Condition category
Circulatory System
Date applied
21/07/2009
Date assigned
04/09/2009
Last edited
07/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J DeVries

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1100 DD
Netherlands

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

http://www.amc.nl/

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

  1. 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.

Additional files

Editorial Notes