The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: Traditional care with paper
* Device: Health-on G App. + Physician Web


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (%) |  | Change from baseline to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c (%) |  | Change from baseline to 12 weeks | 
| Change in SDSCA(Summary of Diabetes Self-Care Activities) |  | from baseline to 24 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mobile Application, Diabetes management