Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

International Navigator Hypoglycaemia Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843609
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 5, 2010
Karolinska Institutet
Schneider Children's Medical Center, Israel
Information provided by:
University Medical Centre Ljubljana

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Hypoglycemia Device: Navigator continuous glucose monitor (Freestyle Navigator®) Not Applicable

Detailed Description:


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 in the incidence or fear of hypoglycaemia through the availability of high fidelity real-time glucose data and alarms throughout the day. As well as in adults, this may be particularly important in both children and adolescents with type 1 diabetes mellitus (T1DM).

Study Overview:

This is a multicentre, prospective, randomised, controlled, intervention study, being conducted at 3 study centres; Ljubljana in Slovenia, Tel Aviv in Israel and Stockholm in Sweden.

The aim is to enroll 100 subjects (50 adult and 50 paediatric), but enrolling up to 120 eligible subjects to allow for dropouts. The subject population will be randomly assigned 50:50 to either the control group or intervention group.

Subjects will be asked to participate for 7 months, consisting of a one-month 'run-in' period on SMBG followed by a 6-month test period. Enrolment will take place within a 16-week period. A blood sample will be taken for centralized baseline measurement of HbA1c. To be included in the study a subject must have an HbA1c level at inclusion below 7.5 % All subjects will undergo a one-month run-in period. Each subject will be given a FreeStyle blood glucose meter and strips to perform self monitoring of blood glucose (SMBG) according to their standard glycaemic management regime, as advised by their health care professional (HCP).

Subjects will then be required to return to the clinic at the end of the run-in period to have another blood sample taken for centralized measurement of HbA1c and to be randomly assigned to Group 1 (intervention) or Group 2 (control) for the next 6-month test period.

Group 1 will be required to use the FreeStyle Navigator CGM to manage their glycaemic control, wearing individual sensors for a series of five day durations, for the next six months.

Group 2 will continue in the study for the next 6 months using SMBG to manage their glycaemic control with the FreeStyle meter and strips provided. Every second week the subject will wear a 'masked' FreeStyle Navigator sensor for 5 days. Subjects will be encouraged to alternate the days that they wear the FreeStyle Navigator sensors, so that data is obtained from days in both the week and weekend.

Subjects will return to the clinic at 3 months and 6 months (after entering the study test-phase) for centralized HbA1c measurement. Subjects (and parents of paediatric subjects) within the intervention group will also be asked to complete a subject satisfaction questionnaire on their experience with the device.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Continuous glucose monitoring
Continuously wearing the FreeStyle Navigator continuous glucose monitor, displaying real-time glucose values and sounding alarms
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 %
Other Name: Free Style Navigator

No Intervention: Control
Using SMBG with standard routine instructions

Primary Outcome Measures :
  1. Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia). [ Time Frame: 6 months after randomisation ]

Secondary Outcome Measures :
  1. No concomitant rise in HbA1c [ Time Frame: 6 months after randomization ]
  2. Glycaemic variability [ Time Frame: 6 months after randomization ]
  3. Frequency and area under the curve (AUC) of hypoglycaemia [ Time Frame: 6 months after randomization ]
  4. Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire); [ Time Frame: 6 months after randomization ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00843609

Layout table for location information
Schneider Children's Medical Center of Israel
Petah Tikva, Israel, 49202
UMC Ljubljana - University Children's Hospital
Ljubljana, Slovenia, 1000
Karolinska Institutet
Stockholm, Sweden
Sponsors and Collaborators
University Medical Centre Ljubljana
Karolinska Institutet
Schneider Children's Medical Center, Israel
Layout table for investigator information
Principal Investigator: Tadej Battelino, Prof. UMC Ljubljana
Layout table for additonal information
Responsible Party: Tadej Battelino, MD,PhD, Professor of pediatrics, UMC Ljubljana Identifier: NCT00843609    
Other Study ID Numbers: INHS1
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: February 5, 2010
Last Verified: June 2009
Keywords provided by University Medical Centre Ljubljana:
diabetes mellitus, type 1
continuous glucose monitoring
glycemic variability
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases