Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

Diabetes Clinical Trial

Official title:

Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01137058
• Other study ID #: SNUBH_UH1
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: May 25, 2014
• Start date: June 2009
• Est. completion date: September 2010

Study information

• Verified date: May 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• U-healthcare service
Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.
• SMBG group
Glucose control with self monitoring of blood glucose.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam

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	Target goal of HbA1c (< 7.0%) without hypoglycemia	Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia	24 weeks	Yes
Secondary	quality of life		24 weeks	No
Secondary	amount of exercise		24 weeks	No
Secondary	Body mass index (BMI) changes	Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups	Body mass index	No