Effectiveness Study of the Guardian RT in Type 1 Diabetics

NCT ID: NCT01331343

Last Updated: 2011-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Guardian RT Telemetered Glucose Monitoring System

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Diabetes

INDUSTRY

Sponsor Role lead

Responsible Party

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Medtronic Internationtal Trading Sarl

Locations

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Hospital Sud Francilien

Corbeil-Essonnes, , France

Site Status

CH Robert Debre

Paris, , France

Site Status

Klinik fur Allgemeine Charite

Berlin, , Germany

Site Status

Schneider Children Centre

Petah Tikva, , Israel

Site Status

U.O. Medicina Generale

Milan, , Italy

Site Status

University Children's Hospital

Ljubljana, , Slovenia

Site Status

Huddinge University Hospital

Huddinge, , Sweden

Site Status

Royal Bournemouth Hospital

Dorset, , United Kingdom

Site Status

Countries

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France Germany Israel Italy Slovenia Sweden United Kingdom

Other Identifiers

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EU007_022004

Identifier Type: -

Identifier Source: org_study_id

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