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

Konkuk University Medical Center

Status: Unknown

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: conventional treatment; Device: insulin pump

Study type: Interventional

Funder types: Other

Identifiers

NCT02198846

KU_PUMP1

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Insulin pump

Experimental group

Description:

insulin pump

Treatment:

Device: insulin pump

conventional treatment

Active Comparator group

Description:

intensification of conventional treatment

Treatment:

Drug: conventional treatment