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Smartphone Application for Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mobile application for diabetes
Sponsored by
Kangbuk Samsung Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Mobile healthcare, Health Services Research, Community Health Services, Diabetes self-management education

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • aged ≥ 19 years;
  • android smartphone users;
  • no changes in medication for diabetes for at least 6 months;
  • HbA1c levels ≥6.5% within the last 3 months.

Exclusion Criteria:

  • currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation;
  • pregnant or had plans for pregnancy within 6 months;
  • plans to participate in other clinical studies or illiteracy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    control

    Arm Description

    Intervention was the addition of mobile healthcare-based diabetes self-management education, which consisted of "mobile application for diabetes" and individualized regular message feedback sent by healthcare professionals, to current diabetes management.

    Participants of control group maintained previous diabetes management in Kangbuk Samsung Hospital throughout this study. Providers were not involved with patient prescriptions.

    Outcomes

    Primary Outcome Measures

    hemoglobin A1c levels
    serum glycated hemoglobin levels

    Secondary Outcome Measures

    body mass index
    The changes in body mass index
    blood pressure
    The changes in blood pressure
    serum triglyceride
    The changes in serum triglyceride levels
    serum high-density lipoprotein cholesterol
    The changes in serum high-density lipoprotein cholesterol levels
    serum low-density lipoprotein cholesterol
    The changes in serum low-density lipoprotein cholesterol levels
    Summary of Diabetes Self-Care Activities Questionnaire
    scores of Summary of Diabetes Self-Care Activities Questionnaire to measure the current status of diabetic patients' self-care activities (diet, exercise, blood glucose, foot care, and smoking) with each scale of 0 to 7 points.
    Audit of Diabetes Dependent Quality of Life
    scores of Audit of Diabetes Dependent Quality of Life to measure effects of diabetes on the quality of patients' life with each scale of -9 to +3 points.
    the Korean version of the Appraisal of Diabetes Scale
    scores of the Korean version of the Appraisal of Diabetes Scale to measure how diabetic patients recognize about the disease with each scale of 1 to 5 points.
    the Problem Areas in Diabetes
    scores of the Problem Areas in Diabetes to measure level of stress related to diabetes with each scale of 0 to 4 points.

    Full Information

    First Posted
    March 1, 2018
    Last Updated
    March 15, 2018
    Sponsor
    Kangbuk Samsung Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03468283
    Brief Title
    Smartphone Application for Type 2 Diabetes
    Official Title
    A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of Smartphone Application in Patients With Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 7, 2012 (Actual)
    Primary Completion Date
    February 6, 2013 (Actual)
    Study Completion Date
    March 13, 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kangbuk Samsung Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. In addition, this is regarded as the most effective method for prevention and treatment of diabetes. However, many diabetic patients are now reported to lack proper management in Korea with a low level of compliance with treatment instruction. In that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. Accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the Internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. These investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. This clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. This study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (ICF). The subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. Based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. The feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes Mellitus, Type 2
    Keywords
    Mobile healthcare, Health Services Research, Community Health Services, Diabetes self-management education

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    72 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Intervention was the addition of mobile healthcare-based diabetes self-management education, which consisted of "mobile application for diabetes" and individualized regular message feedback sent by healthcare professionals, to current diabetes management.
    Arm Title
    control
    Arm Type
    No Intervention
    Arm Description
    Participants of control group maintained previous diabetes management in Kangbuk Samsung Hospital throughout this study. Providers were not involved with patient prescriptions.
    Intervention Type
    Other
    Intervention Name(s)
    mobile application for diabetes
    Intervention Description
    Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.
    Primary Outcome Measure Information:
    Title
    hemoglobin A1c levels
    Description
    serum glycated hemoglobin levels
    Time Frame
    at six months
    Secondary Outcome Measure Information:
    Title
    body mass index
    Description
    The changes in body mass index
    Time Frame
    at six months
    Title
    blood pressure
    Description
    The changes in blood pressure
    Time Frame
    at six months
    Title
    serum triglyceride
    Description
    The changes in serum triglyceride levels
    Time Frame
    at six months
    Title
    serum high-density lipoprotein cholesterol
    Description
    The changes in serum high-density lipoprotein cholesterol levels
    Time Frame
    at six months
    Title
    serum low-density lipoprotein cholesterol
    Description
    The changes in serum low-density lipoprotein cholesterol levels
    Time Frame
    at six months
    Title
    Summary of Diabetes Self-Care Activities Questionnaire
    Description
    scores of Summary of Diabetes Self-Care Activities Questionnaire to measure the current status of diabetic patients' self-care activities (diet, exercise, blood glucose, foot care, and smoking) with each scale of 0 to 7 points.
    Time Frame
    at six months
    Title
    Audit of Diabetes Dependent Quality of Life
    Description
    scores of Audit of Diabetes Dependent Quality of Life to measure effects of diabetes on the quality of patients' life with each scale of -9 to +3 points.
    Time Frame
    at six months
    Title
    the Korean version of the Appraisal of Diabetes Scale
    Description
    scores of the Korean version of the Appraisal of Diabetes Scale to measure how diabetic patients recognize about the disease with each scale of 1 to 5 points.
    Time Frame
    at six months
    Title
    the Problem Areas in Diabetes
    Description
    scores of the Problem Areas in Diabetes to measure level of stress related to diabetes with each scale of 0 to 4 points.
    Time Frame
    at six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: aged ≥ 19 years; android smartphone users; no changes in medication for diabetes for at least 6 months; HbA1c levels ≥6.5% within the last 3 months. Exclusion Criteria: currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation; pregnant or had plans for pregnancy within 6 months; plans to participate in other clinical studies or illiteracy.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32945775
    Citation
    Lee DY, Yoo SH, Min KP, Park CY. Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial. JMIR Mhealth Uhealth. 2020 Sep 18;8(9):e19153. doi: 10.2196/19153.
    Results Reference
    derived

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    Smartphone Application for Type 2 Diabetes

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