The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

Healthconnect

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Device: Health-on G App. + Physician Web; Other: Traditional care with paper

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02451631

SB02

Details and patient eligibility

About

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

Full 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.

Enrollment: 184 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Traditional care

Active Comparator group

Description:

Traditional care with paper(SMBG) and healthcare staff advice in office

Treatment:

Other: Traditional care with paper

Health-On G App.+ Physician web portal

Experimental group

Description:

Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data

Treatment:

Device: Health-on G App. + Physician Web