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Trial record 1 of 1 for:    NCT04161170
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Digital Integrated Healthcare Platform in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04161170
Recruitment Status : Unknown
Verified January 2020 by Jae Hyeon Kim, MD, PhD, Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : November 13, 2019
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Jae Hyeon Kim, MD, PhD, Samsung Medical Center

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: Digital integrated healthcare platform Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 294 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Change of HbA1c (glycated hemoglobin) at 6months from baseline [ Time Frame: Change of HbA1c (glycated hemoglobin) at 6months from baseline ]
    Change of HbA1c (glycated hemoglobin) at 6months from baseline


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: glycated hemoglobin at baseline, 3, 6, 12 months ]
    glycated hemoglobin

  2. number of intervention for education in interventinal group C [ Time Frame: number of intervention for education in interventinal group C at baseline, 3, 6, 12 months ]
    The number of educational intervention by digital integrated healthcare platform

  3. hypoglycemic events [ Time Frame: hypoglycemic events at baseline, 3, 6, 12 months ]
    the number of hypoglycemic events

  4. adverse events [ Time Frame: adverse events at baseline, 3, 6, 12 months ]
    the number and types of hypoglycemic events

  5. patient satisfaction questionnaire score [ Time Frame: patient satisfaction questionnaire score at baseline, 3, 6, 12 months ]
    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.

  6. body weight [ Time Frame: body weight at baseline, 3, 6, 12 months ]
    body weight

  7. BMI (body mass index) [ Time Frame: BMI at baseline, 3, 6, 12 months ]
    BMI (body mass index)

  8. body fat (%) [ Time Frame: body fat (%) at baseline, 3, 6, 12 months ]
    body fat (%)

  9. step count [ Time Frame: average step count at baseline, 3, 6, 12 months ]
    step count

  10. burned calories [ Time Frame: average burned calories at baseline, 3, 6, 12 months ]
    burned calories

  11. walking distances [ Time Frame: average walking distances at baseline, 3, 6, 12 months ]
    walking distances

  12. intake calories [ Time Frame: intake calories at baseline, 3, 6, 12 months ]
    intake calories

  13. fasting glucose level [ Time Frame: average fasting glucose level at baseline, 3, 6, 12 months ]
    fasting glucose level

  14. total cholesterol level [ Time Frame: total cholesterol level at baseline, 3, 6, 12 months ]
    total cholesterol level

  15. HDL cholesterol level [ Time Frame: HDL cholesterol level at baseline, 3, 6, 12 months ]
    HDL cholesterol level

  16. Triglycerides level [ Time Frame: Triglycerides level at baseline, 3, 6, 12 months ]
    Triglycerides level

  17. LDL cholesterol level [ Time Frame: LDL cholesterol level at baseline, 3, 6, 12 months ]
    LDL cholesterol level

  18. mean glucose level by CGMS (continuous glucose monitoring system) in interventional group C [ Time Frame: mean glucose level by CGMS at baseline, 3, 6, 12 months ]
    mean glucose level by CGMS in interventional group C

  19. glycemic variability by CGMS in interventional group C [ Time Frame: glycemic variability by CGMS at baseline, 3, 6, 12 months ]
    glycemic variability by CGMS in interventional group C

  20. standard deviation by CGMS in interventional group C [ Time Frame: standard deviation by CGMS at baseline, 3, 6, 12 months ]
    standard deviation by CGMS in interventional group C

  21. average applying time of CGMS in interventional group C [ Time Frame: average applying time of CGMS at baseline, 3, 6, 12 months ]
    average applying time of CGMS in interventional group C

  22. time in range of <54mg/dL by CGMS in interventional group C [ Time Frame: time in range of <54mg/dL by CGMS at baseline, 3, 6, 12 months ]
    time in range of <54mg/dL by CGMS in interventional group C

  23. time in range of <70mg/dL by CGMS in interventional group C [ Time Frame: time in range of <70mg/dL by CGMS at baseline, 3, 6, 12 months ]
    time in range of <70mg/dL by CGMS in interventional group C

  24. time in range of 70-180 mg/dL by CGMS in interventional group C [ Time Frame: time in range of 70-180 mg/dL by CGMS at baseline, 3, 6, 12 months ]
    time in range of 70-180 mg/dL by CGMS in interventional group C

  25. time in range of >180 mg/dL by CGMS in interventional group C [ Time Frame: time in range of >180 mg/dL by CGMS at baseline, 3, 6, 12 months ]
    time in range of >180 mg/dL by CGMS in interventional group C

  26. time in range of >250 mg/dL by CGMS in interventional group C [ Time Frame: time in range of >250 mg/dL by CGMS at baseline, 3, 6, 12 months ]
    time in range of >250 mg/dL by CGMS in interventional group C



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04161170


Contacts
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Contact: Jae Hyeon Kim, MD PhD +82-2-3410-1580 jaehyeonmd.kim@samsung.com

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jae Hyeon Kim, M.D.,Ph. D    82-2-3410-1580    jaehyeonmd.kim@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: Jae Hyeon Kim, MD PhD Samsung Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Hyeon Kim, MD, PhD, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04161170    
Other Study ID Numbers: 2019-05-028-007
First Posted: November 13, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jae Hyeon Kim, MD, PhD, Samsung Medical Center:
Continuous glucose monitoring system
Artificial intelligence
Diabetes
Digital healthcare
Education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases