Randomised controlled trial is a specific type of scientific experiment, and the gold standard for a clinical trial. RCTs are often used to test the efficacy or effectiveness of various types of medical intervention within a patient population. RCTs may also provide an opportunity to gather useful information about adverse effects. In recent years the performance and accuracy of self-monitoring blood glucose (SMBG) devices have been closely watched by regulatory agencies and medical professionals. Mainly, because every day thousands of patients with diabetes lance their fingers many times in order to perform self-monitoring of their blood glucose values.
Material and methods:
Male and female subjects with diabetes type I or II being in good physical and mental health were enrolled in the study. Female subjects were allowed to participate in this study only if they were not pregnant in self reporting. In total 60 diabetic patients were enrolled in the study. The primary objective of this study was to determine and to compare the amount of capillary blood volume collected after a single lancing of the fingertip. In addition, also the perceived pain during the lancing procedure was determined and compared between the lancets.
The average blood volumes obtained with Droplet® personal lancet 33G and Glucoject® personal lancet 33G used in cooperation with Droplet® lancing device, Microlet 2 lancing device and Glucoject® lancing device were in each case higher than 4 µl except for one puncture. In 50% of pricks the obtained average blood volume was higher than 6 µl. Bleeding time was up to 2 minutes. The study results have also shown that in case of majority of patients the received blood sample volume has been higher than 0.5 µl with a total effectiveness rate of 91.67%.Perceived pain was evaluated as a secondary efficacy variable. The pain perception was measured after each prick. 3 minutes (+/- 1 minute) after pricking the subject noted in his/her worksheet intensity of the perceived pain and.
As demonstrated by the results of clinical evaluations, Droplet® personal lancets 33G type 560 and Glucoject® personal lancets 33G type 560 manufactured by HTL-STREFA S.A. provide sufficient blood sample for personal blood glucose level measurements with minimal pain perception.
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