Purpose: Gestational Diabetes Mellitus (GDM) is a condition affecting 3-4% of pregnant women due to increased resistance to insulin caused by the growth of the fetus. Such a condition disappears just after delivery, but it is an indicator of the insurgence of diabetes type 2 (DT2) later in life: about 40% of the women affected by GDM also develop DT2 [22]. GDM brings several complications during pregnancy to both the mother and the fetus. We aim here at presenting our Personal Health System for monitoring GDM and we also present the results of outpatient monitoring and management by utilizing a personal health system (PHS) for GDM. Methods: The Personal Health System (PHS) was deployed in a feasibility study, modelled as a single-center, parallel group, open randomized controlled trial conducted in Lausanne University Hospital. Patients (n=24) were assigned to 2 different groups: standard protocol group (SP) and telemedicine group (TM). SP patients were managed by regular clinic visits. TM patients were managed with our EPHS system. The targeted feasibility outcome was whole trial feasibility, functioning of the PHS and its appropriateness for patient use. Results: Mean age was 32±5 years and patients were pregnant for 29.1±1.9 weeks at study inclusion. Patients came from 16 different countries. The follow-up rate was 100%. Acceptability in the TM-group was high, as 100% were satisfied with the care provided and equally 100% were at ease with the technology. Overall median[IQR] glucose control was 5.4 mmol/l [4.7-6.4] in the TM-group and 5.7mmol/l [4.9-6.7] in the SP-group (p<0.001). Four out of 6 daily plasma glucose values were significantly better controlled with telemedicine compared to standard care. Conclusion: The feasibility study that we conducted shows that PHSs have a great potential to improve the life of the patient by allowing a better communication of their physiological values to the caregivers. With respect to the particular case of GDM, the study suggests that use of PHS technology may improve glycaemic control in GDM, but to confirm this trend, a main trial is needed.

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.

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