Clinical trial NCT01137058: Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus
Official title: Clinical Efficacy of Ubiquitous Healthcare System for Elderly Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2010-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Target goal of HbA1c (< 7.0%) without hypoglycemia
timeFrame: 24 weeks
Secondary outcomes:
measure: quality of life
timeFrame: 24 weeks
measure: amount of exercise
timeFrame: 24 weeks
measure: Body mass index (BMI) changes
timeFrame: Body mass index
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Soo Lim, MD, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lim S, Kang SM, Kim KM, Moon JH, Choi SH, Hwang H, Jung HS, Park KS, Ryu JO, Jang HC. Multifactorial intervention in diabetes care using real-time monitoring and tailored feedback in type 2 diabetes. Acta Diabetol. 2016 Apr;53(2):189-98. doi: 10.1007/s00592-015-0754-8. Epub 2015 May 5.
citation: Lim S, Kang SM, Shin H, Lee HJ, Won Yoon J, Yu SH, Kim SY, Yoo SY, Jung HS, Park KS, Ryu JO, Jang HC. Improved glycemic control without hypoglycemia in elderly diabetic patients using the ubiquitous healthcare service, a new medical information system. Diabetes Care. 2011 Feb;34(2):308-13. doi: 10.2337/dc10-1447.