the type of treatment or therapy being studied. A therapy could range from a medication addressing a particular characteristic of CF to a device or activity e.g. exercise
the different stages involved in the development of a new medication. Phase I focuses on initial safety in people. Phase 2 evaluates safety, correct dose and early signs of whether the medication works. Phase 3 is the stage before medication licensing and looks at safety and medication effectiveness. Phase 4 evaluates longer term use of a medication after it has been licensed for use
Managing abnormal glucose in cystic fibrosis (MAGIC)- the development of a self-management education programme for people with CFRD
Cystic fibrosis (CF) is a life-shortening genetic disease that damages many of the body’s organs, including the lungs, pancreas and digestive system. Cystic fibrosis related diabetes (CFRD) is the most common complication of CF, affecting 45-50% of adults. CFRD is different from type 1 and 2 diabetes and needs specialist dietary and clinical management. CFRD has a significant effect on nutrition, lung function and survival. The need to educate people with CFRD is important because, keeping blood glucose controlled results in improvements in nutrition, and reduces the development of long term complications from CFRD, including death. NICE recommends that everyone with diabetes should be offered a place on a diabetes self-management education (DSME) programme. However, there are currently no DSME programmes specifically for people with CFRD and there is little evidence to base them on.
This study, informed by the Medical Research Council’s framework for developing complex interventions, aims to develop an evidence-based self-management education programme for people with CFRD that, will be called MAGIC (Managing Abnormal Glucose In Cystic fibrosis). Stage one is a synthesis of qualitative studies and qualitative patient interviews. This will identify patients’ experiences of living with CFRD and their barriers and facilitators to CFRD self-management. It will help establish what educational input people with CFRD want and identify the skills and knowledge people with CFRD require. Stage one will inform stage two. Stage two is the development of the MAGIC programme by a working group of lay members and healthcare professionals. The MAGIC programme will be evaluated with ten CFRD patients within the hospital. This will help inform future studies required to evaluate its effectiveness (feasibility study), and if appropriate a randomised control trial for evaluating the cost-effectiveness and the impact on well-being and survival of the MAGIC programme at a national level.
Trial Reference Number
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Length of participation
the length of time a participant will take part in a trial, from the first to the last appointment
the name of the treatment or therapy being researched
CFRD self-management education programme developed.
the number of participants who need to be recruited for the trial in the UK
CF sponsor type