NCT01137058

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2010

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

June 2, 2010

Last Update Submit

May 25, 2014

Conditions

Diabetes

Outcome Measures

Primary Outcomes (1)

  • Target goal of HbA1c (< 7.0%) without hypoglycemia

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

    24 weeks

Secondary Outcomes (3)

  • quality of life

    24 weeks

  • amount of exercise

    24 weeks

  • Body mass index (BMI) changes

    Body mass index

Study Arms (3)

U-healthcare

EXPERIMENTAL

glucose meter and U-healthcare

Device: U-healthcare service

SMBG group

ACTIVE COMPARATOR

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

Device: SMBG group

control

NO INTERVENTION

conventional treatment

Interventions

U-healthcare serviceDEVICE

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

Also known as: U-healthcare group
U-healthcare
SMBG groupDEVICE

Glucose control with self monitoring of blood glucose.

SMBG group

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes
  • age: 60 \~ 85 yrs
  • HbA1c: 6.5%-11.0%
  • duration of diabetes: less than 30 years
  • BMI: 20-35

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 25936739DERIVED

  • 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.

    PMID: 21270188DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Soo Lim, MD, MPH, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 4, 2010

Study Start

June 1, 2009

Primary Completion

July 1, 2010

Study Completion

September 1, 2010

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

KR(1)