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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 7, 2014
Last verified: July 2014
  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: February 2015
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 7, 2014
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 October 19, 2014