OBJECTIVES

: Describe a protocol for Health care resource use analysis of an integrated database of over 100 clinical trials measuring hypoglycaemic attacks for people with diabetes

METHODS

: Trials to include are prioritized on sample size, follow- times and data availability on blood glucose, hypoglycemic events, PROs, cardiovascular events, hospitalizations, and mortality. The project will iteratively harmonize, structure and integrate the data-sets. Statistical analyses will determine likelihood and scale of different types of resource use for different types of hypoglycemia. They will quantify the probability of having a hypo, and the conditional probability of using each type of resource (e.g. paramedic, A&E, admission to a general ward), and the scale of resource used. We will further examine the effect of recurrent hypoglycemia on future resource use (e.g. insulin dose change, or HbA1c change). Unit costing of resource use items will be conducted for 5 European countries (France, Germany, Italy, Spain, and UK) to enable costing of each type of hypoglycemic event in each country.

RESULTS

: The analysis plan provides a coherent assessment of healthcare resource use associations with hypoglycemia adjusting for observed covariates within the integrated trial data-set. The analyses described will be implemented during 2020 and 2021. We will compare our results with a literature search for existing Real World Evidence studies on the costs of hypoglycemia.

CONCLUSIONS

: This study will provide the first detailed integrated analysis of over 100 trials the healthcare resource use associated with hypoglycemic events. Alongside this work, the Hypo-RESOLVE research will develop a new (or refine an existing) patient reported outcome measure focused on hypoglycaemia. This will enable both the companies that develop interventions and the regulatory and reimbursement authorities that assess them, to understand the value of hypoglycemia reducing approaches both on costs and health related quality of life.