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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

June 28, 2013
July 7, 2014
August 2013
December 2014   (final data collection date for primary outcome measure)
  • Changes of HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Glucose Variability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01891474 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Voice Inception Technique Based U-healthcare Service in Patients With Type 2 Diabetes Mellitus
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes
Device: U-health care
voice inception technique based U-healthcare service
Other Name: U-health care group
  • Experimental: U-health care
    voice inception technique based U-healthcare service
    Intervention: Device: U-health care
  • No Intervention: control
    conventional treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
66
February 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
60 Years to 85 Years
No
Contact: Soo Lim, MD, MPH, PhD +82-31-787-7035 limsoo@snu.ac.kr
Korea, Republic of
 
NCT01891474
SNUBH_Uhealth2
No
Soo Lim, Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
Not Provided
Principal Investigator: Soo Lim, MD, MPH, PhD Seoul National University Bundang Hospital
Seoul National University Bundang Hospital
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP