Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Digital integrated healthcare platform

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 294
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Recruiting
    • Samsung Medical Center
    • Contact: Jae Hyeon Kim, M.D.,Ph. D; Phone Number: 82-2-3410-1580; Email: jaehyeonmd.kim@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control A; no intervention conventional diabetes treatment and clinic visit every 3 months
Active Comparator: Intervention B; apply digital integrated healthcare platform clinic visit every 3 months	Device: Digital integrated healthcare platform; Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system
Experimental: Intervention C; apply digital integrated healthcare platform, CGMS, and medical team monitoring, and education clinic visit every 3 months	Device: Digital integrated healthcare platform; Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	glycated hemoglobin	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	number of intervention for education in interventinal group C at baseline, 3, 6, 12 months
hypoglycemic events	the number of hypoglycemic events	hypoglycemic events at baseline, 3, 6, 12 months
adverse events	the number and types of hypoglycemic events	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.	patient satisfaction questionnaire score at baseline, 3, 6, 12 months
body weight	body weight	body weight at baseline, 3, 6, 12 months
BMI (body mass index)	BMI (body mass index)	BMI at baseline, 3, 6, 12 months
body fat (%)	body fat (%)	body fat (%) at baseline, 3, 6, 12 months
step count	step count	average step count at baseline, 3, 6, 12 months
burned calories	burned calories	average burned calories at baseline, 3, 6, 12 months
walking distances	walking distances	average walking distances at baseline, 3, 6, 12 months
intake calories	intake calories	intake calories at baseline, 3, 6, 12 months
fasting glucose level	fasting glucose level	average fasting glucose level at baseline, 3, 6, 12 months
total cholesterol level	total cholesterol level	total cholesterol level at baseline, 3, 6, 12 months
HDL cholesterol level	HDL cholesterol level	HDL cholesterol level at baseline, 3, 6, 12 months
Triglycerides level	Triglycerides level	Triglycerides level at baseline, 3, 6, 12 months
LDL cholesterol level	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 in interventional group C	mean glucose level by CGMS at baseline, 3, 6, 12 months
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Investigators: Principal Investigator: Jae Hyeon Kim, MD PhD, Samsung Medical Center

Publications and helpful links

General Publications

• Park SW, Kim G, Hwang YC, Lee WJ, Park H, Kim JH. Validation of the effectiveness of a digital integrated healthcare platform utilizing an AI-based dietary management solution and a real-time continuous glucose monitoring system for diabetes management: a randomized controlled trial. BMC Med Inform Decis Mak. 2020 Jul 10;20(1):156. doi: 10.1186/s12911-020-01179-x.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Anticipated): August 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 8, 2019
• First Posted (Actual): November 13, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Diabetes; Artificial intelligence; Education; Continuous glucose monitoring system; Digital healthcare
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2019-05-028-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No