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

Healthconnect3 sites in 1 country184 target enrollmentApril 2015

ConditionsType 2 Diabetes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Type 2 Diabetes
Sponsor: Healthconnect
Enrollment: 184
Locations: 3
Primary Endpoint: Change in HbA1c (%)
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

March 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Healthconnect

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in HbA1c (%)

Time Frame: Change from baseline to 24 weeks

Secondary Outcomes

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)