- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02451631
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 Contact
- Name: Hye Kyung, Hwang
- Phone Number: 82-2-6292-3426
- Email: hkhwang@hconnect.co.kr
Study Contact Backup
- Name: Su Jin Park
- Phone Number: 82-6292-3403
- Email: shelly@hconnect.co.kr
Study Locations
-
-
-
Kyunggi-do, Korea, Republic of
- Not yet recruiting
- Seoul National University Bundang Hospital
-
Contact:
- Soo Lim, MD.PhD
- Email: limsoo@snu.ac.kr
-
Principal Investigator:
- Soo Lim, MD.PhD.
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Hospital
-
Contact:
- Young Min Cho, MD. PhD.
- Email: ymchomd@snu.ac.kr
-
Principal Investigator:
- Yong Min Cho, MD. PhD
-
Seoul, Korea, Republic of
- Recruiting
- Seoul National University Boramae Medical Center
-
Contact:
- Min Kyong Moon, MD.PhD.
- Email: mkmoon@snu.ac.kr
-
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
|
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
|
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
Collaborators
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
- 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.
- 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.
- 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.
- 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.
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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