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International Navigator Hypoglycaemia Study

NCT00843609 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2010-02-05

No results posted yet for this study

Summary

The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitoring System in people with Type 1 diabetes mellitus at good glycemic control. The investigators hypothesize that the access to real-time continuous glucose concentration data along with alarms will enable people with type 1 diabetes at reasonable metabolic control to reduce the time spent in hypoglycaemia.

Conditions

Interventions

DEVICE

Navigator continuous glucose monitor (Freestyle Navigator®)

Continuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 %

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Schneider Children's Medical Center, Israel

    collaborator OTHER

  • University Medical Centre Ljubljana

    lead OTHER

Principal Investigators

  • Tadej Battelino, Prof. · UMC Ljubljana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2009-12-31
Completion
2010-01-31

Countries

  • Israel
  • Slovenia
  • Sweden

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843609 on ClinicalTrials.gov