LIBERATES
Research type
Research Study
Full title
IMPROVING GLUCOSE CONTROL IN PATIENTS WITH DIABETES FOLLOWING MYOCARDIAL INFARCTION: THE ROLE OF A NOVEL GLYCAEMIA MONITORING STRATEGY
IRAS ID
223768
Contact name
Ramzi Ajjan
Contact email
Sponsor organisation
University of Leeds
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The LIBERATES study is investigating new ways to monitor blood sugar (glucose) in patients with Type 2 Diabetes who have had a heart attack. The aim is to see if patients using the new way to monitor blood glucose improve overall glucose levels by keeping them in the normal range, which may improve outcome and quality of life. Patients who have been identified as eligible (who have had a heart attack in the last 5 days) by the treating Cardiology team will be approached by a Research Nurse about the study while they are in hospital. If the patient would like to take part they will be given a Patient Information Leaflet and the Research Nurse will take informed consent. They will then be randomly assigned to one of two groups. The standard group will monitor their blood glucose using finger prick testing (as normal) and will wear a small sensor on the back of the arm that analyses glucose levels in detail between days 0-30 and 76-90. The results from this sensor are for research purposes only and will not be available to the participant. The intervention group will wear a similar sensor on the back of their arm for 90 days (changed every 14 days by the participant following training) and will be able to access glucose results using a reader. Both groups will attend study visits at day 15, 30, 76 and 91 following enrolment (day 0) and a final follow-up call will be made after one year. Blood tests will be taken at day 0 and day 91 and participants will be asked to fill in three short questionnaires at day 0 and day 91. Participants will have their blood glucose results reviewed at study visits and treatment may be adjusted accordingly.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
17/YH/0163
Date of REC Opinion
28 Jun 2017
REC opinion
Further Information Favourable Opinion