Insulin-treatment in type 1 diabetes mellitus (T1DM) is associated with elevated risk of hypoglycaemia and weight gain, which may act as a barrier to achieving optimal glycaemic control. For patients inadequately controlled by insulin alone, adjunct dapagliflozin can reduce body weight and improve glycaemic control without increased risk of hypoglycaemia. This study aimed to empirically quantify the inter-relationships between hypoglycaemia, body mass index (BMI) and quality of life using DEPICT-2 trial data. A two-stage linear regression framework evaluated (1) the relationship between hypoglycaemic fear score (HFS) and the occurrence of severe hypoglycaemia, the number of documented symptomatic events and patient age, and (2) the relationship between health-related utility (EQ-5D) and prognostic factors for utility, including HFS and BMI. Model selection was based on clinically-relevant factors. A linked evidence approach correlated the relationship between treatment, hypoglycaemia incidence and HbA1c over 52-weeks, to the relationships captured within the regression models. HFS increased as a function of incidence of severe hypoglycaemia (coefficient estimate (CE): 14.62, p=0.004) and frequency of symptomatic events (log transposed, CE: 1.32, p=0.0026). In turn, increased HFS and increased BMI were both independently associated with a significant reduction in utility (CE 0.0024, p<0.001 and 0.0026, p=0.0016 respectively). In DAPA-treated patients, attainment of target glycaemic control was not associated with an increased rate of hypoglycaemic events. This study demonstrates that fear of hypoglycaemia, driven by increased incidence of hypoglycaemia, and BMI are significant determinants of quality of life for people with T1DM. These findings support the role of dapagliflozin in T1DM management, which was associated with achievement of glycaemic control targets and weight loss, without increased hypoglycaemia.


J. Gordon: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, GlaxoSmithKline plc., Novartis AG, Novo Nordisk A/S, Pfizer Inc., Takeda Canada, Takeda Pharmaceutical Company Limited. L.M. Beresford-Hulme: None. H. Bennett: Consultant; Self; AstraZeneca. Employee; Self; Health Economics and Outcomes Research Ltd. A. Tank: Employee; Self; AstraZeneca. C. Edmonds: Employee; Self; AstraZeneca. P. McEwan: Consultant; Self; AstraZeneca. Employee; Self; Health Economics and Outcomes Research Ltd.

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