Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01137058|
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : May 28, 2014
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 or disease||Intervention/treatment||Phase|
|Diabetes||Device: U-healthcare service Device: SMBG group||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||July 2010|
|Actual Study Completion Date :||September 2010|
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.
No Intervention: control
- Target goal of HbA1c (< 7.0%) without hypoglycemia [ Time Frame: 24 weeks ]Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia
- quality of life [ Time Frame: 24 weeks ]
- amount of exercise [ Time Frame: 24 weeks ]
- Body mass index (BMI) changes [ Time Frame: Body mass index ]Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01137058
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Korea, Republic of|
|Principal Investigator:||Soo Lim, MD, MPH, PhD||Seoul National University Bundang Hospital|