Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology. To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.

Detailed Description
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Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension. Thus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.

Official Title
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Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes

Intervention / Treatment
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* Device: U-healthcare service
* Device: SMBG group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes age: 60   85 yrs HbA1c: 6.5%-11.0% duration of diabetes: less than 30 years BMI: 20-35 Exclusion Criteria: systemic corticosteroid administered within previous 6 months history of myocardial ischemia Heart failure, NYHA Class II-IV Thyroid disease with abnormal TFT Anti-obesity drugs or slimming products within previous 3 months

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: U-healthcare<br>glucose meter and U-healthcare | Device: U-healthcare service<br>* Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.<br>* Other names: U-healthcare group;|
| Active Comparator: SMBG group<br>Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group. | Device: SMBG group<br>* Glucose control with self monitoring of blood glucose.<br>|
| No Intervention: control<br>conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target goal of HbA1c (< 7.0%) without hypoglycemia | Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  | 24 weeks | 
| amount of exercise |  | 24 weeks | 
| Body mass index (BMI) changes | Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups | Body mass index |