Status:
COMPLETED
International Navigator Hypoglycaemia Study
Lead Sponsor:
University Medical Centre Ljubljana
Collaborating Sponsors:
Karolinska Institutet
Schneider Children's Medical Center, Israel
Conditions:
Diabetes Mellitus, Type 1
Hypoglycemia
Eligibility:
All Genders
10-65 years
Phase:
NA
Brief 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...
Detailed Description
Background: Real-time continuous glucose monitoring is expected to allow patients to reduce glycaemic fluctuations and to improve their ability to achieve tight glycaemic control without an increase ...
Eligibility Criteria
Inclusion
- Subject with Type 1 diabetes (\> 1year since diagnosis)
- CSII or MDI
- HbA1c at inclusion \< 7.5 %
- No concomitant diseases that influence metabolic control
- No current use of CGM
Exclusion
- Subject has known allergy to medical grade adhesives
- Subject has a medical condition, which in the Investigator's opinion, may compromise patient safety
- Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management
- Subject is currently using another CGM device or has used real-time continuous glucose monitoring in the previous 4 weeks
- Subject is receiving peritoneal dialysis solutions containing icodextrin
- Female subject who is pregnant or planning to become pregnant within the planned study duration
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT00843609
Start Date
October 1 2008
End Date
January 1 2010
Last Update
February 5 2010
Active Locations (3)
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1
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
2
UMC Ljubljana - University Children's Hospital
Ljubljana, Slovenia, 1000
3
Karolinska Institutet
Stockholm, Sweden