International Navigator Hypoglycaemia Study: Evaluation of the Incidence and Duration of Hypoglycaemia Using the Freestyle Navigator® Continuous Glucose Monitoring System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 122
- Locations
- 5
- Primary Endpoint
- Reduction in time spent in hypoglycaemia, defined as continuous glucose <3.5mmol/l (63mg/dl) (with or without symptomatic hypoglycaemia).
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 65 Years (Child, Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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 Outcomes
- Quality of Life measures (Fear of Hypoglycaemia score and subject satisfaction questionnaire);(6 months after randomization)
- 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)