Evidence map›Paper›PMID 42115542›Full record

ArticleDiabetes, obesity & metabolism2026

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.

Vaios Koutroukas, Jonah Thomas, Gilberte Martine-Edith, Aikaterina Tziannou, Patrick Divilly, Uffe Søholm, Claire L Meek, Simon Heller, Julia K Mader, Ulrik Pedersen-Bjergaard and 9 more

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Article in Diabetes, obesity & metabolism, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

19 authors.

Vaios KoutroukasDiabetes Research Centre, University of Leicester, College of Life Sciences, Leicester, UK.ORCID https://orcid.org/0000-0001-6120-8057
Jonah ThomasDiabetes Research Centre, University of Leicester, College of Life Sciences, Leicester, UK.
Gilberte Martine-EdithDiabetes Research Centre, University of Leicester, College of Life Sciences, Leicester, UK.
Aikaterina TziannouDiabetes Research Centre, University of Leicester, College of Life Sciences, Leicester, UK.
Patrick DivillySt. Vincent's University Hospital, Dublin, University College Dublin, Dublin, Ireland.
Uffe SøholmSchool of Psychology, Deakin University, Melbourne, Australia.
Claire L MeekDiabetes Research Centre, University of Leicester, College of Life Sciences, Leicester, UK.
Simon HellerDivision of Clinical Medicine, School of Medicine and Population Health, University of Sheffield, Sheffield, UK.ORCID https://orcid.org/0000-0002-2425-9565
Julia K MaderDivision of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.ORCID https://orcid.org/0000-0001-7854-4233
Ulrik Pedersen-BjergaardDepartment of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID https://orcid.org/0000-0003-0588-4880
Bastiaan E de GalanDepartment of Internal Medicine, Radboud University Medical Center, Nijmegen, the Netherlands.
Eric RenardDepartment of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.ORCID https://orcid.org/0000-0002-3407-7263
Mark L EvansWolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.ORCID https://orcid.org/0000-0001-8122-8987
Rory J McCrimmonDivision of Molecular and Clinical Medicine, University of Dundee, Dundee, UK.ORCID https://orcid.org/0000-0002-3957-1981
Jane SpeightSchool of Psychology, Deakin University, Melbourne, Australia.
Frans PouwerSchool of Psychology, Deakin University, Melbourne, Australia.
Stephanie A AmielDepartment of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, King's College London, London, UK.
Pratik ChoudharyDiabetes Research Centre, University of Leicester, College of Life Sciences, Leicester, UK.
Hypo‐RESOLVE consortium

Funding

European Union's Horizon 2020 Research and Innovation Programme and European Federation of Pharmaceutical Industries and Associations and T1D ExchangeInnovative Medicines Initiative 2 Joint Undertaking (JU) 777460Juvenile Diabetes Research Foundation, International Diabetes FederationThe Leona M. and Harry B. Helmsley Charitable Trust
6 · The paper itself

Abstract

aimsGold 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

methodsThis 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.

resultsGold 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).

conclusionsGold 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.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2HypoglycemiaHypoglycemic AgentsInsulinAdultAgedAwarenessBlood GlucoseFemaleGlycated HemoglobinHumansIncidenceMiddle AgedSurveys and QuestionnairesBlood GlucoseGlycated HemoglobinHypoglycemic AgentsInsulincontinuous glucose monitoring (CGM)hypoglycaemiatype 1 diabetestype 2 diabetes

Identifiers

PMID42115542
PMCPMC13341389

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.