NCT00843609

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 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.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2008

Geographic Reach
3 countries

3 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

October 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

February 5, 2010

Status Verified

June 1, 2009

Enrollment Period

1.2 years

First QC Date

February 12, 2009

Last Update Submit

February 4, 2010

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Keywords

diabetes mellitus, type 1hypoglycemiacontinuous glucose monitoringHbA1cglycemic variability

Outcome Measures

Primary Outcomes (1)

  • Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia).

    6 months after randomisation

Secondary Outcomes (4)

  • No concomitant rise in HbA1c

    6 months after randomization

  • Glycaemic variability

    6 months after randomization

  • Frequency and area under the curve (AUC) of hypoglycaemia

    6 months after randomization

  • Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire);

    6 months after randomization

Study Arms (2)

Continuous glucose monitoring

EXPERIMENTAL

Continuously wearing the FreeStyle Navigator continuous glucose monitor, displaying real-time glucose values and sounding alarms

Device: Navigator continuous glucose monitor (Freestyle Navigator®)

Control

NO INTERVENTION

Using SMBG with standard routine instructions

Interventions

Navigator continuous glucose monitor (Freestyle Navigator®)DEVICE

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

Also known as: Free Style Navigator
Continuous glucose monitoring

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subject with Type 1 diabetes (\> 1year since diagnosis)
  • CSII or MDI
  • No concomitant diseases that influence metabolic control
  • No current use of CGM

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Schneider Children's Medical Center of Israel

Petah Tikva, 49202, Israel

Location

UMC Ljubljana - University Children's Hospital

Ljubljana, 1000, Slovenia

Location

Karolinska Institutet

Stockholm, Sweden

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Tadej Battelino, Prof.

    UMC Ljubljana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2009

First Posted

February 13, 2009

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

January 1, 2010

Last Updated

February 5, 2010

Record last verified: 2009-06

Locations

IL(1)SL(1)SE(1)