Effectiveness Study of the Guardian RT in Type 1 Diabetics

Type 1 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331343
• Other study ID #: EU007_022004
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2011
• Last updated: April 15, 2011
• Start date: June 2004
• Est. completion date: June 2005

Study information

• Verified date: April 2011
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2005
• Est. primary completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 59 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• Guardian RT Telemetered Glucose Monitoring System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Diabetes

Countries where clinical trial is conducted

France,  Germany,  Israel,  Italy,  Slovenia,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Change in A1c (%) between continuous use of CGM and control		12 weeks	No
Secondary	Difference in change in A1c (%) between biweekly use of CGM and control		12 weeks	No
Secondary	Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM		12 weeks	No