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

This study is currently recruiting participants.
Verified December 2013 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01891474
First received: June 28, 2013
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

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).


Condition Intervention
Diabetes
Device: U-health care

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

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Changes of HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Glucose Variability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Target goal of HbA1c (< 7.0%) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Severe hypoglycemia [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]
  • Drug Compliance [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Self monitoring blood glucose compliance [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • weight change [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Diabetes Self-Care Activities [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
  • Michigan Diabetes Knowledge Test [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: August 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: U-health care
voice inception technique based U-healthcare service
Device: U-health care
voice inception technique based U-healthcare service
Other Name: U-health care group
No Intervention: control
conventional 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.

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01891474

Contacts
Contact: Soo Lim, MD, MPH, PhD +82-31-787-7035 limsoo@snu.ac.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Soo Lim, MD, MPH, PhD    +82-31-787-7035    limsoo@snu.ac.kr   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Soo Lim, MD, MPH, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01891474     History of Changes
Other Study ID Numbers: SNUBH_Uhealth2
Study First Received: June 28, 2013
Last Updated: December 31, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 14, 2014