NCT01891474

Brief Summary

Ubiquitous healthcare service for elderly patients with type 2 diabetes have been developed and improved glycemic control. However, previous U-healthcare service had some limitations, which needs specific devices to check blood glucose and send it to central system. Voice inception technique based U-healthcare service is expected to improve glycemic control without specific devices. To evaluate the clinical efficacy of this system, researchers plan to compare the improvement of glycemic control, self-management, and quality of life between U-health care group (intervention) and conventional treatment group (control).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Aug 2013

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

First Submitted

Initial submission to the registry

June 28, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 27, 2015

Status Verified

October 1, 2015

Enrollment Period

1.4 years

First QC Date

June 28, 2013

Last Update Submit

October 23, 2015

Conditions

Diabetes

Outcome Measures

Primary Outcomes (2)

  • Changes of HbA1c

    24 weeks

  • Glucose Variability assessed by 3 day SMBG

    24 weeks

Secondary Outcomes (9)

  • Target goal of HbA1c (< 7.5%)

    24 Weeks

  • Target goal of HbA1c (< 8.0%)

    24 Weeks

  • Hypoglycemia

    24 Weeks

  • Drug Compliance

    24 Weeks

  • Self monitoring blood glucose compliance

    24 Weeks

  • +4 more secondary outcomes

Study Arms (2)

U-health care

EXPERIMENTAL

voice inception technique based U-healthcare service

Device: U-health care

control

NO INTERVENTION

conventional treatment

Interventions

U-health careDEVICE

voice inception technique based U-healthcare service

Also known as: U-health care group
U-health care

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: 7.0%-11.0%
  • Basal insulin or premixed insulin user

You may not qualify if:

  • Type 1 diabetes
  • short acting insulin or insulin pump user
  • systemic corticosteroid administered within previous 6 months
  • history of myocardial ischemia
  • Heart failure, New York Heart Association (NYHA) Class II-IV
  • Thyroid disease with abnormal thyroid function test
  • Anti-obesity drugs or slimming products within previous 3 months
  • severe liver or kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

Location

Related Publications (1)

  • Kim KM, Park KS, Lee HJ, Lee YH, Bae JS, Lee YJ, Choi SH, Jang HC, Lim S. Efficacy of a New Medical Information system, Ubiquitous Healthcare Service with Voice Inception Technique in Elderly Diabetic Patients. Sci Rep. 2015 Dec 11;5:18214. doi: 10.1038/srep18214.

    PMID: 26658492DERIVED

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 28, 2013

First Posted

July 3, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2015

Study Completion

March 1, 2015

Last Updated

October 27, 2015

Record last verified: 2015-10

Locations

KR(1)