Ubiquitous Healthcare Service With Multifactorial Intervention in Diabetes Care

Diabetes Mellitus With Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02025296
• Other study ID #: U-healthcare system
• Status: Completed
• Phase: N/A
• First received: December 23, 2013
• Last updated: October 11, 2014
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus With Hypoglycemia
• Hypoglycemia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	SNUBH	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	Yes
Secondary	Hypoglycemia	Numbers of hypoglycemic events	6 months	Yes
Secondary	Obesity index	Changes of BMI and Waist circumference	6 months	No
Secondary	Lifestyle	Changes of caloric intake and exercise	6 months	No