Cognitions, outcomes and behaviours around hypoglycaemia v3.0
Research type
Research Study
Full title
Characterisation of cognitions, outcomes and behaviours around hypoglycaemia in adults with type 1 diabetes and preserved awareness of hypoglycaemia (COBrAware)
IRAS ID
271164
Contact name
Stephanie A Amiel
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 8 months, 3 days
Research summary
Insulin treatment for type 1 diabetes inevitably carries risk of hypoglycaemia (low blood sugar) which can be severe enough to cause coma, seizure, even death. Being unable to feel when blood glucose is falling, a condition called impaired awareness of hypoglycaemia (IAH), increases risk of severe hypoglycaemia 6-fold. On the other hand, patients with preserved hypoglycaemia awareness (HA) are able to feel when the blood glucose is falling. This is thought to be advantageous, and is associated with a decreased rate of severe hypoglycaemia (SH). However, the risk remains of SH and patients may perceive SH as unpleasant, inconvenient, and frightening - even though medically safe.\n\nThis is a questionnaire based study, using validated questionnaires. The approach is to recruit a cohort of people with T1D with HA and use the questionnaires to characterise their cognitions and behaviours around hypoglycaemia and its avoidance, as well as aspects of quality of life. The HA cohort will be matched for number, gender, age and diabetes duration to the participants in the current HARPdoc trial, all of whom have IAH and SH, and who are completing the same questionnaires. We will compare responses between the matched groups. \n\nThis will be the first study in adults with type 1 diabetes and preserved awareness of hypoglycaemia to characterise such a range of cognitions, outcomes and behaviours and the first to match patients with HA and IAH for diabetes duration. The identification of novel risk factors associated with IAH could inform future intervention development to prevent or reverse IAH.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
19/YH/0390
Date of REC Opinion
11 Nov 2019
REC opinion
Favourable Opinion