Introduction: We developed a unique remote monitoring and control diabetes management system (MDRS) supporting the use of an artificial pancreas (AP) at home. In this study, we aimed at assessing the efficacy and safety of the MDRS and its ability to prevent or shorten nocturnal hypoglycemia episodes without the use of an AP, as well as evaluating parental attitudes toward the use of such a system in the future.
Materials and methods: This was a prospective, case control, randomized study. Eighteen patients treated nightly over a 2-week period by the MDRS were compared with 19 patients treated with sensor-augmented pump (SAP) therapy. We analyzed the performance of the MDRS, the number and duration of hypo- or hyperglycemia episodes, and the efficacy of the MDRS in detecting them. Parents of the study participants completed the hypoglycemia fear survey, attitude, and satisfaction questionnaires.
Results: The MDRS allows continuous monitoring of the patients using it. Without the use of an AP, the MDRS did not significantly prevent nocturnal hypoglycemia episodes. The patients and their parents found the system reliable and user-friendly. The overall impression of the MDRS users was favorable, with a keen interest of the patients and their caregivers to use such a system in the future.
Conclusions: The MDRS is reliable and safe remote monitoring system for AP at-home systems. Remote monitoring of type 1 diabetes patients treated with SAP therapy is a promising and feasible task that is highly anticipated by patients and their caregivers.
Trial registration: ClinicalTrials.gov NCT01509157.