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AIDA Evaluation 2 (of 14)

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PROTOCOL

The prospective randomised-controlled clinical trial protocol described here makes use of two study arms – each receiving different educational interventions. To date, this approach has been used for a pilot study run at the Ospedale di Marino (Rome, Italy) involving 24 volunteers with insulin-dependent (type 1) diabetes mellitus. A preliminary analysis of the data obtained so far is also outlined here.

During lessons, Arm A of the study was exposed to the AIDA simulator (the active intervention), while Arm B (the Control group) benefited from conventional educational methods using standard presentations with slides and transparencies. Six lessons were held for each study arm (one per week). Attendance at each lesson was recorded, as was the incidence of drop outs from the study.

The subjects also carefully documented the incidence of any symptomatic hypoglycemic episodes (‘hypos’), whether mild (sweating, dizziness), moderate (nausea, vomiting), or severe (requiring assistance).

Fig. 1 - Outline of the study. Preliminary (pre-randomisation) phase.

AIDA EVALUATION - OVERVIEW - FIGURE 1

Footnotes for Fig. 1.

1 Initial invitation(s) / recruitment based on study inclusion / exclusion criteria [5].

2 For the initial pilot study we used the ‘hypo’ / low BG risk and an assessment of ‘education status’ for stratification purposes. Education status was determined by what level (grade) subjects previously reached at school / university. However using education status was found to be not as discriminatory as HbA1c. Therefore for future studies the ‘hypo’ / low BG risk and HbA1c level will be used for stratification purposes.

3 ‘Hypo’ / low BG risk determined from initial 7 days’ self-monitoring blood glucose (SMBG) data collection.

4 Stratification should ensure that equal proportions from each of the four groups should end up in each of the two study arms (ARM A [simulator] or ARM B [conventional education])

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AIDA Website home Return to AIDA Website Home Page 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
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