Clinical trial NCT02025296: Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care
Official title: Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus With Hypoglycemia
Keywords: Telemedicine
Clinical decision support system
Ubiquitous healthcare
Diabetes Care
Multifactorial Intervention
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: proportion of patients achieving the target of HbA1c <7% without hypoglycemia
timeFrame: 6 months
Secondary outcomes:
measure: Hypoglycemia
timeFrame: 6 months
measure: Obesity index
timeFrame: 6 months
measure: Lifestyle
timeFrame: 6 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: SNUBH
state: Gyeonggi
Study officials:
affiliation: SNUBH
name: Soo Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: