Clinical trial NCT03468283: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Mobile healthcare
Health Services Research
Community Health Services
Diabetes self-management education
Lead sponsor: Kangbuk Samsung Hospital
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: hemoglobin A1c levels
timeFrame: at six months
Secondary outcomes:
measure: body mass index
timeFrame: at six months
measure: blood pressure
timeFrame: at six months
measure: serum triglyceride
timeFrame: at six months
measure: serum high-density lipoprotein cholesterol
timeFrame: at six months
measure: serum low-density lipoprotein cholesterol
timeFrame: at six months
measure: Summary of Diabetes Self-Care Activities Questionnaire
timeFrame: at six months
measure: Audit of Diabetes Dependent Quality of Life
timeFrame: at six months
measure: the Korean version of the Appraisal of Diabetes Scale
timeFrame: at six months
measure: the Problem Areas in Diabetes
timeFrame: at six months
Other outcomes:
Locations:
Study officials:
References:
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.