Smartphone Application for Type 2 Diabetes

NCT ID: NCT03468283

Last Updated: 2018-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-07
• Study Completion Date: 2013-03-13

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

mobile application for diabetes

Intervention Type: OTHER

Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

mobile application for diabetes

Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Kangbuk Samsung Hospital

OTHER

Sponsor Role: lead

Responsible Party

Cheol-Young Park

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 32945775 (View on PubMed)

Other Identifiers

KBC12093

Identifier Type: -

Identifier Source: org_study_id