Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes

Samsung Medical Center294 enrolled

Overview

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change of HbA1c (glycated hemoglobin) at 6months from baseline

Time frame: Change of HbA1c (glycated hemoglobin) at 6months from baseline

Secondary Outcomes

HbA1c

glycated hemoglobin

Time frame: glycated hemoglobin at baseline, 3, 6, 12 months

number of intervention for education in interventinal group C

The number of educational intervention by digital integrated healthcare platform

Time frame: number of intervention for education in interventinal group C at baseline, 3, 6, 12 months

hypoglycemic events

the number of hypoglycemic events

Time frame: hypoglycemic events at baseline, 3, 6, 12 months

adverse events

the number and types of hypoglycemic events

Time frame: adverse events at baseline, 3, 6, 12 months

patient satisfaction questionnaire score

patient satisfaction questionnaire score includes 8 questions and each question has score range 0 (min) - 6 (max). For questions number 2 and 3, higher score mean worse outcome in hypoglycemia but for the rest of questions, higher scores mean better outcome in diabetes management.

Time frame: patient satisfaction questionnaire score at baseline, 3, 6, 12 months

body weight

Time frame: body weight at baseline, 3, 6, 12 months

BMI (body mass index)

Time frame: BMI at baseline, 3, 6, 12 months

body fat (%)

Time frame: body fat (%) at baseline, 3, 6, 12 months

step count

Time frame: average step count at baseline, 3, 6, 12 months

burned calories

Time frame: average burned calories at baseline, 3, 6, 12 months

walking distances

Time frame: average walking distances at baseline, 3, 6, 12 months

intake calories

Time frame: intake calories at baseline, 3, 6, 12 months

fasting glucose level

Time frame: average fasting glucose level at baseline, 3, 6, 12 months

total cholesterol level

Time frame: total cholesterol level at baseline, 3, 6, 12 months

HDL cholesterol level

Time frame: HDL cholesterol level at baseline, 3, 6, 12 months

Triglycerides level

Time frame: Triglycerides level at baseline, 3, 6, 12 months

LDL cholesterol level

Time frame: 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 in interventional group C

Time frame: mean glucose level by CGMS at baseline, 3, 6, 12 months

glycemic variability by CGMS in interventional group C

Time frame: glycemic variability by CGMS at baseline, 3, 6, 12 months

standard deviation by CGMS in interventional group C

Time frame: standard deviation by CGMS at baseline, 3, 6, 12 months

average applying time of CGMS in interventional group C

Time frame: average applying time of CGMS 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 in interventional group C

Time frame: time in range of <54mg/dL by CGMS 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 in interventional group C

Time frame: time in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months

time in range of 70-180 mg/dL by CGMS in interventional group C

Time frame: time in range of 70-180 mg/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 in interventional group C

Time frame: time in range of >180 mg/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 in interventional group C

Time frame: time in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months

Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts