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

Not Applicable
Completed
Conditions
Diabetes Mellitus
Interventions
Other: Tailored mobile coaching messages
Registration Number
NCT03033407
Lead Sponsor
Kangbuk Samsung Hospital
Brief 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.

Detailed 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 & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
148
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Intervention-Maintenance groupTailored mobile coaching messagesIntervention 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.
Control-Intervention groupTailored mobile coaching messagesIntervention 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.
Primary Outcome Measures
NameTimeMethod
glycated hemoglobin levelsat 6 months
Secondary Outcome Measures
NameTimeMethod
change in blood pressure within each groupbetween baseline and 6 months
change in low-density lipoprotein cholesterol within each groupbetween baseline and 6 months
change in triglyceride within each groupbetween baseline and 6 months
change in body mass index within each groupbetween baseline and 6 months
change in high-density lipoprotein cholesterol within each groupbetween baseline and 6 months
change in glycated hemoglobin levels within each groupbetween baseline and 6 months
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