A Study to Compare Insulin Pump With Conventional Treatment in Type 2 Diabetes

Not Applicable

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: conventional treatment; Device: insulin pump

• Registration Number: NCT02198846
• Lead Sponsor: Konkuk University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-23
• Last Update Submitted: 2014-07-23
• Study First Posted: 2014-07-24
• Last Update Posted: 2014-07-24
• Primary Completion: 2014-12
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Type 2 diabetes
• age: 18 ~ 85 yrs
• HbA1c: > 7.5%
• no change of anti-diabetic medication within 3 months

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment	conventional treatment	intensification of conventional treatment
Insulin pump	insulin pump	insulin pump

Primary Outcome Measures

Name	Time	Method
change of HbA1c	24 weeks

Secondary Outcome Measures

Name	Time	Method
changes of body weight	24 weeks
change of beta cell function	24 weeks	insulin secretion-sensitivity index-2; = insulinogenic index x Matsuda index
Percent of patients who reach target goal of HbA1c (<7.0%)	24 weeks
frequency of hypoglycemia	24 weeks	severe hypoglycemia : glucose \<40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl

Trial Locations

Locations (1)

Konkuk University Chungju Hospital; 🇰🇷 Chungju, Korea, Republic of