Effectiveness Study of the Guardian RT in Type 1 Diabetics

Phase 4

Completed

• Conditions: Type 1 Diabetes Mellitus

• Registration Number: NCT01331343
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2004-06
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Status Verified: 2011-04
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-06
• Study First Posted: 2011-04-08
• Last Update Submitted: 2011-04-15
• Last Update Posted: 2011-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in Change in A1c (%) between continuous use of CGM and control	12 weeks

Secondary Outcome Measures

Name	Time	Method
Difference in change in A1c (%) between biweekly use of CGM and control	12 weeks
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM	12 weeks

Trial Locations

Locations (8)

Hospital Sud Francilien; 🇫🇷 Corbeil-Essonnes Cedex, France

Royal Bournemouth Hospital; 🇬🇧 Dorset, United Kingdom

Huddinge University Hospital; 🇸🇪 Huddinge, Sweden

U.O. Medicina Generale; 🇮🇹 Milano, Italy

CH Robert Debre; 🇫🇷 Paris, France

Klinik fur Allgemeine Charite; 🇩🇪 Berlin, Germany

University Children's Hospital; 🇸🇮 Ljubljana, Slovenia

Schneider Children Centre; 🇮🇱 Petah Tikva, Israel