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

NCT ID: NCT02198846

Last Updated: 2014-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin pump

insulin pump

Group Type EXPERIMENTAL

insulin pump

Intervention Type DEVICE

stop any antihyperglycemic medication and convert to insulin pump

conventional treatment

intensification of conventional treatment

Group Type ACTIVE_COMPARATOR

conventional treatment

Intervention Type DRUG

intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)

Interventions

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insulin pump

stop any antihyperglycemic medication and convert to insulin pump

Intervention Type DEVICE

conventional treatment

intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Konkuk University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Soo Bong Choi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Soo Bong Choi, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Konkuk University

Locations

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Konkuk University Chungju Hospital

Chungju, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Soo Bong Choi, MD.PhD

Role: CONTACT

+82-10-4949-9504

Facility Contacts

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Soo Bong Choi, MD.PhD

Role: primary

+82-10-4949-9504

Other Identifiers

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KU_PUMP1

Identifier Type: -

Identifier Source: org_study_id

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