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

Kangbuk Samsung Hospital

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Tailored mobile coaching messages

Study type: Interventional

Funder types: Other

Identifiers

NCT03033407

KBSMC 2014-09-021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Intervention-Maintenance group

Experimental group

Description:

Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. This study was divided into two phases. In six-month phase 1 study, the participants in I-M group received tailored mobile coaching. And during the second half six-month phase 2 study, they could receive only regular information messages without individualized coaching.

Treatment:

Other: Tailored mobile coaching messages

Control-Intervention group

Active Comparator group

Description:

Intervention was adding 'Tailored mobile coaching messages' onto conventional diabetes management. In six-month phase 1 study, the participants in Control-Intervention group maintained usual care for diabetes. During the second half six-month phase 2 study, they received tailored mobile coaching.

Treatment:

Other: Tailored mobile coaching messages