Clinical trial NCT04161170: Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Continuous glucose monitoring system
Artificial intelligence
Diabetes
Digital healthcare
Education
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2019-11-13
Enrollment: 294
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group A: no intervention Interventional group B: digital integrated healthcare platform Interventional group C: digital integrated healthcare platform + CGMS apply + medical team monitoring + educational intervation
Primary purpose: TREATMENT

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change of HbA1c (glycated hemoglobin) at 6months from baseline
timeFrame: Change of HbA1c (glycated hemoglobin) at 6months from baseline
Secondary outcomes:
measure: HbA1c
timeFrame: glycated hemoglobin at baseline, 3, 6, 12 months
measure: number of intervention for education in interventinal group C
timeFrame: number of intervention for education in interventinal group C at baseline, 3, 6, 12 months
measure: hypoglycemic events
timeFrame: hypoglycemic events at baseline, 3, 6, 12 months
measure: adverse events
timeFrame: adverse events at baseline, 3, 6, 12 months
measure: patient satisfaction questionnaire score
timeFrame: patient satisfaction questionnaire score at baseline, 3, 6, 12 months
measure: body weight
timeFrame: body weight at baseline, 3, 6, 12 months
measure: BMI (body mass index)
timeFrame: BMI at baseline, 3, 6, 12 months
measure: body fat (%)
timeFrame: body fat (%) at baseline, 3, 6, 12 months
measure: step count
timeFrame: average step count at baseline, 3, 6, 12 months
measure: burned calories
timeFrame: average burned calories at baseline, 3, 6, 12 months
measure: walking distances
timeFrame: average walking distances at baseline, 3, 6, 12 months
measure: intake calories
timeFrame: intake calories at baseline, 3, 6, 12 months
measure: fasting glucose level
timeFrame: average fasting glucose level at baseline, 3, 6, 12 months
measure: total cholesterol level
timeFrame: total cholesterol level at baseline, 3, 6, 12 months
measure: HDL cholesterol level
timeFrame: HDL cholesterol level at baseline, 3, 6, 12 months
measure: Triglycerides level
timeFrame: Triglycerides level at baseline, 3, 6, 12 months
measure: LDL cholesterol level
timeFrame: LDL cholesterol level at baseline, 3, 6, 12 months
measure: mean glucose level by CGMS (continuous glucose monitoring system) in interventional group C
timeFrame: mean glucose level by CGMS at baseline, 3, 6, 12 months
measure: glycemic variability by CGMS in interventional group C
timeFrame: glycemic variability by CGMS at baseline, 3, 6, 12 months
measure: standard deviation by CGMS in interventional group C
timeFrame: standard deviation by CGMS at baseline, 3, 6, 12 months
measure: average applying time of CGMS in interventional group C
timeFrame: average applying time of CGMS at baseline, 3, 6, 12 months
measure: time in range of <54mg/dL by CGMS in interventional group C
timeFrame: time in range of <54mg/dL by CGMS at baseline, 3, 6, 12 months
measure: time in range of <70mg/dL by CGMS in interventional group C
timeFrame: time in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months
measure: time in range of 70-180 mg/dL by CGMS in interventional group C
timeFrame: time in range of 70-180 mg/dL by CGMS at baseline, 3, 6, 12 months
measure: time in range of >180 mg/dL by CGMS in interventional group C
timeFrame: time in range of >180 mg/dL by CGMS at baseline, 3, 6, 12 months
measure: time in range of >250 mg/dL by CGMS in interventional group C
timeFrame: time in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jae Hyeon Kim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.