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AIDA Evaluation 10 (of 14)

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DISCUSSION

An initial, pilot evaluation study using this randomised controlled trial (RCT) approach, involving 24 insulin-dependent (type 1) diabetic patients, has been conducted in the Ospedale di Marino in Marino (Rome), Italy. As well as confirming the utility of this evaluation approach – this initial study has also been used to derive data for power calculations (see below) in order to support further, larger-scale studies – to investigate use of the AIDA diabetes simulation approach for supporting interactive clinician / nurse / educator-led education.

It will be self-evident but the ‘wizard’ / teacher / ‘facilitator’ who runs any AIDA-based lessons must be fully conversant with all the simulator’s functions prior to embarking on such a study. Otherwise we may end up assessing the teacher’s learning curve with the program, rather more than how much people with diabetes actually benefit from the lessons.

Larger trials are clearly needed, but this study does demonstrate the feasibility of using a prospective RCT approach for the evaluation of educational diabetes simulation software such as AIDA.


POWER CALCULATIONS

With power calculations it is necessary to know the effect size that one might observe before one can apply such calculations, and with this study it is difficult to be certain what the effect size will really be.

However some power calculation estimates of sample sizes have now been carried out based on the HbA1c data in the n=24 pilot study presented on these Web pages. These estimates, we are reliably informed, suggest that a sample size of at least 36 subjects would be required to show a statistically significant effect on HbA1c levels. Having said that in the n=24 pilot study we observed 7 ‘drop outs’ (5 non-attenders in the control group lessons, and 2 non-attenders in the AIDA simulator group lessons). It is stated a priori in the study protocol [5] that any subject who misses more than 2 lessons is automatically excluded from the study and any subsequent analyses. This gives an overall drop-out rate of 29% for the pilot study.

On the basis of this experience, 52 subjects would need to be recruited in order to be confident to have data at the end of the study for analysis from 36 patients.

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AIDA Website home Return to AIDA Website Home Page AIDA is a freeware diabetic 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 31st December, 2000. (c) www.2aida.org, 2000. All rights reserved. Disclaimer. For the AIDA European Website, please click here. For the Diabetes / Insulin Tutorial, please click here.