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

July 23, 2014 updated by: Soo Bong Choi, Konkuk University Medical Center

A Study to Compare the Efficacy and Safety of Insulin Pump Treatment in Patients With Uncontrolled Type 2 Diabetes Mellitus

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Chungju, Korea, Republic of
        • Recruiting
        • Konkuk University Chungju hospital
        • Contact:
        • Principal Investigator:
          • Soo Bong Choi, MD.PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Insulin pump
insulin pump
Device: insulin pump
stop any antihyperglycemic medication and convert to insulin pump
Active Comparator: conventional treatment
intensification of conventional treatment
Drug: conventional treatment
intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change of HbA1c
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes of body weight
Time Frame: 24 weeks
24 weeks
frequency of hypoglycemia
Time Frame: 24 weeks
severe hypoglycemia : glucose <40 mg/dl mild hypoglycemia : glucose 40 - 70 mg/dl
24 weeks
change of beta cell function
Time Frame: 24 weeks

insulin secretion-sensitivity index-2

= insulinogenic index x Matsuda index
24 weeks
Percent of patients who reach target goal of HbA1c (<7.0%)
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Soo Bong Choi, MD.PhD, Konkuk University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

July 22, 2014

First Submitted That Met QC Criteria

July 23, 2014

First Posted (Estimate)

July 24, 2014

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 23, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KU_PUMP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on insulin pump

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe