International Navigator Hypoglycaemia Study
Condition: Diabetes Mellitus, Type 1; Hypoglycemia
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

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.
    

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 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.
    

Intervention name(s): Navigator continuous glucose monitor (Freestyle Navigator®)
Intervention type(s): Device
Intervention description(s): Continuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 %
Other intervention name(s): Free Style Navigator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes mellitus, type 1; hypoglycemia; continuous glucose monitoring; HbA1c; glycemic variability