Validation of Diabetes Management Effectiveness of Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring System
试验速览
- 阶段
- 不适用
- 入组人数
- 294
- 试验地点
- 2
- 主要终点
- Change of HbA1c (glycated hemoglobin) at 6months from baseline
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Change of HbA1c (glycated hemoglobin) at 6months from baseline
时间窗: Change of HbA1c (glycated hemoglobin) at 6months from baseline
Change of HbA1c (glycated hemoglobin) at 6months from baseline
次要结局
- patient satisfaction questionnaire score(patient satisfaction questionnaire score at baseline, 3, 6, 12 months)
- total cholesterol level(total cholesterol level at baseline, 3, 6, 12 months)
- HbA1c(glycated hemoglobin at baseline, 3, 6, 12 months)
- hypoglycemic events(hypoglycemic events at baseline, 3, 6, 12 months)
- adverse events(adverse events at baseline, 3, 6, 12 months)
- body weight(body weight at baseline, 3, 6, 12 months)
- number of intervention for education in interventinal group C(number of intervention for education in interventinal group C at baseline, 3, 6, 12 months)
- BMI (body mass index)(BMI at baseline, 3, 6, 12 months)
- step count(average step count at baseline, 3, 6, 12 months)
- burned calories(average burned calories at baseline, 3, 6, 12 months)
- walking distances(average walking distances at baseline, 3, 6, 12 months)
- fasting glucose level(average fasting glucose level at baseline, 3, 6, 12 months)
- body fat (%)(body fat (%) at baseline, 3, 6, 12 months)
- intake calories(intake calories at baseline, 3, 6, 12 months)
- time in range of <70mg/dL by CGMS in interventional group C(time in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months)
- time in range of >250 mg/dL by CGMS in interventional group C(time in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months)
- HDL cholesterol level(HDL cholesterol level at baseline, 3, 6, 12 months)
- time in range of <54mg/dL by CGMS in interventional group C(time in range of <54mg/dL by CGMS at baseline, 3, 6, 12 months)
- time in range of >180 mg/dL by CGMS in interventional group C(time in range of >180 mg/dL by CGMS at baseline, 3, 6, 12 months)
- glycemic variability by CGMS in interventional group C(glycemic variability by CGMS at baseline, 3, 6, 12 months)
- time in range of 70-180 mg/dL by CGMS in interventional group C(time in range of 70-180 mg/dL by CGMS at baseline, 3, 6, 12 months)
- Triglycerides level(Triglycerides level at baseline, 3, 6, 12 months)
- LDL cholesterol level(LDL cholesterol level at baseline, 3, 6, 12 months)
- mean glucose level by CGMS (continuous glucose monitoring system) in interventional group C(mean glucose level by CGMS at baseline, 3, 6, 12 months)
- standard deviation by CGMS in interventional group C(standard deviation by CGMS at baseline, 3, 6, 12 months)
- average applying time of CGMS in interventional group C(average applying time of CGMS at baseline, 3, 6, 12 months)
研究者
Jae Hyeon Kim, MD, PhD
Professor
Samsung Medical Center