Medical & Science, Patient Focused Drug Development, Novo Nordisk A/S, Søborg, Denmark.
Department of Psychology, University of Southern Denmark, Odense, Denmark.
PLoS One. 2023 Mar 17;18(3):e0283148. doi: 10.1371/journal.pone.0283148. eCollection 2023.
The aim of this study was to determine the acceptability and psychometric properties of the Hypo-METRICS (Hypoglycemia MEasurement, ThResholds and ImpaCtS) application (app): a novel tool designed to assess the direct impact of symptomatic and asymptomatic hypoglycemia on daily functioning in people with insulin-treated diabetes.
100 adults with type 1 diabetes mellitus (T1DM, n = 64) or insulin-treated type 2 diabetes mellitus (T2DM, n = 36) completed three daily 'check-ins' (morning, afternoon and evening) via the Hypo-METRICs app across 10 weeks, to respond to 29 unique questions about their subjective daily functioning. Questions addressed sleep quality, energy level, mood, affect, cognitive functioning, fear of hypoglycemia and hyperglycemia, social functioning, and work/productivity. Completion rates, structural validity, internal consistency, and test-retest reliability were explored. App responses were correlated with validated person-reported outcome measures to investigate convergent (rs>±0.3) and divergent (rs<±0.3) validity.
Participants' mean±SD age was 54±16 years, diabetes duration was 23±13 years, and most recent HbA1c was 56.6±9.8 mmol/mol. Participants submitted mean±SD 191±16 out of 210 possible 'check-ins' (91%). Structural validity was confirmed with multi-level confirmatory factor analysis showing good model fit on the adjusted model (Comparative Fit Index >0.95, Root-Mean-Square Error of Approximation <0.06, Standardized Root-Mean-square Residual<0.08). Scales had satisfactory internal consistency (all ω≥0.5), and high test-retest reliability (rs≥0.7). Convergent and divergent validity were demonstrated for most scales.
High completion rates and satisfactory psychometric properties demonstrated that the Hypo-METRICS app is acceptable to adults with T1DM and T2DM, and a reliable and valid tool to explore the daily impact of hypoglycemia.
本研究旨在确定 Hypo-METRICS(低血糖测量、阈值和影响)应用程序(app)的可接受性和心理测量特性:这是一种新工具,旨在评估有胰岛素治疗的糖尿病患者中症状性和无症状性低血糖对日常功能的直接影响。
100 名 1 型糖尿病(T1DM,n=64)或胰岛素治疗 2 型糖尿病(T2DM,n=36)的成年人通过 Hypo-METRICS app 在 10 周内完成了 3 次每日“签到”(上午、下午和晚上),以回答 29 个关于他们主观日常功能的独特问题。问题涉及睡眠质量、精力水平、情绪、影响、认知功能、对低血糖和高血糖的恐惧、社交功能和工作/生产力。探索了完成率、结构效度、内部一致性和测试-重测信度。应用程序的响应与经过验证的个人报告结果测量相关联,以调查收敛(rs>±0.3)和发散(rs<±0.3)有效性。
参与者的平均年龄为 54±16 岁,糖尿病病程为 23±13 年,最近的 HbA1c 为 56.6±9.8 mmol/mol。参与者提交了 210 次可能签到中的平均 191±16 次(91%)。多水平验证性因子分析证实了结构效度,表明调整模型的拟合良好(比较拟合指数>0.95,近似均方根误差<0.06,标准化均方根残差<0.08)。量表具有令人满意的内部一致性(所有 ω≥0.5)和较高的测试-重测信度(rs≥0.7)。大多数量表都表现出收敛和发散的有效性。
高完成率和令人满意的心理测量特性表明,Hypo-METRICS app 可被 T1DM 和 T2DM 成年人接受,是一种可靠有效的工具,可用于探索低血糖对日常的影响。