Strict glycaemic control in ST-elevation myocardial infarction patients at the coronary care unit using the Paradigm® Real-Time system
ISRCTN | ISRCTN55085730 |
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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
Scientific
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
Study information
Study design | Single centre randomised controlled intervention trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
Participant information sheet | Not available in web format, please email J.Hermanides@amc.uva.nl to request a patient 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 | 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 outcome measures | 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. |
Overall study start date | 01/07/2007 |
Completion date | 01/09/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Both |
Target number of participants | 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
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
c/o Dr J DeVries
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
Website | http://www.amc.nl/ |
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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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 01/07/2010 | Yes | No |