The consortium activities have been organized in eight work packages with clearly defined objectives and responsibilities for each specific partner. All project management activities will be conducted as part of WP1, including communication and dissemination activities and the coordination of the patient advisory committee (PAC).
Lead: Eurice/NN
Work package 1 will provide a clear organizational framework and all necessary support mechanisms to enable a smooth project workflow in Hypo-RESOLVE and to ensure that all contractual commitments will be met on time. Our objectives:
Lead: UNIVDUN/NN
Work package 2 addresses the molecular/cellular and pathophysiological mechanisms as well as the consequences of hypoglycaemia through non-clinical and clinical studies.
Lead: SIB/SAN/Abbott
Work package 3 will harmonise, structure and integrate multiple clinical trial datasets and CGM data into pooled databases, develop the necessary computational tools to enable querying for statistical analysis of the data in WP4-7 and ensure the sustainability of the resulting platform by using current clinical and data sharing standards. Our objectives:
Lead: USFD/NN
Work package 4 has the following objectives:
Lead: KCL/Abbott/MDT
The overall aim of work package 5 is to understand the predictors for and impact of CGM-detected low values on biological, patient reported and health-economic outcomes in order to provide guidance to industry, academics and regulators for its successful use in clinical trials, particularly as an end point. WP5 will:
Lead: SDU/Lilly
The aim of work package 6 is to provide a comprehensive assessment of the impact of hypoglycaemia on the quality of life (QoL) of people with diabetes and their family members and to identify knowledge gaps by conducting: a) rapid and systematic reviews to summarise and critique the current evidence base, b) secondary analyses of pooled trial/CGM data, and c) innovative research that fills knowledge gaps.
WP6 will:
Lead: USFD/SAN
Work package 7 will utilise our knowledge on valuing health related quality of life and economic evaluation to assess the quality of life impact of hypoglycaemia on day-to-day living for people with diabetes and the cost to health care systems of hypoglycaemia. To achieve this, we will undertake a set of tasks to assess and value the burden of hypoglycaemia in terms of patient reported outcomes and we will combine analyses of the pooled trial dataset and localised costs to estimate the costs of hypoglycaemia to the health care system in five European countries. WP7 will address the following objectives:
Lead: MUG/NN/MDT
Work package 8 has the following objectives: