NCT01331343

Effectiveness Study of the Guardian RT in Type 1 Diabetics

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: Medtronic MiniMed, Inc. · Industry
• Sex: All
• Age: 8 Years – 59 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
DEVICE	Guardian RT Telemetered Glucose Monitoring System

Timeline

• Start date: 2004-06-01
• Primary completion: 2005-06-01
• Completion: 2005-06-01
• First posted: 2011-04-08
• Last updated: 2011-04-18

Locations

8 sites across 7 countries: France, Germany, Israel, Italy, Slovenia, Sweden, United Kingdom