Objective: To examine reliability and validity of a newly developed fear of hypoglycemia (FoH) screener as a practical and actionable tool for in-clinic use in adults with type 1 diabetes (T1D), in accordance with ADA’s position on psychosocial care.

Methods: In this validation study, adults with T1D were recruited from the T1D Exchange Registry to complete a draft screener online; potential items were previously identified from literature review, and interviews with health care professionals (HCPs) and people with T1D. Standard psychometric analyses assessed reliability and validity of the screener. The final FoH screener comprised 9 items assessing 2 domains – “worry” (6 items) and “behavior” (3 items).

Results: The final sample comprised 592 adults with T1D (age 43.1 ± 15.3 years; duration of T1D 24.1 ± 15 years, 66.7% females, 91.6% White, 5.2% Hispanic, self-reported HbA1c 7.1% ± 1.2%). Approximately 30% of participants reported severe hypoglycemia in the past 12 months; 33.4% reported impaired awareness of hypoglycemia. The FoH screener showed internal consistency (Cronbach’s α=0.88) and was highly correlated (r=0.71-0.75) with the Hypoglycemia Fear Survey (“worry” and “behavior” subscales and total scores), confirming reliability. Construct validity of the FoH screener was demonstrated with significant correlations with depression (r=0.44), anxiety (r=0.47), Diabetes Distress Subscales (powerlessness, management distress, hypoglycemia distress) (r=0.49-0.66); These correlations are considered moderate. Additionally, multivariable regression analysis showed that higher FoH screener scores were significantly associated with higher HbA1c (regression coefficient, β=0.04) and multi-morbidities (β=0.03).

Conclusions: This 9-item FoH screener demonstrated good reliability and validity. Further research is planned to assess clinical usability to help appropriately identify patients and assist effective HCP-patient conversations around FoH.

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