Type 2 Diabetes Clinical Trial
Official title:
Validation of Diabetes Management Effectiveness of Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring System
In this three multicenter clinical trial, investigators will study the efficacy of digital
integrated healthcare platform and CGMS (continuous glucose monitoring system) on diabetes
management in patients with Type 2 diabetes. The platform is based on monitoring and
intervention by medical staff using AI (aritificial intelligence)-based diet management
solution.
The study group includes 3 groups; a total of 294 participants with 1:1:1 randomized
allocation: Control group A (no intervention and conventional diabetes management with
regular outpatiant clinic visit every 3 months), Interventional group B (applying digital
integrated healthcare platform by themselves, no monitoring and intervention by medical
staff), and Interventional group C (applying digital integrated healthcare platform based on
monitoring and intervention by medical staff using AI-based diet management solution and
applying CGMS).
This parallel study will be conducted for 48 weeks.
The reason why it is difficult to improve the lifestyle of patients with diabetes using
existing digital healthcare applications (apps) is that there is a limit of sustainability
that most people do not continue to use digital healthcare apps, thus, it can be possible
only with monitoring and intervention by medical staff.
Not only users, but also medical staff can access integrated biometric data on the digital
integrated healthcare platform so that individual patient-specific management systems that
monitor and intervene can continuously motivate patients to manage themselves. Also, it could
be a prerequisite for the successful management of patients with diabetes using digital
healthcare apps, many existing apps have been identified as failure cases in previous
studies. In this clinical trial, investigators will study the efficacy of digital integrated
healthcare platform based on monitoring and intervention by medical staff using AI
(aritifical intelligence)-based diet management solution.
In addition, in this clinical trial, the latest medical device, real-time continuous glucose
monitoring system (CGMS) will be applied to monitor blood glucose levels. It has been
reported that glucose level is well controlled when the number of self blood glucose
measurement is performed frequently, but in practice, patients have time and space limitation
in self blood glucose measurement, and it is difficult to change the management pattern of
patients by encouraging self blood glucose measurement. Therefore, by applying a CGMS every
three months, not only the patient but also the medical staff can access the 24-hour blood
glucose values, and can actively participate in the blood sugar management of the patients.
Therefore, investigators plan to conduct clinical trial using digital integrated healthcare
platform using AI-based diet management solution and real-time CGMS
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