Smartphone Application for Type 2 Diabetes

A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of Smartphone Application in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: mobile application for diabetes

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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.	Other: mobile application for diabetes; Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.
No Intervention: control; Participants of control group maintained previous diabetes management in Kangbuk Samsung Hospital throughout this study. Providers were not involved with patient prescriptions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin A1c levels	serum glycated hemoglobin levels	at six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	The changes in body mass index	at six months
blood pressure	The changes in blood pressure	at six months
serum triglyceride	The changes in serum triglyceride levels	at six months
serum high-density lipoprotein cholesterol	The changes in serum high-density lipoprotein cholesterol levels	at six months
serum low-density lipoprotein cholesterol	The changes in serum low-density lipoprotein cholesterol levels	at six months
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.	at six months
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.	at six months
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.	at six months
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.	at six months

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2012
• Primary Completion (Actual): February 6, 2013
• Study Completion (Actual): March 13, 2013

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 15, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2018
• Last Update Submitted That Met QC Criteria: March 15, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Health Services Research; Community Health Services; Diabetes self-management education; Mobile healthcare
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: KBC12093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No