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
Summary of Research
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.
Summary of Results
This study explored the relationship between diabetes and adrenal insufficiency (AI), focusing on blood sugar patterns, especially at night. Adrenal insufficiency is a condition where the body does not produce enough cortisol, a hormone essential for regulating blood sugar levels. People with AI need lifelong treatment with steroid medications, such as hydrocortisone or prednisolone, to replace cortisol. When AI occurs alongside insulin-treated diabetes, managing blood sugar levels becomes even more challenging, increasing the risk of complications such as low blood sugar (hypoglycaemia).
The research was led by a team from Imperial College London and Imperial College NHS Trust, supported by a grant from the Imperial Charity Fellowship. It involved 27 adults under specialist endocrine care, including 14 people with both AI and insulin-treated diabetes. The study also included 13 individuals with AI but without diabetes for comparison. Participants were matched based on age, sex, and the type of steroid medication they used.
The study took place at a leading NHS hospital in London, UK, and ran for 30 days. Each participant used a continuous glucose monitoring (CGM) device to track their blood sugar levels throughout the day and night. These devices provided valuable insights into how often participants experienced hypoglycaemia, as well as periods of high blood sugar (hyperglycaemia) and blood sugar levels within the target range. Participants continued their usual treatment with either hydrocortisone or prednisolone, and those with diabetes received additional education on managing their condition if needed.
The results showed that severe hypoglycaemia was rare in this group, which is reassuring for people living with both conditions. There were no significant differences in the frequency of low blood sugar between people using hydrocortisone and those using prednisolone.
This research provides the first published data on blood sugar patterns in people with both insulin-treated diabetes and adrenal insufficiency, highlighting the unique challenges they face. The findings suggest that both steroid medications are generally safe with regard to low blood sugar risks.
The study also underscores the need for further research. Larger studies are required to confirm these findings and explore the long-term impact of different steroid medications on blood sugar control and health outcomes. Such research could help improve care for people managing these complex conditions.
If you would like to learn more about this study, you can visit the clinical trial registry (NCT05806190) or contact Dr. Shaila Khan, at Shaila.khan4@nhs.netREC name
West of Scotland REC 4
REC reference
23/WS/0012
Date of REC Opinion
17 Mar 2023
REC opinion
Further Information Favourable Opinion