Hypoglycaemia in people with type 1 diabetes and adrenal insufficiency

• Research type

  Research Study

• Full title

  The effect of prednisolone versus hydrocortisone as glucocorticoid replacement therapy on hypoglycaemia frequency in people with Type 1 diabetes and adrenal insufficiency: a pilot study.

• IRAS ID

  61536

• Sponsor organisation

  King’s College London

• Eudract number

  2008-002336-15

• ISRCTN Number

  xx

• Research summary

  Does changing glucocorticoid replacement from hydrocortisone to prednisolone reduce the frequency of nocturnal hypoglycaemia in people with type 1 diabetes (T1DM) and adrenal insufficiency (AI)? Background: T1DM is due to absent insulin secretion and is treated with insulin replacement. The most serious adverse effect of insulin is hypoglycaemia (low blood glucose). The body has mechanisms to protect against hypoglycaemia including secretion of cortisol, a glucocorticoid hormone, from the adrenal glands. In people with AI cortisol secretion is deficient. People with both T1DM and AI may have increased risk of hypoglycaemia compared to those with T1DM alone.The management of AI includes glucocorticoid replacement, usually with hydrocortisone tablets taken 2-3 times per day with the last dose taken in the late afternoon. Blood cortisol falls to low levels 5-7 hours after taking a hydrocortisone tablet, so this regimen results in low glucocorticoid levels at night. This may predispose to nocturnal hypoglycaemia in people with T1DM. Prednisolone, another glucocorticoid, lasts longer. An alternative regimen is prednisolone taken twice per day, last dose at 6pm. This provides more sustained glucocorticoid levels at night and may therefore reduce nocturnal hypoglycaemia. Both therapies are used for AI in clinical practice, although only hydrocortisone is licensed for AI in the UK. Study design:The study will be run at King??s College Hospital, London and will recruit people with T1DM and AI taking hydrocortisone as glucocorticoid replacement. Participants will be involved in the trial for 11 weeks and will take hydrocortisone for 5 weeks and prednisolone for 5 weeks in random order. Participants will be asked to record all episodes of hypoglycaemia, to keep a diary recording blood glucose readings and insulin doses, to wear a continuous glucose monitoring system (CGMS) for at least 4 days during each study phase and to answer questionnaires about their hypoglycaemia.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  11/LO/0658

• Date of REC Opinion

  31 Aug 2011

• REC opinion

  Further Information Favourable Opinion