Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
Medical Ethical Committee of the Academic Medical Centre, Amsterdam approved on the 3rd January 2007 (ref: ABR 15308)
Study design
Single centre randomised controlled intervention trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please email J.Hermanides@amc.uva.nl to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/07/2007
Overall trial end date
01/09/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
20
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
01/09/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
c/o Dr J DeVries
Meibergdreef 9
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academic Medical Centre (AMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20597828
Publication citations
-
Results
Hermanides J, Engström AE, Wentholt IM, Sjauw KD, Hoekstra JB, Henriques JP, DeVries JH, Sensor-augmented insulin pump therapy to treat hyperglycemia at the coronary care unit: a randomized clinical pilot trial., Diabetes Technol. Ther., 2010, 12, 7, 537-542, doi: 10.1089/dia.2010.0023.