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Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes

NCT ID: NCT00536549

Last Updated: 2008-05-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

127 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Detailed Description

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In diabetes management, compliance, disease awareness and empowerment of the patient play an important role and the immediate feedback on the effects of diet and exercise that the self monitoring blood glucose (SMBG) may provide, could enhance patient empowerment. Increased use of SMBG has been shown to be associated with improved medication compliance and better metabolic control by several studies. However, because of many factors, including pain and inconvenience, many diabetic patients do not accept frequent fingersticks for self blood glucose monitoring (SBGM) levels. In addition, the SBGM result gives the data for only a few seconds, without any information on glucose trends.

So we need new glucose monitoring method that could reflect glucose trends and glycemic excursion continuously because glucose monitoring still remains the cornerstone of evaluating the efficacy of therapy and motivating self disease control in subjects with diabetes.

Few studies have examined the effects of real time continuous glucose monitoring system targeting type 2 diabetes. So our goal is to determine whether the Guardian Continuous Glucose Monitoring System in the home setting is more useful than frequent self blood glucose monitoring with a view to modifying patient's diet and exercise habits or improvement self disease control efforts and at last glycemic control in patients with type 2 diabetes

Conditions

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Type 2 Diabetes

Keywords

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Glucose monitoring system life style intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A

Guardina RT monitoring

Group Type EXPERIMENTAL

Guardian RT

Intervention Type DEVICE

B

Group Type ACTIVE_COMPARATOR

Education about the self monitoring blood glucose

Intervention Type BEHAVIORAL

Interventions

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Guardian RT

Intervention Type DEVICE

Education about the self monitoring blood glucose

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* Group 1: HbA1c \< 8% with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months.
* Group 2: HbA1c \>= 8% and the fasting blood glucose must be \< 130 at the same time with a stable insulin or oral hypoglycemic agents (OHA) regimen for the prior 2 months with no plans to switch modality of insulin or OHA administration during the next 3months

Exclusion Criteria

* Use of corticosteroids or hormone therapy within the last 6 months
* Presence of another chronic illness
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University

OTHER

Sponsor Role lead

Responsible Party

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Korea University

Principal Investigators

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Sei H Baik, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine

Locations

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Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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Korean Health 21 R & D Project

Identifier Type: -

Identifier Source: org_study_id