Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

Not Applicable

Completed

• Conditions: Diabetes Mellitus With Hypoglycemia
• Interventions: Device: U-healthcare

• Registration Number: NCT02025296
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-23
• Study First Submitted QC: 2013-12-27
• Study First Posted: 2014-01-01
• Primary Completion: 2014-08
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-11
• Last Update Posted: 2014-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
U-healthcare	U-healthcare	individualized multidisciplinary u-healthcare service combined with exercise monitoring and dietary feedback on glucose control

Primary Outcome Measures

Name	Time	Method
proportion of patients achieving the target of HbA1c <7% without hypoglycemia	6 months	The primary endpoint of the present study was the proportion of patients achieving the target of HbA1c \<7% without hypoglycemia at 6 months.

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia	6 months	Numbers of hypoglycemic events
Obesity index	6 months	Changes of BMI and Waist circumference
Lifestyle	6 months	Changes of caloric intake and exercise

Trial Locations

Locations (1)

SNUBH; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of