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Trial record 35 of 13671 for:    diabetes

The Mobile Diabetes Mgmt. Study With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02451631
Recruitment Status : Unknown
Verified May 2015 by Healthconnect.
Recruitment status was:  Recruiting
First Posted : May 22, 2015
Last Update Posted : May 22, 2015
Sponsor:
Collaborators:
Seoul National University Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Information provided by (Responsible Party):
Healthconnect

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Other: Traditional care with paper Device: Health-on G App. + Physician Web Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2015
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Traditional care
Traditional care with paper(SMBG) and healthcare staff advice in office
Other: Traditional care with paper
Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.

Experimental: Health-On G App.+ Physician web portal
Patient self-mgmt using Health-On G Application on smartphone; Healthcare staffs monitoring through physician web to review data
Device: Health-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.




Primary Outcome Measures :
  1. Change in HbA1c (%) [ Time Frame: Change from baseline to 24 weeks ]

Secondary Outcome Measures :
  1. Change in HbA1c (%) [ Time Frame: Change from baseline to 12 weeks ]
  2. Change in SDSCA(Summary of Diabetes Self-Care Activities) [ Time Frame: from baseline to 24 weeks ]
  3. Change in WHOQOL-BREF (World Health Organization Quality Of Life-BREF) [ Time Frame: from baseline to 24weeks ]
  4. Change in FBG(Fasting Blood Glucose) [ Time Frame: from baseline to 12weeks and 24weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451631


Contacts
Contact: Hye Kyung, Hwang 82-2-6292-3426 hkhwang@hconnect.co.kr
Contact: Su Jin Park 82-6292-3403 shelly@hconnect.co.kr

Locations
Korea, Republic of
Seoul National University Bundang Hospital Not yet recruiting
Kyunggi-do, Korea, Republic of
Contact: Soo Lim, MD.PhD       limsoo@snu.ac.kr   
Principal Investigator: Soo Lim, MD.PhD.         
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Min Kyong Moon, MD.PhD.       mkmoon@snu.ac.kr   
Principal Investigator: Min Kyong Moon, MD.PhD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Young Min Cho, MD. PhD.       ymchomd@snu.ac.kr   
Principal Investigator: Yong Min Cho, MD. PhD         
Sponsors and Collaborators
Healthconnect
Seoul National University Hospital
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Investigators
Principal Investigator: Young Min Cho, MD.PhD Seoul National University Hospital