AIMS To demonstrate the relationships between hypoglycaemia, body mass index (BMI) and quality of life, and to examine the impact of dapagliflozin on patient-reported treatment satisfaction in patients with type 1 diabetes mellitus (T1DM), using data from the DEPICT (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1 Diabetes) clinical trial programme. METHODS A two-stage modelling approach, using a linear regression framework, was adopted to evaluate the relationship between hypoglycaemia, BMI and quality of life. Hypoglycaemia fear score (HFS) was modelled as a function of hypoglycaemic events (non-severe documented symptomatic and severe) and, subsequently, quality of life (as measured by the EQ-5D questionnaire) was modelled as a function of HFS and BMI. A linked evidence approach correlated the relationship between treatment, hypoglycaemic events and glycated haemoglobin (HbA1c), to the relationships captured within the regression models. The proportion of patients achieving increased patient-reported treatment satisfaction, as measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) total score, was compared between study arms. RESULTS Incident severe hypoglycaemia was associated with significantly higher HFS (coefficient estimate [CE] 14.62, P=0.004). The frequency of symptomatic hypoglycaemic events was associated with a significantly higher HFS (log transposed, CE 1.32, P=0.026). Higher HFS and higher BMI were both independently associated with a significantly lower EQ-5D score (HFS: CE -0.0024, P<0.001; BMI: CE -0.0026, P=0.016). Significantly higher proportions of dapagliflozin-treated patients achieved ≥3-point increases in DTSQ total score compared to patients in the placebo group. CONCLUSION The results of this study demonstrated that increases in hypoglycaemia and BMI were associated with reduced quality of life in people with T1DM. Dapagliflozin-treated patients achieved a reduction in HbA1c whilst avoiding an increase in hypoglycaemic events. The results also showed that treatment with dapagliflozin was associated with an improvement in treatment satisfaction.

中文翻译：

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1 型糖尿病患者低血糖、体重指数和生活质量之间的关系：来自 DEPICT 临床试验计划的观察。

目的 为了证明低血糖、体重指数 (BMI) 和生活质量之间的关系，并使用来自 DEPICT (Dapagliflozin 1 型糖尿病控制不足患者的评估）临床试验计划。方法采用线性回归框架的两阶段建模方法评估低血糖、BMI和生活质量之间的关系。低血糖恐惧评分 (HFS) 被建模为低血糖事件（非严重记录的症状和严重）的函数，随后，生活质量（通过 EQ-5D 问卷测量）被建模为 HFS 和 BMI 的函数。关联证据方法将治疗、低血糖事件和糖化血红蛋白 (HbA1c) 之间的关系与回归模型中捕获的关系相关联。通过糖尿病治疗满意度问卷 (DTSQ) 总分衡量，在研究组之间比较了患者报告的治疗满意度提高的患者比例。结果 严重低血糖事件与显着较高的 HFS 相关（系数估计值 [CE] 14.62，P=0.004）。症状性低血糖事件的频率与显着较高的 HFS 相关（对数转置，CE 1.32，P=0.026）。较高的 HFS 和较高的 BMI 均与显着较低的 EQ-5D 评分独立相关（HFS：CE -0.0024，P<0.001；BMI：CE -0.0026，P=0.016）。与安慰剂组患者相比，达格列净治疗患者的 DTSQ 总分增加 ≥ 3 分的比例显着增加。结论 本研究结果表明，低血糖和 BMI 的增加与 T1DM 患者的生活质量降低有关。接受达格列净治疗的患者 HbA1c 降低，同时避免了低血糖事件的增加。结果还表明，达格列净治疗与治疗满意度的提高有关。接受达格列净治疗的患者 HbA1c 降低，同时避免了低血糖事件的增加。结果还表明，达格列净治疗与治疗满意度的提高有关。接受达格列净治疗的患者 HbA1c 降低，同时避免了低血糖事件的增加。结果还表明，达格列净治疗与治疗满意度的提高有关。