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Sponsored by: |
Korea University |
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Information provided by: | Korea University |
ClinicalTrials.gov Identifier: | NCT00536549 |
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
Condition | Intervention |
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Type 2 Diabetes |
Device: Guardian RT Behavioral: Education about the self monitoring blood glucose |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Enrollment: | 127 |
Study Start Date: | February 2007 |
Study Completion Date: | October 2007 |
Primary Completion Date: | October 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental
Guardina RT monitoring
|
Device: Guardian RT |
B: Active Comparator | Behavioral: Education about the self monitoring blood glucose |
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
Ages Eligible for Study: | 20 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Korea, Republic of | |
Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine | |
Seoul, Korea, Republic of, 152-703 |
Principal Investigator: | Sei H Baik, MD | Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine |
Responsible Party: | Korea University ( Sei Hyun Baik ) |
Study ID Numbers: | Korean Health 21 R & D Project |
Study First Received: | September 27, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00536549 |
Health Authority: | South Korea: Institutional Review Board |
Glucose monitoring system life style intervention |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |