The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02451631
• Other study ID #: SB02
• Status: Recruiting
• Phase: N/A
• First received: May 18, 2015
• Last updated: May 21, 2015
• Start date: April 2015
• Est. completion date: March 2016

Study information

• Verified date: May 2015
• Source: Healthconnect
• Contact: Hye Kyung, Hwang
• Phone: 82-2-6292-3426
• Email: hkhwang[@]hconnect.co.kr
• Is FDA regulated: No
• Health authority: South Korea: Ministry of Food and Drug SafetySouth Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: March 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

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

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Kyunggi-do
Korea, Republic of	Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Healthconnect	Seoul National University Bundang Hospital, Seoul National University Hospital, SMG-SNU Boramae Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c (%)		Change from baseline to 24 weeks	No
Secondary	Change in HbA1c (%)		Change from baseline to 12 weeks	No
Secondary	Change in SDSCA(Summary of Diabetes Self-Care Activities)		from baseline to 24 weeks	No
Secondary	Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)		from baseline to 24weeks	No
Secondary	Change in FBG(Fasting Blood Glucose)		from baseline to 12weeks and 24weeks	No