About this trial
Glucose monitoring after Acute Myocardial infarct in people with diabetes is a Dexcom funded study that is investigating whether the use of continuous glucose monitors (Dexcom ONE model) in people with type 2 diabetes facilitates time in glycaemic range in the 6 months after an acute myocardial infarction. As an exploratory outcome it will investigate whether time in glycaemic range is associated with changes in mortality and major adverse cardiac events in the 6 months after acute myocardial infarct.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged >18 years
Known or newly diagnosed type 2 diabetes
Taking one or more oral hypoglycaemic agent, GLP1 receptor analogue and/or insulin
Admitted to Hammersmith Hospital cardiology inpatient services with ACS
Disqualifiers
HbA1c <48mmol/mol
People who have previously had bariatric surgery
People taking hydroxyurea
People who undergo haemodialysis or peritoneal dialysis
Trial design
Single group
Treatments tested in this trial
Dexcom ONE Continuous Glucose Monitoring System
DeviceThe Dexcom ONE is comprised of a sensor, transmitter and display device (receiver and/or compatible smart device). The system features a redesigned, one-touch auto-applicator and sleek, discreet transmitter. CGM involves insertion of a small plastic cannula to the subcutaneous tissue of the abdominal skin by members of the study team. The cannula is attached to a small data. The cannula is attached to a small transmitter which is taped to the skin and sends data about interstitial glucose via Bluetooth to a receiver which displays a blood glucose reading. The Dexcom G6 sends glucose readings to a compatible smart device or the Dexcom receiver every 5 minutes.
Treatment groups
Trial outcomes
Primary outcomes
Primary outcome: Percent time spent in glucose target range (3.9-10mmol/L)
Percent time spent in glucose target range (3.9-10mmol/L)
Secondary outcomes
Number hypoglycaemic excursions.
Number of detected excursions on CGM to glucose \<3.9mmol/L
Time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL; <3.0mmol/L, 54mg/dL),
Time spent with glucose \<3.9mmol/L, time spent with glucose \<3mmol/L
Time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL).
Secondary outcome
Time in hyperglycaemia (>10mmol/L, 180mg/dL).
Secondary outcome
Other outcomes
MACE endpoint defined as death due to cardiac cause or hospitalisation with acute coronary syndrome (including MI and unstable angina); heart failure; unscheduled revascularisation; arrhythmia; cerebrovascular event
Exploratory outcome
All cause mortality
Exploratory outcome
Duration of hospital admission before 'medically fit for discharge'.
Exploratory outcome
Escalation to High Dependency Unit or Intensive Care Unit during primary hospital episode.
Exploratory outcome
Sponsors and contacts
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