Effectiveness Study of the Guardian RT in Type 1 Diabetics

April 15, 2011 updated by: Medtronic Diabetes

The Guard Control Trial - Randomized, Controlled, Muti-centric, Clinical Study to Assess Whether Type 1 Diabetic Patients in Poor Glycemic Control Can Improve Using the Real-time Values of the Guardian RT Versus Conventional Self-Monitoring Blood Glucose

The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian RT glucose sensor can improve glycemic control over a 12-week period, compared to patients using self-monitoring blood glucose testing (SMBG) alone.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c generally assesses the average/long term quality of glycemic control. On a daily basis, patients assess their glycemic control through finger stick measurements (SMBG), which allows them to adjust their therapy. A device which would provide a patient with a real-time glucose value, as well as high and low alerts, could aid the patient in knowing when to perform confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less frequently.

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Corbeil-Essonnes Cedex, France
        • Hospital Sud Francilien
      • Paris, France
        • CH Robert Debre
  • Germany
      • Berlin, Germany
        • Klinik fur Allgemeine Charite
  • Israel
      • Petah Tikva, Israel
        • Schneider Children Centre
  • Italy
      • Milano, Italy
        • U.O. Medicina Generale
  • Slovenia
      • Ljubljana, Slovenia
        • University Children's Hospital
  • Sweden
      • Huddinge, Sweden
        • Huddinge University Hospital
  • United Kingdom
      • Dorset, United Kingdom
        • Royal Bournemouth Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 59 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 Diabetes for at least 12 months
  • HbA1c must be 8.1% or above at study entry
  • Intensive Insulin Therapy 3 months prior to study entry

Exclusion Criteria:

  • Impaired hearing or vision (must see screens and hear alarms)
  • Unable to comply with protocol
  • Chronic debilitating or psychiatric disturbances

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Change in A1c (%) between continuous use of CGM and control
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in change in A1c (%) between biweekly use of CGM and control
Time Frame: 12 weeks
12 weeks
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

June 1, 2005

Study Completion (Actual)

June 1, 2005

Study Registration Dates

First Submitted

April 5, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (Estimate)

April 8, 2011

Study Record Updates

Last Update Posted (Estimate)

April 18, 2011

Last Update Submitted That Met QC Criteria

April 15, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EU007_022004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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