Concept & Approach

The overall aim of our project is to reduce the burden and consequences of hypoglycaemia among people living with diabetes. This requires finding answers to questions which, nearly 100 years after the discovery of insulin, still need to be solved. To help address these questions, we have assembled a unique consortium of leading experts in basic, clinical, psychological/behavioural and economic aspects of hypoglycaemia research, who will work collaboratively with industry partners, and other stakeholder groups. It is our collective aim to tackle these challenges through a comprehensive multi-level approach putting the voices and needs of people living with diabetes at the heart of our research.

In detail, the Hypo-RESOLVE consortium will address the following challenges

Conductingintegratednon-clinicalandtranslational studiestoidentifyunderlyingmolecularmechanisms, consequencesandbiomarkersofimpairedawareness of hypoglycaemia (IAH) and (recurrent) hypoglycaemia.Combininglargedatasetsobtainedfromvarious pharmaceutical/technologycompaniesusing different methods of data captureConductingextensivestatisticalanalysesinlargedata setstoconfirmexistingpredictorsandconsequences of hypoglycaemia and identify new associationsEstablishinghowthevastpotentialofcontinuousglucose monitoring(CGM)systemsasclinicalandresearchtools,can beusedinclinicalpracticeandincorporatedsuccessfullyin future clinical trialsDeterminethepsychologicalimpactofhypoglycaemiain peoplewithdiabetesandfamilymembers,anddevelop patientrelatedoutcome(PRO)measures,whichreliably assessthepsychologicalimpactofhypoglycaemiaand canbeincludedasstandardoutcomemeasuresinfuture clinical trials, both commercial and academicUndertakehealtheconomicanalyseswhichextend beyondseverehypoglycaemiaandwillmeasurethe economic impact of hypoglycaemic episodesEstablishadialoguewithregulatorsandotherstakeholderabout hypoglycaemiaingeneralandmorespecificallythelearningsfrom theHypo-RESOLVEprojectinordertodevelopaconsensuson definitionsanddatacollectionmethodsforthestandardisationof clinical in-vestigations with regard to hypoglycaemia