Can a new method of monitoring improve the control of blood glucose levels in patient with Type II diabetes who have had a heart attack?

Phase 2

Completed

• Conditions: Specialty: Cardiovascular disease, Primary sub-specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Ischaemic heart diseases, Metabolic and Endocrine/ Diabetes mellitus; Nutritional, Metabolic, Endocrine; Diabetes mellitus

• Registration Number: ISRCTN14974233
• Lead Sponsor: niversity of Leeds

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33081502/ protocol (added 23/10/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36516054/ (added 11/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-13
• Study Completion: 2020-04-30
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 141

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.