NCT04161170

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
294

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2019

Typical duration for not_applicable type-2-diabetes

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

November 20, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

November 8, 2019

Last Update Submit

January 14, 2020

Conditions

Type 2 Diabetes

Keywords

Continuous glucose monitoring systemArtificial intelligenceDiabetesDigital healthcareEducation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (26)

  • HbA1c

    glycated hemoglobin at baseline, 3, 6, 12 months

  • number of intervention for education in interventinal group C

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

  • hypoglycemic events

    hypoglycemic events at baseline, 3, 6, 12 months

  • adverse events

    adverse events at baseline, 3, 6, 12 months

  • patient satisfaction questionnaire score

    patient satisfaction questionnaire score at baseline, 3, 6, 12 months

  • +21 more secondary outcomes

Study Arms (3)

Control A

NO INTERVENTION

no intervention conventional diabetes treatment and clinic visit every 3 months

Intervention B

ACTIVE COMPARATOR

apply digital integrated healthcare platform clinic visit every 3 months

Device: Digital integrated healthcare platform

Intervention C

EXPERIMENTAL

apply digital integrated healthcare platform, CGMS, and medical team monitoring, and education clinic visit every 3 months

Device: Digital integrated healthcare platform

Interventions

Digital integrated healthcare platformDEVICE

Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system

Intervention BIntervention C

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \~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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

RECRUITING

Related Publications (2)

  • Lee YB, Kim G, Jun JE, Park H, Lee WJ, Hwang YC, Kim JH. An Integrated Digital Health Care Platform for Diabetes Management With AI-Based Dietary Management: 48-Week Results From a Randomized Controlled Trial. Diabetes Care. 2023 May 1;46(5):959-966. doi: 10.2337/dc22-1929.

    PMID: 36821833DERIVED

  • 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.

    PMID: 32650771DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Jae Hyeon Kim, MD PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jae Hyeon Kim, MD PhD

CONTACT

+82-2-3410-1580jaehyeonmd.kim@samsung.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 13, 2019

Study Start

November 20, 2019

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)