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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01891474
• Other study ID #: SNUBH_Uhealth2
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: October 23, 2015
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• U-health care
voice inception technique based U-healthcare service

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of HbA1c		24 weeks	No
Primary	Glucose Variability assessed by 3 day SMBG		24 weeks	No
Secondary	Target goal of HbA1c (< 7.5%)		24 Weeks	Yes
Secondary	Target goal of HbA1c (< 8.0%)		24 Weeks	Yes
Secondary	Hypoglycemia		24 Weeks	No
Secondary	Drug Compliance		24 Weeks	No
Secondary	Self monitoring blood glucose compliance		24 Weeks	No
Secondary	Weight change		24 Weeks	No
Secondary	Quality of life assessed by SF36		24 Weeks	No
Secondary	Diabetes Self-Care Activities		24 Weeks	No
Secondary	Michigan Diabetes Knowledge Test		24 Weeks	No