Effectiveness Study of the Guardian RT in Type 1 Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01331343
Recruitment Status : Completed
First Posted : April 8, 2011
Last Update Posted : April 18, 2011
Information provided by:
Medtronic Diabetes

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Device: Guardian RT Telemetered Glucose Monitoring System Phase 4

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  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2004
Actual Primary Completion Date : June 2005
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Difference in Change in A1c (%) between continuous use of CGM and control [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Difference in change in A1c (%) between biweekly use of CGM and control [ Time Frame: 12 weeks ]
  2. Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 59 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01331343

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

Responsible Party: Severine Liabat, Medtronic Internationtal Trading Sarl Identifier: NCT01331343     History of Changes
Other Study ID Numbers: EU007_022004
First Posted: April 8, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011

Keywords provided by Medtronic Diabetes:
Glycemic Control
Continuous Glucose Monitoring

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases