Introduction & Objective: Hypoglycemia awareness is commonly assessed using legacy patient-reported outcome measures (PROMs; e.g., Gold and Clarke). However, they may not meet current FDA PROM standards. The 5-item Impaired Awareness scale of the HypoA-Q short form (SF) was developed in accordance with FDA standards. Our aim was to validate it in a large cohort of US adults with type 1 diabetes.

Methods: We surveyed registrants of the national T1D Exchange registry, collecting demographics; 6-month severe hypoglycemia (SH) history; and responses to HypoA-Q SF, Gold and Clarke. The Clarke hypoglycemia awareness factor (“ClarkeHAF”) was calculated to exclude items about SH history. Analyses included Cronbach’s α (internal consistency reliability), Spearman correlations (convergent and divergent validity), multiple logistic regression analysis (predictive validity) and X2 test (SH odds with HypoA-Q SF score ≥12).

Results: The survey was completed by 1,580 participants (52% women, median[IQR] age 43[33—58]y, diabetes duration 24[12—37]y, 87% non-Hispanic Caucasian, 94% using continuous glucose monitors). The HypoA-Q SF had satisfactory reliability (α=0.79). Convergent validity was supported by moderate-to-strong correlations with the single-item Gold (rs=.63), 8-item Clarke (rs=.79), and ClarkeHAF scores (rs=.82; P<.001 for all). Divergent validity was supported by weak correlation with diabetes duration (rs=.18, P<.001), and no correlation with HbA1c. After adjusting for age, sex and diabetes duration, higher HypoA-Q SF scores were associated with greater SH risk (95%CI: .59—.65, P<.001), performing comparably to Gold (.57—.63, P<.001) and ClarkeHAF (.59—.65, P<.001), while the 8-item Clarke score (retaining SH history items) performed better in predicting SH (.70—.75). HypoA-Q SF score ≥12 was associated with 5.2-fold higher odds of SH (P<.001).

Conclusion: These findings support future use of the HypoA-Q SF for assessing hypoglycemia awareness and risk for SH.

Disclosure

Y. Lin: None. W. Ye: None. E. Hepworth: None. A.M. Matus: None. A. Flatt: None. N. de Zoysa: None. J.A. Shaw: Advisory Panel; Mogrify. M.R. Rickels: Consultant; Vertex Pharmaceuticals Incorporated, Sernova, Corp. Research Support; Dompé. S.A. Amiel: Advisory Panel; Vertex Pharmaceuticals Incorporated. Other Relationship; Sanofi. J. Speight: None.

Funding

National Institutes of Health (U01DK135111, K23DK129724)

© 2024 by the American Diabetes Association
2024
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