Results of a post-registration clinical study of the TruCare III insulin pump in children and adolescents with type 1 diabetes mellitus

BACKGROUND: The increase in the incidence of diabetes mellitus, including type 1 diabetes in children, is a priority issue for the national healthcare system. Currently, due to the development of medical technologies, there has been a significant increase in the number of insulin pump dispensers available to patients. It is an important task for the medical community to conduct research aimed at evaluating the effectiveness and safety of these medical devices.

AIM: Analysis of the use of the TruCare III insulin pump (Wuxi Apex Medical Co., Ltd., China) which is registered for use in patients with type 1 diabetes mellitus aged 4 to 17 years, based on four main criteria: effectiveness, safety, tolerability, and ease of use.

MATERIALS AND METHODS: The open-label comparative study involved 30 children aged 8 to 17 years with a diagnosis of type 1 diabetes mellitus who had been receiving insulin therapy with an insulin pump for at least 3 months at the time of the study. The study was conducted at the Russian Children's Clinical Hospital, a branch of the Pirogov Russian National Research Medical University of the Ministry of Health of the Russian Federation (Pirogov University).

RESULTS: The TruCare III insulin pump, manufactured by Wuxi Apex Medical Co., Ltd. (China), fully complies with modern medical technology standards. It has demonstrated high efficiency, safety, good tolerability, and ease of use.

CONCLUSION: In the absence of contraindications to pump-based insulin therapy, the TruCare III insulin pump can be recommended as an alternative to other insulin pump models registered in the Russian Federation for patients with type 1 diabetes, including children and adolescents aged 4 to 17 years.

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