Evidence map›Paper›PMID 40738676›Full record

ArticleInternal medicine (Tokyo, Japan)2026

Comparing the Validity of Three Methods for Identifying Impaired Awareness of Hypoglycemia in Predicting Severe Hypoglycemia in Adults with Type 1 Diabetes Mellitus: The PR-IAH Study.

Naoki Sakane, Ken Kato, Sonyun Hata, Erika Nishimura, Rika Araki, Kunichi Kouyama, Masako Hatao, Yuka Matoba, Yuichi Matsushita, Masayuki Domichi and 3 more

Abstract readComparative StudyValidation Study
PubMed Full text at PMC Publisher
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Article in Internal medicine (Tokyo, Japan), 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

13 authors.

Naoki SakaneDivision of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Japan.
Ken KatoDiabetes Center, National Hospital Organization Osaka National Hospital, Japan.
Sonyun HataDiabetes Center, National Hospital Organization Osaka National Hospital, Japan.
Erika NishimuraDiabetes Center, National Hospital Organization Osaka National Hospital, Japan.
Rika ArakiDepartment of Diabetes and Endocrinology, National Hospital Organization National Mie Hospital, Japan.
Kunichi KouyamaDepartment of Diabetes and Metabolism, National Hospital Organization Hyogo-Chuo National Hospital, Japan.
Masako HataoDepartment of Diabetes and Endocrinology, National Hospital Organization Himeji Medical Center, Japan.
Yuka MatobaDepartment of Diabetes, Endocrinology and Metabolism, National Hospital Organization Kokura Medical Center, Japan.
Yuichi MatsushitaDepartment of Diabetology and Metabolism, National Hospital Organization Okayama Medical Center, Japan.
Masayuki DomichiDivision of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Japan.
Akiko SuganumaDivision of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Japan.
Seiko SakaneDivision of Preventive Medicine, Clinical Research Institute, National Hospital Organization Kyoto Medical Center, Japan.
Takashi MurataDepartment of Clinical Nutrition, National Hospital Organization Kyoto Medical Center, and Diabetes Center, National Hospital Organization Kyoto Medical Center, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Objective Impaired awareness of hypoglycemia (IAH) contributes to severe hypoglycemia (SH) in adults with type 1 diabetes mellitus (T1DM). This study compared the validity of the Gold, Clarke, and Pedersen-Bjergaard methods for predicting SH in Japanese adults with T1DM. Methods IAH was assessed at baseline using three methods, and a prospective cohort study was conducted in adults with T1DM. Multivariate Cox proportional hazards regression models adjusted for covariates were used to compare the three methods for predicting SH, and diagnostic validity was calculated. Patients We enrolled 286 participants (mean age: 50.5±14.6 years, men: 36.7%, diabetes duration: 17.6±11.1 years, mean HbA1c level: 7.7±0.9%). Results The prevalence of IAH identified using the Gold, Clarke, and Pedersen-Bjergaard methods was 12.2%, 19.2%, and 30.1%, respectively. The Clarke method showed the strongest association with SH [adjusted hazard ratio (aHR), 8.27; 95% confidence interval (CI), 3.43-20.0, p<0.001], whereas the Gold and Pedersen-Bjergaard methods had associations of aHR 1.90 (95% CI: 0.67-5.36, p=0.227) and aHR 2.65 (95% CI: 1.16-6.03; p=0.020), respectively. The Clarke method demonstrated 65.2% sensitivity, 84.8% specificity, a 27.3% positive predictive value, a 96.5% negative predictive value, a positive likelihood ratio of 4.29, a negative likelihood ratio of 0.41, and an overall diagnostic validity of 83.2%. Conclusion Among the three methods, the Clarke method demonstrated the highest validity for predicting SH development. This information may assist physicians in assessing IAH in clinical practice.

Indexed as

AwarenessDiabetes Mellitus, Type 1HypoglycemiaAdultCohort StudiesFemaleHumansMaleMiddle AgedPredictive Value of TestsProspective StudiesReproducibility of ResultsSeverity of Illness Indexdiagnostic validityimpaired hypoglycemia awarenesssevere hypoglycemiatype 1 diabetes mellitus

Identifiers

PMID40738676
PMCPMC12979807

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