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

October 23, 2015 updated by: Soo Lim, Seoul National University Bundang Hospital

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seongnam, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
conventional treatment
Experimental: U-health care
voice inception technique based U-healthcare service
Device: U-health care
voice inception technique based U-healthcare service
Other Names:
  • U-health care group

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Investigators

  • Principal Investigator: Soo Lim, MD, MPH, PhD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

June 28, 2013

First Submitted That Met QC Criteria

June 28, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUBH_Uhealth2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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