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Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02025296
Enrollment
100
Registered
2014-01-01
Start date
2013-12-31
Completion date
2014-10-31
Last updated
2014-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus With Hypoglycemia

Keywords

Telemedicine, Clinical decision support system, Ubiquitous healthcare, Diabetes Care, Multifactorial Intervention

Brief summary

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.

Detailed description

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.

Interventions

DEVICEU-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

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients with type 2 diabetes mellitus * Glycated hemoglobin (HbA1c) levels: 7.0-10.5%

Exclusion criteria

* Patients who were unable to use text messages or to access the internet for any reason

Design outcomes

Primary

MeasureTime frameDescription
proportion of patients achieving the target of HbA1c <7% without hypoglycemia6 monthsThe primary endpoint of the present study was the proportion of patients achieving the target of HbA1c \<7% without hypoglycemia at 6 months.

Secondary

MeasureTime frameDescription
Hypoglycemia6 monthsNumbers of hypoglycemic events
Obesity index6 monthsChanges of BMI and Waist circumference
Lifestyle6 monthsChanges of caloric intake and exercise

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026