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The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Traditional care with paper
Health-on G App. + Physician Web
Sponsored by
Healthconnect
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Mobile Application, Diabetes management

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Seoul National University Boramae Medical CenterRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional care

Health-On G App.+ Physician web portal

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in HbA1c (%)

Secondary Outcome Measures

Change in HbA1c (%)
Change in SDSCA(Summary of Diabetes Self-Care Activities)
Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)
Change in FBG(Fasting Blood Glucose)

Full Information

First Posted
May 18, 2015
Last Updated
May 21, 2015
Sponsor
Healthconnect
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02451631
Brief Title
The Mobile Diabetes Mgmt. Study With Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Healthconnect
Collaborators
Seoul National University Hospital, Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Mobile Application, Diabetes management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional care
Arm Type
Active Comparator
Arm Description
Traditional care with paper(SMBG) and healthcare staff advice in office
Arm Title
Health-On G App.+ Physician web portal
Arm Type
Experimental
Arm Description
Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data
Intervention Type
Other
Intervention Name(s)
Traditional care with paper
Intervention Description
Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.
Intervention Type
Device
Intervention Name(s)
Health-on G App. + Physician Web
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in HbA1c (%)
Time Frame
Change from baseline to 24 weeks
Secondary Outcome Measure Information:
Title
Change in HbA1c (%)
Time Frame
Change from baseline to 12 weeks
Title
Change in SDSCA(Summary of Diabetes Self-Care Activities)
Time Frame
from baseline to 24 weeks
Title
Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)
Time Frame
from baseline to 24weeks
Title
Change in FBG(Fasting Blood Glucose)
Time Frame
from baseline to 12weeks and 24weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hye Kyung, Hwang
Phone
82-2-6292-3426
Email
hkhwang@hconnect.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Su Jin Park
Phone
82-6292-3403
Email
shelly@hconnect.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD.PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Kyunggi-do
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD.PhD
Email
limsoo@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Soo Lim, MD.PhD.
Facility Name
Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Kyong Moon, MD.PhD.
Email
mkmoon@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Min Kyong Moon, MD.PhD
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Min Cho, MD. PhD.
Email
ymchomd@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Yong Min Cho, MD. PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
21270188
Citation
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.
Results Reference
background
PubMed Identifier
14747232
Citation
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.
Results Reference
background
PubMed Identifier
31221711
Citation
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.
Results Reference
derived
PubMed Identifier
30377185
Citation
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.
Results Reference
derived

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The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

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