Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis
Conditions
Interventions
Patients who have been identified as eligible (who have had a heart attack in the last 5 days) by the treating Cardiology team are approached by a Research Nurse about the study while they are in hosp
Sponsors
University of Leeds
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients aged = 18 years 2. Type 2 Diabetes Mellitus defined as a preadmission diagnosis 3. Pre-admission treatment of hyperglycaemia with sulphonylurea and/or insulin, with or without additional hypoglycaemic agents 4. MI defined as typical symptoms of cardiac ischaemia associated with a typical rise in troponin levels using the 99th percentile threshold cut-off as per the Third Universal Definition of MI. Patients with either ST-elevation MI (STEMI) or non-ST elevation MI (NSTEMI) are eligible to participate. 5. Patient has provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Solely diet-controlled T2DM preadmission 2. Patient has active malignancy other than localised squamous cell or basal cell skin carcinoma. 3. Patient who has a current pacemaker fitted, known to be pregnant or requiring dialysis. 4. Patient is unable to follow study instructions or considered unsuitable for trial participation at the discretion of the treating clinician/nurse. 5. Patient previously participated in the LIBERATES trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time per day (00:00 to 23:59) spent in euglycaemia (defined as glucose =3.9 and =10.0 mmol/L) is measured using the Self-monitoring of Blood Glucose (SMBG) (Standard Arm) with continuous glucose monitoring using the Freestyle Libre Flash Glucose Monitoring System and Ambulatory Glucose Profile (AGP) between days 76 to 91 post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time per day (00:00 to 23:59) spent in euglycaemia (=3.9 and =10.0 mmol/L) is measured using AGP readings taken automatically by glucose sensor devices worn in each arm of the study between days 15-30 post-randomisation 2.Time per day (00:00 to 23:59) spent in hypoglycaemia (10.0 mmol/L) is measured using AGP readings taken automatically by glucose sensor devices worn in each arm of the study between days 15-30 and 76-91 post-randomisation 4. HbA1c is measured using blood tests measuring for HbA1c readings at day 91 post-randomisation 5. Weight (Kg) is measured using kilograms at baseline and day 91 post-randomisation 6. Blood Pressure is measured using blood pressure monitors at day 91 post-randomisation 7. Health and treatment related quality of life are measured via EQ-5D-5L, Diabetes Treatment Satisfaction Questionnaire and Questionnaire and the Audit of Diabetes Dependent Quality of Life (ADDQoL) questionnaire at 91 days post-randomisation 8. Cost Effectiveness is measured using a validated Health Economics model at day 91 post-randomisation 9. Adverse events measured comparing the number of adverse events reported between the two trial arms at day 91 post-randomisation | — |
Countries
England, United Kingdom
Contacts
Public ContactVictoria;Debbie Goss;Hukins
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Outcome results
None listed