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

This study has been completed.
Sponsor:
Information provided by:
Korea University
ClinicalTrials.gov Identifier:
NCT00536549
First received: September 27, 2007
Last updated: May 19, 2008
Last verified: May 2008
History of Changes
  Purpose

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
Type 2 Diabetes
 Device: Guardian RT
Behavioral: Education about the self monitoring blood glucose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Korea University:

Primary Outcome Measures:
  • HbA1c, fasting blood glucose level, weight change, blood pressure in the morning, lipid profiles [ Time Frame: basline, 12weeks later ]

Secondary Outcome Measures:
  • three day diary meals and seven day physical activity diary [ Time Frame: basline, 12 weeks later ]

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
Experimental: A
Guardina RT monitoring
 Device: Guardian RT
Active Comparator: B Behavioral: Education about the self monitoring blood glucose

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

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00536549

Locations
Korea, Republic of
Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Korea University
Investigators
Principal Investigator: Sei H Baik, MD Division of Endocrinology and Metabolism, Department of Internal Medicine,Korea University College of Medicine
  More Information

No publications provided

Responsible Party: Sei Hyun Baik, Korea University
ClinicalTrials.gov Identifier: NCT00536549     History of Changes
Other Study ID Numbers: Korean Health 21 R & D Project
Study First Received: September 27, 2007
Last Updated: May 19, 2008
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea University:
Glucose monitoring system
life style intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013