Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161170
• Other study ID #: 2019-05-028-007
• Status: Recruiting
• Phase: N/A
• Start date: November 20, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2020
• Source: Samsung Medical Center
• Contact: Jae Hyeon Kim, MD PhD
• Phone: +82-2-3410-1580
• Email: jaehyeonmd.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 294
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Digital integrated healthcare platform
Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of HbA1c (glycated hemoglobin) at 6months from baseline	Change of HbA1c (glycated hemoglobin) at 6months from baseline	Change of HbA1c (glycated hemoglobin) at 6months from baseline
Secondary	HbA1c	glycated hemoglobin	glycated hemoglobin at baseline, 3, 6, 12 months
Secondary	number of intervention for education in interventinal group C	The number of educational intervention by digital integrated healthcare platform	number of intervention for education in interventinal group C at baseline, 3, 6, 12 months
Secondary	hypoglycemic events	the number of hypoglycemic events	hypoglycemic events at baseline, 3, 6, 12 months
Secondary	adverse events	the number and types of hypoglycemic events	adverse events at baseline, 3, 6, 12 months
Secondary	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.	patient satisfaction questionnaire score at baseline, 3, 6, 12 months
Secondary	body weight	body weight	body weight at baseline, 3, 6, 12 months
Secondary	BMI (body mass index)	BMI (body mass index)	BMI at baseline, 3, 6, 12 months
Secondary	body fat (%)	body fat (%)	body fat (%) at baseline, 3, 6, 12 months
Secondary	step count	step count	average step count at baseline, 3, 6, 12 months
Secondary	burned calories	burned calories	average burned calories at baseline, 3, 6, 12 months
Secondary	walking distances	walking distances	average walking distances at baseline, 3, 6, 12 months
Secondary	intake calories	intake calories	intake calories at baseline, 3, 6, 12 months
Secondary	fasting glucose level	fasting glucose level	average fasting glucose level at baseline, 3, 6, 12 months
Secondary	total cholesterol level	total cholesterol level	total cholesterol level at baseline, 3, 6, 12 months
Secondary	HDL cholesterol level	HDL cholesterol level	HDL cholesterol level at baseline, 3, 6, 12 months
Secondary	Triglycerides level	Triglycerides level	Triglycerides level at baseline, 3, 6, 12 months
Secondary	LDL cholesterol level	LDL cholesterol level	LDL cholesterol level at baseline, 3, 6, 12 months
Secondary	mean glucose level by CGMS (continuous glucose monitoring system) in interventional group C	mean glucose level by CGMS in interventional group C	mean glucose level by CGMS at baseline, 3, 6, 12 months
Secondary	glycemic variability by CGMS in interventional group C	glycemic variability by CGMS in interventional group C	glycemic variability by CGMS at baseline, 3, 6, 12 months
Secondary	standard deviation by CGMS in interventional group C	standard deviation by CGMS in interventional group C	standard deviation by CGMS at baseline, 3, 6, 12 months
Secondary	average applying time of CGMS in interventional group C	average applying time of CGMS in interventional group C	average applying time of CGMS at baseline, 3, 6, 12 months
Secondary	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 in range of <54mg/dL by CGMS at baseline, 3, 6, 12 months
Secondary	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 in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months
Secondary	time in range of 70-180 mg/dL by CGMS in interventional group C	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
Secondary	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 in range of >180 mg/dL by CGMS at baseline, 3, 6, 12 months
Secondary	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 in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months