International Navigator Hypoglycaemia Study
|ClinicalTrials.gov Identifier: NCT00843609|
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : February 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Hypoglycemia||Device: Navigator continuous glucose monitor (Freestyle Navigator®)||Not Applicable|
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).
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||122 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- No concomitant rise in HbA1c [ Time Frame: 6 months after randomization ]
- Glycaemic variability [ Time Frame: 6 months after randomization ]
- Frequency and area under the curve (AUC) of hypoglycaemia [ Time Frame: 6 months after randomization ]
- Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire); [ Time Frame: 6 months after randomization ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843609
|Schneider Children's Medical Center of Israel|
|Petah Tikva, Israel, 49202|
|UMC Ljubljana - University Children's Hospital|
|Ljubljana, Slovenia, 1000|
|Principal Investigator:||Tadej Battelino, Prof.||UMC Ljubljana|