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Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01137058
First received: June 2, 2010
Last updated: May 23, 2011
Last verified: June 2010
History of Changes
  Purpose

Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology.

To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.


Condition Intervention
Diabetes
 Device: U-healthcare service
Device: SMBG group

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: Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Target goal of HbA1c (< 7.0%) without hypoglycemia [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia


Secondary Outcome Measures:
  • quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • amount of exercise [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Body mass index (BMI) changes [ Time Frame: Body mass index ] [ Designated as safety issue: No ]
    Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups


Enrollment: 150
Study Start Date: June 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: U-healthcare
glucose meter and U-healthcare
 Device: U-healthcare service
Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.
Other Name: U-healthcare group
Active Comparator: SMBG group
Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group.
 Device: SMBG group
Glucose control with self monitoring of blood glucose.
Other Name: SMBG group
No Intervention: control
conventional treatment

Detailed Description:

Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension.

Thus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.

  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: 6.5%-11.0%
  • duration of diabetes: less than 30 years
  • BMI: 20-35

Exclusion Criteria:

  • systemic corticosteroid administered within previous 6 months
  • history of myocardial ischemia
  • Heart failure, NYHA Class II-IV
  • Thyroid disease with abnormal TFT
  • Anti-obesity drugs or slimming products within previous 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01137058

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Korea, Republic of
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 by Seoul National University Bundang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Soo Lim, MD, MPH, PhD, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01137058     History of Changes
Other Study ID Numbers: SNUBH_UH1
Study First Received: June 2, 2010
Last Updated: May 23, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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 17, 2013