Type 2 Diabetes Patients Benefit from the COMODITY12 mHealth System: Results of a Randomised Trial.

Patient acceptance is one of the major barriers toward widespread use of mHealth systems. The aim of this study was to assess system operability and whole trial feasibility, including patients' experience with their use of COMMODITY12 mHealth system under. Secondary study aims included assessment of several metabolic parameters as well as patient adherence to the treatment. This was a prospective parallel-arm randomized controlled trial in outpatients diagnosed with DM2, being treated in the primary care settings in Lodz region, Poland, with 6 weeks period of follow-up. Patients opinions were collected with 7-item questionnaire, assessing different aspects of system use, as well as EuroQol-5D-5 L questionnaire, assessing health-related quality of life. Sixty patients (female, 24, male, 36, mean age +/- SD 59.5 +/- 6.8) completed study. All four layers of the COMMODITY12 system proved to work smooth under real-life conditions, without major problems. All dimensions of experience with system use were assessed well, with maximum values for clearness of instructions, and ease of use (4.80, and 4.63, respectively). Health related quality of life, as assessed with cumulative utility measure, improved significantly in COMMODITY12 system users (P < 0.05). mHealth system modestly improved glycaemic and blood pressure control, assuring high level of patient adherence with overall adherence reaching 92.9 %. Study proved that the COMODITY12 system is well accepted by type 2 diabetes patients taking part in clinical trial, leading to several clinical benefits, and improved quality of life. Nevertheless, before future commercialisation of the system, several minor problems identified during the study need to be addressed.