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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Guardian RT
Education about the self monitoring blood glucose
Sponsored by
Korea University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Type 2 Diabetes focused on measuring Glucose monitoring system, life style intervention

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

A

B

Arm Description

Guardina RT monitoring

Outcomes

Primary Outcome Measures

HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles

Secondary Outcome Measures

three day diary meals and seven day physical activity diary

Full Information

First Posted
September 27, 2007
Last Updated
May 19, 2008
Sponsor
Korea University
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1. Study Identification

Unique Protocol Identification Number
NCT00536549
Brief Title
Effect of Real Time Continuous Glucose Monitoring System on the Management of Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Korea University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Glucose monitoring system, life style intervention

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
127 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Guardina RT monitoring
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Guardian RT
Intervention Type
Behavioral
Intervention Name(s)
Education about the self monitoring blood glucose
Primary Outcome Measure Information:
Title
HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles
Time Frame
basline, 12weeks later
Secondary Outcome Measure Information:
Title
three day diary meals and seven day physical activity diary
Time Frame
basline, 12 weeks later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sei H Baik, MD
Organizational Affiliation
Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
City
Seoul
ZIP/Postal Code
152-703
Country
Korea, Republic of

12. IPD Sharing Statement

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

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