Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
SMARTCARE_DM
Randomized, Multi-center, Open-label, Parallel Group Study to Evaluate the Effect of the Smart Care-diabetes Management System on Subjects With Diabetes
1 other identifier
interventional
554
1 country
1
Brief Summary
SMARTCARE-diabetes management system' to evaluate the long-term effects on patients with diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Dec 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 19, 2011
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFebruary 6, 2013
February 1, 2013
1.8 years
July 19, 2011
February 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients who attain,Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
Rate of patients who attain, Hemoglobin A1C ≤ 7.0% and Blood pressure ≤ 130/80 and and LDL-Cholesterol ≤ 100 or LDL-Cholesterol ≤ 70, all at 12 months.
0 to 12 months
Secondary Outcomes (7)
Change in Hemoglobin A1C at visit 3,4,6 from baseline
0 to 12 months
change in QOL(Quality of life)
0 to 12 months
Treatment satisfaction(DTSQ, Diabetes Treatment Satisfaction Questionnaire)
0 to 12 months
Changes in lipid profile at Visit 4 and 6 from baseline.
0 to 12 months
Changes in body weight
0 to 12 months
- +2 more secondary outcomes
Study Arms (2)
SMARTCARE service
EXPERIMENTALU-Health service
Usual care
NO INTERVENTIONUsual care
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- At least 1 year after being diagnosed with Type 2 diabetes
- % ≤ HbA1c ≤ 10.0%
- Agreed to participate voluntarily in the study
You may not qualify if:
- Severe chronic disease
- Diabetes mellitus complications
- Severe renal disease; Serum creatinin \> 1.5(men), \> 1.4 (women)
- Severe liver disease or AST, ALT ≥ 2.5 x ULN
- Known not to be taking medication reliably 3 months before the screening visit
- Insulin pump user
- Being registered for other clinical research or are planning to participate in other clinical researches during this study
- Pregnant woman
- Illiterate
- Being assessed irrelevant by the investigator
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medicrostar
Seoul, 137-701, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
kun-ho YOON, professor
Seoul St. Mary's Hospital
- PRINCIPAL INVESTIGATOR
sung-woo PARK, Professor
Kanbuk Samsung Medical Center
- PRINCIPAL INVESTIGATOR
Jung-yeol PARK, Professor
Asan Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2011
First Posted
January 6, 2012
Study Start
December 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
February 6, 2013
Record last verified: 2013-02