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A Comparison of Validated Methods Used to Assess Impaired Awareness of Hypoglycaemia in Type 1 Diabetes: An Observational Study

Research output: Contribution to journalArticlepeer-review

Kshitiz Ghandi, Beatrice Pieri, Anne Dornhorst, Sufyan Hussain

Original languageEnglish
Pages (from-to)441-451
Number of pages11
JournalDiabetes Therapy
Issue number1
PublishedJan 2021

Bibliographical note

Funding Information: The authors would like to thank the clinical team and participants of the study. No funding or sponsorship was received for this study or the publication of this article. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. Kshitiz Ghandi, Beatrice Pieri and Anne Dornhorst have nothing to disclose. Sufyan Hussain reports personal fees from Abbott Diabetes Care and Roche Diabetes care, outside the submitted work. The research work was performed at Imperial College London Healthcare NHS Trust. Writing of the manuscript was performed subsequently at King?s College London. KG is currently at Health Education West Midlands, Birmingham, UK. Beatrice Pieri is currently at York Teaching Hospitals NHS Foundation Trust, York, UK. Sufyan Hussain is currently at Guy?s and St Thomas? Hospital NHS Trust, London in addition to King?s College London, London, UK. The study was not required to have IRB approval as it used existing routine clinical data accessed directly by the clinical team caring for the patients and met local requirements to be undertaken as a clinical audit. No intervention was implemented on the patients for the purpose of the study, and no patient-identifiable information was used in the study. Retrospective analysis of questionnaires used in routine practice was approved as an audit by Imperial College Healthcare NHS Trust Clinical governance office. Informed consent was obtained from all participants at the time of questionnaire completion. Anonymised datasets generated and/or analysed during the current study are available from the corresponding author on reasonable request from qualified researchers. Publisher Copyright: © 2020, The Author(s). Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

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Introduction: Clarke, Gold and Pedersen are validated methods to assess awareness of hypoglycaemia. Identifying impaired awareness of hypoglycaemia (IAH) is critical for supporting people with structured education and diabetes technologies, to reduce harm of hypoglycaemia. This study compares the Clarke score, Gold score and Pedersen methods and their correlations with features of hypoglycaemia unawareness and patient characteristics, to evaluate the accuracy of the methods in identifying IAH. Methods: This retrospective, observational questionnaire-based study collected routine clinical data from 100 people with type 1 diabetes. The questionnaire included the three validated scoring methods, frequency of severe and nocturnal hypoglycaemia, knowledge and worry of hypoglycaemia and hypoglycaemia symptom scores using the Edinburgh Hypoglycaemia Scale. Data were analysed for IAH prevalence and the associations with features of IAH. The concordance of Clarke, Gold and Pedersen methods was evaluated using Spearman’s correlation coefficient. Results: The prevalence of IAH in this cohort identified by Clarke, Gold and Pedersen methods was 18%, 19% and 61% respectively. The mean autonomic symptom score in people with IAH was significantly reduced using the Clarke method (P = 0.0002) but not on Gold (P = 0.12) and Pedersen methods (P = 0.79). For people with IAH assessed using the Clarke method, scores for night-time worry regarding hypoglycaemia (P = 0.04) and self-reported frequency of nocturnal hypoglycaemia (P = 0.001) were increased. Spearman’s correlation coefficients between Pedersen and Clarke and Pedersen and Gold were R s = 0.555 (P < 0.001) and R s = 0.645 (P < 0.001) respectively. A moderate association was observed between Clarke and Gold R s = 0.5669 (P < 0.001). Conclusion: Whilst Clarke and Gold methods determined a similar prevalence of IAH, people identified with IAH assessed by the Clarke method had a significant association with the features and characteristics of IAH, including reduced autonomic symptoms. This study suggests that performing more than one score is important for a reliable risk assessment of IAH.

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