Hypoglycaemia in adults with diabetes and adrenal failure
Research type
Research Study
Full title
Frequency of nocturnal hypoglycaemia in adults with insulin-treated diabetes and adrenal failure using prednisolone or hydrocortisone: a pilot study.
IRAS ID
319768
Contact name
Monika Reddy
Contact email
Sponsor organisation
Imperial College London and Imperial College Healthcare NHS Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 16 days
Research summary
Adrenal insufficiency is a serious condition that requires lifelong steroid replacement and is associated with increased mortality compared to the general population. Individuals with autoimmune primary adrenal failure may have other autoimmune endocrinopathies including type 1 diabetes which is associated with an increased risk of cardiovascular disease and morbidity from hypoglycaemia (low blood sugar levels). The mortality for primary adrenal insufficiency is greater when treated with prednisolone compared to hydrocortisone, both of which are used for steroid replacement in adrenal insufficiency. This proposed study will investigate the frequency of hypoglycaemia as a potential contributor to this mortality excess.
Aims: To assess nocturnal hypoglycaemia in people with adrenal insufficiency and insulin-treated diabetes taking prednisolone and hydrocortisone and compare outcomes with people with adrenal insufficiency without diabetes.
Research procedures: Prospective observational study in people with confirmed adrenal failure and insulin-treated diabetes, who already receive prednisolone or hydrocortisone, with age and sex matched controls without diabetes. We will assess time spent in glucose ranges and number of hypoglycaemic episodes by continuous glucose monitoring. We will compare these outcomes in the prednisolone group versus the hydrocortisone group, and in people with and without diabetes.
Summary: We propose that nocturnal hypoglycaemia is a contributing factor to the excess mortality in people who live with both adrenal insufficiency and insulin-treated diabetes. We plan to establish the optimal treatment for reducing hypoglycaemic episodes. This study will aim to improve safety in a group of individuals with a unique profile of increased mortality and morbidity.
REC name
West of Scotland REC 4
REC reference
23/WS/0012
Date of REC Opinion
17 Mar 2023
REC opinion
Further Information Favourable Opinion