Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes
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About
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.
Full description
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
Enrollment
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Volunteers
Inclusion criteria
- 19~70 aged patients with type 2 diabetes
- Patients who have not taken diabetic medications for more than 4 weeks and patients who have taken at least one type of oral hypoglycemic agents at same dosage for more than 12 weeks
- Those who have glycated hemoglobin within 7.0% to 8.5% within the last 3 months
- overweight or obese: BMI (body mass index) ≥ 23 kg / m2
- Those who have agreed to use medical record and participate research by applying the digital integrated healthcare platform
- Those who voluntarily signed the consent form after listening the explanation of the clinical trial.
Exclusion criteria
- Diabetes other than type 2 diabetes, including type 1 diabetes and gestational diabetes
- Those who are receiving insulin or GLP-1 agonist other than oral hypoglycemic agents
- Uncontrolled chronic liver disease (hemochromatosis, liver cancer, autoimmune liver disease, cirrhosis of the liver, viral hepatitis-includes all A, B and C, Wilson's disease)
- Those with acute renal failure (up to 1.5 times higher than existing serum creatinine)
- Those with mental illness (schizophrenia, depression, bipolar disorder, etc.)
- Those who are currently taking weight loss agents
- Those who had alcohol or drug addiction within the last three months
- Those who are taking medications that may affect glucose metabolism (eg, corticosteroids, immunoreactive drugs, etc.)
- Those who are pregnant or lactating and planning to become pregnant during the clinical trial (women of childbearing age may agree to the contraceptive plan).
- Those who are deemed inappropriate for participation in clinical trials
Trial design
Primary purpose
Allocation
Interventional model
Masking
294 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Jae Hyeon Kim, MD PhD
Data sourced from clinicaltrials.gov
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