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?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2017
INTERVENTION: 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 hospital. If the patient would like to take part they are given a Patient Information Leaflet and the Research Nurse takes informed consent. They then are randomly assigned to one of two groups. The standard group have their blood glucose monitored using finger prick testing (as normal) and 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 are not be available to the participant. The intervention group wear a similar sensor on the back of their arm for 90 days (changed every 14 days by the participant following training) and are able to access glucose results using a reader. Both groups attend study visits at day 15, 30, 76 and 91 following enrolment (baseline) and a final follow‐up call are made after one year. Blood tests are taken at baseline and day 91 and participants are asked to fill in three short questionnaires at baseline and day 91. Participants have their blood glucose results reviewed at study visits and treatment may be adjusted accordingly. CONDITION: Specialty: Cardiovascular disease, Primary sub‐specialty: Atherothrombosis; UKCRC code/ Disease: Cardiovascular/ Ischaemic heart diseases, Metabolic and Endocrine/ Diabetes mellitus ; Nutritional, Metabolic, Endocrine ; Diabetes mellitus PRIMARY OUTCOME: 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 OUTCOME: 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 (<3.9 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 days 76‐91 post‐randomisation ; 3. Time per day (00:00 to 23:59) spent in hyperglycaemia (>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; 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
Epistemonikos ID: 6144e7f348f94fd7147136bac2d85c04c6175633
First added on: Aug 23, 2024