Hypo-METRICS Version 1.0
Research type
Research Study
Full title
Hypo-METRICS: Hypoglycaemia MEasurement, ThResholds and ImpaCtS
IRAS ID
259415
Contact name
Pratik Choudhary
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 3 months, 29 days
Research summary
Hypoglycaemia or low blood glucose is a major barrier to achieving optimal glucose control. New technology, such as continuous glucose monitors (CGM), help us to better identify hypoglycaemia and develop strategies to avoid it. These devices measure glucose in the interstitial fluid just under skin, rather than in the blood, and provide information not only on how low glucose is, but also for how long. Recent studies showed that over half of episodes of low glucose with these systems are not recognised by people with diabetes, and even people without diabetes can have sensor values that are in the hypoglycaemia range for a prolonged period. In this setting, with increasing use of these devices, we need to firstly better define hypoglycaemia using CGM; and then also evaluate the impact of symptomatic as well as asymptomatic episodes of low sensor glucose on a variety of clinical, patient related and health economic outcomes such as mood, quality of sleep and productivity.
In this multi-national observational study, we will recruit 600 patients using insulin and use CGM devices that are blinded ( to avoid influencing participant behaviour) for 10 weeks, while we use a bespoke app to collect data information on symptomatic hypoglycaemia, as well as on a variety of parameters such as sleep, mood, and well-being. We can then analyse these data to identify the best threshold and duration of low sensor glucose that provides the best match to patient detected hypoglycaemia to provide a better definition of clinically relevant low sensor glucose. We will also evaluate the impact of symptomatic as well as asymptomatic low sensor glucose on the other parameters that we are assessing.
We believe these data will guide our understanding of which low glucose events are harmful, and help assess differences in hypoglycaemia between treatments.REC name
South Central - Oxford B Research Ethics Committee
REC reference
20/SC/0112
Date of REC Opinion
12 Jun 2020
REC opinion
Further Information Favourable Opinion