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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Seoul National University Bundang Hospital | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional care | Active Comparator | Traditional care with paper(SMBG) and healthcare staff advice in office |
|
| Health-On G App.+ Physician web portal | Experimental | Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional care with paper | Other | Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (%) | Change from baseline to 24 weeks |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hye Kyung, Hwang | Contact | 82-2-6292-3426 | hkhwang@hconnect.co.kr | |
| Su Jin Park | Contact | 82-6292-3403 | shelly@hconnect.co.kr |
| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD.PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Not yet recruiting | Kyunggi-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21270188 | Background | 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. | |
| 14747232 | Background |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010209 | Paper |
| ID | Term |
|---|---|
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Health-on G App. + Physician Web | Device | 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. |
|
| from baseline to 24weeks |
| Change in FBG(Fasting Blood Glucose) | from baseline to 12weeks and 24weeks |
| Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| 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. |
| 31221711 | Derived | 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. |
| 30377185 | Derived | 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. |
| D004700 | Endocrine System Diseases |