Smartphone Application for Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03468283
• Other study ID #: KBC12093
• Status: Completed
• Phase: N/A
• First received: March 1, 2018
• Last updated: March 15, 2018
• Start date: August 7, 2012
• Est. completion date: March 13, 2013

Study information

• Verified date: March 2018
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: March 13, 2013
• Est. primary completion date: February 6, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• mobile application for diabetes
Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin A1c levels	serum glycated hemoglobin levels	at six months
Secondary	body mass index	The changes in body mass index	at six months
Secondary	blood pressure	The changes in blood pressure	at six months
Secondary	serum triglyceride	The changes in serum triglyceride levels	at six months
Secondary	serum high-density lipoprotein cholesterol	The changes in serum high-density lipoprotein cholesterol levels	at six months
Secondary	serum low-density lipoprotein cholesterol	The changes in serum low-density lipoprotein cholesterol levels	at six months
Secondary	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
Secondary	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
Secondary	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
Secondary	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