Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus
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.
|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|
- 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
- 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
|Study Start Date:||June 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|