Brain responses to hypoglycaemia awareness restoration programs
Research type
Research Study
Full title
Using neuroimaging to understand the role of cognitions in restoring hypoglycaemia awareness in adults with type 1 diabetes and impaired awareness of hypoglycaemia.
IRAS ID
232646
Contact name
Pratik Choudhary
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Hypoglycemia [low blood glucose] is the major side effect of insulin treatment for type 1 diabetes. Most people are alerted to low blood glucose by symptoms, allowing them to treat the hypoglycemia before glucose drops too low. However, over time, with repeated exposure to hypoglycemia, the brain can get “used” to hypoglycemia and some people lose their ability to detect falling glucose [Impaired awareness of hypoglycemia - IAH] . This puts them at increased risk of severe hypoglycemia [SH], where they may lose consciousness, or have seizures and need someone else to help them. These episodes can lead to injuries and even death in some cases.
Studies using MRI brain scans during controlled experimental hypoglycemia found that those with IAH did not have the normal perception that hypoglycemia was unpleasant or stressful, and these episodes did not have any emotional value that may lead them to avoid such episodes in the future. We think that these thought processes may be a cause that leads to IAH, or may be a barrier to them accessing or utilising treatments that can stop the hypoglycemia.
Addressing these thoughts may be a useful therapeutic strategy, and we are currently in the process of evaluating a novel intervention - Hypoglycemia awareness restoration program [HARPdoc] - comparing it in a randomized controlled trial with another program called Blood glucose awareness training [BGAT]. In this study, we want to see if these interventions can restore to normal the abnormal brain responses to hypoglycaemia seen in people with IAH.
Participants will undergo brain scans during controlled hypoglycemia before and 1 year after the intervention, to evaluate the impact of the intervention on their brain responses to hypoglycemia.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/1464
Date of REC Opinion
27 Sep 2018
REC opinion
Further Information Favourable Opinion