Effectiveness Study of the Guardian RT in Type 1 Diabetics

This study has been completed.
Sponsor:
Information provided by:
Medtronic Diabetes
ClinicalTrials.gov Identifier:
NCT01331343
First received: April 5, 2011
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
Device: Guardian RT Telemetered Glucose Monitoring System
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Medtronic Diabetes:

Primary Outcome Measures:
  • Difference in Change in A1c (%) between continuous use of CGM and control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in change in A1c (%) between biweekly use of CGM and control [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: June 2004
Study Completion Date: June 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   8 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331343

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

No publications provided

Responsible Party: Severine Liabat, Medtronic Internationtal Trading Sarl
ClinicalTrials.gov Identifier: NCT01331343     History of Changes
Other Study ID Numbers: EU007_022004
Study First Received: April 5, 2011
Last Updated: April 15, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Diabetes:
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

ClinicalTrials.gov processed this record on October 01, 2014