Gold and Clarke Questionnaires Identify Different People With Insulin‐Treated Diabetes and Impaired Awareness of Hypoglycaemia in Almost 60% of Cases: A Post Hoc Analysis From the Hypo‐ METRICS Study
Year: 2026
Type: article
Abstract: AIMS: Gold and Clarke questionnaires are used to identify impaired awareness of hypoglycaemia (IAH) and severe hypoglycaemic event (SHE) risk in people with diabetes (pwD). We explored their overlap, including Clarke's Hypoglycaemia Awareness Status (Clarke-HAS) subfactor, and subsection differences in SHE incidence (Gold, Clarke, overlap). MATERIALS AND METHODS: This post hoc analysis of the Hypo-METRICS study recruited pwD on insulin (type 1: T1D; type 2: T2D) with ≥ 1 hypoglycaemic event in the previous 3 months. IAH was defined as Gold ≥ 4, Clarke ≥ 4, Clarke-HAS ≥ 2. RESULTS: Gold and Clarke were completed by 232 pwT1D and 285 pwT2D (age: 47 vs. 62 years, p < 0.001; HbA1c: 56 mmol/mol (7.3%) vs. 57 mmol/mol (7.4%), p = 0.03). IAH prevalence in T1D vs. T2D was 21% vs. 26% (p = 0.1), 14% vs. 18% (p = 0.2), and 41% vs. 48% (p = 0.2) according to Gold, Clarke and Clarke-HAS. The overlap between Gold ≥ 4, Clarke ≥ 4 was 40% (T1D: 45%; T2D: 37%); between Gold ≥ 4, Clarke-HAS ≥ 2 it was 45% (T1D: 43%; T2D: 47%). The overlap between Gold ≥ 4, Clarke ≥ 4 was 41% vs. 39% in CGM vs. non-CGM users (T1D: 50% vs. 35%; T2D: 32% vs. 40%); between Gold ≥ 4, Clarke-HAS ≥ 2 it was 39% vs. 53% (T1D: 38% vs. 54%; T2D: 40% vs. 53%). In the IAH sample, SHE rate was lower in people found with IAH by Gold vs. Clarke, 9% vs. 53%, and in those assessed by Gold-Clarke overlap vs. Clarke, 20% vs. 53% (all p < 0.001). CONCLUSIONS: Gold and Clarke show moderate consistency (37%-54%) in identifying IAH in insulin-treated diabetes, with/without CGM use, each associated with different SHE rates, indicating the two questionnaires measure different, independent aspects of IAH.
Source: Diabetes Obesity and Metabolism
DOI: 10.1111/dom.70869
Authors: Vaios Koutroukas, Jonah Thomas, Gilberte Martine‐Edith, Aikaterina Tziannou, Patrick Divilly, Uffe Søholm, Claire L. Meek, Simon Heller, Julia K. Mader, Ulrik Pedersen‐Bjergaard, Bastiaan E. de Galan, Eric Renard, Mark L. Evans, Rory J. McCrimmon, Jane Speight, Frans Pouwer, Stephanie A. Amiel, Pratik Choudhary
Institutions: University of Leicester, Leicester General Hospital, University College Dublin, St. Vincent's University Hospital, Deakin University, Diabetes Victoria, University of Sheffield, Medical University of Graz, University of Copenhagen, Nordsjællands Hospital, Maastricht University Medical Centre, Radboud University Medical Center, Maastricht University, Université de Montpellier, Centre Hospitalier Universitaire de Montpellier, Institut de Génomique Fonctionnelle, University of Cambridge, Cambridge University Hospitals NHS Foundation Trust, Wellcome/MRC Institute of Metabolic Science, University of Dundee, Steno Diabetes Centers, University of Southern Denmark, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam UMC Location Vrije Universiteit Amsterdam, King's College London
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,380
Funders: Juvenile Diabetes Research Foundation International, Eli Lilly and Company, Sanofi, Leona M. and Harry B. Helmsley Charitable Trust, University of Dundee, European Federation of Pharmaceutical Industries and Associations, National Institute for Health and Care Research, Department of Health and Social Care, European Commission, Radboud Universiteit, Novo Nordisk, Université de Montpellier, Abbott Diabetes Care, Menzies Centre for Australian Studies, King's College London, University of London, NIHR Leicester Biomedical Research Centre, Breakthrough T1D
OpenAlex ID: W7160839569