Glucose Monitoring After Acute Myocardial Infarct in People With Diabetes

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorImperial College London

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Dexcom ONE Continuous Glucose Monitoring System

    Device

    The 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

160 Participants
are divided into 4 treatment groups
Group A: Real time CGM post acute myocardial infarctExperimental treatment 1 intervention
Group B: Blinded CGM post acute myocardial infarctNo intervention 0 interventions
Group C: Blinded CGM historical acute myocardial infarct (>6 months and <10 years ago)No intervention 0 interventions
Group D: Cardiovascular outcomes control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Primary outcome: Percent time spent in glucose target range (3.9-10mmol/L)

Percent time spent in glucose target range (3.9-10mmol/L)

Time frame
26 weeks

Secondary outcomes

1

Number hypoglycaemic excursions.

Number of detected excursions on CGM to glucose \<3.9mmol/L

Time frame
26 weeks
2

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 frame
26 weeks
3

Time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL).

Secondary outcome

Time frame
26 weeks
4

Time in hyperglycaemia (>10mmol/L, 180mg/dL).

Secondary outcome

Time frame
26 weeks

Other outcomes

1

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

Time frame
26 weeks
2

All cause mortality

Exploratory outcome

Time frame
26 weeks
3

Duration of hospital admission before 'medically fit for discharge'.

Exploratory outcome

Time frame
26 weeks
4

Escalation to High Dependency Unit or Intensive Care Unit during primary hospital episode.

Exploratory outcome

Time frame
26 weeks

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