Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in 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 have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Voice inception technique based U-healthcare service is expected to improve glycemic control without specific devices. To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between U-health care group (intervention) and conventional treatment group (control).

Detailed Description
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Ubiquitous healthcare for chronic disease such as diabetes is intensively developing field. Nowadays, various methods are tried to find the most effective and easiest way for supplying U-health care. Here, researchers are going to investigate the efficacy and safety of voice inception technique based U-healthcare service.

Official Title
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An Open, Parallel-group, Randomized, Interventional Study to Compare the Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus

Conditions
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Diabetes

Intervention / Treatment
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* Device: U-health care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Type 2 diabetes age: 60   85 yrs HbA1c: 7.0%-11.0% Basal insulin or premixed insulin user Exclusion Criteria: Type 1 diabetes short acting insulin or insulin pump user systemic corticosteroid administered within previous 6 months history of myocardial ischemia Heart failure, New York Heart Association (NYHA) Class II-IV Thyroid disease with abnormal thyroid function test Anti-obesity drugs or slimming products within previous 3 months severe liver or kidney disease

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-health care<br>voice inception technique based U-healthcare service | Device: U-health care<br>* voice inception technique based U-healthcare service<br>* Other names: U-health care group;|
| No Intervention: control<br>conventional treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of HbA1c |  | 24 weeks | 
| Glucose Variability assessed by 3 day SMBG |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target goal of HbA1c (< 7.5%) |  | 24 Weeks | 
| Target goal of HbA1c (< 8.0%) |  | 24 Weeks | 
| Hypoglycemia |  | 24 Weeks | 
| Drug Compliance |  | 24 Weeks | 
| Self monitoring blood glucose compliance |  | 24 Weeks | 
| Weight change |  | 24 Weeks | 
| Quality of life assessed by SF36 |  | 24 Weeks | 
| Diabetes Self-Care Activities |  | 24 Weeks | 
| Michigan Diabetes Knowledge Test |  | 24 Weeks |