October 8, 2019 – Results seem promising
The CE-study has started on 3 June 2019. This was the first period of three, each with 6-8 participants who used the Inreda AP during three weeks in their daily lives. The study period ended on 12 September last. Now that the tests are completed, we will analyse the results. The outcomes so far are positive and promising. We look forward with anticipation to the conclusions of this study.
Then, we expect to obtain CE in May 2020. Later that year, we will set up several larger studies with the Inreda AP. This means that the system, at first, will enter the market in a study setting. We need to do this in order to monitor the long term use of the Inreda AP and eventually to realize a reimbursement of the device. Regulations demand this approach, because the Inreda AP is an innovation, not merely an adaptation of an existing product, such as an insulin pump.