Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo‐RESOLVE) project

Abstract

Background Hypoglycaemia is the most frequent complication of treatment with insulin or insulin secretagogues in people with diabetes. Severe hypoglycaemia, i.e. an event requiring external help because of cognitive dysfunction, is associated with a higher risk of adverse cardiovascular outcomes and all-cause mortality, but underlying mechanism(s) are poorly understood. There is also a gap in the understanding of the clinical, psychological and health economic impact of 'non-severe' hypoglycaemia and the glucose level below which hypoglycaemia causes harm.Aim To increase understanding of hypoglycaemia by addressing the above issues over a 4-year period.Methods Hypo-RESOLVE is structured across eight work packages, each with a distinct focus. We will construct a large, sustainable database including hypoglycaemia data from >100 clinical trials to examine predictors of hypoglycaemia and establish glucose threshold(s) below which hypoglycaemia constitutes a risk for adverse biomedical and psychological outcomes, and increases healthcare costs. We will also investigate the mechanism(s) underlying the antecedents and consequences of hypoglycaemia, the significance of glucose sensor-detected hypoglycaemia, the impact of hypoglycaemia in families, and the costs of hypoglycaemia for healthcare systems.

The suitability of patient-reported outcome measures used to assess the impact of hypoglycaemia on quality of life in people with diabetes: a systematic review using COSMIN methods

“…Our intention was to provide researchers and clinicians with a robust evidence base to assist them when selecting PROMs for this purpose. The review was undertaken as part of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo-RESOLVE) project, an international collaboration of clinicians, scientists, industry partners and people with diabetes [ 21 ].…”

Function and Emotion in Everyday Life With Type 1 Diabetes (FEEL-T1D): Protocol for a Fully Remote Intensive Longitudinal Study

“…FEEL-T1D is, to our knowledge, the first study to examine dynamic reciprocal relationships between blood glucose levels, objective cognitive and physical function, and subjective function and well-being among adults with T1D. It is one of only 3 studies, to our knowledge, using EMA methodology to investigate associations between CGM-derived blood glucose metrics and other momentary variables among individuals with diabetes, with the other 2 being the international HypoRESOLVE (Hypoglycemia Refining Solutions for Better Lives) project [ 57 ] and the DIA-LINK study in Germany [ 58 ]. This study is innovative in its use of CGM, EMA, mobile cognitive testing, and accelerometry, analyzed with sophisticated statistical methods, to achieve its aims.…”

The consequences of hypoglycaemia

“…1 . Individual episodes of hypoglycaemia are inconvenient, unpleasant and potentially dangerous and recurrent episodes have long-term negative health implications that are still being explored [ 61 ]. Minimising hypoglycaemic exposure must remain a key target for diabetes therapies and hypoglycaemia experience must always be a metric for assessing the effectiveness of diabetes management.…”