Competence reinforcement for qualitative medical device study

Purpose and goal

The primary purpose of the useability test is to investigate via web-based surveys, distributed at the start and at end of the test period, how patients with insulin-treated type 2 diabetes experience the benefit of Actiste Diabetes Management Service compared to the perceived benefit of the aids they currently use in the treatment of diabetes. In order to properly assess the impact that ADMS may have on everyday life of patients in Sweden, we have used a validated questionnaire MedTech20®, a generic method measuring patient benefits when using any kind of medical device.

Expected results and effects

The domain "Sense of security" received high or very high scores. "Perceived security" and "Sense of control" received the highest scores, 94%, 88%, when the answers "Agree", "Agree a lot" and "Strongly agree" were combined. Current results for "Perceived Reliability" and "Help Remembering Data" were 76.5%, 71%. These results show a high level of confidence in Actiste®. Conclusion: ADMS has perceptions of the respondents as reliable and safe to use and offer a sense of control, which gives confidence in all the attributes associated with "Sense of security".

Planned approach and implementation

Recruitment of researchers will take place at the health center by the responsible diabetes specialist nurse . The research persons to be included as test users will receive information in more detail and the request to test Actiste Diabetes Manage Service ( ADMS) for 90 days. Research persons as well as caregivers will be given a username and password linked to an online information “Actiste Coach site” with access to instructional videos, training materials and practical information and access to the surveys. This study will follow the recommendations of the Declaration of Helsinki.