Strict glycaemic control in ST-elevation myocardial infarction patients at the coronary care unit using the Paradigm® Real-Time system

Strict glycaemic control in ST-elevation myocardial infarction patients at the coronary care unit using the Paradigm® Real-Time system: a single-centre randomised controlled intervention trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN55085730

Enrollment

Registered

2009-09-04

Start date

2007-07-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ST-elevated myocardial infarction, hyperglycaemia Circulatory System Acute myocardial infarction

Interventions

Intervention group: Insulin treament with sensor augmented insulin pump. Before the STEMI patients are treated with PTCA, an intravenous starting insulin bolus is injected based on the at-admission g

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent 2. Admitted to the Critical Care Unit (CCU) after primary percutanerous transluminal coronary angioplasty (PTCA) for acute STEMI 3. Admission glucose concentration greater than or equal to 7.7 mmol/l, either known or not known with previous diabetes mellitus 4. Aged 30 - 80 years, inclusive, either sex

Exclusion criteria

Exclusion criteria: 1. Known type 1 diabetes mellitus 2. Abdominal abnormalities that might hinder either glucose measurement by the sensor or the continuous subcutaneous insulin infusion 3. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results 4. Simultaneous participation in other studies

Design outcomes

Primary

Measure	Time frame
Areas under the curve (AUCs) and percentage of time spent greater than or equal to 7.7 mmol/l and less than or equal to 3.9 mmol/l per patient as assessed by the Paradigm® Real-Time system in the treatment group compared to the control group. All endpoints (both primary and secondary) will be measured at 48 and 72 hours after admission.	—

Secondary

Measure	Time frame
1. Mean absolute difference between reference blood glucose and glucose values measured by the Paradigm® Real-Time system 2. Bland Altman analysis of the reference blood glucose and glucose values measured by the Paradigm® Real-Time system 3. ST resolution, difference between intervention and control group 4. Changes in cardiological parameters, differences between intervention and control group All endpoints (both primary and secondary) will be measured at 48 and 72 hours after admission.	—

Measure

Time frame

1. Mean absolute difference between reference blood glucose and glucose values measured by the Paradigm® Real-Time system 2. Bland Altman analysis of the reference blood glucose and glucose values measured by the Paradigm® Real-Time system 3. ST resolution, difference between intervention and control group 4. Changes in cardiological parameters, differences between intervention and control group All endpoints (both primary and secondary) will be measured at 48 and 72 hours after admission.

—

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026