Skin temperature sensor to identify hypoglycaemia.
Research type
Research Study
Full title
Feasibility assessment of the potential for using a skin temperature sensor to identify hypoglycaemia in the sleeping child with diabetes
IRAS ID
124610
Contact name
Julian Hamilton-Shield
Contact email
Research summary
Feasibility assessment of the potential for using a skin temperature sensor to identify hypoglycaemia in the sleeping child with diabetes.\n\nHypoglycaemia is a major side effect of insulin therapy for diabetes in childhood. The current incidence of severe hypoglycaemia in type 1 diabetes is about one event per child per year. Parents are particularly worried about hypoglycaemic events during the night as these may go unrecognised by parent or child leading to coma, seizures and death. There are currently no easy and patient acceptable ways to continuously monitor blood sugar levels overnight. Associated with hypoglycaemia, the body undergoes significant activation of the autonomic nervous system leading to changes in skin blood flow and temperature. \n\nWe wish to study a novel skin sensor developed from a similar device already in use to monitor fertility induced temperature changes in ovulating women, to examine if the device is sensitive enough to pick up changes in skin temperature and sweating during periods of hypoglycaemia in children. If these initial studies are promising, the sensor will be further developed into a compact wireless device designed to alarm when these events occur, thus alerting parents to this potentially serious scenario during diabetes therapy.\n\nIn this feasibility study, children with diabetes will not be studied as hypoglycaemia cannot be predicted nor induced in this population. However, in children with poor linear growth hypoglycaemia is induced with insulin in a controlled setting in the paediatric endocrine department as it is the best method of evaluating growth hormone responses. The device will therefore be evaluated initially as a “proof of principle study” in this cohort of children in whom hypoglycaemia is predictable and safely monitored within the hospital clinical investigations unit. This will provide sufficient information to assess the potential for practical device use and its further development.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
14/WM/0002
Date of REC Opinion
26 Feb 2014
REC opinion
Further Information Favourable Opinion