A Study to Evaluate the Efficacy of Diabetes Management Based on Ubiquitous Healthcare System

Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Controlled, Open-label Study to Evaluate the Efficacy of the S-Diabetes Care Program Based on Ubiquitous Healthcare System in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033407
• Other study ID #: KBSMC 2014-09-021
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: January 24, 2017
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: January 2017
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.

Description:

The incidence and prevalence of type 2 diabetes is increasing rapidly worldwide. Considering the fact that complications of diabetes result in greater expenditure and reduced productivity is a socioeconomic concern, adequate glycemic control is important not only as individual health problem but also as challenge to healthcare systems worldwide. To support patients' behavior change efforts, including healthy lifestyle choices, disease self-management, and prevention of diabetes complication, multifaceted professional interventions are needed. Ubiquitous healthcare based on information and communication technology is one of these approaches.

The aim of this study is to investigate whether adding tailored mobile coaching system to present community primary care for diabetes management would result in better glycemic control and other diabetes-related outcomes in adult patients with type 2 diabetes, compared with maintaining usual diabetes management only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Korean policyholders with type 2 diabetes;

• Aged = 19 years;

• Smartphone users;

• Glycated hemoglobin (HbA1c) = 6.5% within 3 months.

Exclusion Criteria:

• Currently had serious concomitant disease other than diabetes;

• Had admission histories due to malignancy, myocardial infarction, cerebral infarction, or organ transplantation;

• Pregnant or had plan for pregnancy within 6 months;

• Planned for attending other clinical;

• Illiteracy.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Tailored mobile coaching messages
Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glycated hemoglobin levels		at 6 months
Secondary	change in glycated hemoglobin levels within each group		between baseline and 6 months
Secondary	change in body mass index within each group		between baseline and 6 months
Secondary	change in low-density lipoprotein cholesterol within each group		between baseline and 6 months
Secondary	change in high-density lipoprotein cholesterol within each group		between baseline and 6 months
Secondary	change in triglyceride within each group		between baseline and 6 months
Secondary	change in blood pressure within each group		between baseline and 6 months