Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: SMBG group; Device: U-healthcare service

• Registration Number: NCT01137058
• Lead Sponsor: Seoul National University Bundang Hospital

Brief Summary

Ubiquitous healthcare service for elderly patients with type 2 diabetes provides real-time glycemic monitoring and glucose control implemented by clinical decision support system (CDSS) using wire and wireless communication and information technology.

To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life among three study groups: control, self glucose monitoring, and U-healthcare group.

Detailed Description

Recently, the application of internet-based glucose control system showed better long term glucose control compared to the conventional treatment. This study has become the foundation of web-based methodology in the glucose control. In addition, the combined application of mobile device and web-based monitoring system for chronic diseases showed improvement in various metabolic parameters in obese patients with diabetes and hypertension.

Thus, the application of U-healthcare based on advanced information technology would be helpful in the diabetes management. We plan to provide an individualized U-healthcare service using advanced information technology that enables more effective glucose control.

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-03
• Study First Posted: 2010-06-04
• Primary Completion: 2010-07
• Study Completion: 2010-09
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-25
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Type 2 diabetes
• age: 60 ~ 85 yrs
• HbA1c: 6.5%-11.0%
• duration of diabetes: less than 30 years
• BMI: 20-35

Exclusion Criteria

• systemic corticosteroid administered within previous 6 months
• history of myocardial ischemia
• Heart failure, NYHA Class II-IV
• Thyroid disease with abnormal TFT
• Anti-obesity drugs or slimming products within previous 3 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMBG group	SMBG group	Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group.
U-healthcare	U-healthcare service	glucose meter and U-healthcare

Primary Outcome Measures

Name	Time	Method
Target goal of HbA1c (< 7.0%) without hypoglycemia	24 weeks	Percent of patients who reach target goal of HbA1c (\< 7.0%) without hypoglycemia

Secondary Outcome Measures

Name	Time	Method
quality of life	24 weeks
amount of exercise	24 weeks
Body mass index (BMI) changes	Body mass index	Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of