Ubiquitous Healthcare for Elderly Patients With Type 2 Diabetes Mellitus

NCT ID: NCT01137058

Last Updated: 2014-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-09-30

Brief Summary

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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

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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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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U-healthcare

glucose meter and U-healthcare

Group Type EXPERIMENTAL

U-healthcare service

Intervention Type DEVICE

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

SMBG group

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

Group Type ACTIVE_COMPARATOR

SMBG group

Intervention Type DEVICE

Glucose control with self monitoring of blood glucose.

control

conventional treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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U-healthcare service

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

Intervention Type DEVICE

SMBG group

Glucose control with self monitoring of blood glucose.

Intervention Type DEVICE

Other Intervention Names

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U-healthcare group

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo Lim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Lim, MD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 25936739 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21270188 (View on PubMed)

Other Identifiers

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SNUBH_UH1

Identifier Type: -

Identifier Source: org_study_id

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