The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Device: Health-on G App. + Physician Web; Other: Traditional care with paper

• Registration Number: NCT02451631
• Lead Sponsor: Healthconnect

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.

Study Timeline

• Study Start: 2015-04
• Status Verified: 2015-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Study First Posted: 2015-05-22
• Last Update Posted: 2015-05-22
• Primary Completion: 2015-11
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health-On G App.+ Physician web portal	Health-on G App. + Physician Web	Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data
Traditional care	Traditional care with paper	Traditional care with paper(SMBG) and healthcare staff advice in office

Primary Outcome Measures

Name	Time	Method
Change in HbA1c (%)	Change from baseline to 24 weeks

Secondary Outcome Measures

Name	Time	Method
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
Change in HbA1c (%)	Change from baseline to 12 weeks
Change in SDSCA(Summary of Diabetes Self-Care Activities)	from baseline to 24 weeks

Trial Locations

Locations (3)

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Kyunggi-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of