Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: U-health care

• Registration Number: NCT01891474
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2013-06-28
• Study First Submitted QC: 2013-06-28
• Study First Posted: 2013-07-03
• Study Start: 2013-08
• Primary Completion: 2015-01
• Study Completion: 2015-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Type 2 diabetes
• age: 60 ~ 85 yrs
• HbA1c: 7.0%-11.0%
• Basal insulin or premixed insulin user

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
U-health care	U-health care	voice inception technique based U-healthcare service

Primary Outcome Measures

Name	Time	Method
Changes of HbA1c	24 weeks
Glucose Variability assessed by 3 day SMBG	24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of