Frequency Of Agreement Feasibility Study

Sanofi-Aventis Research and Development and PAREXEL both funded the study and covered the costs of developing protocols, conducting studies, and collecting and analyzing data. More than 50% of direct and indirect costs have been absorbed by PAREXEL. The second part was a 3-day extension study in which six MT (both as in Part 1 plus four additional MTs: a pulse oxymeter [9], a glycometer [10], a weight scale [11] and an activity monitor worn on the wrist [12] were tested on 22 subjects (Fig. 1; Table 1). A cross-design aspect has been put in place to randomly assign Part 2 subjects, so that half of them collect MT data first and are followed by CSD data, and the other half would first collect CSD data, followed by MT data. Participation in Part 2 was optional; A total of 18 Part 1 subjects chose to participate, while 4 others were recruited from Sanofi`s study to participate only in the second part. Thirteen subjects were randomly assigned during the extension study to be placed in the UPR for 3 days, while 9 subjects had to leave the UPR on the afternoon of the first day (after the last measurement of the data) and the remaining measurements were performed at home only with STMs. In the extension study, four different physical tests were conducted to simulate some typical clinical tests and to vary the conditions (such as tranquility, low activity, high activity) in which data from TM were collected (Table 2). All TM were CE-marked (legal requirement to market a device in the European Union) and all TM, with the exception of the Striiv Activity Monitor and the A-D Weight Scale, had received a provision from the FDA for a significant equivalency of 510 (k) (Table 1). As the research was exploratory, no statistical hypothesis was given, no performance calculations were made to determine sample size, and no p-value is reported. Different scenarios were studied for some devices and parts of the study (for example. B analyses based on 1-day 1-14-day data of the pre-dose dose or on the basis of data from the Part 2 tests. The devices were assessed for repeatability (the amount of variation within a subject on the same device under the same conditions) and the amount of variability and accuracy between the pair of devices versus the CAR).

Due to the exploratory nature of the study, no definitive conclusions were reached as to the interchangeability of the devices. Nevertheless, the data provide general information on the performance of the device and recommendations for the future design of the studies. Mobile technology and standard clinical device pairs were tested in parts 1 and 2 of the study. Finally, an important finding of this study is that the documented performance of STMs (i.e. reliability, repeatability and compliance with accepted reference devices) in pilot trials has been essential, even for 510 (k) and CE-labelled MTs, to provide expectations for their use in clinical trials [6].