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Randomised controlled trial evaluation |
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Welcome to the Web-based AIDA evaluation - randomisation facility
The way this randomisation process works is by stratifying patients by both 'hypo' risk and HbA1c levels. The reason for doing this is to ensure that there are not too many patients with low (or high) 'hypo' risk in either the AIDA simulator or control groups. Similarly we wish to try and ensure that there are not too many (or too few) patients of either high or low HbA1c levels in either the AIDA simulator or control groups.
Therefore, before we can proceed with randomisation, you need to separate your patients into four groups - as shown below:
1. Low 'hypo' risk, low HbA1c level patients
2. High 'hypo' risk, low HbA1c level patients
3. Low 'hypo' risk, high HbA1c level patients
4. High 'hypo' risk, high HbA1c level patients
'Hypo' risk is categorized based on symptomatic 'hypo' event data and self-monitoring blood glucose (SMBG) data collection during the previous week.
- Low 'hypo' risk is defined as no symptomatic hypoglycaemic events and recorded SMBG data greater than (or equal to) 70 mg/dl (3.9 mmol/l) during that week.
- High 'hypo' risk is defined as any symptomatic hypoglycaemic event(s) or recorded SMBG data less than 70 mg/dl (3.9 mmol/l) during that week.
HbA1c levels are categorized based on the average (arithmetic mean) HbA1c level for each participant over the past 12 months. This provides an indication of their recent metabolic control.
The cutoff to be applied to separate a low HbA1c from a high HbA1c is the average HbA1c level for the group being randomised. While the arithmetic mean could be used - it would be better to make use of the median (50th percentile) - so that half of the group had an HbA1c level above the median while the other half of the group had an HbA1c level below the median.
In this way, each group for randomisation can be split into two, according to their recent HbA1c levels. Each participating centre should have its patients randomised separately.
Having arranged your patients into four groups - by 'hypo' risk and HbA1c levels - you can now proceed to submit their details below - in order to have them randomly assigned to the AIDA simulator or control groups. Should you have any queries about any of this process - please do not hesitate to contact Dr. Eldon Lehmann by using the on-line AIDA contact form.
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AIDA is a freeware diabetes software simulator program of glucose-insulin action + insulin dose & diet adjustment in diabetes mellitus. It is intended purely for education, self-learning and / or teaching use. It is not meant for individual blood glucose prediction or therapy planning. Caveats
This Web page was last updated on 11th March, 2001. (c) www.2aida.org, 2000. All rights reserved. Disclaimer. For the AIDA US Mirror Site, please click here. For the Diabetes / Insulin Tutorial, please click here.
