A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes
A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus
1 other identifier
interventional
140
1 country
1
Brief Summary
Insulin deficiency resulted from progressive beta cell failure and insulin resistance in type 2 diabetes requires exogenous insulin therapy, escaping from oral antihyperglycemic agents. Previous data have been suggested that continuous subcutaneous insulin infusion (CSII) does not only have efficacy in glucose control but also restore beta cell failure. The investigators plan to compare the efficacy/safety and beta cell function between insulin pump treatment and the intensification of conventional treatment in patients with uncontrolled type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes-mellitus
Started Jun 2014
Shorter than P25 for not_applicable type-2-diabetes-mellitus
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
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 22, 2014
CompletedFirst Posted
Study publicly available on registry
July 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJuly 24, 2014
July 1, 2014
6 months
July 22, 2014
July 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
change of HbA1c
24 weeks
Secondary Outcomes (4)
changes of body weight
24 weeks
frequency of hypoglycemia
24 weeks
change of beta cell function
24 weeks
Percent of patients who reach target goal of HbA1c (<7.0%)
24 weeks
Study Arms (2)
Insulin pump
EXPERIMENTALinsulin pump
conventional treatment
ACTIVE COMPARATORintensification of conventional treatment
Interventions
intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- age: 18 \~ 85 yrs
- HbA1c: \> 7.5%
- no change of anti-diabetic medication within 3 months
You may not qualify if:
- systemic corticosteroid administered within previous 6 months
- pregnancy
- severe liver or renal disease, heart failure
- History of cancer within 5 years
- Thyroid disease
- Anti-obesity drugs or slimming products within previous 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Konkuk University Chungju Hospital
Chungju, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Soo Bong Choi, MD.PhD
Konkuk University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
July 22, 2014
First Posted
July 24, 2014
Study Start
June 1, 2014
Primary Completion
December 1, 2014
Study Completion
March 1, 2015
Last Updated
July 24, 2014
Record last verified: 2014-07