Extrait

Background and study aims Type 1 diabetes mellitus (T1DM) is a lifelong condition where a person is unable to prevent their blood sugar (glucose) levels from becoming too high. When a person is suffering from TD1M, the body is unable to produce a hormone called insulin, which is responsible for breaking down glucose and turning it into energy. The only effective way of treating T1DM is by regularly injecting the insulin that the body is unable to produce. It is very important that sufferers take their insulin regularly, as otherwise it can lead to serious complications. Diabetic ketoacidosis (DKA) is a potentially life-threatening complication of T1DM. When glucose cannot be used for energy because there isn’t enough insulin, the body starts to break down fats. This causes toxic chemicals called ketones to build up in the body which if left untreated, can lead to coma and death. It has been found that T1DM patients who suffer from other illnesses, are more likely to suffer repeated episodes of DKA (recurrent DKA, rDKA) because of not taking insulin or not managing to balance their medication with their lifestyle well enough (disease management). Mentalization-based therapy (MBT) is a type of talking therapy which aims to improve behavioural control, better regulation of emotions, improving personal relationships, and increasing the ability to achieve goals in life. The aim of this study is to assess the feasibility of using MTB as a treatment for diabetic patients with rDKA. Who can participate? Adults with T1DM and have had two or more admissions to hospital for diabetic ketoacidosis in the last 12 months. What does the study involve? In the first part of the study, four diabetes departments in south-east London are asked to count the numbers of potential participants (adults with T1DM who have rDKA) admitted, and the number of those who are transferred to intensive care units. In the second part of the study, participants are offered 40 weekly individual 50 minute mentalization based therapy (MBT) sessions, held at the King's College Hospital diabetes clinic. The participants are followed up at 3 months at which point the number of DKA episodes will be counted as well as having a blood test to test their blood sugar control. Participants also complete a number of questionnaires to assess their mental wellbeing. What are the possible benefits and risks of participating? Participants may benefit from a lower risk of suffering episodes of diabetic ketoacidosis in the future and improvements to their mental wellbeing which is likely to improve their blood sugar control. The main risk is that the program may not succeed and diabetic ketoacidosis admissions continue to occur. Where is the study run from? King's College Hospital (lead centre) and five other NHS hospital in London (UK) When is the study starting and how long is it expected to run for? June 2013 to September 2017 Who is funding the study? Novo Nordisk UK Research Foundation (UK) Who is the main contact? Dr Christopher Garrett [email protected]

Critère d'inclusion

• Diabetic Ketoacidosis

Liens

• isrctn