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Effectiveness Study of the Guardian RT in Type 1 Diabetics

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Guardian RT Telemetered Glucose Monitoring System
Sponsored by
Medtronic Diabetes
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Diabetes, Glycemic Control, Continuous Glucose Monitoring

Eligibility Criteria

8 Years - 59 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Sud Francilien
  • CH Robert Debre
  • Klinik fur Allgemeine Charite
  • Schneider Children Centre
  • U.O. Medicina Generale
  • University Children's Hospital
  • Huddinge University Hospital
  • Royal Bournemouth Hospital

Outcomes

Primary Outcome Measures

Difference in Change in A1c (%) between continuous use of CGM and control

Secondary Outcome Measures

Difference in change in A1c (%) between biweekly use of CGM and control
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM

Full Information

First Posted
April 5, 2011
Last Updated
April 15, 2011
Sponsor
Medtronic Diabetes
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1. Study Identification

Unique Protocol Identification Number
NCT01331343
Brief Title
Effectiveness Study of the Guardian RT in Type 1 Diabetics
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 Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
June 2005 (Actual)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Diabetes

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Diabetes, Glycemic Control, Continuous Glucose Monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Guardian RT Telemetered Glucose Monitoring System
Primary Outcome Measure Information:
Title
Difference in Change in A1c (%) between continuous use of CGM and control
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Difference in change in A1c (%) between biweekly use of CGM and control
Time Frame
12 weeks
Title
Difference in change in A1c (%) between biweekly use of CGM and continuous use of CGM
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital Sud Francilien
City
Corbeil-Essonnes Cedex
Country
France
Facility Name
CH Robert Debre
City
Paris
Country
France
Facility Name
Klinik fur Allgemeine Charite
City
Berlin
Country
Germany
Facility Name
Schneider Children Centre
City
Petah Tikva
Country
Israel
Facility Name
U.O. Medicina Generale
City
Milano
Country
Italy
Facility Name
University Children's Hospital
City
Ljubljana
Country
Slovenia
Facility Name
Huddinge University Hospital
City
Huddinge
Country
Sweden
Facility Name
Royal Bournemouth Hospital
City
Dorset
Country
United Kingdom

12. IPD Sharing Statement

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Effectiveness Study of the Guardian RT in Type 1 Diabetics

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