Clinical trial NCT02451631: The Mobile Diabetes Mgmt. Study With Type 2 Diabetes
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Mobile Application
Diabetes management
Lead sponsor: Healthconnect
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
First posted: 2015-05-22
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in HbA1c (%)
timeFrame: Change from baseline to 24 weeks
Secondary outcomes:
measure: Change in HbA1c (%)
timeFrame: Change from baseline to 12 weeks
measure: Change in SDSCA(Summary of Diabetes Self-Care Activities)
timeFrame: from baseline to 24 weeks
measure: Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF)
timeFrame: from baseline to 24weeks
measure: Change in FBG(Fasting Blood Glucose)
timeFrame: from baseline to 12weeks and 24weeks
Other outcomes:
Locations:
city: Kyunggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Young Min Cho, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.