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

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
U-health care
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

U-health care

control

Arm Description

voice inception technique based U-healthcare service

conventional treatment

Outcomes

Primary Outcome Measures

Changes of HbA1c
Glucose Variability assessed by 3 day SMBG

Secondary Outcome Measures

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

Full Information

First Posted
June 28, 2013
Last Updated
October 23, 2015
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01891474
Brief Title
Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
U-health care
Arm Type
Experimental
Arm Description
voice inception technique based U-healthcare service
Arm Title
control
Arm Type
No Intervention
Arm Description
conventional treatment
Intervention Type
Device
Intervention Name(s)
U-health care
Other Intervention Name(s)
U-health care group
Intervention Description
voice inception technique based U-healthcare service
Primary Outcome Measure Information:
Title
Changes of HbA1c
Time Frame
24 weeks
Title
Glucose Variability assessed by 3 day SMBG
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Target goal of HbA1c (< 7.5%)
Time Frame
24 Weeks
Title
Target goal of HbA1c (< 8.0%)
Time Frame
24 Weeks
Title
Hypoglycemia
Time Frame
24 Weeks
Title
Drug Compliance
Time Frame
24 Weeks
Title
Self monitoring blood glucose compliance
Time Frame
24 Weeks
Title
Weight change
Time Frame
24 Weeks
Title
Quality of life assessed by SF36
Time Frame
24 Weeks
Title
Diabetes Self-Care Activities
Time Frame
24 Weeks
Title
Michigan Diabetes Knowledge Test
Time Frame
24 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, MPH, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
26658492
Citation
Kim KM, Park KS, Lee HJ, Lee YH, Bae JS, Lee YJ, Choi SH, Jang HC, Lim S. Efficacy of a New Medical Information system, Ubiquitous Healthcare Service with Voice Inception Technique in Elderly Diabetic Patients. Sci Rep. 2015 Dec 11;5:18214. doi: 10.1038/srep18214.
Results Reference
derived

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

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