Response to impaired awareness of hypoglycaemia in a study protocol

Al Momani, Huda Y S, Rodriguez Pascual, Carlos, Al-Azzam, Sayer and Ahmadi, Keivan (2021) Response to impaired awareness of hypoglycaemia in a study protocol. Research in Social and Administrative Pharmacy, 17 (10). pp. 1856-1857. ISSN 1551-7411

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Response to impaired awareness of hypoglycaemia in a study protocol
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We thank Dr Brož and Dr Brožová for their interest in our study protocol and their comments. We also thank the Editor for the opportunity to respond to the letter by Brož and Brožová that was recently published in Research in Social and Administrative Pharmacy Journal.1 Broz's letter raised a concern regarding impaired awareness of hypoglycaemia (IAH) and its potential negative effect on the study's results. In this letter we will layout our approach in acknowledging and addressing the IAH.

The ROSE-ADAM randomised controlled trial (RCT) aimed to evaluate the effectiveness of the SUGAR intervention, as an applicable health service, into wider practice.2 Consequently, the RCT was designed to be pragmatic as reported in the study protocol. The eligibility requirements were relaxed so the recruited sample would be more representative of the target population. The exclusion criteria were kept to the minimum and involved only patients with severe medical conditions; whom either had variations in diabetes management approaches or had impaired capacity to understand the study. Accordingly, we believe the exclusion of about 10–37% of insulin-treated patients with type 2 diabetes who are at potential risk of IAH, would limit the generalisability and decrease the statistical power of our study.

Keywords:Randomised control trial, Impaired Awareness of Hypoglycaemia, diabetes mellitus, elderly
Subjects:A Medicine and Dentistry > A990 Medicine and Dentistry not elsewhere classified
Divisions:College of Science > Lincoln Medical School
ID Code:44349
Deposited On:30 Mar 2021 08:22

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