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
Secondary identifying numbers N/A
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

Study designSingle centre randomised controlled intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please email J.Hermanides@amc.uva.nl to request a patient information sheet
Scientific titleStrict 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 objectivesUsing 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) studiedST-elevated myocardial infarction, hyperglycaemia
InterventionIntervention 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 typeOther
Primary outcome measureAreas 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 outcome measures1. 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.
Overall study start date01/07/2007
Completion date01/09/2009

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants20
Key inclusion criteria1. 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 criteria1. 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 enrolment01/07/2007
Date of final enrolment01/09/2009

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Meibergdreef 9
Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre

c/o Dr J DeVries
Meibergdreef 9
Amsterdam
1100 DD
Netherlands

Website http://www.amc.nl/
ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Hospital/treatment centre

Academic Medical Centre (AMC) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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