Type 2 Diabetes
Conditions
Keywords
Mobile Application, Diabetes management
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.
Interventions
OTHERTraditional care with paper
Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.
DEVICEHealth-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.
Sponsors
Seoul National University Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Healthconnect
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c (%) | Change from baseline to 24 weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Contacts
Primary ContactHye Kyung, Hwang
Backup ContactSu Jin Park
Outcome results
None listed