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Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
U-healthcare service
SMBG group
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

U-healthcare

SMBG group

control

Arm Description

glucose meter and U-healthcare

Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group.

conventional treatment

Outcomes

Primary Outcome Measures

Target goal of HbA1c (< 7.0%) without hypoglycemia
Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia

Secondary Outcome Measures

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

Full Information

First Posted
June 2, 2010
Last Updated
May 25, 2014
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01137058
Brief Title
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

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
U-healthcare
Arm Type
Experimental
Arm Description
glucose meter and U-healthcare
Arm Title
SMBG group
Arm Type
Active Comparator
Arm Description
Diabetic patients who do self monitoring of blood glucose only were categorized into self monitoring of blood glucose (SMBG) group.
Arm Title
control
Arm Type
No Intervention
Arm Description
conventional treatment
Intervention Type
Device
Intervention Name(s)
U-healthcare service
Other Intervention Name(s)
U-healthcare group
Intervention Description
Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.
Intervention Type
Device
Intervention Name(s)
SMBG group
Intervention Description
Glucose control with self monitoring of blood glucose.
Primary Outcome Measure Information:
Title
Target goal of HbA1c (< 7.0%) without hypoglycemia
Description
Percent of patients who reach target goal of HbA1c (< 7.0%) without hypoglycemia
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
quality of life
Time Frame
24 weeks
Title
amount of exercise
Time Frame
24 weeks
Title
Body mass index (BMI) changes
Description
Comparison of body mass index changes among control, self monitoring of blood glucose (SMBG) and ubiquitous healthcare groups
Time Frame
Body mass index

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD, MPH, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25936739
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.
Results Reference
derived
PubMed Identifier
21270188
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.
Results Reference
derived

Learn more about this trial

Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

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