- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00843609
International Navigator Hypoglycaemia Study
International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Continuous glucose monitoring
Continuously wearing the FreeStyle Navigator continuous glucose monitor, displaying real-time glucose values and sounding alarms
|
Continuous use of the Free Style Navigator for monitoring of glycemia in patients with type 1 diabetes with HbA1c below 7.5 %
Other Names:
|
No Intervention: Control
Using SMBG with standard routine instructions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
6 months after randomisation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
No concomitant rise in HbA1c
Time Frame: 6 months after randomization
|
6 months after randomization
|
Glycaemic variability
Time Frame: 6 months after randomization
|
6 months after randomization
|
Frequency and area under the curve (AUC) of hypoglycaemia
Time Frame: 6 months after randomization
|
6 months after randomization
|
Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire);
Time Frame: 6 months after randomization
|
6 months after randomization
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tadej Battelino, Prof., UMC Ljubljana
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- INHS1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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