NCT02451631

Brief Summary

A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service Using U-Healthcare Clinical Decision Support System (CDSS) and U-Healthcare Gateway in Patients with Type 2 Diabetes Mellitus

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2015

Shorter than P25 for not_applicable type-2-diabetes

Geographic Reach
1 country

3 active sites

Status
unknown

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

April 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

7 months

First QC Date

May 18, 2015

Last Update Submit

May 21, 2015

Conditions

Type 2 Diabetes

Keywords

Mobile ApplicationDiabetes management

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c (%)

    Change from baseline to 24 weeks

Secondary Outcomes (4)

  • Change in HbA1c (%)

    Change from baseline to 12 weeks

  • Change in SDSCA(Summary of Diabetes Self-Care Activities)

    from baseline to 24 weeks

  • Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)

    from baseline to 24weeks

  • Change in FBG(Fasting Blood Glucose)

    from baseline to 12weeks and 24weeks

Study Arms (2)

Traditional care

ACTIVE COMPARATOR

Traditional care with paper(SMBG) and healthcare staff advice in office

Other: Traditional care with paper

Health-On G App.+ Physician web portal

EXPERIMENTAL

Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data

Device: Health-on G App. + Physician Web

Interventions

Traditional care with paperOTHER

Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.

Traditional care
Health-on G App. + Physician WebDEVICE

Patients use their smart-phone or receive rental phone, and download Health-On G application. Algorithm-based personalized feedback are provided when patients' data are linked to Health-On G Application. Patient self-monitoring blood glucose data from glucometer are transferred to App. automatically by bluetooth, or input manually, check medication regimen, input food intake and exercise, and step counts are linked by Activity tracker. Personalized feedback are instantly provided based on data. Entered data are also connected to web-based physician portal. Physician web portal is provided, where they're able to review their patient's all data. Health-On G is defined as a U-Healthcare medical device consisting of gateway and decision support system.

Health-On G App.+ Physician web portal

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • Type 2 diabetes patients (who have taken stably oral diabetic drugs or insulin, and been doing lifestyle improvement by doctor's advice for recent over 3 months)
  • in case insulin treated, patients with basal insulin once a day or premixed insulin twice a day
  • HbA1c between 7.0% and 10.0%
  • ability to understand and use smartphone application

You may not qualify if:

  • type 1 diabetes or patients using insulin pump
  • severe complications (stage IV,V chronic kidney failure, diabetic food complications, unstable angina pectoris, MI or stroke, surgical procedure of coronary \& peripheral artery within recent 6 months)
  • uncontrolled hypertension
  • pregnant woman, fertile woman who will not use contraception
  • unable to use application during treatment
  • taking medication which can affect on glucose level
  • alcohol abuse or dependency
  • over 2.5 times from the upper limit of liver enzyme level
  • DKA(diabetic ketoacidosis) or HHS(Hyperglycemic hyperosmolar syndrome) history during recent 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Bundang Hospital

Kyunggi-do, South Korea

NOT YET RECRUITING

Seoul National University Boramae Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (4)

  • 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: 21270188BACKGROUND

  • Kwon HS, Cho JH, Kim HS, Song BR, Ko SH, Lee JM, Kim SR, Chang SA, Kim HS, Cha BY, Lee KW, Son HY, Lee JH, Lee WC, Yoon KH. Establishment of blood glucose monitoring system using the internet. Diabetes Care. 2004 Feb;27(2):478-83. doi: 10.2337/diacare.27.2.478.

    PMID: 14747232BACKGROUND

  • Kim EK, Cho YM. Response to Comment on Kim et al. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care 2019;42:3-9. Diabetes Care. 2019 Jul;42(7):e126. doi: 10.2337/dci19-0021. No abstract available.

    PMID: 31221711DERIVED

  • Kim EK, Kwak SH, Jung HS, Koo BK, Moon MK, Lim S, Jang HC, Park KS, Cho YM. The Effect of a Smartphone-Based, Patient-Centered Diabetes Care System in Patients With Type 2 Diabetes: A Randomized, Controlled Trial for 24 Weeks. Diabetes Care. 2019 Jan;42(1):3-9. doi: 10.2337/dc17-2197. Epub 2018 Oct 30.

    PMID: 30377185DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Paper

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Manufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Young Min Cho, MD.PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hye Kyung, Hwang

CONTACT

82-2-6292-3426hkhwang@hconnect.co.kr

Su Jin Park

CONTACT

82-6292-3403shelly@hconnect.co.kr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2015

First Posted

May 22, 2015

Study Start

April 1, 2015

Primary Completion

November 1, 2015

Study Completion

March 1, 2016

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

KR(3)