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

NCT00536549 | Completed DMC

• 1 other identifier: Korean Health 21 R & D Project
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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

Conditions

Type 2 Diabetes

Keywords

Glucose monitoring system; life style intervention

Outcome Measures

Primary Outcomes (1)

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

  basline, 12weeks later

Secondary Outcomes (1)

• three day diary meals and seven day physical activity diary

  basline, 12 weeks later

Study Arms (2)

A

EXPERIMENTAL

Guardina RT monitoring

Device: Guardian RT

B

ACTIVE COMPARATOR

Behavioral: Education about the self monitoring blood glucose

Interventions

Guardian RT DEVICE

A

Education about the self monitoring blood glucose BEHAVIORAL

B

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Use of corticosteroids or hormone therapy within the last 6 months
• Presence of another chronic illness

Sponsors & Collaborators

• Korea University: lead

Study Sites (1)

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

Seoul, 152-703, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sei H Baik, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: September 28, 2007
• Study Start: February 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 20, 2008

Record last verified: 2008-05

Locations

KR (1)