Abstrakt
We read with interest the protocol of the SUGAR intervention study by Almomani et al. that was published recently in Research in Social and Administrative Pharmacy. The study aims to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus.
Although we agree with the most parts of the protocol outline, we would like to make one comment focused on impaired awareness of hypoglycemia (IAH) that may contribute to a further and more detailed discussion of the issue. Up to 10% of insulin-treated patients with type 2 diabetes develop IAH, which greatly increases the risk of mild and severe hypoglycemia.
As these patients usually report any or only reduced number of hypoglycemia, we believe that the involvement of such patients into the study might significantly negatively influence the study results. Thus we recommend using, for example, a method of Gold et al. to evaluate the presence and level of IAH.
This method poses the question "do you know when your hypos are commencing?" The respondent then completes a 7-point Likert scale, with 1 representing "always aware" and 7 representing "never aware". A score of >=4 implies IAH, and we suggest to exclude these individuals from the study.
With great respect, we suggest taking these comments into consideration if the study protocol will be revisited.