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

ISRCTN	ISRCTN55085730
DOI	https://doi.org/10.1186/ISRCTN55085730
Protocol serial number	N/A
Sponsor	Academic Medical Centre (AMC) (Netherlands)
Funder	Academic Medical Centre (AMC) (Netherlands)

Submission date: 21/07/2009
Registration date: 04/09/2009
Last edited: 07/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr J DeVries
Scientific

Meibergdreef 9
Amsterdam
1100 DD
Netherlands

Study information

Primary study design	Interventional
Study design	Single centre randomised controlled intervention trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Using the Paradigm® Real-Time system that comprises a glucose sensor, insulin pump, and an algorithm advising the optimal insulin bolus, is beneficial for maintaining strict glycaemic control, as compared to the current standard practice in ST-elavated myocardial infarction (STEMI) patients who are admitted to the Coronary Care Unit.
Ethics approval(s)	Medical Ethical Committee of the Academic Medical Centre, Amsterdam approved on the 3rd January 2007 (ref: ABR 15308)
Health condition(s) or problem(s) studied	ST-elevated myocardial infarction, hyperglycaemia
Intervention	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 glucose, using a standardised algorithm and a Paradigm® Real-Time system (combining sensor and pump) is inserted subcutaneously in the abdominal periumbilical skin. If the patient's glucose value exceeds the upper (6.1 mmol/l) or lower range (4.8 mmol/l) an alarm will go off. Pre-meal insulin bolus advice as recommended by the Paradigm Bolus Wizard will be followed. Basal pump rate will be individually calculated and adjusted using a standardised algorithm. After 48 hours, the Paradigm® Real-Time system will be disconnected. Control group: Standard care with blinded continuous glucose monitoring. Before treatment with PTCA, the monitoring part of the Paradigm® Real-Time system (so only the sensor, not the pump) is inserted subcutaneously in the abdominal periumbilical skin of those patients randomised to the control group. In the control group, the Paradigm® Real-Time glucose readings are blinded until after the experiment which helps avoiding confusing interference with standard practice. Responsibility for the standard care will remain with the team of nurses and the consulting internal medicine physician. After 48 hours, the Paradigm® Real-Time sensor will be disconnected.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/09/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	20
Key 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
Key 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
Date of first enrolment	01/07/2007
Date of final enrolment	01/09/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Meibergdreef 9

Amsterdam
1100 DD
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes