Abstract

Effective control of type 1 diabetes mellitus (DM1) is a difficult and burdensome task for the patient and/or his/her parents/caretakers as well as healthcare professionals. Another approach to improve glycemic control could be the use of telemedicine. The purpose of this study was to evaluate the possibility and effectiveness of remote monitoring and education of children with newly diagnosed DM1. Materials and methods of the research: a multicenter prospective open uncontrolled experimental clinical study was conducted between Oct. 2020 and Feb. 2022. The study was conducted in the two clinical centers as follows: Endocrinology Research Centre of the Ministry of Healthcare of Russia; and M.F. Vladimirsky Moscow Oblast Regional Scientific and Research Clinical Institute (MONIKI), both located in Moscow, Russia. Children aged 1 to 18 years old diagnosed with DM1 within 12 weeks prior to inclusion in the study and receiving intensified insulin therapy were invited to participate in the study. Results: the study included 220 children with DM1 living overall the Moscow Oblast region aged 1 to 18 years old (median age 8.1 (5.1–10.9) years old), of which 48% were male and 52% female. During the period of remote monitoring 1062 remote consultations were concluded as follows: 12% via videoconferencing, 64% via audio, and 34% via specialized mobile app. The duration of consultations averaged as follows: 14.9, 20.7 and 14.8 minutes for consultations via videoconferencing, audio and mobile app, respectively. Glycated hemoglobin (HbA1c) level was one of the main indicators for evaluating the effectiveness of participation of children with DM1 in the program of remote observation and education. HbA1c values decreased statistically significantly by the end of the study by –5.0% (p<0.001). As a result, there was a statistically significant (p<0.001) (+55%) increase in the number of children with HbA1c level of less than 7%, thus, most of the children reached the target indicators of glycemic control. In addition to indicators of glycemic control, indicators of the quality of life and the level of distress in parents of children with DM1 were analyzed using specialized questionnaires as supplemental criteria reflecting the clinical effectiveness of remote monitoring. After the first month of participation parents/caretakers showed a statistically significant decrease in the level of stress associated with DM1 in their children (p=0.033), while at the same time the level returned to baseline values (p=0.201) by the end of the project. Conclusion: the outpatient monitoring of children with newly diagnosed DM1 using telemedicine and specialized mobile products (“niche apps”) is an effective (in terms of glycemic control) addition to traditional dispensary monitoring which increases the accessibility of medical care and its convenience to the patients and the quality of life for pediatric patients and their parents/caretakers.

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