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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Glucose Variability assessed by 3 day SMBG
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
Soo Lim
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Glucose Variability assessed by 3 day SMBG
Time Frame: 24 weeks
Changes of HbA1c
Time Frame: 24 weeks
Secondary Outcomes
- Target goal of HbA1c (< 7.5%)(24 Weeks)
- Target goal of HbA1c (< 8.0%)(24 Weeks)
- Michigan Diabetes Knowledge Test(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)