An interventional study of U-healthcare in Diabetes Mellitus With Hypoglycemia, sponsored by Seoul National University Bundang Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2014-10-15.
Sponsored by Seoul National University Bundang Hospital · Not applicable, Interventional, and Treatment
Recently, we generated a new multidisciplinary ubiquitous healthcare system by upgrading our clinical decision supporting system (CDSS) rule engine, and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. We hypothesize that individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback will result in better glucose control with less hypoglycemia in an elderly population.
The use of telemedicine (also known as connected health, e-health, or telehealth) has been proven to be beneficial in chronic disease management. Now, the classic concept of telemedicine has been evolving to ubiquitous (u)-healthcare system with advanced information technologies which provides real-time individualized feedback using a monitoring device attached to the internet or a mobile phone system.
A few studies showed that adopting a u-healthcare system helped patients improve their blood glucose control and reduced hypoglycemia or weight gain. In a previous study, supervised telemonitoring was effective for blood pressure control in hypertensive patients in primary care settings. A recent study showed that telemonitoring with pharmacist's help achieved better blood pressure control compared with usual care during 12 months of intervention.
A clinical decision support system (CDSS) is the key to this system, building up an individualized CDSS rule engine is the crux of the u-healthcare system because current glucose control status, antidiabetic medications, lifestyle, and severity of hypoglycemia vary between individual patients.
Recently, our u-healthcare team generated a new multidisciplinary u-healthcare system by upgrading the CDSS rule engine, and integrating a physical activity-monitoring device and dietary feedback into a comprehensive package. With this integrated system, we investigate the effect of individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control with less hypoglycemia in Korean elderly population.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 8,368 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Seoul National University Bundang Hospital is the lead sponsor of 368 studies on the registry; 55 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
measurement of their blood glucose level using a glucometer at least eight times a week
individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control
Device: U-healthcare
use of a public switched telephone network (PSTN)-connected glucometer to measure their blood glucose level at the same frequency as the SMBG group
proportion of patients achieving the target of HbA1c <7% without hypoglycemia
The primary endpoint of the present study was the proportion of patients achieving the target of HbA1c \<7% without hypoglycemia at 6 months.
Time frame: 6 months
Hypoglycemia
Numbers of hypoglycemic events
Time frame: 6 months
Obesity index
Changes of BMI and Waist circumference
Time frame: 6 months
Lifestyle
Changes of caloric intake and exercise
Time frame: 6 months
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
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Seoul National University Bundang Hospital