Using Distribution-Based Methods to Determine Minimal Important Differences With the Hypoglycemia Fear Survey-II in Adults With Type 1 Diabetes

Author(s)

Boateng-Kuffour A1, Callahan P1, Chandarana K1, Barry D1, Chen L1, Kelly CS1, Nguyen H2, Chapman KS2, Cornelius EM2, Wolf WA2, Polonsky WH3
1Vertex Pharmaceuticals, Boston, MA, USA, 2T1D Exchange, Boston, MA, USA, 3Behavioral Diabetes Institute, San Diego, CA, USA

OBJECTIVES: To estimate the minimal important difference (MID) for the hypoglycemia fear survey (HFS-II) in adult continuous glucose monitor (CGM) users with type 1 diabetes (T1D).

METHODS: A cross-sectional, observational study was conducted with adult (≥18 years) CGM users with self-reported T1D diagnosis. Participants completed the HFS-II survey (score 0 - 72; higher score = greater hypoglycemia fear), as part of a larger study.

RESULTS: A total of 1,847 participants completed the survey. Overall, 67.5% (n=1247) participants were female, the mean age was 45.9 years (standard deviation [SD] = 15.3) and participants averaged 30.0 (SD = 15.1) years living with T1D. The mean HFS-II total scale score was 40.2 (SD = 22.1). The MIDs for the HFS-II total scale was 5.2 based on the standard error (SE) of measurement, 10.6 based on 8% of the theoretical score range, and 11.0 based on the SD multiplied by 0.5. The MIDs for HFS-Worry and HFS-Behavior were 3.4 and 3.6 based on the SE of measurement, 5.8 and 4.8 based on 8% of the theoretical score range, and 7.4 and 4.6 based on SD multiplied by 0.5, respectively.

CONCLUSIONS: This is the first study to calculate the MID for HFS-II in adult CGM users with T1D. The variability in MID per distribution-based method observed is consistent with the current literature on HFS-II MID observed for people with type 2 diabetes.

Conference/Value in Health Info

2024-11, ISPOR Europe 2024, Barcelona, Spain

Value in Health, Volume 27, Issue 12, S2 (December 2024)

Code

PCR194

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Diabetes/Endocrine/Metabolic Disorders (including obesity)

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