The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

May 21, 2015 updated by: Healthconnect

A Multi-center, Randomized, Parallel, Open Clinical Trial to Evaluate the Glycemic Control Effect of the Mobile Healthcare Service in Patients With Type 2 Diabetes Mellitus

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The Mobile Diabetes Intervention Study is evaluating a diabetes mgmt. algorithm system by using patient mobile application and physician web-based portal. The investigators hypothesize that patient self-monitoring of blood glucose, dietary and exercise by using application and physician's remote monitoring can additional decrease of HbA1c over 6 month.

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Kyunggi-do, Korea, Republic of
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Soo Lim, MD.PhD.
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Yong Min Cho, MD. PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Boramae Medical Center
        • Contact:
        • Principal Investigator:
          • Min Kyong Moon, MD.PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20-80 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional care
Traditional care with paper(SMBG) and healthcare staff advice in office
Other: Traditional care with paper
Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.
Experimental: Health-On G App.+ Physician web portal
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c (%)
Time Frame: Change from baseline to 24 weeks
Change from baseline to 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HbA1c (%)
Time Frame: Change from baseline to 12 weeks
Change from baseline to 12 weeks
Change in SDSCA(Summary of Diabetes Self-Care Activities)
Time Frame: from baseline to 24 weeks
from baseline to 24 weeks
Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)
Time Frame: from baseline to 24weeks
from baseline to 24weeks
Change in FBG(Fasting Blood Glucose)
Time Frame: from baseline to 12weeks and 24weeks
from baseline to 12weeks and 24weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Healthconnect

Collaborators

Seoul National University Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center

Investigators

  • Principal Investigator: Young Min Cho, MD.PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

March 1, 2016

Study Registration Dates

First Submitted

May 18, 2015

First Submitted That Met QC Criteria

May 21, 2015

First Posted (Estimate)

May 22, 2015

Study Record Updates

Last Update Posted (Estimate)

May 22, 2015

Last Update Submitted That Met QC Criteria

May 21, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SB02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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