ins. For both types of diabetes, SDH alone had no significant associations with the changes in daily functioning scores. However, daytime and night-time PRH (with or without SDH) were significantly associated with worsening of energy levels, mood, cognitive functioning, negative affect and fear of hypoglycaemia later that day or while asleep. In addition, night-time PRH (with or without SDH) was significantly associated with worsening of sleep quality (type 1 and type 2 diabetes) and memory (type 2 diabetes). Further, daytime PRH (with or without SDH), was associated with worsening of fear of hyperglycaemia while asleep (type 1 diabetes), memory (type 1 and type 2 diabetes) and social functioning (type 2 diabetes). Conclusions/interpretation: This prospective, real-world study reveals impact on several domains of daily functioning following PRH but not following SDH alone. These data suggest that the observed negative impact is mainly driven by subjective awareness of hypoglycaemia (i.e. PRH), through either symptoms or sensor alerts/readings and/or the need to take action to prevent or treat episodes. Graphical Abstract: (Figure presented.)
KW - Daily functioning
KW - Ecological momentary assessment
KW - Hypoglycaemia
KW - Quality of life
U2 - 10.1007/s00125-024-06233-1
DO - 10.1007/s00125-024-06233-1
M3 - Article
SN - 0012-186X
VL - 67
SP - 2160
EP - 2174
JO - Diabetologia
JF - Diabetologia
IS - 10
ER -