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Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01137058
Enrollment
150
Registered
2010-06-04
Start date
2009-06-30
Completion date
2010-09-30
Last updated
2014-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

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.

Interventions

DEVICEU-healthcare service

Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.

Glucose control with self monitoring of blood glucose.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Target goal of HbA1c (< 7.0%) without hypoglycemia24 weeksPercent of patients who reach target goal of HbA1c (\< 7.0%) without hypoglycemia

Secondary

MeasureTime frameDescription
quality of life24 weeks
amount of exercise24 weeks
Body mass index (BMI) changesBody mass indexComparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026