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

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
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
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
Learn more about this trial
Smartphone Application for Type 2 Diabetes
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