Validation of Diabetes Management Effectiveness of Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring System
Trial ID: NCT04161170
Status: UNKNOWN
Study type: INTERVENTIONAL
Phase: NA
Start date: 2019-11-20
Completion date: 2021-12-31
Sponsor: Samsung Medical Center
Conditions: Type 2 Diabetes
Interventions: Digital integrated healthcare platform
Locations: Samsung Medical Center
Countries: South Korea
Enrollment: 294
Age range: 19 Years - 70 Years
Sex: ALL

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.

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

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