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

Hypo-RESOLVE Consortium

doi:10.1111/dom.70869

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

Hypo-RESOLVE Consortium

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Journal	Diabetes, Obesity & Metabolism
Early online date	11 May 2026
DOIs	https://doi.org/10.1111/dom.70869
Publication status	E-pub ahead of print - 11 May 2026

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

continuous glucose monitoring (CGM)
hypoglycaemia
type 1 diabetes
type 2 diabetes

ASJC Scopus subject areas

Internal Medicine
Endocrinology, Diabetes and Metabolism
Endocrinology

Access to Document

10.1111/dom.70869Licence: CC BY

Final published version
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium,provided the original work is properly cited.© 2026 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.
Final published version, 1.42 MBLicence: CC BY

Hypoglycaemia - REdefining SOLutions for better liVEs (Hypo-RESOLVE) (Joint with Stichting Katholieke Universiteit, King's College London, Medizinische Universitat Graz and 19 others)
McCrimmon, R. (Investigator)
COMMISSION OF THE EUROPEAN COMMUNITIES
1/05/18 → 1/11/23
Project: Research

Cite this

@article{3626b06ebe05493597ec0736b4e2f44b,

title = "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",

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.",

keywords = "continuous glucose monitoring (CGM), hypoglycaemia, type 1 diabetes, type 2 diabetes",

author = "\{Hypo-RESOLVE Consortium\} and Vaios Koutroukas and Jonah Thomas and Gilberte Martine-Edith and Aikaterina Tziannou and Patrick Divilly and Uffe S{\o}holm and Meek, \{Claire L\} and Simon Heller and Mader, \{Julia K\} and Ulrik Pedersen-Bjergaard and \{de Galan\}, \{Bastiaan E\} and Eric Renard and Evans, \{Mark L\} and McCrimmon, \{Rory J\} and Jane Speight and Frans Pouwer and Amiel, \{Stephanie A\} and Pratik Choudhary",

note = "Publisher Copyright: {\textcopyright} 2026 The Author(s). Diabetes, Obesity and Metabolism published by John Wiley \& Sons Ltd.",

year = "2026",

month = may,

day = "11",

doi = "10.1111/dom.70869",

language = "English",

journal = "Diabetes, Obesity \& Metabolism",

issn = "1462-8902",

publisher = "Wiley",

}

TY - JOUR

T1 - Gold and Clarke Questionnaires Identify Different People With Insulin-Treated Diabetes and Impaired Awareness of Hypoglycaemia in Almost 60% of Cases

T2 - A Post Hoc Analysis From the Hypo-METRICS Study

AU - Hypo-RESOLVE Consortium

AU - Koutroukas, Vaios

AU - Thomas, Jonah

AU - Martine-Edith, Gilberte

AU - Tziannou, Aikaterina

AU - Divilly, Patrick

AU - Søholm, Uffe

AU - Meek, Claire L

AU - Heller, Simon

AU - Mader, Julia K

AU - Pedersen-Bjergaard, Ulrik

AU - de Galan, Bastiaan E

AU - Renard, Eric

AU - Evans, Mark L

AU - McCrimmon, Rory J

AU - Speight, Jane

AU - Pouwer, Frans

AU - Amiel, Stephanie A

AU - Choudhary, Pratik

PY - 2026/5/11

Y1 - 2026/5/11

N2 - 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.

AB - 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.

KW - continuous glucose monitoring (CGM)

KW - hypoglycaemia

KW - type 1 diabetes

KW - type 2 diabetes

U2 - 10.1111/dom.70869

DO - 10.1111/dom.70869

M3 - Article

C2 - 42115542

SN - 1462-8902

JO - Diabetes, Obesity & Metabolism

JF - Diabetes, Obesity & Metabolism

ER -

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

Abstract

UN SDGs

Keywords

ASJC Scopus subject areas

Access to Document

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Projects

Hypoglycaemia - REdefining SOLutions for better liVEs (Hypo-RESOLVE) (Joint with Stichting Katholieke Universiteit, King's College London, Medizinische Universitat Graz and 19 others)

Cite this