NCT01331343

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_4

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 8, 2011

Completed
Last Updated

April 18, 2011

Status Verified

April 1, 2011

Enrollment Period

1 year

First QC Date

April 5, 2011

Last Update Submit

April 15, 2011

Conditions

Type 1 Diabetes Mellitus

Keywords

DiabetesGlycemic ControlContinuous Glucose Monitoring

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (2)

  • 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

Interventions

Guardian RT Telemetered Glucose Monitoring SystemDEVICE

Eligibility Criteria

Age8 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Impaired hearing or vision (must see screens and hear alarms)
  • Unable to comply with protocol
  • Chronic debilitating or psychiatric disturbances

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Hospital Sud Francilien

Corbeil-Essonnes, France

Location

CH Robert Debre

Paris, France

Location

Klinik fur Allgemeine Charite

Berlin, Germany

Location

Schneider Children Centre

Petah Tikva, Israel

Location

U.O. Medicina Generale

Milan, Italy

Location

University Children's Hospital

Ljubljana, Slovenia

Location

Huddinge University Hospital

Huddinge, Sweden

Location

Royal Bournemouth Hospital

Dorset, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 5, 2011

First Posted

April 8, 2011

Study Start

June 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 18, 2011

Record last verified: 2011-04

Locations

FR(2)SE(1)GB(1)DE(1)IT(1)SL(1)IL(1)