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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01891474
First received: June 28, 2013
Last updated: October 23, 2015
Last verified: October 2015
  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
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

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

Primary Outcome Measures:
  • Changes of HbA1c [ Time Frame: 24 weeks ]
  • Glucose Variability assessed by 3 day SMBG [ Time Frame: 24 weeks ]

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

Enrollment: 70
Study Start Date: August 2013
Study Completion Date: March 2015
Primary Completion Date: January 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Soo Lim, MD, MPH, PhD Seoul National University Bundang Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 23, 2015

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

ClinicalTrials.gov processed this record on June 23, 2017