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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Tailored mobile coaching messages


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention-Maintenance group<br>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. | Other: Tailored mobile coaching messages<br>* 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.<br>|
| Active Comparator: Control-Intervention group<br>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. | Other: Tailored mobile coaching messages<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated hemoglobin levels |  | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glycated hemoglobin levels within each group |  | between baseline and 6 months | 
| change in body mass index within each group |  | between baseline and 6 months | 
| change in low-density lipoprotein cholesterol within each group |  | between baseline and 6 months | 
| change in high-density lipoprotein cholesterol within each group |  | between baseline and 6 months | 
| change in triglyceride within each group |  | between baseline and 6 months | 
| change in blood pressure within each group |  | between baseline and 6 months |